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NEW YORK STATE DEPARTMENT OF HEALTH WADSWORTH CENTER ALBANY, NY

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.

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NEW YORK STATE DEPARTMENT OF HEALTH WADSWORTH CENTER ALBANY, NY

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  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 HEALTHWADSWORTH CENTERALBANY, NY

  2. 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

  3. Results of 733 EIA HIV-1/2 reactive specimens tested using the HIV-1/2 discriminatory assay, January 2006 – September 2007.

  4. Details of test results for 6 Multispot HIV-1/HIV-2 reactive specimens that were Western blot indeterminate and HIV-1 RNA positive. * Weakly reactive WB band

  5. 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

  6. Details of test results for 110 Multispot HIV-1/HIV-2 nonreactive specimens that had detectable levels of HIV-1 RNA. * Weakly reactive WB band

  7. 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.

  8. 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.

  9. 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.

  10. 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.

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