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Adult and Pediatric HIV/AIDS Confidential Case Reports
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Supplemental Surveillance Activity 1: HIV Incidence Surveillance Technical Guidance
1
Technical Guidance for
HIV/AIDS Surveillance
Programs
HIV Incidence Surveillance
HIV Incidence and Case Surveillance Branch
Atlanta, Georgia
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Notes
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12-2
August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Contents — HIV Incidence Surveillance
Policies and Procedures for HIV Incidence Surveillance .....................................................12-5
Background ............................................................................................................. 12-5
Introduction.......................................................................................................... 12-5
Structural Requirements.......................................................................................... 12-6
Policies and Procedures...................................................................................... 12-6
The BED Assay for STARHS .............................................................................. 12-7
Testing and ARV Use History Data ..................................................................... 12-8
Staffing Needs..................................................................................................... 12-8
Process Standards ................................................................................................ 12-10
Obtaining Testing and ARV Use History Data................................................... 12-11
Obtaining Remnant HIV-Positive Specimens for Testing Using STARHS ........ 12-12
Determining the Disposition of Specimens and Communicating with the Public
Health and CDC STARHS Laboratories ....................................................... 12-13
Entering Data into Surveillance Databases....................................................... 12-14
Creating the HIS Dataset and Transferring Data to CDC.................................. 12-15
Ensuring Security and Confidentiality................................................................ 12-16
Analyzing and Disseminating Data.................................................................... 12-16
Training Staff ..................................................................................................... 12-17
Outcome Standards .............................................................................................. 12-17
References ............................................................................................................ 12-18
Epidemiologic Flow Chart for HIV Incidence Surveillance .................................................12-19
Operational Public Health Laboratory Flow Chart for HIV Incidence Surveillance.............12-20
National Center for HIV, STD, and TB Prevention’s Non-research Determination
for HIV Incidence Surveillance ......................................................................................12-21
Standard HIV Incidence Surveillance Data Elements ........................................................12-23
Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV
Incidence Surveillance ..................................................................................................12-26
Purpose ................................................................................................................. 12-26
Introduction............................................................................................................ 12-26
Laboratory Types .................................................................................................. 12-26
Laboratory Types .............................................................................................. 12-27
Specimen Information ........................................................................................... 12-27
Type of Specimens Shipped to CDC STARHS Laboratory............................... 12-27
Specimen Volume ............................................................................................. 12-27
Sample Storage................................................................................................. 12-27
Specimen Numbering........................................................................................ 12-28
Specimen Retention .......................................................................................... 12-28
Packaging and Shipping Procedures .................................................................... 12-28
Shipping Guidance ............................................................................................ 12-28
August 2007
Contents
12-3
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Frequency of Shipments ................................................................................... 12-28
Shipping Couriers ............................................................................................. 12-28
Coordinating Shipments.................................................................................... 12-29
Additional Information for Commercial Laboratories Only ............................ 12-29
Tracking Shipments .......................................................................................... 12-29
Additional Information Related to APHL-Contracted Commercial
Laboratories Only ..................................................................................... 12-29
Sample Rejection Criteria ................................................................................. 12-30
Confidentiality and HIPAA Regulations................................................................. 12-30
Funding for Specimen Handling............................................................................ 12-30
Specimen Transport Options ................................................................................ 12-31
Option A: Specimen Originated at Private Laboratory and Is Sent Directly to the
CDC STARHS Laboratory.............................................................................12-31
Option B: Specimen Originated at or Sent Via State / Local Public Health Laboratory 12-34
Responsibilities ..................................................................................................... 12-38
Private Laboratories .......................................................................................... 12-38
Selection of a Model Type ............................................................................ 12-38
Additional Laboratory Report Information ..................................................... 12-38
Public Health Laboratories ................................................................................ 12-39
Sample Storage and Retention..................................................................... 12-39
Aliquoting and Sample Shipment.................................................................. 12-39
State/Local HIV Incidence Surveillance Coordinator ........................................ 12-39
Sample Disposition ....................................................................................... 12-39
Data Management ........................................................................................ 12-39
CDC STARHS Laboratory................................................................................. 12-39
Sample Rejection Criteria ............................................................................. 12-39
Sample Storage and Retention..................................................................... 12-39
Results Reporting ......................................................................................... 12-40
References............................................................................................................ 12-40
Guidance for Processing, Storage, and Shipping of Specimens to the CDC
STARHS Laboratory ..................................................................................................... 12-44
Purpose................................................................................................................. 12-44
Introduction ........................................................................................................... 12-44
CDC STARHS Laboratory..................................................................................... 12-44
Setting and Personnel for Specimen Processing.................................................. 12-44
Materials................................................................................................................ 12-45
Specimen Collection and Processing.................................................................... 12-45
Shipping ................................................................................................................ 12-46
Packing Procedures for Shipping to the CDC STARHS Laboratory ................. 12-46
HICSB Incidence Surveillance STARHS Specimen Submission Form ............................. 12-49
Training and Certification for Shipping Infectious Substances .......................................... 12-50
12-4
Contents
August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Technical Guidance for HIV/AIDS Surveillance Programs —
Policies and Procedures for HIV Incidence Surveillance
Background
Introduction
Although historically AIDS surveillance data have been of great value, current data do not
represent the entire population affected by the HIV epidemic. Unlike AIDS data, HIV data
provide a window into the epidemic at an earlier stage of disease, thereby allowing public
health officials to monitor the epidemic more effectively and completely, allocate
resources, and plan and implement programs, particularly prevention programs. In the
past, however, biomedical technology did not discriminate between recent and chronic
HIV infection; as a result the incidence of HIV infection in the United States could not be
measured directly. The serologic testing algorithm for recent HIV seroconversion
(STARHS)1 is performed on remnant serum specimens from confirmed HIV antibody
positive tests and consists of a series of two tests, a standard, sensitive, HIV antibody test
currently followed by a test to determine the normalized optical density (ODN) level of the
concentration of HIV-specific antibodies to total antibodies. STARHS distinguishes
between recent and long-standing HIV-1 infection on a population level and should allow
the estimation of local and national HIV incidence.
HIV incidence surveillance (HIS) is the aspect of the national HIV/AIDS surveillance
system that uses STARHS results, as well as data on the history of testing and use of
medications with antiretroviral (ARV) properties for each case reported to HIV/AIDS
surveillance programs, to generate an HIV incidence estimate. HIS will give a more
representative picture of the HIV epidemic, its trends, and its impact on the public’s
health. The Centers for Disease Control and Prevention’s (CDC’s) human subjects
protection process has determined that the implementation of HIS programs using
STARHS, like other public health surveillance activities, is not research (see National
Center for HIV, STD, and TB Prevention’s Non-research Determination
for HIV Incidence Surveillance).
The primary functions of HIS are to:
•
Incorporate STARHS into routine HIV surveillance activities by testing HIVseropositive specimens obtained from persons with a new HIV diagnosis using an
assay approved for this purpose
•
Collect HIV testing and ARV use history information for persons with newly
reported HIV infections as part of routine HIV surveillance
•
Apply a statistical model(s) to estimate HIV incidence locally and nationally using
a combination of STARHS results and information from surveillance case reports,
and testing and ARV use history information for all persons with a new diagnosis
of HIV infection
•
Use incidence data to assist with local HIV prevention program planning and
evaluation using incidence data.
August 2007
Background
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
The tasks to achieve the functions of HIS include:
•
Elicit collection and reporting of testing and ARV use history information by all
providers reporting HIV cases to the health department
•
Ensure that an aliquot of each confirmed seropositive specimen from a newly
diagnosed case is shipped to the CDC STARHS laboratory
•
Determine the disposition of remnant HIV-positive specimens and coordinate
communication between the Incidence Surveillance Coordinator (ISC) and the
public health laboratory or the CDC STARHS laboratory regarding specimens
shipped to and stored at the these laboratories
•
Enter STARHS and testing and ARV use history information into the designated
HIS database
•
Electronically transfer data to CDC
•
Ensure that HIS data handling procedures comply with all security and
confidentiality guidelines as described in Technical Guidance for HIV/AIDS
Surveillance Programs, Vol. III: Security and Confidentiality Guidelines
•
Analyze and disseminate data locally
•
Train staff in the policies and procedures of the HIV/AIDS surveillance system as
well as those of the HIS system
The prerequisites (structural requirements), best practices (process standards), and
outcome standards for HIS are described next.
Structural Requirements
All persons with a new diagnosis of HIV infection who were tested confidentially should
be reported to the HIV surveillance system in accordance with Technical Guidance for
HIV/AIDS Surveillance Programs, Vol. I: Policies and Procedures. In areas incorporating
HIS into their HIV/AIDS surveillance systems, information regarding HIV testing history
and ARV use, as well as the STARHS result of a remnant of the diagnostic HIV-positive
specimen, should be included for all cases. HIV/AIDS surveillance case report data, in
combination with these data elements, will be used to calculate population-based HIV
incidence estimates.
Policies and Procedures
HIS is a fully integrated component of HIV/AIDS surveillance; therefore, documentation
of HIS activities should be incorporated into locally tailored policies and procedures
manuals developed for HIV/AIDS surveillance (Technical Guidance for HIV/AIDS
Surveillance Programs, Vol. I: Policies and Procedures) to establish standardization,
maintain continuity of meaning, document changes over time, and develop training
programs. All manuals describing policies and procedures of the local surveillance
program should address the needs of HIV/AIDS surveillance as well as the specific
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Structural Requirements
August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
policies related to HIS. In addition to the information listed in Technical Guidance for
HIV/AIDS Surveillance Programs, Vol. I: Policies and Procedures, HIS specific policies
and procedures should include information related to
•
Training of testing providers in collection of additional data used for HIV
incidence estimation
•
Laboratory contacts
•
Determining which specimens should be tested using STARHS (and which should
be discarded)
•
Specimen aliquoting
•
Specimen shipping guidance
The BED Assay for STARHS
The assay STARHS currently uses is the BED HIV-1 Capture enzyme immunoassay
(EIA) manufactured by Calypte Biomedical Corporation. The principle of the BED HIV-1
Capture EIA is based on the observation that the ratio of HIV-specific IgG to total IgG
increases with time after HIV infection2. The BED HIV-1 Capture EIA is applied to the
diagnostic HIV-positive specimen, and the assay is sensitive to the length of time since the
infection (i.e., antibody level present). The time from when a specimen would first be
reactive on the standard EIA to the time when the serum or plasma, if tested with the BED
HIV-1 Capture EIA, reaches an optical density (OD) level predetermined to distinguish
recent from nonrecent infections is defined as the STARHS mean window period.
Although the mean STARHS window period may vary slightly by HIV subtype, the mean
window period for calculating population-based incidence estimates in the United States
is 156 days when the BED HIV-1 Capture EIA is used.
The BED HIV-1 Capture EIA for STARHS is performed only on HIV antibody positive
sera2 and is not approved as a diagnostic test. Because of the variability in antibody
development in individuals, the predictive value of an individual’s STARHS result is
low; the results are reliable only as part of the population-based HIV incidence estimate.
The Food and Drug Administration (FDA) has ruled that the BED HIV-1 Capture EIA be
labeled “For Surveillance use only. Not for diagnostic or clinical use.” Under FDA
regulations, results of STARHS performed for purposes of HIS cannot be returned to
individuals or their health care providers or used for clinical management. As with earlier
assays used for STARHS, data show that the BED HIV-1 Capture EIA can produce a
substantial number of false-positive and false-negative classifications on the individual
level3. At the population level, the number of false positives is approximately equal to the
number of false negatives thus effectively “canceling” each other out. However, the
number of misclassifications can be large, and each of the misclassified individual results
would receive an incorrect interpretation. STARHS results may also be misclassified
because of the use of ARV therapies or late stage of the disease. Evaluation of the BED
HIV-1 Capture EIA has determined that the specimens of persons with low HIV-1specific antibodies resulting from ARV therapy or disease progression (i.e., AIDS) could
lead to the incorrect conclusion that these persons were recently infected. When a person
has AIDS, this is thought to be due to a loss of immune response as immune deficiency
August 2007
Structural Requirements
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
progresses. When a person is taking ARV therapy, this result is thought to be due to
suppression of the HIV viral load, which in turn reduces antigenic stimulation and the
quantity of circulating HIV-1-specific antibodies. The effect of ARVs taken for postexposure prophylaxis or for concurrent hepatitis B infection, for example, is not known.
Theoretically, it could take longer to develop a full immune response to HIV infection.
CDC data reliably support using STARHS for estimating incidence at the population
level only.
Testing and ARV Use History Data
Information on testing behavior is needed, such as recency of testing and testing
frequency. Additionally, history of ARV use (for example, pre- or post-exposure
prophylaxis or treatment for hepatitis) and immunological status (CD4 cell counts and
viral loads) must be included for all cases reported to the surveillance system.
Information needed for HIV incidence estimation is available as part of a standard case
report, and nearly all testing and ARV use history information is gathered as part of a
comprehensive HIV counseling session. However, not all of the required HIS data
elements have been collected uniformly, and many have not previously been recorded.
Therefore, a standard set of HIV testing and ARV use history data elements needed for the
HIV incidence estimate has been developed (see Standard HIV Incidence Surveillance
Data Elements), and providers of HIV testing should be trained in the appropriate
reporting of those data.
Staffing Needs
Implementation of the HIS system requires personnel with specific skills and dedicated
time to integrate HIS into the existing core HIV/AIDS surveillance system effectively.
Generally, HIS staff should have
•
An understanding of HIS and the characteristics of the HIV/AIDS surveillance in
their area
•
Good communication skills
•
Strong leadership skills
•
Enthusiasm about disease reporting for public health purposes
•
Dedication to the successful implementation of HIS
•
Ability to work closely with CDC, other states, local sites, private providers, and
laboratories
The recommended staffing plan including roles and responsibilities follows. In terms of
personnel time, CDC recommends that one full-time equivalent (FTE) be dedicated to the
ISC position. Successful implementation and integration of HIS requires a full-time ISC
dedicated to implementing and maintaining the system. Other personnel assigned to HIS
may vary depending on the implementation phase, prevalence of HIV/AIDS, and
available resources.
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Structural Requirements
August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
ISC
•
Provide overall management of the HIS system
Serve as lead on the area specific implementation of the HIS guidance
•
Oversee data collection processes
Determine the disposition of HIV-positive specimens reported to the
surveillance system
Receive STARHS results
Oversee collection of HIV testing and treatment history information from
public HIV testing sites and private providers
•
Collaborate with other HIS staff
HIV incidence epidemiologist
Development of training materials and courses
Data collection procedures
HIV incidence data manager
Data collection methods
Data entry and quality assessment
Data editing and file correction
Data transport procedures
Preparation of monthly reports
Security and confidentiality procedures
HIV incidence laboratory liaison
Specimen transfer
Specimen tracking
•
Manage any employee or other service contracts related to HIS
•
Serve as the primary point of contact for CDC on HIS
•
Participate in CDC site visits, trainings, and workshops
Epidemiologist/Trainer
• Serve as lead on training HIV testing providers and laboratories on HIS, including
development/modification of surveillance area-specific training materials
•
Coordinate HIS and epidemiology activities with the ISC
•
Participate in the development or modification of testing and ARV use history data
elements
•
Participate in data dissemination activities
Collaborate with stakeholders to determine data needs and frequency of
reporting
Identify results and surveillance issues for review and dissemination
Develop a data dissemination plan in collaboration with the ISC and CDC
•
Participate in CDC site visits, trainings, and workshops as appropriate
August 2007
Structural Requirements
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Laboratory Liaison
•
Act as the liaison between the public health, private, and community laboratories
and the ISC
•
Oversee preparation and shipping of public health laboratory specimens to the
CDC STARHS laboratory
•
Monitor quality control procedures outlined for preparing specimens for testing
using STARHS
•
Monitor security and confidentiality of specimens and STARHS results
•
Track specimens identified for testing using STARHS (all laboratories)
•
Participate in CDC site visits, trainings, and workshops as appropriate
Data Manager
•
Assist ISC with daily management of HIS data
•
Conduct data collection from surveillance sites
Serve as subject matter expert on HIV incidence data elements and data
management programs
Receive data transfer from other health department entities and the CDC
STARHS lab, and incorporate those data into the HIS database and datasets for
transfer to CDC
Conduct data quality assessments
•
Conduct data management
Modify CDC’s generic data management programs for use at the area level
Develop and implement edit checks and conduct data cleaning
Collaborate with the ISC, epidemiologist, and other area surveillance and
prevention staff, as needed, on data cleaning, data entry, and data set
preparation
Prepare datasets for local analysis
Collaborate with CDC on dataset preparation for national incidence estimates
Prepare HIV incidence data reports for local use in collaboration with the ISC,
epidemiologist, and CDC
•
Maintain security and confidentiality of HIV incidence data
•
Participate in CDC site visits, trainings, and workshops as appropriate
Process Standards
HIS involves the following processes:
12-10
•
Obtaining testing and ARV use history data from providers
•
Identifying laboratories that perform HIV-related tests and obtaining remnant
specimens for testing using STARHS
Process Standards
August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
•
Determining specimen disposition as it relates to testing using STARHS
•
Establishing a schedule for contact between the ISC and the public health
laboratory and the CDC STARHS laboratory to communicate regarding shipping,
testing, and discarding remnant specimens that are housed at the laboratory
•
Entering data into the HIS database
•
Electronically transferring data to CDC
•
Ensuring that data handling procedures comply with Security and Confidentiality
Guidelines (see Technical Guidance for HIV/AIDS Surveillance Programs, Vol.
III: Security and Confidentiality Guidelines and Model State Public Health
Privacy Act)
•
Analyzing and disseminating data locally
•
Training staff in HIV/AIDS surveillance and HIS methods
Obtaining Testing and ARV Use History Data
The primary purpose of gathering HIV testing and ARV use history is to calculate a
statistical weight (see Statistical Method for Generating Population-Based HIV Incidence
Estimates) that will allow inference to the general population. The weight reflects the
probability that an individual will be tested during the STARHS window period and is
related to the data elements listed in Standard HIV Incidence Surveillance Data Elements.
Testing and ARV use history data are reported by providers and surveillance staff using
the area standard reporting procedures or other procedures meeting the routine security
and confidentiality guidelines for HIV/AIDS surveillance. These data
•
Should be included for all adult/adolescent (> 13 years at diagnosis) HIV/AIDS
cases newly reported to the HIV/AIDS surveillance system by all providers of HIV
testing
•
May be collected through client/patient interview and/or chart abstraction
•
If based on patient self-report, should be collected when an individual presents for
an HIV test or returns for the results
Takes advantage of the individual’s ability to recall information that is more
proximal to the event
Should be recorded and reported to the surveillance system on the basis of the
patient’s self-report within 3 months of the HIV diagnosis
Longer intervals may increase the risk of recall bias, yet this consideration
should not prevent efforts to obtain the information even after 3 months if
necessary
CDC has assisted in developing materials for use in training providers to collect HIV
testing and ARV use history data. These materials are available at all sites, or upon request
from CDC.
August 2007
Process Standards
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Obtaining Remnant HIV-Positive Specimens for Testing Using STARHS
To be most useful, testing using STARHS should be performed on the HIV-positive
diagnostic serum or plasma specimen. For the purposes of this guidance, the HIV-positive
diagnostic specimen is the HIV-positive specimen from the diagnostic test that resulted or
should have resulted in the case being reported to the HIV/AIDS surveillance system.
Remnant specimens for all confirmed HIV-positive diagnostic specimens should be tested
using STARHS.
•
Laboratories performing routine diagnostic confirmatory HIV testing by Western
blot, indirect fluorescent antibody (IFA) tests, immunological status tests such as
CD4, or viral load counts should report to the state/local health department
surveillance program per existing requirements.
•
In each surveillance area, all laboratories should be identified from a review of
local HIV surveillance data and laboratory licensing records and must be
approached to request that remnants of all diagnostic specimens be made available
for testing using STARHS
Surveillance areas should maintain a directory of laboratory contacts at all
reporting laboratories to facilitate communication in the event that reporting or
shipping of specimens is disrupted or that changes in policy or procedures need
to be communicated
Originating laboratories are those to which a specimen is first sent for testing
Reference laboratories are those to which a specimen is sent for confirmatory
testing when the originating laboratory does not do confirmatory testing
•
All remnant specimens from HIV-diagnostic Western blot or IFA tests must be
shipped to the CDC STARHS laboratory in New York for testing using STARHS.
A minimum of 0.5 mL HIV-positive serum or plasma specimen is necessary
for testing using STARHS
Private or community laboratories performing HIV diagnostic testing should
choose one of two options for shipping the remnant HIV-positive serum or
plasma specimen to the CDC STARHS laboratory (see Guidance for the
Remnant HIV-Positive Specimen Transportation Activities for HIV
Incidence Surveillance)
Ship the specimen directly to the CDC STARHS laboratory
Ship the specimen to the state public health laboratory affiliated with the
health department that receives the new HIV case report for processing
State public health laboratories can then batch and ship all specimens
identified for testing using STARHS to the CDC STARHS laboratory
State public health laboratories conducting HIV diagnostic testing should ship
their own HIV-positive specimens identified for testing using STARHS
directly to the CDC STARHS laboratory
Specimen availability for testing using STARHS depends on the testing needs for the
specimen. Uses of the remnant of specimens should follow the CDC HIS recommended
hierarchy (described below) for specimen aliquoting to ensure adequate specimen volume
12-12
Process Standards
August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
for multiple diagnostic tests. When multiple tests must be performed on a collected serum
or plasma specimen, the aliquots must be made available with the following hierarchy in
mind:
1.
HIV diagnostic testing
2.
Testing with STARHS
3.
HIV drug resistance genotyping (known as Variant, Atypical, and Resistant HIV
Surveillance [VARHS])
Aliquots made following this hierarchy will ensure that adequate specimen volume is
available according to the priority for data determined by CDC.
Determining the Disposition of Specimens and Communicating with the
Public Health and CDC STARHS Laboratories
A specimen should be held at the state public health laboratory or the CDC STARHS
laboratory (i.e., specimens shipped directly from private or commercial laboratories) until
the area ISC, using routine HIV/AIDS surveillance reporting procedures (i.e., HIV/AIDS
Reporting System [HARS/eHARS]), determines whether the specimen represents the
person’s first reported positive HIV test result in the HIS area. A specimen should be
tested using STARHS if
1.
the specimen represents the diagnostic specimen (the HIV-positive specimen that
led, or should have led, a case to be reported to HARS/eHARS) or
2.
the diagnostic specimen is unavailable and the specimen was drawn within 3
months of the diagnostic specimen and
3.
the specimen was drawn for an HIV-related test (viral load, polymerase chain
reaction [PCR] test, CD4 level).
A specimen should not be tested using STARHS if
1.
the specimen is not the diagnostic specimen that led, or should have led, the
individual to be reported to HARS/eHARS and
2.
the individual had a previous specimen that was tested using STARHS or
3.
the individual did not have a previous specimen tested using STARHS but the
specimen was drawn more than 3 months after the diagnostic specimen.
Because a remnant sample of every Western blot positive blood specimen will be shipped
by originating or reference laboratories to either the state or local public health laboratory
or to the CDC STARHS laboratory, the HIS program must inform the appropriate
laboratory of the disposition of the specimen.
•
Specimens for cases not previously reported to HARS/eHARS (or those drawn
within 3 months of a diagnostic specimen that is unavailable) will constitute the
test list. A test list should
Be compiled for the state or local public health laboratory and for the CDC
STARHS laboratory
August 2007
Process Standards
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
•
Include those specimens located at the individual laboratory that should be
tested using STARHS
Be cumulative
Specimens that are neither diagnostic specimens nor drawn within 3 months of a
diagnostic specimen that is unavailable will constitute the toss list. A toss list
should
Be compiled for the state or local public health laboratory and for the CDC
STARHS laboratory
Include those specimens held at the laboratory that should not be tested using
STARHS
Be cumulative
Specimens should be handled, packaged, and shipped according to the CDC STARHS
laboratory shipping protocol (see Guidance for the Remnant HIV-Positive Specimen
Transportation Activities for HIV Incidence Surveillance). Specimens shipped as
diagnostic specimens and packed in dry ice must be handled according to the procedures
for packing and shipping specimens with dry ice (see Guidance for Processing, Storage,
and Shipping of Specimens to the CDC STARHS Laboratory).
The ISC should regularly, at an interval to be determined locally (e.g., monthly), inform
area laboratory designees (e.g., at the public health laboratory) and the CDC STARHS
laboratory of all stored specimens, or remnant specimens, with a positive HIV diagnostic
test to be tested using STARHS (the test list) and those to be discarded (the toss list).
•
For those specimens on the test list
An aliquot of blood to be used for STARHS is drawn from the specimen
At the local public health laboratory before shipping
At the CDC STARHS laboratory if the specimen was shipped directly to
the CDC STARHS laboratory
The aliquot is relabeled with a unique STARHS identification number (SID)
The SID is paired with the corresponding specimen number and is sent to the
ISC with no other identifying data
After STARHS, the results are returned to the ISC with results identified by
SID only
•
Specimens on the toss list should be discarded according to routine laboratory
protocols for HIV-positive serum or plasma specimens.
•
The ISC should inform the CDC STARHS lab to discard all specimens that have
been tested with STARHS. If the ISC would like to have these specimens returned
at the surveillance area’s expense, he/she should make arrangements with the CDC
STARHS lab.
Entering Data into Surveillance Databases
Data elements needed for the calculation of statistical weights used to make populationbased HIV incidence estimates fall into one of four categories.
12-14
Process Standards
August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
•
Demographic data
Age
Sex
Race/ethnicity
HIV risk factors
•
HIV testing and ARV use history data
•
Clinical data
CD4 count
Viral load
•
Laboratory data
Specimen collection date
SID
STARHS results
All data elements needed for HIS are included in eHARS, but could not be added to
HARS. Only demographic data and clinical data are included in the HARS database. As a
result, an HIS Access database was developed to store the additional data related to HIS.
Until a surveillance area begins using eHARS and eHARS accommodates this
information, the jurisdiction should enter data into both HARS/eHARS and the HIS
Access database as appropriate. Testing and ARV use history information and laboratory
data related to the diagnostic HIV test (including specimen collection date and SID) are
variables that should be entered into the separate HIS Access database along with the
unique state number (HARS/eHARS “stateno”) assigned to each case. A list of data
elements necessary for HIS, but not included in HARS can be found in Standard HIV
Incidence Surveillance Data Elements.
Creating the HIS Dataset and Transferring Data to CDC
HIS data entry and management take place at state or local health departments by using
one of three data management systems:
•
HIS Access database (until conversion to eHARS)
•
eHARS
•
Software that is compatible with CDC software
Information is merged into the data management systems from other sources:
•
Excel spreadsheet containing STARHS results identified by SID only from the
CDC STARHS laboratory
•
Program Evaluation Monitoring System (PEMS)
•
Other databases
For states that have not transitioned to eHARS, data are merged by using unique
identifiers reported with each case for data transfer to CDC:
August 2007
Process Standards
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
•
the HARS/eHARS stateno links HARS/eHARS records to corresponding HIS
Access database records
When eHARS has the ability to import HIS data, merging datasets before transferring data
to CDC will no longer be necessary.
Before the 15th of each month, the complete dataset from the preceding month (see Access
Database 3.1a Users Manual and Access Database Version 3.1 Data Dictionary) should
be transmitted to CDC over the Secure Data Network (SDN). Data transmitted to CDC
must include no personal identifiers and must be encrypted and password protected
according to Technical Guidance for HIV/AIDS Surveillance Programs, Vol. III: Security
and Confidentiality Guidelines.
Ensuring Security and Confidentiality
HIV testing is a medical procedure. Therefore, policies and procedures are in place to
protect the confidentiality of tested persons and their medical records. STARHS should be
performed only on specimens that have tested positive for HIV. HIS data are considered
part of routine HIV surveillance data and should be held to the standards of security and
confidentiality for HIV/AIDS surveillance outlined in Technical Guidance for HIV/AIDS
Surveillance Programs, Vol. III: Security and Confidentiality Guidelines. Policies and
procedures, based on these guidelines and local laws, are already in place at state and local
health departments and are used to secure hard copy and electronic information to protect
the confidentiality of persons reported as having HIV infection. These measures must be
extended to protect the STARHS information held locally. Access by HIS staff to
information in HARS, HIV testing and ARV use history, and STARHS data is governed
by the same security and confidentiality requirements.
Analyzing and Disseminating Data
Data from persons who choose to have a confidential HIV test and who test positive will
be used to estimate the incidence of HIV nationally and in participating areas, including
the incidence of undiagnosed HIV infection. HIV incidence estimates can be used to
assess current HIV prevention programs locally, regionally, and nationally. HIS data will
be stratified by selected factors such as demographic or behavioral factors, thus creating
subpopulation data at the national and local levels. If the sampling procedure has
sufficient statistical power, this stratification will allow comparisons between areas and
among groups with different risk factors. The methods used to generate the populationbased incidence estimate are described in Statistical Method for Generating PopulationBased HIV Incidence Estimates, which introduces the methods, statistical formulas, and
different groups for which incidence estimates will be made.
CDC will have the primary responsibility for analyzing interpreting, and disseminating
these data; surveillance areas will contribute as appropriate. Results from the aggregate
CDC database will be analyzed regularly and feedback will be provided to participating
areas. Aggregate results will also be published in CDC’s HIV/AIDS Surveillance Reports.
Area-specific analyses should be conducted at the discretion of participating areas. As
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Process Standards
August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
appropriate, results will be presented at conferences and published in peer-reviewed
journals. The number of representative authors from participating areas and CDC will be
determined for each presentation or paper.
In addition to the variables needed to estimate HIV incidence, the following data elements
will be used to evaluate the performance of the BED HIV-1 Capture EIA for determining
of estimates of HIV incidence:
•
Whether AIDS has been diagnosed and if so, the date of diagnosis
•
At the time of HIV diagnosis,
whether HIV ARV agents have been used for post-exposure prophylaxis or for
any other medical condition (e.g., lamivudine for treatment of hepatitis B), and
if so, the name(s) of the agent, and dates and duration of use
where available, CD4 count, viral load, and HIV-1 subtype along with the type
of test used to determine the subtype
As a result, all HIV-positive diagnostic specimens should be tested using STARHS
irrespective of the time to AIDS diagnosis for an individual, or evidence of previous ARV
use.
Training Staff
Because HIS is a fully integrated component within the HIV/AIDS surveillance system,
all HIS staff should receive training in the local policies and procedures for core
surveillance including
•
active and passive surveillance methods
•
laboratory reporting mechanisms
•
data management processes
In accordance with Technical Guidance for HIV/AIDS Surveillance Programs, Vol. III:
Security and Confidentiality Guidelines, HIS staff must also receive training in security
and confidentiality procedures, and should sign a confidentiality statement upon being
hired and annually thereafter.
Outcome Standards
Outcome standards described in the “Introduction to Policies and Procedures” and “Data
Quality” sections of Technical Guidance for HIV/AIDS Surveillance Programs, Vol. I:
Policies and Procedures can be applied to HIS. These sections address issues of
completeness of case ascertainment, timeliness of reporting, evaluation of standard data
edits, and missing/unknown information. Meeting core surveillance standards for case
ascertainment and timeliness is essential for HIS to be successful given the time-sensitive
nature of HIS data elements, including testing and ARV use history data and STARHS.
The quality of the HIV incidence estimate depends on the quality of data included in the
HIS system. All outcome standards for HIS relate only to cases that reside within the
surveillance area at the time of diagnosis.
August 2007
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
•
The minimum standard for passing standard data edits related to HIS data is 97%
with a target of 100%
•
At least 85% of newly reported HIV/AIDS cases for a diagnosis year should have
testing history and ARV use data within 12 months of the date of the initial
HIV/AIDS case report, measured at 12 months after the close of the diagnosis year
•
At least 85% of cases newly reported to the surveillance system and diagnosed
using a serum/plasma specimen or having a follow-up HIV-related test conducted
on a serum/plasma specimen within 3 months of the diagnosis should have a
specimen transported to the CDC STARHS laboratory within 12 months of
diagnosis assessed for the most recent diagnosis year at 12 months after that
diagnosis year
References
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1.
Janssen RS, Satten GA, Stramer SL, et al. New testing strategy to detect early
HIV-1 infection for use in incidence estimates and for clinical and prevention
purposes. JAMA 1998; 280:42–48.
2.
Parekh B, Kennedy MS, Dobbs T, et al. Quantitative detection of increasing HIV
type 1 antibodies after seroconversion: a simple assay for detecting recent HIV
infection and estimating incidence. AIDS Research & Human Retroviruses
2002;18(4):295–307.
3.
Linley L, Reed C. Applicability of Population-Based STARHS HIV Incidence
Measure in Determining Recency of Individual Infection among Patients
Attending STD Clinics. In Program and abstract of the 11th Annual Conference
on Retroviruses and Opportunistic Infections; February 2004; San Francisco.
Abstract 854.
August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Epidemiologic Flow Chart for HIV Incidence Surveillance
August 2007
Epidemiologic Flow Chart for HIV Incidence Surveillance
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Operational Public Health Laboratory Flow Chart
for HIV Incidence Surveillance
* Applies only to laboratories participating in Variant, Atypical, and Resistant HIV Surveillance (VARHS)
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Operational Public Health Laboratory Flow Chart for HIV Incidence Surveillance
August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
National Center for HIV, STD, and TB Prevention’s
Non-research Determination for HIV Incidence Surveillance
NCHSTP Research/Non-research Determination
(Request to Classify Project as Not Involving Human Subjects or Research)
August 2007National Center for HIV, STD, and TB Prevention’s Non-research Determination for HIV Incidence Surveillance
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
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National Center for HIV, STD, and TB Prevention’s Non-research Determination for HIV Incidence SurveillanceAugust 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Standard HIV Incidence Surveillance Data Elements
Required Surveillance Data Elements
Required Laboratory/Specimen Related Variables
Variable Description
Valid Value
Antiretroviral use
0 = no
1 = yes
7 = refused
9 = don’t know
Antiretroviral (ARV) medications taken
22 = Agenerase (amprenavir)
30 = Aptivus (tipranavir, TPV)
32 = Atripla (efavirenz/emtricitabine/tenofovir DF)
24 = Combivir (lamivudine/ zidovudine)
06 = Crixivan (indinavir, IDV)
11 = Emtriva (emtricitabine, FTC)
03 = Epivir (lamivudine, 3TC)
28 = Epzicom (abacavir/lamivudine)
25 = Fortovase (saquinavir, SQV)
10 = Fuzeon (enfuvirtide, T20)
19 = Hepsera (adefovir)
02 = Hivid (zalcitabine, ddC)
23 = Hydroxyurea
18 = Invirase (saquinavir, SQV)
16 = Kaletra (lopinavir/ ritonavir)
31 = Lexiva (fosamprenavir, 908)
07 = Norvir (ritonavir, RTV)
88 = Other
33 = Prezista (darunavir, DRV)
09 = Rescriptor (delavirdine, DLV)
26 = Retrovir (zidovudine, ZDV, AZT)
15 = Reyataz (atazanavir, ATV)
08 = Saquinavir (Fortavase, Invirase)
21 = Sustiva (efavirenz, EFV)
13 = Trizivir (abacavir/lamivudine/zidovudine)
27 = Truvada (tenofovir DF/emtricitabine)
99 = Unspecified
01 = Videx (didanosine, ddl)
14 = Videx EC (didanosine, ddl)
17 = Viracept (nelfinavir, NFV)
05 = Viramune (nevirapine, NVP)
12 = Viread (tenofovir DF, TDF)
04 = Zerit (stavudine, d4T)
20 = Ziagen (abacavir, ABC)
August 2007
Standard HIV Incidence Surveillance Data Elements
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Variable Description
Valid Value
Date Highly Active Antiretroviral Treatment yyyymmdd
(HAART) use began
Date HAART use ended
yyyymmdd
Date information is extracted either from the yyyymmdd
client by interview or the medical chart by
abstraction
Date of first positive HIV test
yyyymmdd
Date of last negative HIV test
yyyymmdd
Ever tested negative
0 = no
1 = yes
7 = refused
9 = don’t know
Number of HIV tests in the 2 years before
first positive test
1–99
R = refused
D = don’t know
Clinical Laboratory Improvement
Amendments (CLIA) code for source lab
where specimen originated
text
Date of STARHS test
yyyymmdd
Date specimen was obtained
yyyymmdd
Specimen approved for STARHS
0 = no
1 = yes
2 = pending
Laboratory ID
33D0654341 = NYST
33D0654341 = CDCSTARHS
33D0654341 = NY
33D0654341 = CDCSTAR
21D0649758 = MARY01
50D0661430 = WASH
Optical density
text
Reason STARHS not performed
1 = quantity not sufficient (QNS)
2 = specimen never received at public lab
3 = broken in transit
4 = other
Results received
0 = no
1 = yes
Specimen identification number from source text
lab
STARHS identification number (SID)
text
STARHS regional laboratory specimen
identification number (same as STARHS
laboratory imported variable SPECIMEN
ID)
text
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Standard HIV Incidence Surveillance Data Elements
August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Variable Description
Valid Value
STARHS test result
01 = long term
02 = recent
91 = QNS
92 = not received by STARHS lab
93 = broken
94 = other
State laboratory CLIA code
text
State laboratory specimen ID number
text
Test assay
BED = BED
BVLS = BVLS (Vironostika LS)
OTLS = OTLS (Vironostika LS)
OTV = OTV (Vironostika LS)
AVID = AVID
Type of test performed on specimen (Logical 5220-9 = EIA/ELISA
Observation Identifiers Names and Codes 21009-6 = Western blot
[LOINC])
5472-6 = CD4
25835-0 = Viral Load (NASBA)
5017-9 = Viral Load (bDAN)
25836-8 = Viral Load (RT-PCR)
Type of specimen obtained
August 2007
1 = blood finger stick
2 = blood venipuncture
3 = blood spot
4 = oral mucosal transudate
5 = urine
8 = other
9 = unknown
Standard HIV Incidence Surveillance Data Elements
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Guidance for the Remnant HIV-Positive Specimen
Transportation Activities for HIV Incidence Surveillance
Purpose
This guidance provides an overview of the incidence surveillance specimen transport
activities and describes two possible specimen transport models that originating
laboratories may use to ship remnant diagnostic serum specimens to the CDC STARHS
laboratory for testing for recent HIV-1 infection using the serologic testing algorithm for
recent HIV seroconversion (STARHS). Originating laboratories may choose to select
either model but must clearly communicate their choice to and coordinate with the
state/local HIV Incidence Surveillance Coordinator (ISC), who will be responsible for
managing the results.
Introduction
In December 2004, an expert consultation was convened by the Centers for Disease
Control and Prevention (CDC) and the Association of Public Health Laboratories
(APHL). The purpose of the 5th HIV Incidence Consultation on Laboratory and Specimen
Transport was to discuss the best approaches for transporting remnant HIV-positive sera
from private and public laboratories to the CDC STARHS laboratory for testing using
STARHS. The consultation participants included HIV incidence surveillance staff from
CDC and state/local areas, and personnel from commercial, private, university, and public
health laboratories, APHL, and the American Clinical Laboratory Association. The goal
for the meeting was to gather input from stakeholders for developing an infrastructure for
shipping specimens from private (including university and/or medical center),
commercial, and public health laboratories to the CDC STARHS laboratory.
Participants concluded that two models were acceptable for shipping specimens from
testing laboratories to the CDC STARHS laboratory. This guidance describes both
specimen transportation models. The models differ in 1) the extent of the testing
laboratories’ involvement in aliquoting/labeling samples for STARHS; 2) the physical
storage location of the samples until the ISC determines specimen disposition (i.e.,
whether to be tested using STARHS or to be discarded); and 3) the frequency of
shipments to the CDC STARHS laboratory.
Each testing laboratory may choose either model, but this choice should be clearly
communicated to the ISC.
Laboratory Types
For the purposes of this guidance, there are three laboratory types. Although each testing
laboratory may independently decide which specimen transport model will work best for
that facility, CDC has provided suggestions based on the type of laboratory and that
facility’s relationship with the state/local public health laboratory.
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Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV Incidence Surveillance August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Laboratory Types
1.
Private Laboratories:
a.
Larger commercial laboratories that process samples from many states
and/or jurisdictions (examples in this category are Quest Diagnostics Inc,
Laboratory Corporation of America [LabCorp], ARUP Laboratories,
Specialty Laboratories, and Mayo Clinic)
b. Smaller private/university/hospital or medical center laboratories that
provide service primarily at the state or local level, but may also process
samples for more than one state and/or jurisdiction
2.
Public health laboratories (PHLs)
Specimen Information
Type of Specimens Shipped to CDC STARHS Laboratory
HIV-positive serum from diagnostic samples confirmed by Western blot (WB) or
immunofluorescence assay (IFA) will ultimately be shipped to the CDC STARHS
laboratory, depending on the specimen transport model chosen by the originating
laboratory. Detailed information about which samples will be shipped is included in the
model descriptions of this guidance (see Specimen Transport Options).
Specimen Volume
The optimal quantity of serum required for STARHS testing is 0.5mL per aliquot.
However, if less than 0.5mL of the remnant sample is available for testing using
STARHS, the sample should still be sent to the CDC STARHS laboratory. The CDC
STARHS laboratory is the only laboratory that should determine whether a sample is
rejected because of insufficient quantity.
Sample Storage
Short-term (less than 1 week) storage of samples in the refrigerator (temperatures ranging
from 2° to 8°C) is acceptable, but for long-term storage (more than 1 week), samples must
be frozen at -20°C or colder. This includes any period that the samples are kept at the
originating/testing laboratory or the “pass-through” public health laboratory before
shipment to the CDC STARHS laboratory or the interim period while STARHS
disposition is being determined. Effort should be made to avoid repeated freezing and
thawing of samples, as this may give erroneous results.
•
If not already in practice, a daily temperature log should be kept to ensure the
freezer is operating properly
•
The freezer should be housed in a location with proper ventilation to avoid
overheating and freezer failure
•
The freezer should contain adequate space to store specimens
August 2007 Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV Incidence Surveillance
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Specimen Numbering
The specimen number on the samples shipped to the CDC STARHS laboratory will either
be the original laboratory-assigned specimen accession number or the STARHS
identification number, depending on the transport model selected by the originating
laboratory. Detailed information about specimen numbering is included in the model
descriptions of this guidance (see Specimen Transport Options).
Specimen Retention
The ISC must coordinate with the laboratory storing HIV-positive remnant sera (the CDC
STARHS laboratory and/or their state/local PHL) to identify samples that should be tested
using STARHS. However, not all stored samples will be tested using STARHS, and those
that will not be tested will have to be identified for disposal. The ISC should regularly
notify the storage laboratory about which samples should be tested using STARHS and
which should be disposed of by submitting a list of laboratory-assigned specimen
accession numbers with “test” or “toss” for each specimen according to the decision
reached. The state/local ISC and the storing laboratory should communicate regularly
(every 1–3 months) to discuss any specimens for which no disposition has been
communicated to determine whether the sample can be disposed of or whether further
investigation is needed. Samples should not be destroyed or disposed of until the
disposition is definitively determined.
Packaging and Shipping Procedures
Shipping Guidance
Shipping procedures are described in detail in Guidance for Processing, Storage, and
Shipping of Specimens to the CDC STARHS Laboratory. Specimens may be shipped
from originating laboratories to the state PHL as a pass-through facility or to the CDC
STARHS laboratory as diagnostic specimens. However, because of the requirement for
dry ice, all laboratories shipping HIV-positive samples must be certified to ship dangerous
goods.
Frequency of Shipments
The frequency of specimen shipments to the CDC STARHS laboratory or the passthrough facility should be on a regular schedule, every 1–3 months, and will be
determined by the shipping laboratory, considering factors such as specimen retention
policies and freezer/storage space, and in consultation with the ISC and the receiving
laboratory.
Shipping Couriers
Specimens must be shipped on dry ice by same-day or overnight delivery service to ensure
that specimens do not thaw in transit. The shipping laboratory may decide which courier
service to use for specimen transport.
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Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV Incidence Surveillance August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Shipments from private laboratories to the PHL may be shipped by Federal Express (or a
similar commercial courier) or an established local courier service. Funding permitting,
program areas may elect to set up a billing account with Federal Express (or a similar
commercial courier) to pay for shipping costs incurred by the private laboratory to either
the state/local PHL or the CDC STARHS laboratory (see Funding for Specimen
Handling).
Coordinating Shipments
For larger private laboratories that process samples from multiple states and jurisdictions,
program areas should collaborate to coordinate specimen shipment mechanisms. A
summary of the participating commercial laboratories, primary laboratory contact,
primary ISC contact, and shipping arrangements, is available on the HIV Incidence and
Case Surveillance Branch (HICSB) password accessible website at:
https://team.cdc.gov/team/cdc/dispatch.cgi/hicsb_Incidence/folderFrame/100027/0/def/61fd
Additional Information for Commercial Laboratories Only
APHL set up a Federal Express billing account for the large commercial laboratories
participating through an APHL contract (ARUP Laboratories, LabCorps, and Mayo
Clinic) to defer costs of shipping samples to the CDC STARHS laboratory. The APHL
Federal Express billing account is available through the end of 2007 only for those
commercial laboratories under contract to APHL.
Tracking Shipments
The shipping laboratory should notify the receiving laboratory (state PHL or CDC
STARHS laboratory) by fax or email when specimens are shipped, including the name of
the courier and the tracking number of the shipment. The receiving laboratory will be
responsible for tracking the shipments and will notify the originating laboratory if the
specimens are not received.
Note: Private laboratories shipping specimens for multiple jurisdictions should provide
shipment tracking information to the designated primary ISC responsible for
shipping oversight, following procedures established by agreement between the
laboratories and participating agencies.
Additional Information Related to APHL-Contracted Commercial
Laboratories Only
As part of the contract between APHL and its participating commercial laboratories,
APHL will track shipments from these commercial laboratories to the CDC STARHS
laboratory. The contracted commercial laboratories must provide APHL with a list of
sample numbers sent to the CDC STARHS laboratory. The CDC STARHS laboratory
must notify APHL of any shipments sent from an APHL-contracted laboratory that are
received by the CDC STARHS laboratory. This notification is needed for billing
purposes at APHL.
August 2007 Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV Incidence Surveillance
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Sample Rejection Criteria
Sample rejection due to thawing, breakage, insufficient quantity, or lost-in-transit status
will be determined and recorded by the CDC STARHS laboratory. The CDC STARHS
laboratory will include sample rejection information with the STARHS results report that
is transmitted to the ISC.
Confidentiality and HIPAA Regulations
STARHS must ensure that confidentiality is protected and maintained to meet standards
for HIV surveillance. The Privacy Rule of the Health Insurance Portability and
Accountability Act (HIPAA) regulations permit protected health information to be shared
for the purposes of public health surveillance activities1. This protection allows the
originating laboratories to send specimens labeled with their laboratory-assigned
accession number to either the state PHL or the CDC STARHS laboratory, where samples
to be tested using STARHS will be reassigned a unique STARHS identification number
before testing. This process will minimize relabeling errors and simplify the shipment
procedures for private laboratories. However, the state/local public health department
must have the laboratory accession number to link the test result to the patient information
in the surveillance record. Therefore, the laboratory accession number must be included
on the HIV laboratory report sent to the state/local public health department by the
originating laboratory.
Funding for Specimen Handling
As a rule, surveillance is not a remunerated activity. However, through a Cooperative
Agreement with APHL (# U60/CCU303019-17), funds were made available to provide a
predetermined fee to offset personnel, administrative, and handling costs incurred by
participating high-volume, multijurisdictional commercial laboratories (ARUP
Laboratories, Mayo Clinic, and LabCorps) for an initial start-up period. The APHL
Cooperative Agreement was effective through June 2006 for covering specimen handling
fees for these participating laboratories, and was extended through the end of 2007 to
cover only shipping expenses for these laboratories. Reimbursement for these laboratories
beyond the initial start-up period and for all other private laboratories is not covered by the
APHL Cooperative Agreement; funding for specimen handling costs may be made
available through the state’s Cooperative Agreement with CDC for HIV/AIDS Incidence
Surveillance (Program Announcement 04017), but handling fee reimbursement is not
recommended.
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Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV Incidence Surveillance August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Specimen Transport Options
Option A: Specimen Originated at Private Laboratory and Is Sent Directly
to the CDC STARHS Laboratory
Transportation Overview
In this transportation model, the originating private laboratory performing the
confirmatory testing will send all confirmed HIV-positive diagnostic specimens
directly to the CDC STARHS laboratory (bypassing the state/local PHL) by overnight
shipping in accordance with the procedures described in Guidance for Processing,
Storage, and Shipping of Specimens to the CDC STARHS Laboratory. The CDC
STARHS laboratory will store specimens until specimen disposition is determined by
the state/local ISC, at which point, the CDC STARHS laboratory will pull samples to
be tested using STARHS, aliquot, relabel them with a STARHS identification number,
and perform STARHS. All samples that should not be tested using STARHS (i.e.,
samples that are not the diagnostic specimen) will be discarded.
In this model, the originating laboratory would continue to submit laboratory report
information in the current manner to the appropriate jurisdiction, but must also include
the laboratory-assigned specimen accession number and the collection date on the
report.
Figure 1 graphically depicts the flow of specimens and reports when samples
originate at a private laboratory and are then shipped directly to the CDC STARHS
laboratory.
Procedures for Specimens Sent Directly from a Private Laboratory to the
CDC STARHS Laboratory
•
The ISC notifies the CDC HIV Incidence Surveillance (HIS) Coordinator about
each private laboratory that plans to send specimens directly to the CDC STARHS
laboratory. The ISC should send the following information to the CDC HIS
Coordinator for each laboratory:
Name of laboratory and laboratory point of contact;
Full contact information, including mailing address, phone number, fax, and
email; and
Estimated number of positive samples expected per year.
•
The CDC HIS Coordinator will provide the CDC STARHS laboratory with this
information from private laboratories. This information is important for the CDC
STARHS laboratory to plan for storage capacity.
August 2007 Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV Incidence Surveillance
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
12-32
•
The state/local ISC should provide the private laboratory with a copy of the
HICSB Incidence Surveillance STARHS Specimen Submission Form. The form
should be prefilled with the laboratory contact information, the name and address
of the person who will receive the STARHS results (ISC), and the appropriate
check box marked for Incidence Surveillance:
•
The submitting private laboratory must include a copy of the HICSB Incidence
Surveillance STARHS Specimen Submission Form with a list of all laboratoryassigned accession numbers included in the shipment. If more than one specimen
box is included in the shipping container, then each box should contain its own
STARHS Specimen Submission Form. If possible, an encrypted electronic version
of the list of specimen accession numbers should also be included in the shipment;
this version will help the CDC STARHS laboratory log the samples with minimal
chance of entry errors. Note: the manifest should not contain any patient
identifiers other than specimen accession numbers. At the time of shipment, the
submitting laboratory should also mail a copy of the shipping manifest to the ISC,
notifying him/her of the shipment. This notification is critical for the ISC to be
able to track specimens. As previously noted, identifying information for
specimens should not be faxed or emailed, even if encrypted.
•
The CDC STARHS laboratory will not provide the private laboratories with any
shipping materials, labels or cryovials, but will return the shipping container if a
prepaid return air bill is included in the shipment. Surveillance sites may provide
the private laboratories with prepaid shipping labels or shipping account numbers
(i.e., Federal Express) to cover shipping expenses.
•
Specimens shipped from private laboratories directly to the CDC STARHS
laboratory will be stored frozen, indicated only by their original laboratoryassigned accession number. On a monthly basis, the ISC will send to the CDC
STARHS laboratory a written list of specimens (identified by the original
laboratory-assigned accession number, and, if known, the name of the originating
lab) that are to be tested using STARHS (test list) or to be disposed of (toss list).
The CDC STARHS laboratory will not assign a STARHS identification number
unless the ISC notifies the laboratory that the sample is to be tested using
STARHS. The CDC STARHS laboratory will continue to hold specimens that are
not on one of these two lists.
•
The CDC STARHS laboratory will test the specimens and send the STARHS
results back to the designated ISC listed on the HICSB Incidence Surveillance
STARHS Specimen Submission Form. Samples will be tested and reported by the
newly assigned STARHS identification number.
•
Periodically, the CDC STARHS laboratory will review the stored specimens to
reconcile the status of any samples that have been stored for a lengthy period. This
review will reveal any specimens that the ISC never ordered to be tested or
discarded. The length of time specimens must be held will vary widely by
surveillance site depending on such factors as reporting delays, etc.
Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV Incidence Surveillance August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Roles of Parties Involved
Role of Private Laboratories
The private laboratories are responsible for forwarding two items for HIV
incidence testing: (1) a laboratory report to the public health surveillance
department per local requirements, including the collection date, the laboratoryassigned specimen accession number, and identification information about the
testing facility; and (2) remnant HIV-positive serum from WB- or IFAconfirmed diagnostic samples labeled with the laboratory-assigned specimen
accession number.
The private laboratories may elect to aliquot 0.5 mL of the remnant sera for
shipment to the CDC STARHS laboratory so that any additional portion of the
remnant sera may be stored at their facility; or they may send the entirety of their
remnant sera, without any further manipulation, to the CDC STARHS
laboratory.
Before sending shipments to the CDC STARHS laboratory, private laboratories
should carefully review Guidance for Processing, Storage, and Shipping of
Specimens to the CDC STARHS Laboratory to ensure proper shipping and
handling of specimens.
Role of CDC STARHS Laboratory
The CDC STARHS laboratory must store all remnant HIV-positive serum
samples received until specimen disposition has been determined by the
appropriate jurisdiction’s ISC. The ISC will provide the CDC STARHS
laboratory with a list of all samples to be tested using STARHS (test list) and a
list of all samples to be discarded (toss list), listed by specimen accession
number. The samples on the toss list should be discarded according to
established laboratory methods.
The CDC STARHS laboratory will pull all samples on the test list and aliquot
them into the designated cryogenic vial for testing. The CDC STARHS
laboratory will simultaneously relabel the samples to be tested using STARHS
with a STARHS identification number. The CDC STARHS laboratory must
provide the appropriate ISC with a link between the STARHS identification
number and the original specimen accession number. After the ISC has been
provided with the linkage information, the CDC STARHS laboratory will
destroy the laboratory copy of the specimen accession information.
The CDC STARHS laboratory will test all samples on the test list by the
STARHS identification number and send results to the ISC from the appropriate
jurisdiction. The STARHS results are for surveillance purposes only therefore
results will not be reported back to the originating laboratory, provider, or client.
August 2007 Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV Incidence Surveillance
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Role of the State/Local HIV Incidence Surveillance Coordinator
The ISC from the jurisdiction where the specimen originated will determine the
disposition of the specimen and coordinate with the CDC STARHS laboratory to
ensure that the specimen is either tested or discarded as appropriate. The ISC
will also maintain the link between the original specimen accession number and
the STARHS number, and will manage the STARHS results.
Specimen Numbering
Specimens will be stored at the CDC STARHS laboratory by the original
laboratory-assigned specimen accession number. Once a specimen appears on
the test list the sample will be assigned a unique STARHS identification number
and will be tested using STARHS. For all subsequent procedures, only the
STARHS identification number will be used.
Theoretical Laboratory Types for This Transportation Model
The laboratories that would best use this model are high-volume,
multijurisdictional commercial laboratories. However, other private laboratories
may also choose this specimen transport model.
Note: The testing laboratory may choose either of the two transport models.
With the exception of public health laboratories, the examples listed in
this section are merely suggestions, not requirements, for the types of
laboratories that may choose this model.
Option B: Specimen Originated at or Sent Via State / Local Public Health
Laboratory
Transportation Overview
In this transportation model, confirmatory testing will have been performed at either
the PHL or a private laboratory. For samples originating at a private laboratory, that
laboratory will send all confirmed HIV-positive diagnostic specimens to the
state/local PHL. The state/local PHL will store all specimens received from the private
laboratories until sample disposition is determined by the ISC. All specimens on the
test list (those to be tested using STARHS) will be pulled, aliquoted into the
designated cryogenic vials provided by the CDC STARHS laboratory, relabeled with a
STARHS identification number, and shipped to the CDC STARHS laboratory by
overnight shipping in accordance with the procedures described in Guidance for
Processing, Storage, and Shipping of Specimens to the CDC STARHS Laboratory. All
specimens that are on the toss list (those that are not to be tested using STARHS) will
be pulled and discarded according to existing laboratory procedures.
In this model, the originating laboratory would continue to submit laboratory report
information in the current manner, but must also include the laboratory-assigned
specimen accession number, other relevant specimen identifiers, and testing laboratory
identification on the report.
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Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV Incidence Surveillance August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Many laboratories send enzyme immunoassay (EIA) positive specimens to a reference
laboratory for confirmatory WB or IFA, which usually results in different laboratory
accession numbers. In this case, care must be taken to ensure that the appropriate
specimen accession numbers are associated with the correct surveillance report.
Figure 2a graphically depicts the flow of specimens and reports when samples
originate at the PHL and are then shipped to the CDC STARHS laboratory. Figure 2b
describes the flow of specimens and reports when samples originate at a private
laboratory and are sent to the PHL for storage before shipment to the CDC STARHS
laboratory.
Procedures for Specimens Sent from a Private Laboratory through a
State Public Health Laboratory to the CDC STARHS Laboratory
•
The ISC works with each private laboratory to set up procedures for shipping
specimens to the state PHL.
•
The ISC should provide the private laboratory with a copy of the HICSB Incidence
Surveillance STARHS Specimen Submission Form. The form can be prefilled
with the state PHL contact information, or a new form may be developed in
agreement with the PHL. Some private laboratories already have existing
mechanisms for transporting specimens to the PHL. These procedures may also be
used.
•
The submitting private laboratory must include a list of all laboratory-assigned
specimen accession numbers included in the shipment to the PHL. At the time of
shipment, the private laboratory will mail a copy of the list to the ISC, notifying
him/her of the shipment. The private laboratory should also notify the PHL of the
shipment by calling or emailing the PHL with the shipment tracking number, if
applicable, and the number of samples sent. This information is critical for both
parties to be able to track specimens.
•
The PHL will store the specimens from the private laboratory, holding them until
specimen disposition is determined by the ISC. Specimens should be stored frozen
and according to the original laboratory-assigned specimen accession number. On
a regular basis, the ISC will notify the PHL which specimens they are storing
should be pulled for STARHS testing (test list) and those that can be discarded
(toss list).
•
The PHL will discard all specimens on the toss list and will prepare all specimens
on the test list for testing using STARHS.
All specimens to be tested using STARHS will be pulled, thawed, and
aliquoted into the designated cryovials provided by the CDC STARHS
laboratory.
Using labels provided to the PHL by the CDC STARHS laboratory, the PHL
will relabel the samples to be tested using STARHS with a unique STARHS
identification number.
August 2007 Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV Incidence Surveillance
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
The PHL will send the ISC the linkage information between the original
laboratory-assigned specimen accession number and the new unique STARHS
identification number.
The PHL will ship all relabeled specimens to the CDC STARHS laboratory
according to the procedures described in Guidance for Processing, Storage,
and Shipping of Specimens to the CDC STARHS Laboratory.
The PHL should provide the CDC STARHS laboratory with a completed
HICSB Incidence Surveillance STARHS Specimen Submission Form, listing
all samples in the shipment by the newly assigned STARHS identification
number. The PHL should also include an encrypted electronic version of the
specimen list in the shipment; this version will help minimize data entry errors
at the CDC STARHS laboratory. The list of STARHS identification numbers
on the HICSB Incidence Surveillance STARHS Specimen Submission Form
serves as verification from the ISC that all samples in the shipment are to be
tested using STARHS.
A copy of the completed HICSB Incidence Surveillance STARHS Specimen
Submission Form should also be mailed to the ISC as notification of the
shipment.
The PHL should also notify the CDC STARHS laboratory of the shipment by
calling or emailing the laboratory to provide the shipment tracking number and
number of samples sent.
•
The CDC STARHS laboratory will test all samples received from the PHL with a
preassigned and labeled STARHS identification number and send STARHS
results back to the designated ISC listed on the HICSB Incidence Surveillance
STARHS Specimen Submission Form.
•
Periodically the PHL should review their stored specimens to reconcile the status
of any samples that have been stored for a lengthy period. This review will reveal
any specimens that the ISC did not order to be tested or discarded. The length of
time specimens must be held will vary widely by surveillance site depending on
such factors as reporting delays, etc.
Roles of Parties Involved
Role of Private Laboratories
The private laboratories are responsible for forwarding two items for HIV
incidence testing: (1) a laboratory report to the public health surveillance
department per local requirements with specimen identifiers, the laboratoryassigned specimen accession number, and identification information about the
testing facility; and (2) remnant HIV-positive serum from WB- or IFAconfirmed diagnostic samples labeled with the laboratory-assigned specimen
accession number and testing laboratory identification information.
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Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV Incidence Surveillance August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
The private laboratories may elect to aliquot 0.5 mL of the remnant sera to send
to the PHL so that any additional portion of the remnant sera may be stored at
their facility, or they may send the entirety of their remnant sera, without any
further manipulation, to the PHL.
Before sending shipments to the CDC STARHS laboratory, private laboratories
should carefully review Guidance for Processing, Storage, and Shipping of
Specimens to the CDC STARHS Laboratory to ensure proper shipping and
handling of specimens.
Role of Public Health Laboratories
The PHL must store all remnant HIV-positive serum samples (tested in their own
facility or shipped from a private laboratory) until specimen disposition has been
determined by the ISC. The ISC will provide the PHL with a list of all samples to
be tested using STARHS (test list) and a list of all samples to be discarded (toss
list) listed by specimen accession number.
The PHL will pull all samples that will not be tested using STARHS and discard
them according to existing laboratory procedures.
The PHL will pull all samples to be tested using STARHS and aliquot them into
the designated cryogenic vial provided by the CDC STARHS laboratory. Using
labels provided to the PHL by the CDC STARHS laboratory, the PHL will
simultaneously relabel the samples with a STARHS identification number. The
PHL must also provide the ISC with a link between the STARHS identification
number and the original specimen accession number. The PHL will ship all
samples to be tested using STARHS, labeled only with the STARHS
identification number, to the CDC STARHS laboratory according to the
procedures described in Guidance for Processing, Storage, and Shipping of
Specimens to the CDC STARHS Laboratory.
Role of State/Local HIV Incidence Surveillance Coordinator
The state/local ISC from the jurisdiction where samples originated will
determine the disposition of all samples stored at the PHL and coordinate with
the PHL to ensure that specimens are either tested using STARHS or discarded
as appropriate. The ISC will also maintain the link between the original
specimen accession number and the STARHS number, and will manage the
STARHS results.
Role of CDC STARHS Laboratory
Using the STARHS identification number, the CDC STARHS laboratory will
test all samples received from a PHL. Once testing is complete, the CDC
STARHS laboratory will return results to the appropriate jurisdiction’s ISC.
August 2007 Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV Incidence Surveillance
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Specimen Numbering
Specimens will be stored at the PHL labeled with the original laboratory-assigned
specimen accession number. Once specimen disposition is determined, each sample to
be tested using STARHS will be assigned a unique STARHS identification number by
the PHL before shipment to the CDC STARHS laboratory. For all subsequent
procedures, only the STARHS identification number is used.
Theoretical Laboratory Types for this Transportation Model
The laboratory types that would best use this model are single-jurisdiction laboratories
such as hospital, medical center, university, or small independent reference
laboratories, or local branches of large commercial laboratories. In many cases, these
laboratories already have working relationships and established procedures for
submitting samples to their state and/or local PHL and would prefer not to change
their existing practices. All state/local PHLs performing confirmatory testing for HIV
also fall into this category, except they would simply hold samples until the ISC
determines specimen disposition.
Note: The testing laboratory may choose either of the two transport models. With
the exception of public health laboratories, the examples listed in this section
are merely suggestions, not requirements, for the types of laboratories that
may choose this model.
Responsibilities
Private Laboratories
Selection of a Model Type
Each private laboratory performing confirmatory testing of HIV diagnostic specimens
must select one of the two specimen transport model types and inform the ISC which
model was chosen. The private laboratory must send remnant sera from confirmed
HIV-seropositive samples to either the state/local PHL or to the CDC STARHS
laboratory.
Additional Laboratory Report Information
The private laboratory must include the laboratory-assigned specimen accession
number on the laboratory report form sent to the HIV surveillance department, per
state/local disease reporting requirements.
Many laboratories send EIA-positive specimens to a reference laboratory for
confirmatory WB or IFA. In this case, care must be taken to ensure that the
appropriate specimen accession numbers are associated with the correct surveillance
report.
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Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV Incidence Surveillance August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Public Health Laboratories
Sample Storage and Retention
The PHL will often serve a dual function as a testing laboratory or a pass-through
facility for private laboratories. The PHL will store all WB- or IFA-confirmed positive
samples and/or all samples received from private laboratories until sample disposition
is determined by the ISC.
Aliquoting and Sample Shipment
Once sample disposition has been determined by the ISC, the PHL will be responsible
for pulling the identified samples, aliquoting samples into the appropriate tubes, and
relabeling the samples with a STARHS identification number for testing. The PHL
will send the ISC the linkage information between the laboratory-assigned specimen
accession number and the STARHS identification number. The PHL will ship all
samples to be tested using STARHS (test list) to the CDC STARHS laboratory and
discard all samples on the toss list according to existing laboratory procedures.
State/Local HIV Incidence Surveillance Coordinator
Sample Disposition
The ISC will determine sample disposition for all HIV-seropositive diagnostic
samples tested in the jurisdiction. The ISC will coordinate with the PHL and/or the
CDC STARHS laboratory to ensure the proper samples are tested.
Data Management
To ensure that STARHS results can be matched to surveillance data, the ISC will
retain the linkage information between the laboratory-assigned specimen accession
number and the STARHS identification number. The ISC will send cumulative
incidence data to CDC monthly on or before the 15th of each month. If the ISC is in a
local jurisdiction, then results should be sent to the state ISC for matching purposes
before submitting data to CDC.
CDC STARHS Laboratory
Sample Rejection Criteria
Sample rejection due to thawing, breakage, insufficient quantity, or lost-in-transit
status will be determined and recorded by the CDC STARHS laboratory. The CDC
STARHS laboratory will include sample rejection information with the STARHS
results report that is transmitted to the ISC.
Sample Storage and Retention
All samples that are shipped directly from a private laboratory and not a state PHL
must be stored (see Sample Storage) at the CDC STARHS laboratory until sample
disposition is determined by the ISC. Storage time may vary from state-to-state
depending on the state’s surveillance practices. Once sample disposition has been
August 2007 Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV Incidence Surveillance
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
determined by the ISC, the CDC STARHS laboratory will be responsible for pulling
all samples on the ISC’s test and toss lists. The samples on the toss list will be
discarded. The samples on the test list will be aliquoted into the appropriate tubes and
relabeled with a STARHS identification number for testing. The CDC STARHS
laboratory will apply a label to the sample tube and then to a line listing of specimen
accession numbers received from the ISC or PHL for those samples to be tested using
STARHS. The CDC STARHS laboratory will send the ISC the linkage information
and then destroy the linkage information held at the CDC STARHS laboratory. All
subsequent testing and results will refer only to the STARHS identification number
and will no longer include the original specimen accession number.
Results Reporting
The CDC STARHS laboratory will report STARHS results by the STARHS
identification number only to the ISC with jurisdiction over the sample as designated
by the HICSB Incidence Surveillance STARHS Specimen Submission Form. The
results reporting mechanism will adhere to the methods agreed upon between CDC
and the CDC STARHS laboratory.
References
1.
12-40
CDC. HIPAA Privacy Rule and public health: guidance from CDC and the U.S.
Department of Health and Human Services. MMWR 2003;52:1–12. Available at
http://www.cdc.gov/mmwr/preview/mmwrhtml/m2e411a1.htm.
Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV Incidence Surveillance August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Figure 1. Specimen originates at national commercial laboratory or private laboratory
and is sent directly to the CDC STARHS laboratory
August 2007 Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV Incidence Surveillance
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Figure 2a. Specimen originates at a public health laboratory (PHL performed the
confirmatory HIV testing)
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Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV Incidence Surveillance August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Figure 2b. Specimen originates at a private laboratory (for example, a university hospital
laboratory, regional or local independent commercial laboratory) and
sample is sent to state public health laboratory (serves as a pass-through
facility)
August 2007 Guidance for the Remnant HIV-Positive Specimen Transportation Activities for HIV Incidence Surveillance
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Guidance for Processing, Storage, and Shipping of Specimens
to the CDC STARHS Laboratory
Purpose
This standard operating procedure describes methods for the handling, storing, and
shipping serum specimens that will be tested for recent HIV-1 infection using STARHS.
Results from these tests will help estimate HIV incidence.
Introduction
Remnant serum from HIV-positive diagnostic specimens is to be collected and frozen by
using vials and labels specified or supplied by the CDC STARHS laboratory. Ideally, 0.5
mL should be collected for each aliquot. Frozen serum will be shipped to the CDC
STARHS laboratory for testing.
CDC STARHS Laboratory
The CDC STARHS laboratory is the Wadsworth Center Retroviral Immunology
Diagnostic HIV Testing Laboratory which is part of the New York State Department of
Health. Frozen aliquots will be shipped to:
NYSDOH Wadsworth Center
Axelrod Institute
Diagnostic HIV Testing Lab: STARHS
120 New Scotland Avenue
Albany, New York 12208
Attn: N'ko Lea Ali-Napo
Setting and Personnel for Specimen Processing
•
Centrifugation, aliquoting, and shipping should be performed at or under the
auspices of a laboratory that is certified under the Clinical Laboratory
Improvement Amendments (CLIA) for handling HIV+ specimens.
•
All personnel handling specimens should receive blood borne pathogens training.
See the Occupational Safety and Health Administration (OSHA) Bloodborne
Pathogens Standard:
http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051
•
12-44
Personnel handling or processing specimens should have appropriate laboratory
training in the relevant laboratory techniques for handling HIV+ specimens and for
performing the specific tasks required.
Guidance for Processing, Storage, and Shipping of Specimens to the CDC STARHS Laboratory
August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
•
The setting in which centrifugation, aliquoting, and shipping occurs should meet
Biosafety Level 2 specifications required by the U.S. Department of Health and
Human Services for handling of specimens containing HIV:
Biosafety in Microbiological and Biomedical Laboratories (BMBL), 4th ed.
Washington: 1999. p. 20–27, 171–175. Available from URLs:
http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm and
http://www.cdc.gov/od/ohs/pdffiles/4th%20BMBL.pdf
Materials
•
Cryogenic vials—Supplied by CDC STARHS laboratory
•
Specimen labels—Supplied by CDC STARHS laboratory: label will identify
sample (barcode, number, etc.) by STARHS identification number
•
Cardboard storage boxes for cryogenic vials—Can be supplied by CDC STARHS
laboratory if requested
•
Freezer—STARHS samples can be refrigerated at 2–8oC, but for long-term
storage and shipping, samples should be frozen at -20oC
If not already in practice, a daily temperature log should be kept to ensure the
freezer is operating properly
The freezer should be housed in a location with proper ventilation to avoid
overheating and freezer failure
Staff must be certain there is adequate space in freezer to store specimens
•
A supply of dry ice in pellet form
•
Insulated shipping containers certified to ship frozen diagnostic specimens (HIV+
serum and dry ice)
•
Shipping courier air bills
•
Materials for shipper packing—See Packing Procedures for Shipping to the CDC
STARHS Laboratory in this document
•
HICSB Incidence Surveillance STARHS Specimen Submission Form
Specimen Collection and Processing
All processing of specimens should be done by personnel qualified to handle HIV+
specimens under the auspices of a laboratory equipped for the handling of HIV+
specimens [Biosafety in Microbiological and Biomedical Laboratories (BMBL), 4th ed.
Washington: 1999. p. 20–27, 171–175. Available from URLs:
http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm and
http://www.cdc.gov/od/ohs/pdffiles/4th%20BMBL.pdf].
August 2007
Guidance for Processing, Storage, and Shipping of Specimens to the CDC STARHS Laboratory
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
•
Aliquot the serum (0.5 mL per cryogenic vial). Use labels to identify the specimen
and record this information in the proper setting (specimen log for eventual
transfer to HIV Incidence Surveillance database).
•
Store aliquots in refrigerator or freezer until specimen disposition has been
determined and scheduled shipping date has arrived.
Shipping
•
Specimens for STARHS should be sent to the CDC STARHS laboratory at the
address on the HICSB Incidence Surveillance STARHS Specimen Submission
Form and in the CDC STARHS Laboratory section of this document. All
specimens will be shipped as diagnostic specimens according to the International
Air Transport Association (IATA) Packing Instructions 650. Dry ice will be
included with each shipment per IATA Packing Instructions 904.
Because samples will be shipped with dry ice, shipping personnel must be
trained and certified to ship dangerous goods. See Training and Certification
for Shipping Infectious Substances for a list of companies that provide
training.
Establish contact with Lea N'ko Ali-Napo ([email protected]) at the
CDC STARHS laboratory.
Ensure that adequate STP320 or equivalent shipping containers are available.
The CDC STARHS laboratory will return them to the submitting laboratory if
a return air bill is included in the shipment. The shippers are expensive and
need to be re-used.
Ensure that you have an adequate supply of shipping courier air bills, which
can be obtained free of charge from most couriers.
Packing Procedures for Shipping to the CDC STARHS Laboratory
All of the following steps should be read and understood before starting the preparation of
the actual shipment:
12-46
•
Bring the STP320 shipper or equivalent that is to be used for the shipment and
materials needed for packing the specimens into the area in which the shipment
will be prepared.
•
If the shipper is new and being used for the first time, check to be sure that it
includes the following items:
Two (2) sheets of bubble wrap
Two (2) STP 710 or equivalent certified secondary containers
Two (2) 250-mL absorbent strips
Class 9 label and dry ice quantity label
Other hazard and handling labels
One (1) instruction sheet
Guidance for Processing, Storage, and Shipping of Specimens to the CDC STARHS Laboratory
August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
•
For a diagram of the above contents, refer to the Saf-T-Pak catalog.
•
Use only what is needed of the above contents for each individual shipment. Save
leftover supplies for future shipments.
•
If the shipper is being re-used, the proper labels will already be in place on the
outer cardboard container. Ensure that adequate supplies of the other materials
listed above are on hand.
•
Put on personal protective equipment.
•
Remove cryogenic vials from freezer and accurately record the specimen
accession or STARHS identification numbers. The specimen numbers can either
be written directly onto the STARHS Specimen Submission Form or on a separate
list that will be attached to the form. Return them to the freezer. Repeat the process
until all specimen numbers have been recorded for each vial that is going to be
shipped.
•
These specimens should remain frozen at all times and therefore should not
be removed from a freezing temperature environment for more than a few
minutes.
•
Prepare 3 copies of the HICSB Incidence Surveillance STARHS Specimen
Submission Form listing or attaching the specimen number for each vial to be
shipped.
Copy 1 (original) should be sent with the specimens in the shipment.
Copy 2 should be mailed to ISC as notification of shipment.
Copy 3 should be retained by the submitting laboratory for its records.
•
If possible, on a floppy disk or CD, also include an encrypted electronic version of
the list of specimen numbers in the shipment. This will help the CDC STARHS
laboratory staff minimize the amount of data entry they have to do when logging in
the samples, thereby minimizing errors.
•
Prepare the shipping courier air bill that the CDC STARHS laboratory will use to
return the shipper back to the submitting laboratory for re-use. The air bill MUST
be completely filled in with the return address, the CDC STARHS laboratory
address, and the proper billing number.
•
If dry ice is in another location which requires leaving the area in which the
shipment is prepared, use a separate container to bring the dry ice that is needed for
shipping back into the shipping area at this time.
•
Bring the specimens to the area in which the shipment is prepared. Work quickly,
keeping in mind that these specimens should remain frozen at all times and
therefore should not be removed from a freezing temperature environment
for more than a few minutes.
•
Re-check the screw-cap lids on the specimen vials and tighten if necessary.
August 2007
Guidance for Processing, Storage, and Shipping of Specimens to the CDC STARHS Laboratory
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Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
•
Place the specimens into the secondary leak-proof container and make sure samples are
surrounded by bubble wrap and absorbent strips. The vials should not move around or rattle inside
the vessel.
•
Place the secondary vessel into the inner box and place the inner box into the polystyrene cooler.
•
Pack dry ice pellets in the shipper and around the inner box. The STP320 shipper will hold ~8 kg
of dry ice (~10 lb) and, if packed completely, will keep the contents frozen for greater than 80
hours.
•
DO NOT PUT DRY ICE INSIDE THE INNER BOX.
•
Place the lid on the polystyrene cooler.
•
Place one copy of the completed HICSB Incidence Surveillance STARHS Specimen Submission
Form on top of the shipping box return form with the completed return FedEx air bill stapled to it.
Fold in half and place on top of the polystyrene lid.
•
Fold over the top flaps and seal the shipping container with clear shipping tape.
•
The outer box must have a mark in the form of a square set at an angle of 45° (diamond shaped).
The mark must be at least 2 inches by 2 inches and include the UN 3373 designation. The proper
shipping name—“Diagnostic specimens”—must be marked on the outer package adjacent to the
diamond-shaped mark. Labels can be purchased to place on the outer box that fulfill this
requirement.
•
Apply the Class 9 Hazard Label over the lower diamond-shaped outline on the box.
•
Apply the net quantity dry ice label to the outlined area adjacent to the Class 9 Hazard Label.
Write the approximate amount (in kg) of dry ice you used to pack the container.
•
Prepare the shipping courier paper work addressed to the CDC STARHS laboratory. Select the
overnight shipping option.
•
Call or email the CDC STARHS laboratory to notify them of the shipment. Provide the CDC
STARHS laboratory with the shipment tracking information and the total number of samples in
the shipment.
Note: Do not fax or email laboratory-assigned specimen accession numbers or STARHS
identification numbers.
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Guidance for Processing, Storage, and Shipping of Specimens to the CDC STARHS Laboratory
August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
HICSB Incidence Surveillance
STARHS Specimen Submission Form
Please complete this form and send it with each shipment. Specimens should be sent to
NYSDOH Wadsworth Center
Axelrod Institute
Diagnostic HIV Testing Lab: STARHS
120 New Scotland Avenue
Albany, NY 12208
Attn: N'ko Lea Ali-Napo
SHIPPING FACILITY INFORMATION:
RESULTS SENT TO:
Name: ________________________________________
Name: __________________________________________
Address:_______________________________________
Address: ________________________________________
_______________________________________
_________________________________________
Phone Number: _________________________________
Phone Number: ___________________________________
Fax: __________________________________________
Fax: ____________________________________________
Email: ________________________________________
Email: __________________________________________
Contact Person: _________________________________
Mark the box for the appropriate surveillance activity for these specimens:
INCIDENCE SURVEILLANCE (HICSB)
Note: List of which specimens are appropriate to test for HIV incidence surveillance may be sent separately.
BEHAVIORAL SURVEILLANCE (BCSB)
EVALUATION OF DRIED FLUID SPOT SURVEILLANCE (DFS)
RANGE OF SPECIMEN NUMBERS SENT (OR ATTACH LIST):
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
____________________________________________________________________________________________________
Please identify any specimens on your list that are collected under a research protocol and that should not be tested
using the BED HIV-1 Capture EIA.
01/08/2007
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HICSB Incidence Surveillance STARHS Specimen Submission Form
August 2007
Technical Guidance for HIV/AIDS Surveillance Programs — HIV Incidence Surveillance
Training and Certification for Shipping Infectious Substances
FedEx 800-GO-FEDEX
•
3-day, IATA-based training covers all hazardous materials. Cost is $650.
Saf-T-Pak 800-814-7484
•
Specifically for infectious and diagnostic substances and dry ice. Three options:
one-day seminar, on-site programs, or interactive CD (staff can be trained in 3 to 5
hours using interactive CD). Certificate is good for 2 years OR until regulations
change. Cost is ~$250.
Viking Packing Specialist (Oklahoma; David Weilert, President) 800-788-8525
•
Seminars conducted monthly in Tulsa. Cost is $300 per person. Covers all nine
classes of hazardous materials, covers shipping under IATA, and certificate is
good for 2 years. Will do group classes in local area ($3,000 plus travel costs).
These are some companies that provide training for dangerous goods shipping. The
Centers for Disease Control and Prevention does not endorse any particular company.
Appendix A
Statistical Method for Generating Population-Based HIV Incidence
Estimates
This document is in development and will be added soon.
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Training and Certification for Shipping Infectious Substances
August 2007
| File Type | application/pdf |
| File Title | HIV_Surveillance_Guidelines_Vol_1.book |
| Author | bnk5 |
| File Modified | 2009-11-02 |
| File Created | 2008-02-12 |