CDC Model Performance Evaluation Program (MPEP) Results Form

CDC Model Performance Evaluation Program (MPEP) for Retroviral and AIDS-Related Testing

Attachment 10 Result Form

CDC Model Performance Evaluation Program (MPEP) Results Form

OMB: 0920-0274

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 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Coordinating Center for Infectious Diseases, Mail Stop G-23

Atlanta, Georgia 30333

OMB Form No. 0920-0274

Expiration Date: 10/31/2007

HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1)

ANTIBODY TESTING

WARNING

Because no test method can offer complete assurance that HIV-1, HTLV-I/II, hepatitis B and C viruses, or other infectious agents are absent, these samples should be handled at the Biosafety Level 2 as recommended for any potentially infectious human serum or blood specimen in the Centers for Disease Control and Prevention (CDC) National Institutes of Health (NIH) manual entitled, “Biosafety in Microbiological and Biomedical Laboratories,” 1999, 4th edition, HHS publication No. (CDC) 93-8395, pages 8-14 and pages 19-26 and in the Occupational Safety and Health Administration (OSHA) Final Rule on Occupational Exposure to Bloodborne Pathogens published December 6, 1991 (Federal Register Volume 56, Number 235, pages 64175-64182).

The HIV-1 antibody-positive samples in this panel have been heated at 56C for 60 minutes to inactivate bloodborne viruses including HIV-1, human T-lymphotropic virus types I and II (HTLV-I/II), and hepatitis B and C viruses. The HIV-1 antibody-negative samples have not been heated at 56C for 60 minutes.


M PEP Laboratory Identification No.: (Number can be found on your sample box)

Laboratory Name:___________________________________________________________________

Shipping address of Laboratory (address to which samples should be sent):

Street:________________________________________________________________________________

City:_________________________________________ Country:____________________________

State/Province:_________________________________ ZIP /Postal Code:_____________________

Telephone No.: (_____)________-_________________ Fax No.: (_____)_________-________________

E-mail Address: ________________________________________________________________________

Check if this address differs from that on the shipping label.

Person completing form:

Name/Title:________________________________________________________________________

Results Forms should be received at CDC by February 16, 2007, for results to be included in

the final aggregate report. DO NOT FAX RESULTS.

FOR INTERNAL USE ONLY

F ORM NUMBER SHIPMENT NUMBER

S AMPLE PANEL CODE MPEP NUMBER

Public reporting for this collection of information is estimated to average 10 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/ATSDR Reports Clearance Officer; 1600 Clifton Road, N.E., MS D-24, Atlanta, GA 30333, ATTN: PRA (0920-0274).




GENERAL INSTRUCTIONS_______________________

PLEASE READ ALL INSTRUCTION SHEETS COMPLETELY BEFORE

PROCEEDING WITH ANY SAMPLE TESTING.


RECORD ALL INFORMATION LEGIBLY AND WITHIN THE APPROPRIATE SPACES.

(RECORD FROM LEFT TO RIGHT)


Perform the test procedure(s) on these samples in the same manner in which your laboratory tests patient specimens. DO NOT HEAT INACTIVATE ANY OF THESE SAMPLES.



If you would like to record additional test control values and results, you may photocopy the appropriate blank Laboratory Results page(s) for any procedure before entering results.


1. Enter your Model Performance Evaluation Program (MPEP) laboratory identification number in the boxes provided at the top of each results form in this booklet. Your MPEP number can be found on the identification label affixed to the panel box containing your samples.


  1. If you do not test the samples by one of the procedures for which results forms have been provided, enter the appropriate Nonreporting Code (see below) on the results form in the spaces provided and return to the Centers for Disease Control and Prevention (CDC). Do not use a Nonreporting Code in any field other than the NONREPORTING CODE BOX at the top of each Test Type results form. Do not use a Nonreporting Code if ANY sample test results are reported for a particular Test Type.


NONREPORTING CODES___________________________

CODE REASONS FOR NOT REPORTING RESULTS


T Test not performed in this laboratory


L Samples lost or destroyed in laboratory


R Test reagents not available


S Patient specimens not currently being tested in this laboratory


D Not interested in participating; please delete my laboratory from

the HIV-1 program (please specify reason for deleting on results form)


Q Insufficient sample volume to perform test


G Other (please specify on results form)


For test methods NOT performed in your laboratory, please enter a nonreporting code in the appropriate section. For example, if you do not perform IFA testing, enter “T” in the IFA results section.


INSTRUCTIONS FOR REAGENTS/CONTROLS/DILUENTS___

1. Enter the Manufacturer code, appropriate to the procedure used, in the blocks provided (Manufacturer Codes appropriate for each test procedure are given in the Specific Instructions for each test procedure). For code 99, also enter the manufacturer’s name. Enter the lot number of the reagents and controls used.


2. Enter the NAME of the test kit and/or other reagents, appropriate to the procedure used, in the spaces provided.


3. Place an “X” in the appropriate box for the sample diluent or buffer that is used in the test(s) you perform.



INSTRUCTIONS FOR SURVEY SAMPLES__________________


AA 00000000000000000000000000000000000000000000000000000000000000000000000

11 00000000000000000000000000000000000000000000000000000000000000000000000

AA 00000000000000000000000000000000000000000000000000000000000000000000000

66 00000000000000000000000000000000000000000000000000000000000000000000000

BB 00000000000000000000000000000000000000000000000000000000000000000000000

66 00000000000000000000000000000000000000000000000000000000000000000000000

11 00000000000000000000000000000000000000000000000000000000000000000000000

BB 00000000000000000000000000000000000000000000000000000000000000000000000

 1. Enter in the spaces provided the complete sample code (two-digit code) exactly as it appears on each vial, (e.g., ,… ; , ).


2. For each sample, circle an Interpretation Code indicating your interpretation of the test results you are reporting. Interpretation Codes appropriate for each test procedure are found in the Specific Instructions sections for each test.


3. NOTE: If you need assistance in completing these forms, please call the CDC Model Performance Evaluation Program at (404) 718-1006.


Please Note:

If you have entered and submitted your results online,

please DO NOT return this booklet!


An addressed envelope has been provided for you to mail your completed results form to CDC. If you use the envelope provided, please mail the form so that it reaches CDC by the deadline indicated on the first page. If you use your own envelope, please send your results form to:



Model Performance Evaluation Program

Division of Laboratory Systems

Coordinating Center for Infectious Diseases

Centers for Disease Control and Prevention

Mail Stop G-23

1600 Clifton Road, NE

Atlanta, GA 30333


EIA . . . EIA . . . EIA . . . EIA . . .

SPECIFIC INSTRUCTIONS FOR ENZYME IMMUNOASSAY (EIA)

1. Enter the name of the test kit in the spaces provided; for code 99, also enter the manufacturer’s name.


2. If you use a combination HIV-1/HIV-2 EIA kit, the HIV-2 test control data can be recorded in the spaces provided on the EIA results form for the “Weakly Reactive Control.”

1B 00000000000000000000000000000000000000000000000000000000000000000000000

7B 00000000000000000000000000000000000000000000000000000000000000000000000


0B 00000000000000000000000000000000000000000000000000000000000000000000000

60

8B 00000000000000000000000000000000000000000000000000000000000000000000000

1B 00000000000000000000000000000000000000000000000000000000000000000000000

7B 00000000000000000000000000000000000000000000000000000000000000000000000

50

8B 00000000000000000000000000000000000000000000000000000000000000000000000

1B 00000000000000000000000000000000000000000000000000000000000000000000000

 3. Record all results as absorbance (optical density) units (e.g. 0000.. . , . ) )

However, if your spectrophotometer records the absorbance of a sample as “OVER” or

“****”, use the highest value limit for your instrument for the EIA test results for that sample.


4. For the initial and repeat test controls, record the “mean” absorbance values in the “Initial EIA” and the “Repeat EIA” portions, respectively, of the “Test Controls” section of the results form.


5. If you routinely test in duplicate in the initial EIA, record both of the absorbance (optical density) values in the spaces provided. If you routinely perform a repeat EIA on your samples, record those results under “Repeat EIA,” and if you perform repeat tests in duplicate, record both of the absorbance values in the spaces provided.


6. For each sample, circle a code (see Interpretation Codes below) for the INITIAL EIA interpretation, and another for the FINAL EIA interpretation. NOTE: if you do not perform a repeat EIA, and your initial EIA interpretation can be considered as your final EIA interpretation, then circle a FINAL EIA interpretation.


  1. NOTE: If your laboratory uses Quality Control material in addition to the controls that are included in manufactured EIA test kits, please complete the Quality Control Testing section of the EIA result form.





Please Note: Abbott AxSYM, Abbott IMx, Abbott PRISM, Abbott HIV 1/2 gO, bioMérieux VIDAS HIV DUO, and Ortho Vitros ECi AntiHIV 1+2 have been moved to the EIA portion of the result booklet. Record results for these tests on the EIA results page (page 6).




EIA…(Cont’d)


Manufacturer Codes for EIA_____________________________


CODE

MANUFACTURER

CODE

MANUFACTURER





21


Abbott HIV-1/HIV-2 (rDNA)

70

Bio-Rad Genscreen Plus HIV

Ag-Ab

06

Abbott AxSYM HIV-1/2 gO

32

Dade Behring Enzygnost Anti-HIV-1/2 Plus

30


Abbott HIV-1/HIV-2 3rd Generation Plus

71

Dade Behring Enzygnost HIV Integral

55


Abbott HIV1/2 gO

53

Genetic Systems HIV-2 EIA

40


Abbott IMx

37

Murex Ag/Ab Combination

17


Abbott PRISM

62

Murex HIV-1.2.O

18


Adaltis Detect HIV

56

Ortho Vitros ECi Anti-HIV-1+2

83

bioMérieux Vironostika HIV-1

48

Ortho HIV-1/HIV-2 Ab-Capture

36


bioMérieux Vironostika Uni-form II Ag/Ab

19

Trinity Biotech Recombigen HIV-1/HIV-2

31


bioMérieux Vironostika Uni-form II Plus O

01

Vironostika HIV-1 Plus O

49

bioMérieux VIDAS HIV DUO Ultra Ag/Ab

97

In House (prepared by your laboratory)

51

Bio-Rad Genetic Systems HIV-1/HIV-2 Peptide

98

Noncommerical (e.g., supplied by the State Laboratory)

08

Bio-Rad Genetic Systems HIV-1/2 Plus O

44


Bio-Rad Genetic Systems rLAV

99

Other (specify on the result form)

54


Bio-Rad Genscreen HIV-1/2




INITIAL AND FINAL EIA TEST INTERPRETATION CODES

CODE INITIAL EIA CODE FINAL EIA

R Reactive R Reactive

E Equivocal N Nonreactive

N Nonreactive


MPEP No.

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Coordinating Center for Infectious Diseases, Mail Stop G-23

Atlanta, Georgia 30333


ENZYME IMMUNOASSAY LABORATORY RESULTS FORM


 NONREPORTING CODE  ( Specify reason if code “D” or “G”): __________________

INITIAL EIA

REAGENTS

TEST CONTROLS

Mfr. Code

M anufacturer ___________________ GG


Lot # _______________________________


Kit Name ____________________________


DILUENTS

K it


I n House (please specify):

__________________________________

O ther (please specify):

__________________________________

Reactive Mfr. Code

M anufacturer _____________________ GG


Lot #__________________________________


Weakly Reactive Mfr. Code

M anufacturer _____________________ GG


Lot # ____________________________________


Nonreactive Mfr. Code

M anufacturer _____________________ GG


Lot # ___________________________________


REPEAT EIA

REAGENTS

TEST CONTROLS

Mfr. Code

M anufacturer __________________ GG


Lot #_______________________________


Kit Name _____________________________


DILUENTS

K it


I n House (please specify):

__________________________________

O ther (please specify):

___________________________________

Reactive Mfr. Code

M anufacturer ______________________ GG


Lot # _____________________________________


Weakly Reactive Mfr. Code

M anufacturer _______________________ GG


Lot # _____________________________________



Nonreactive Mfr. Code

M anufacturer ______________________


Lot # __________________________________





TEST CONTROLS


INITIAL EIA ABSORBANCE REPEAT EIA ABSORBANCE

R eactive (Mean) . Reactive (Mean) .

W eakly Reactive (Mean) . Weakly Reactive (Mean) .

N onreactive (Mean) . Nonreactive (Mean) .

C utoff Value . Cutoff Value .


SURVEY SAMPLES

INITIAL EIA INITIAL EIA REPEAT EIA FINAL EIA

Sample Interpretation Interpretation

Code Absorbance 1 Absorbance 2 (Circle One) Absorbance 1 Absorbance 2 (Circle One)

. . R E N . . R N

. . R E N . . R N

. . R E N . . R N

. . R E N . . R N

. . R E N . . R N

. . R E N . . R N


1. What supplemental/confirmatory test(s) do you normally run for repeatedly reactive results obtained using the EIA test kit listed in the Repeat EIA section (or Initial EIA if no Repeat EIA is performed) on the opposite page? Check all that apply.


A. Supplemental/Confirmatory test not run in our laboratory

B. Western blot (WB)

C. Immunofluoresence Assay (IFA)

D. Gen-Probe Aptima HIV-1 RNA Qualitative Assay

E. HIV-1 or HIV-1/2 Rapid Test

F. Send to reference laboratory

G. Other, specify______________________________


2. If you indicated "Gen-Probe Aptima HIV-1 RNA Qualitative Assay" in question 1, for what other purpose(s) do you use this assay? Check all that apply.


A. Only use as Supplemental/Confirmatory test for EIA repeat reactive samples

B. Use as method for screening blood or plasma donors

C. Use to aid in diagnosis of acute or primary HIV infection

D. Other use ____________________________________


3. Please indicate your normal testing sequence for samples to be tested for HIV antibody by placing a number in the box corresponding to the step (1st, 2nd, 3rd, etc.) of the testing algorithm. If two assays occur simultaneously in the testing sequence (e.g., WB and IFA), give both assays the same number.

I nitial EIA in singlicate

I nitial EIA in duplicate

R epeat EIA, if initial EIA is reactive

W B

I FA

G en-Probe Aptima HIV-1 RNA Qualitative Assay

H IV-1 or HIV-1/2 Rapid Test


[ ] No, we are not planning to change or add EIA test kits.


In performing EIA, does your laboratory use quality control material in addition to controls that are included in manufactured EIA test kits?


N O YES If yes, please complete the following section.


QUALITY CONTROL TESTING


DO NOT describe the positive and negative controls provided in the EIA test kit.


Source of Quality Control (QC) Material

In House (prepared by own laboratory)

  Commercial Manufacturer (please specify): ___________________________________________


Frequency of Use of QC Material

With each EIA plate With each set/run of EIA plates

With each new EIA kit lot Daily with the first EIA run

Other (please specify):_____________________________________________________________


Description of QC Material (Please mark only ONE box)

S ingle serum/plasma (i.e., just ONE reactivity material is used for either each EIA plate, for each set/run of EIA plates, for each new EIA kit lot, or daily with the first EIA run.)

M ultiple sera/plasma (i.e., MORE THAN ONE reactivity material is used for either each EIA plate, for each set/run of EIA plates, for each new EIA kit lot, or daily with the first EIA run.)

O ther (please specify):____________________________________________


Reactivity of QC Material

(Note: If single serum/plasma was checked above, only one box should be checked here. If multiple sera/plasma was checked above, then one or more boxes can be checked here.)

Strongly positive

Weakly positive

Negative

All of the above

Other (please specify):____________________________________________



WB . . . WB . . . WB . . . WB . . . WB . . .


SPECIFIC INSTRUCTIONS FOR WESTERN BLOT (WB)

  1. Enter the name of the test kit or individual reagents in the spaces provided; for code 99, also enter the manufacturer’s name. Please indicate with an “X” in the appropriate box the type of conjugate used.


  1. Mark the appropriate box(es) with an “X” to indicate the molecular weight of the protein(s) detected that have a band intensity equal to or greater than the weak positive control provided in the test kit and are used in interpreting your WB results. For those protein(s) detected that have a band intensity less than the weak positive control and are not used in interpreting your WB results, please mark with a “W” (indicating +/- reactivity). If additional proteins are detected, please indicate their molecular weights in the spaces provided under “Other,” for example:


17/18 24 31/32 41 51 55 65/66 120 160 OTHER

X X X X 38 110



3. NOTE: If your laboratory uses Quality Control material, in addition to the controls that are included in manufactured WB test kits, please complete the Quality Control Testing Section of the WB result form.


W ESTERN BLOT MANUFACTURER CODES

CODE MANUFACTURER CODE MANUFACTURER

44 Bio-Rad Genetic Systems HIV-1 28 Genelabs Diagnostics HIV-1 Blot

84 Bio-Rad New LAV Blot 1 97 In House (prepared by own laboratory)

09 Cambridge Biotech (Biotin-Avidin) 98 Noncommercial (e.g., supplied

by the state laboratory)

99 Other (Specify on results form)


Note: Report any Line Immunoassay (e.g., INNO-LIA, Liatek) or Dipstick test results on the “Other” procedures results form, pages 17-20.



WESTERN BLOT INTERPRETATION CODES

CODE INTERPRETATION

R Reactive

I Indeterminate

N Nonreactive

MPEP No.


U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Coordinating Center for Infectious Diseases, Mail Stop G-23

Atlanta, Georgia 30333


WESTERN BLOT LABORATORY RESULTS FORM



N ONREPORTING CODE (Specify reason if code “D” or G”):______________________________


Note: Report any Line Immunoassay (e.g., INNO-LIA, Liatek) or Dipstick test results on the “Other” procedures results form, pages 17-20.







REAGENTS

KIT (OR PREBLOTTED STRIPS)

Mfr.Code

M anufacturer

Lot #______________________________________


Kit Name__________________________________


CONJUGATE Mfr.Code

M anufacturer _


Lot #______________________________________


(If conjugate is contained in a kit, use ONLY the kit

lot number.)





















TEST CONTROLS

Reactive Mfr.Code

M anufacturer


Lot #______________________________________


Weakly Reactive Mfr.Code

M anufacturer


Lot #______________________________________



Nonreactive Mfr Code

M anufacturer__________________________


Lot #______________________________________

B LOTTING BUFFERS

Kit ________________________________


In-House ___________________________

O ther (please specify) _________________







TEST CONTROLS




Molecular Weight of Proteins Detected

REACTIVE CONTROL

17/18 24 31/32 41 51 55 65/66 120 160 OTHER

 


WEAKLY REACTIVE CONTROL

 


NONREACTIVE CONTROL

 



SURVEY SAMPLES



SURVEY SAMPLES

Sample Molecular Weight of Proteins Detected Interpretation

Code 17/18 24 31/32 41 51 55 65/66 120 160 OTHER (Circle One)


 R I N

 R I N

R I N

R I N

R I N

R I N



Western Blot Interpretive Criteria

Please indicate in this box the letter that corresponds to the organization whose criteria you used to interpret these HIV-1 Western blot results.


A. Association of Public Health Laboratories/Centers for Disease Control

and Prevention (APHL/CDC)

B. Consortium for Retrovirus Serology Standardization (CRSS)

C. World Health Organization (WHO)

D. OTHER (please specify):___________________________________



In performing WB, does your laboratory use quality control material in addition to controls that are included in manufactured WB test kits?


NO YES If yes, please complete the following section.


QUALITY CONTROL TESTING


DO NOT describe the positive and negative controls provided in the WB test kit.

Source of Quality Control (QC) Material

In House (prepared by own laboratory)

Commercial Manufacturer (please specify): ____________________________________

Frequency of Use of QC Material

With each tray of strips With each set/run of strips

With each new WB kit lot Daily with the first WB run

Other (please specify):_________________________________________________________


Description of QC Material (Please mark only ONE box)

Single serum/plasma (i.e., just ONE reactivity material is used for either each tray of strips, for each set/run of strips, for

each new WB kit lot, or daily with the first WB run.)

Multiple sera/plasma (i.e., MORE THAN ONE reactivity material is used for either each tray of strips, for each set/run of

strips, for each new WB kit lot, or daily with the first WB run.)

Other (please specify):________________________________________________________

Reactivity of QC Material

(Note: If single serum/plasma was checked above, only one box should be checked here. If multiple sera/plasma was checked above, then one or more boxes can be checked here.)


Strongly positive Weakly positive Negative

All of the above

Other (please specify): _________________________________________________


IFA . . . IFA . . . IFA . . . IFA . . . IFA . . .



SPECIFIC INSTRUCTIONS FOR

I MMUNOFLUORESCENCE ASSAY (IFA)___________


1. If you do not use a commercial kit for IFA, enter the names, manufacturer, and lot numbers of the reagents and controls used.


2. Circle the intensity of fluorescence; e.g., 0, 1+, 2+, 3+, 4+, for both the infected and uninfected cells for test controls and survey samples.


3. NOTE: If your laboratory uses Quality Control material in addition to the controls that are included in manufactured IFA test kits, please complete the Quality Control Testing Section of the IFA result form.


I FA MANUFACTURER CODES____________________


CODE MANUFACTURER CODE MANUFACTURER

92 Sanochemia Fluorognost 98 Noncommercial (e.g., supplied

by the State Laboratory)


97 In House (prepared by 99 Other (please specify on

own laboratory) results form)


IFA INTERPRETATION CODES


CODE INTERPRETATION

R Reactive

I Indeterminate

N Nonreactive



  MPEP No. 

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Coordinating Center for Infectious Diseases, Mail Stop G-23

Atlanta, Georgia 30333


IMMUNOFLUORESCENCE ASSAY LABORATORY RESULTS FORM


N ONREPORTING CODE (Specify reason if code “D” or “G”):_____________________


REAGENTS


KIT

Mfr.Code

M anufacturer

Lot #______________________________________


Kit Name__________________________________


CONJUGATE Mfr.Code

M anufacturer


Lot #______________________________________



CELL LINE Mfr.Code

M anufacturer


Name of

Cell Line _________________________________


Lot #______________________________________





TEST CONTROLS

Reactive Mfr.Code

M anufacturer


Lot #______________________________________


Weakly Reactive Mfr.Code

M anufacturer


Lot #______________________________________


Nonreactive Mfr.Code

M anufacturer


Lot #______________________________________

D ILUENTS

Kit


In House (please specify):


____________________________________


O ther (please specify):

____________________________________






TEST CONTROLS




FLUORESCENCE INTENSITY


INFECTED CELLS UNINFECTED CELLS

(Circle One) (Circle One)

REACTIVE CONTROL 0 1+ 2+ 3+ 4+ 0 1+ 2+ 3+ 4+



WEAKLY REACTIVE CONTROL 0 1+ 2+ 3+ 4+ 0 1+ 2+ 3+ 4+



NONREACTIVE CONTROL 0 1+ 2+ 3+ 4+ 0 1+ 2+ 3+ 4+





SURVEY SAMPLES



Sample

Code

INFECTED CELLS

(Circle One)

UNINFECTED CELLS

(Circle One)

Interpretation

(Circle One)

 

0 1+ 2+ 3+ 4+

0 1+ 2+ 3+ 4+

R I N

 

0 1+ 2+ 3+ 4+

0 1+ 2+ 3+ 4+

R I N

 

0 1+ 2+ 3+ 4+

0 1+ 2+ 3+ 4+

R I N


0 1+ 2+ 3+ 4+

0 1+ 2+ 3+ 4+

R I N

 

0 1+ 2+ 3+ 4+

0 1+ 2+ 3+ 4+

R I N


0 1+ 2+ 3+ 4+

0 1+ 2+ 3+ 4+

R I N





In performing IFA does your laboratory use quality control material in addition to controls that are included in manufactured IFA test kits?


N O YES If “YES”, please complete the following section.



QUALITY CONTROL TESTING



DO NOT describe the positive and negative controls provided in the IFA test kit.


Source of Quality Control (QC) Material

In House (prepared by own laboratory)

Commercial Manufacturer (please specify):__________________________________________


Frequency of Use of QC Material

With each IFA slide With each set/run of IFA slides

With each new IFA kit lot Daily with the first IFA run

Other (please specify):_____________________________________________


Description of QC Material (Please mark only ONE box)

Single serum/plasma (i.e., just ONE reactivity material is used for either each IFA slide, for each set/run of IFA slides, for each new IFA kit lot, or daily with the first IFA run.)

Multiple sera/plasma (i.e., MORE THAN ONE reactivity material is used for either each IFA slide, for each set/run of IFA slides, for each new IFA kit lot, or daily with the first IFA run.)

Other (please specify):_____________________________________________


Reactivity of QC Material

(Note: If single serum/plasma was checked above, only one box should be checked here. If multiple sera/plasma was checked above, then one or more boxes can be checked here.)

Strongly positive

Weakly positive

Negative

All of the above

Other (please specify):______________________________________________



OTHER . . . OTHER . . . OTHER . . .

SPECIFIC INSTRUCTIONS FOR “OTHER”* PROCEDURES

*“Other” procedures include all tests other than Enzyme Immunoassay, Western Blot or Immunofluorescence Assay. Please do not enter results for any HIV rapid tests on this form.


1. Enter the name of the procedure used in the blocks provided. (Please attach a copy of your procedure to the results form.)


2. Place an “X” in the appropriate box that indicates the source of your reagents.


3. Enter the name of the three most essential reagents used in your procedure in the blocks provided; for code 99, also enter the manufacturer’s name. Enter the lot numbers of reagents and controls used.


4. Record the results for the test controls and survey samples using units of measure or description applicable to your procedure.


5. Circle an Interpretation Code for each sample.


  1. NOTE: If your laboratory uses Quality Control material in addition to the controls that are included in manufactured “Other” procedures, please complete the Quality Control Testing Section of the “Other” procedures result form.


M ANUFACTURER CODES FOR “OTHER” PROCEDURES

CODE

MANUFACTURER

C ODE

MANUFACTURER

23


bioMérieux Liatek

97


In House (prepared by own laboratory)

25


Chiron RIBA HIV-1/HIV-2 SIA

98

Noncommercial (e.g., from state laboratory)

27


Innogenetics INNO-LIA HIV-I/II

99

Other (specify on results form)







Note: Abbott AxSYM, Abbott IMx, Abbott PRISM, Abbott HIV 1/2 gO, bioMérieux VIDAS HIV DUO, and Ortho Vitros ECi AntiHIV 1+2 have been moved to the EIA portion of the result booklet. Please record results for these tests on the EIA results page (see EIA manufacturer codes on page 5).




INTERPRETATION CODES___________________________

CODE INTERPRETATION

R Reactive

I Indeterminate

N Nonreactive





M PEP No.

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Coordinating Center for Infectious Diseases, Mail Stop G-23

Atlanta, Georgia 30333


RESULTS FORM FOR PROCEDURES “OTHER” THAN ENZYME IMMUNOASSAY, WESTERN BLOT OR IMMUNOFLUORESCENCE ASSAY (DO NOT REPORT HIV RAPID TESTS ON THIS FORM.)

N ONREPORTING CODE (Specify reason if code “D” or “G”):___________________________


Name of Procedure: ___________________________________________________________________


REAGENTS

REAGENT OBTAINED

I n House


Commercial


REAGENT OR KIT DESCRIPTION


________________________________________

Mfr.Code

M anufacturer

Lot #______________________________________


Kit Name__________________________________





Note: Abbott AxSYM, Abbott IMx, Abbott PRISM, Abbott HIV 1/2 gO, bioMérieux VIDAS HIV DUO, and Ortho Vitros ECi AntiHIV 1+2 have been moved to the EIA portion of the result booklet. Please record results for these tests on the EIA results page (see EIA manufacturer codes on page 5).

TEST CONTROLS

Reactive Mfr.Code

M anufacturer


Lot #______________________________________


Weakly Reactive Mfr.Code

M anufacturer


Lot #______________________________________


Nonreactive Mfr.Code

M anufacturer


Lot #______________________________________


DILUENTS

Kit


I n House (please specify):

____________________________________


O ther (please specify):__________________



TEST CONTROLS



Enter Results Applicable To Your Procedure


REACTIVE CONTROL


WEAKLY REACTIVE CONTROL


NONREACTIVE CONTROL


CUTOFF VALUE



SURVEY SAMPLES



Sample

Code

Enter Results Applicable To Your Procedure

(Specify Units)

Interpretation

(Circle One)



R I N



R I N



R I N



R I N



R I N



R I N




In performing tests OTHER than EIA, WB, or IFA, does your laboratory use quality control material in addition to controls that are included in manufactured tests?


N O YES If yes, please complete the following section.


QUALITY CONTROL TESTING



DO NOT describe the positive and negative controls provided in the “other” test kit.


Source of Quality Control (QC) Material

In House (prepared by own laboratory)

Commercial Manufacturer (please specify): ______________________________________


Frequency of Use of QC Material

With each Other test method With each set/run of Other test

With each new kit lot of Other test Daily with the first run of Other test

Other (please specify):________________________________________________________


Description of QC Material (Please mark only ONE box)

Single serum/plasma (i.e., just ONE reactivity material is used for either each Other test, for each set/run of Other test, for each new kit lot of Other test, or daily with the first run of Other test.)

Multiple sera/plasma (i.e., MORE THAN ONE reactivity material is used for either each Other test, for each set/run of Other test, for each new kit lot of Other test, or daily with the first run of Other test.)

Other (please specify): ________________________________________________________


Reactivity of QC Material

(Note: If single serum/plasma was checked above, only one box should be checked here. If multiple sera/plasma was checked above, then one or more boxes can be checked here.)

Strongly positive

Weakly positive

Negative

All of the above

Other (please specify):________________________________________________________


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Authorswn0
Last Modified ByDvv1
File Modified2007-07-03
File Created2006-12-15
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