1. Evaluation of a Proposed Testing Strategy for Laboratory-based Testing Using an HIV-1/2 Discriminatory Assay for HIV: Strategy 5 Data Needs. R. Boromisa, J. Schwendemann, M. Parker, T. Sullivan. NEW YORK STATE DEPARTMENT OF HEALTH WADSWORTH CENTER ALBANY, NY

4. Description of Multispot (BioRad) HIV-1/HIV-2 Reactive Control Spot and Test Spots 1. Procedural control:Anti-human IgG (goat) 2. HIV-2 Peptide: Peptide representing the HIV-2 virus gp36 3. Recombinant HIV-1: Recombinant gp41 (gp41rDNA) 4. HIV-1 Peptide: Peptide representing the HIV-1 virus gp41

5. Results of 733 EIA HIV-1/2 reactive specimens tested using the HIV-1/2 discriminatory assay, January 2006 – September 2007. HIV-1 (-) HIV-2 (+) HIV-1 (+) HIV-2 (+) HIV-1 (-) HIV-2 (-) HIV-1 (+) HIV-2 (-) 0 Specimens 4 Specimens (0.5%) 4 HIV-1 only after Dilution 110 Specimens (15%) 18 WB ind 92 WB neg 619 Specimens (84.4%) 609 WB pos 9 WB ind 1 WB neg

6. Details of test results for 6 Multispot HIV-1/HIV-2 reactive specimens that were Western blot indeterminate and HIV-1 RNA positive. Specimen number EIA s/co Multispot result WB Band pattern 061100169 8.334,1,1,0p24,p31,p51,*p66,*gp120/160 062010004 9.704,4,3,0*p17,p24,*p31,*gp41,p51,p66, *gp120/160 062580007 7.994,4,3,0p24,* gp41,*p51,p55,p66, gp160 063310037 8.144,4,3,0*p17,p24,*gp41,*p66,gp120/160 063400079 7.814,4,3,0p17,p24,p66,gp120/160 06349003710.034,4,3,0p24,gp120/160 * Weakly reactive WB band

7. Specimen number EIA s/co Multispot Result WB band Pattern 060020151 1.094,1,0,0p24,*p31,*p51,p66, gp120/160 07236002810.104,4,0,0*p24,*p55,*gp120/160 07257003510.504,4,0,0p24,p51 (QNS) 062230059 1.194,2,2,0No Bands Details of test results for 4 HIV-1/HIV-2 reactive specimens that were Western blot indeterminate or negative and HIV-1 RNA negative or QNS. * Weakly reactive WB band

8. Details of test results for 110 Multispot HIV-1/HIV-2 nonreactive specimens that had detectable levels of HIV-1 RNA. Specimen number EIA s/co Multispot result WB Band pattern HIV-1 RNA 0634100691.404,0,0,0No BandsPositive 0604501298.554,0,0,0* p 24Positive * Weakly reactive WB band

9. Data needs for strategy 5: Questions 1 – 4. 1) Number and percentage of specimens reactive on an HIV-1/2 antibody screening test that are false negative on an HIV-1/2 discriminatory assay. There were 110 of 733 EIA HIV-1/2 reactive specimens (15.0%) that were nonreactive for both HIV-1 and HIV-2 on the HIV-1/2 discriminatory assay.

10. Data Needs for Stategy 5: (continued) 2) Number and percentage of specimens reactive for both HIV-1 and HIV-2 on an HIV-1/2 discriminatory assay that are: truly infected with HIV-1 only, truly infected with HIV-2 only, and true dual HIV-1/2 infections. There were 4 of the 733 EIA reactive specimens (0.5%) that were reactive for both HIV-1 and HIV-2 on the HIV-1/2 discriminatory assay. However, all were reactive for HIV-1 only upon conducting the manufacturer’s specified dilution analysis.

11. Data Needs for Strategy 5: (continued) 3) Number and percentage of specimens on an HIV-1/2 antibody screening test that are negative on an HIV-1 supplemental test but truly infected only with HIV-2. None of the 733 EIA HIV-1/2 reactive specimens (0%) were negative on HIV-1 supplemental tests that were truly infected with HIV-2.

12. Data Needs for Strategy 5: (continued) 4) Number and percentage of specimens reactive on two or more HIV-1/2 antibody screening tests that are truly infected with HIV-2. None of the 733 EIA HIV-1/2 reactive specimens (0%) were reactive for HIV-2 on the HIV-1/2 discriminatory assay.