Evaluation of a Three Rapid Test Algorithm for the Diagnosis of HIV Infection at Point-of-Care Rapid Testing Facilities: Strategy 4 Data Needs. R. Boromisa 1, J. Schwendemann 1, M. Parker 1, T. Sullivan 1, M. San Antonio-Gaddy 2, A. Richardson- Moore 2 NEW YORK STATE DEPARTMENT OF HEALTH WADSWORTH CENTER 1 AIDS INSTITUTE 2 ALBANY, NY

Description of test data for 11 A1+/A2+ Western blot indeterminate specimens. Specimen number EIA s/co Multispot result (A2) WB Band patternHIV-1 RNA QNS4,1,0,0p24,p51,*gp160Positive ,4,2,0p24,p51,p66,*gp160Positive ,4,2,0gp41,gp 120/160Positive ,4,3,0p17,p24,p31,p51,p66,*gp120/160Positive ,4,2,0p17,p24,p66,*gp120/160Positive ,2,4,0p24,p51Positive ,0,2,0*p17,p24Positive ,0,3,0p24,p31,p51,p55,p66,*gp160Positive ,0,4,0p24,p31,*gp41,p51,p66,*gp160Invalid ,4,2,0p17,p24,p66,*gp120/160Invalid ,4,0,0p24,p55,*gp120/160QNS * Weakly reactive WB band

Description of test data for 3 A1+/A2+ Western blot negative specimens. Specimen number EIA s/co Multispot result (A2) WB band pattern HIV-1 RNA ,1,1,0No bandsPositive <14,0,3,0No bandsNegative <14,0,1,0No bandsNegative

Description of test data for 3 A1+/A2-/A3+ specimens. Specimen number EIA s/co Multispot result WB band pattern HIV-1 RNA <14,0,0,0No bandsNegative <14,0,0,0No bandsNegative ,0,0,0No bandsNegative

Details of 6 A1+/A2-/A3- specimens that were EIA reactive. Specimen Number EIA s/co WB result HIV-1 RNA Negative Negative Negative Negative Negative NegativeInvalid

Data Needs for Strategy 4: Questions ) Number and percentage of false positive A1+/A2+ results in truly uninfected persons, as detected by laboratory-based supplemental testing. Only 2 of 11 A1+/A2+ WB indeterminate or negative specimens that produced valid HIV-1 RNA results were negative (2/136, 1.5%).

Data Needs for Strategy 4: (continued) 2) Number and percentage of persons referred to medical care on presumptive positive rapid test results who are actually in medical care within six months of receiving the results. In , there were a total of 148 confirmed positive clients. There were 106 clients (71.6%) that accepted referrals for medical care but only 77 (72.6%) reached their referrals.

Data Needs for Strategy 4: (continued) 3) Number and percentage of specimens with negative rapid tests (A1-) that were determined to be false negative results by acute infection screening; and the impact of using risk-based criteria for acute infection screening. This study did not test A1- specimens for acute HIV infection screening. The impact of using risk-based criteria for acute infection screening has not been determined.

Data Needs for Strategy 4: (continued) 4) Number and percentage of specimens with presumptive positive rapid tests results that have false negative results on the A2 test as determined by further clinical evaluation. None of the 38 A2- specimens were false negative. The 3 A2- specimens (7.9%) that were weekly reactive on the A3 rapid test were HIV-1 RNA negative.

Data Needs for Strategy 4: (continued) 5) Number and percentage of specimens with inconclusive rapid test results for one or more of the following: False positive A1 results There were 40 false positive A1+ specimens (40/174, 23.0%) identified in this study: 35 A2-/A3-/WB-, 3 A2- /A3+/WB-/RNA-, and 2 A2+/WB-/RNA-. False negative A2 and A3 results None of the 35 A2-/A3- specimens were thought to be false negatives even though HIV-1 RNA was not performed on EIA- specimens. All 35 specimens were WB negative.

Data Needs for Strategy 4: (continued) 6) For persons with inconclusive rapid test results (A1+/A2- /A3-) Number and percentage of clients that are uninfected There were 40 clients that were determined to be uninfected: 35 A2-/A3-/WB-, 3 A2-/A3+/WB-/RNA- and 2 A2+/WB-/RNA- (40/174, 23.0%). Rates of receipt of laboratory results In , 110 of 148 clients (74.3%) received their confirmed test result.

Whether a change in the message a client receives from a counselor influences client return rates to receive their laboratory test results We cannot say with confidence whether a counseling message changes the return rate for clients since so many other variables, including whether they already knew their HIV positive status or they went directly to a medical provider instead of returning to the program site. Data Needs for Strategy 4: (continued) 6) For persons with inconclusive rapid test results (A1+/A2-/A3-) (continued)

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