National Calicivirus Laboratory Form

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Emergency Cruise Ship Outbreak Investigations (CSOIs)

National Calicivirus Laboratory Form

OMB: 0920-1255

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NCL-3003

Centers for Disease Control and Prevention (CDC)
National Center for Immunization and Respiratory Diseases (NCIRD)
Gastroenteritis and Respiratory Viruses Branch
National Calicivirus Laboratory

FORM FOR SUBMITTING SPECIMENS FROM SUSPECTED NOROVIRUS OUTBREAKS
National Calicivirus Laboratory
DASH Unit 75
Centers for Disease Control and Prevention
1600 Clifton Rd, N.E.
Atlanta, GA 30333
Primary Contact for Epidemiologic Investigation

Telephone:
Alternate:
Fax:

404-639-1923
404-639-3577
404-639-3645

Date: ____________________

Name: _________________________________________

Telephone: ________________________________

Agency: ________________________________________

Email: ____________________________________

Address: _______________________________________
State Outbreak Identification Number: _____________
Outbreak Date: _________________________________
End Date: _____________________________________
Event Date(s): __________________________________

OUTBREAK INFORMATION

ILLNESS CHARACTERISTICS
Number

City

Sick

County

Susceptible

State
Setting
(e.g., long-term
care facility)
Transmission
(e.g., person-toperson, food)
Suspected Source
Additional Comments:

Sought Care
Admitted to
hospital
Deaths
Fever
Diarrhea
Vomitus
Duration
(range, in hours)
Incubation time
(range, in hours)

Public reporting burden of this collection of information is estimated to average 15 minutes per response, including the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a
collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to CDC, Reports Clearance Officer, 1600 Clifton Rd., MS D-74, Atlanta, GA 30333, ATTN: PRA (0920-0004).
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NCL-3003

Centers for Disease Control and Prevention (CDC)
National Center for Immunization and Respiratory Diseases (NCIRD)
Gastroenteritis and Respiratory Viruses Branch
National Calicivirus Laboratory

Primary Contact for Clinical Specimens
Name: _______________________________________________
Telephone: ___________________________________________
Email: _______________________________________________
Specimens Collection:*
Type

Number
collected

Any previous testing
(yes/no)

If yes, details about results

Stool
Vomitus
Serum (acute)
Serum (convalescent)
*See page 3 for specimen collection recommendations.

Specimen Details:
Specimen ID

Date of
Collection

Date onset

Age

Additional Information

Additional Comments:
Revised 06/12
Public reporting burden of this collection of information is estimated to average 15 minutes per response, including the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a
collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to CDC, Reports Clearance Officer, 1600 Clifton Rd., MS D-74, Atlanta, GA 30333, ATTN: PRA (0920-0004).
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NCL-3003

Centers for Disease Control and Prevention (CDC)
National Center for Immunization and Respiratory Diseases (NCIRD)
Gastroenteritis and Respiratory Viruses Branch
National Calicivirus Laboratory

RECOMMENDATIONS FOR COLLECTION of CLINICAL SPECIMENS FOR NOROVIRUS LABORATORY DIAGNOSIS
Stool Samples
Timing. Specimen collection for viral testing should begin on day 1 of the epidemiologic investigation. Delaying collection
of specimens for viral testing while awaiting test results for bacterial or parasitic agents could preclude establishing a
viral diagnosis. Ideally, whole stool specimens should be obtained during the acute phase of illness (i.e., within 48--72
hours after onset) while the stools are still liquid or semisolid when the virus titer is greatest. With the increased
sensitivity of real-time RT-PCR assays, norovirus and sapovirus can be collected later during the illness (i.e., 7--10 days
after onset), if the testing is necessary for either determining the etiology of the outbreak or for epidemiologic purposes
(e.g., a specimen obtained from an ill food handler who might be the source of infection).
Number and Quantity. Ideally, specimens from at least 5 ill persons should be collected during the acute phase of
illness. Bulk samples (i.e., 10--50 ml of stool placed in a stool cup or urine container) are preferred, as are acute diarrhea
specimens that are loose enough to assume the shape of their containers. Serial specimens from persons with acute,
frequent, high-volume diarrhea are useful as reference material for the development of assays. The smaller the
specimen and the more formed the stool, the lower the diagnostic yield. Rectal swabs are of limited or no value because
they usually contain insufficient quantity for typing of the strains. Given the high background rate of norovirus in healthy
individuals, it may often be useful to collect control specimens against which to compare prevalence in cases.
Storage and Transport. Whole Stool and vomitus specimens collected should be stored in watertight containers
(e.g., urine specimen cups) and should be kept refrigerated at 4°C. At this temperature, specimens can be stored
without compromising diagnostic yield for 2--3 weeks, during which time testing for other pathogens can be
completed. If the specimens have to be transported to a laboratory for testing, they should be bagged and
sealed and kept on ice or frozen refrigerant packs in an insulated, waterproof container. If facilities are not
available for testing specimens within 2--3 weeks, specimens can be frozen at -20°C or -70°C for antigen or RTPCR testing.

Vomitus
Vomiting is a characteristic, but not unique symptom of norovirus illness, and vomitus can be collected to supplement
the diagnostic yield from stool specimens during an investigation. Recommendations for collection, storage, and
shipment of vomitus specimens are the same as those for stool specimens.

Serum
Serum specimens may useful in unique circumstances or for special studies, but are not recommended for routine
diagnostics.
Timing. Acute- and convalescent-phase serum specimens should be obtained to test for a diagnostic >4-fold rise in IgG
titer to noroviruses. Acute specimens should be obtained during the first 5 days of symptoms and convalescent serum
should be collected 3 weeks after the onset of disease.
Number and Quantity. Ideally, 10 pairs of specimens from ill persons (i.e., the same persons submitting stool specimens)
and 10 pairs from well persons (controls) should be obtained. Adults 5--7 ml of blood and children 3--4 ml.
Storage. Matching acute and convalescent serologic specimens should be stored and shipped frozen in plastic
(transportable) aliquot tubes Specimens should be collected in tubes containing no anticoagulant, sera should be spun
off and frozen.

Environmental Specimens
Current real-time RT-PCR methods allow detection of noroviruses in water, food, and environmental specimens
established methods are available only for water (at CDC) and shellfish (at FDA’s Gulf Coast Seafood Laboratory). If a
food or water item is strongly suspected as the source of an outbreak, then a sample should be obtained as early as
possible, stored at 4°C (water) or -20°C (food), and CDC (404-639-1923 or 404-639-3577) should be contacted for further
testing.
Public reporting burden of this collection of information is estimated to average 15 minutes per response, including the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a
collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to CDC, Reports Clearance Officer, 1600 Clifton Rd., MS D-74, Atlanta, GA 30333, ATTN: PRA (0920-0004).
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