Evaluation of Rapid Testing Algorithms for Venue-based Anonymous HIV Testing among Non-HIV-Positive Men Who Have Sex with Men, National HIV Behavioral Surveillance (NHBS), 2017

Abstract

HIV rapid testing algorithms (RTAs) using any two orthogonal rapid tests (RTs) allow for on-site confirmation of infection. RTs vary in performance characteristics therefore the selection of RTs in an algorithm may affect identification of infection, particularly if acute. National HIV Behavioral Surveillance (NHBS) assessed RTAs among men who have sex with men recruited using anonymous venue-based sampling. Different algorithms were evaluated among participants who self-reported never having received a positive HIV test result prior to the interview. NHBS project areas performed sequential or parallel RTs using whole blood. Participants with at least one reactive RT were offered anonymous linkage to care and provided a dried blood spot (DBS) for testing at CDC. Discordant results (RT-1 reactive/RT-2 non-reactive) were tested at CDC with lab protocols modified for DBS. DBS were also tested for HIV-1 RNA (VL) and antiretroviral (ARV) drug levels. Of 6500 RTAs, 238 were RT-1 reactive; of those, 97.1% (231/238) had concordant results (RT-1/RT-2 reactive) and 2.9% (7/238) had discordant results. Five DBS associated with discordant results were available for confirmation at CDC. Four had non-reactive confirmatory test results that implied RT-1 false reactivity; one had ambiguous confirmatory test results which was non-reactive in further testing. Regardless of order and type of RT used, RTAs demonstrated high concordant results in the population surveyed. Additional laboratory testing on DBS following discordant results confirmed no infection. Implementing RTAs in the context of anonymous venue-based HIV testing could be an option when laboratory follow-up is not practicable.

The feasibility of modified HIV and antiretroviral drug testing using self-collected dried blood spots from men who have sex with men

“…These two modified protocols were validated and published previously [ 11 ]. Due to the limited blood spots per card, we modified the Abbott RealTi me HIV-1 RNA DBS protocol [ 12 ] with a limit of detection (LOD) of 2.92 log 10 (copies/mL) using a 12 mm perforated circle (~ 70 μL whole blood) to use four 6 mm punches of DBS (~ 50 μL whole blood) [ 13 ]. The validated 4-punch protocol showed a linearity agreement of R 2 = 0.924 when comparing the DBS and 0.8 mL plasma protocols (unpublished data).…”

“…The integrase inhibitor RAL is commonly added to nucleoside analog backbones in antiretroviral therapy. The procedure was described in our previous publication [ 13 ].…”

Performance of HIV rapid testing algorithm in Nigeria: Findings from a household-based Nigeria HIV/AIDS Indicator and Impact Survey (NAIIS)

“…Positive confirmation continues to be even more important as we expand initiation on antiretroviral therapy (ART) immediately after receiving HIV-positive test results [4]. The false positive rate observed by a testing algorithm can be significantly reduced by including a third HIV RT or by including a confirmatory test such as Geenius HIV-1/2 RT (Geenius) or HIV-1 Western blot (WB) [5][6][7][8]. However, the Geenius and WB tests are more complex, expensive, and require appropriate laboratory infrastructure and instrument maintenance.…”

Evaluation of SAMBA II: A Qualitative and Semiquantitative HIV Point-of-Care Nucleic Acid Test

“…47,48 Four 6 mm punches, or approximately 50 mL of WB, were used in a laboratory-validated protocol. 49,50 Blood was eluted in 1.3 mL of Lysis buffer in master mix tubes, both provided with the Abbott m2000sp system. Samples were incubated at 55°C for 30 minutes, vortexed, spun, and placed on m2000 for sample extraction and viral load quantification according to the standard HIV-1 RNA quantitative assay 1.0 mL protocol.…”