'Determine' is used for first screening, STAT-PAK for a second test and Uni-Gold as a 'tie-breaker' test.
Unigold (Trinity Biotec Plc, Wicklow, Ireland) was used as tie-breaker test in case of inconclusive results.
Eligible persons were administered two parallel HIV rapid tests (Determine™, Abbott Laboratories, USA) and Bioline™ (Standard Diagnostics, Kyonggi-do, Korea) by trained counselors, with a tie-breaker test for discordant results (Uni-gold™, Trinity Biotech, Ireland).
The national HIV POCT testing algorithm consisted of SD Bioline HIV 3.0 (Standard Diagnostics, Kyong gi-do, Korea), Determine HIV- 1/ HIV-2 (Abbott Laboratories,Wiesbaden-Delkenheim, Germany) with Unigold (Trinity Biotech, Dublin, Ireland) as the tie-breaker test.
One sample was reactive with the Vitros EIA and was Western blot positive; this sample had a reactive in-country tie-breaker test and was correctly identified as HIV-positive based on in-country testing.
A third tie-breaker test was used to define further the infection status of the 24 participants with discordant HIV rapid tests, but the original designation of the participants as HIV DISC was not changed in the study data set.
Twenty-four samples in the pilot study had discordant HIV rapid test results (HIV DISC, Table 2); the in-country tie-breaker test was reactive for three (12.5%) of those samples.
Those 23 samples (95.8% of the 24 HIV DISC samples) were considered to be HIV-negative; this includes two samples that had a reactive in-country tie-breaker test and were identified as HIV-infected based on in-country testing (one from Tanzania and one from Vulindlela, South Africa).
Rapid HIV testing was done according to the National AIDS/STD Control Program (NASCOP) algorithm using two parallel HIV rapid tests (Determine™, Abbott Laboratories, USA) and Bioline™ (Standard Diagnostics, Kyonggi-do, Korea) with a tie-breaker test for discordant results (Uni-gold™, Trinity Biotech, Ireland).
HIV infection status was correctly determined based on-in country testing for 2,236 (99.5%) of 2,247 participants [7 (0.37%) of 1,907 HIV NEG samples were HIV-positive; 2 (0.63%) of 317 HIV POS samples were HIV-negative; 2 (8.3%) of 24 HIV DISC samples were incorrectly identified as HIV-positive based on the in-country tie-breaker test].
In addition, two of the three participants with discordant HIV rapid tests who had a reactive in-country tie-breaker test and were identified in-country as HIV-infected were found to be HIV-negative based on testing at the HPTN Network Laboratory.
