Relative accuracy of serum, whole blood, and oral fluid HIV tests among Seattle men who have sex with men

Abstract

Background Point-of-care (POC) rapid HIV tests have sensitivity during the “window period” comparable only to earliest generation EIAs. To date, it is unclear whether any POC test performs significantly better than others. Objective Compare abilities of POC tests to detect early infection in real time. Study Design Men who have sex with men (MSM) were recruited into a prospective, cross-sectional study at two HIV testing sites and a research clinic. Procedures compared four POC tests: one performed on oral fluids and three on fingerstick whole blood specimens. Specimens from participants with negative POC results were tested by EIA and pooled nucleic acid amplification testing (NAAT). McNemar’s exact tests compared numbers of HIV-infected participants detected. Results Between February 2010 and May 2013, 104 men tested HIV-positive during 2479 visits. Eighty-two participants had concordant reactive POC results, 3 participants had concordant non-reactive POC tests but reactive EIAs, and 8 participants had acute infection. Of 12 participants with discordant POC results, OraQuick ADVANCE Rapid HIV-1/2 Antibody Test performed on oral fluids identified fewer infections than OraQuick performed on fingerstick (p=.005), Uni-Gold Recombigen HIV Test (p=.01), and Determine HIV-1/2 Ag/Ab Combo (p=.005). Conclusions These data confirm that oral fluid POC testing detects fewer infections than other methods and is best reserved for circumstances precluding fingerstick or venipuncture. Regardless of specimen type, POC tests failed to identify many HIV-infected MSM in Seattle. In populations with high HIV incidence, the currently approved POC antibody tests are inadequate unless supplemented with p24 antigen tests or NAAT.

Associations of Sexually Transmitted Infections With Condom Problems Among Young Men Who Have Sex With Men

“…However, our use of CASI for data collection should have helped reduce social desirability bias 18,19 and the results of one prior study were inconsistent with racial differences in reporting bias for sexual risk behaviors among YMSM 31 . We used OraQuick oral fluid tests for HIV, which may not have detected recent infections 32 and therefore our results may be an underestimate of the association between condom problems and HIV infection.…”

Selecting an HIV Test: A Narrative Review for Clinicians and Researchers

“…To accomplish this, laboratory-based p24/IgM/IgG sensitive assays on serum or plasma should be used whenever possible. In settings with support for specimen processing but without an automated test platform, using serum or plasma with a p24/IgM/IgG sensitive POC test will improve its sensitivity (compared to whole blood) 11,13,14 and offers the potential for earlier diagnosis than with IgM/IgG sensitive tests. Although most people with symptomatic HIV-1 acute retroviral syndrome (e.g., fever, pharyngitis, and lymphadenopathy) will have detectable p24 antigenemia, adding a nucleic acid test to the diagnostic workup (where available) may help capture the small proportion of those with recent infections who are RNA-positive but antigen-negative.…”

Response to the Modeling Analysis by Katz et al. on the Impact of Replacing Clinic-Based HIV Tests With Home Testing Among Men Who Have Sex With Men in Seattle

“…However, this estimate is based on the performance of the professional use version of the In-Home Test on serial plasma specimens, 3 and studies suggest that this test has a significantly longer window period when used on oral fluids. 4,5 …”