HIV rapid screening tests and self-tests: Be aware of differences in performance and cautious of vendors

Abstract

BackgroundRapid tests for HIV testing are essential tools to achieve the 90-90-90 target of the World Health Organization. Many tests are available, some directly from websites. Evaluation of the performance of rapid tests, under close to real-life usage, is therefore needed to ensure accurate diagnosis in the context of the recommendation for their more widespread use.MethodNine third- (3G) or fourth-generation (4G) rapid screening tests or self-tests (two bought on websites), were evaluated on an extensive panel of 200 HIV-negative and 312 HIV-positive samples, representative of a wide variety of clinical situations and HIV genetic diversity. A whole blood reconstitution protocol was designed to simulate real-life usage of these tests in community-based and private settings.FindingsThe specificity was high (98.5–100%) and sensitivity excellent (100%) for samples from patients chronically infected with the pandemic strains. The performance for infrequent situations with a major epidemiological and clinical impact, such as infection with divergent viruses or primary infection, was highly variable, depending on the test. One of the two 4G tests allowed detection of additional positive samples from early stages of infection, whereas the second (sold as a 4G test on a website) corresponded in reality to a 3G test.InterpretationOur study showed that not all tests are equal for the detection of major HIV variants or early stages of HIV infection; adding the detection of specific p24Ag improved the latter point. This study also showed, for the first time, that buying through web-based vendors can be risky, due to the varying performance of the tests and questionable sales practices. Our results are of particular importance in the context of the increasing use of rapid tests in an “outside laboratory” settings.FundSanté Publique France, COREVIH – Normandie, and Rouen University Hospital.

Circulation of multiple subtypes (A, G and CRFs 02_AG) of human immunodeficiency virus type 1 (HIV-1) in selected districts of Punjab province, Pakistan

“…This supports the sensitivity and specificity of the Alere HIV Combo test, which is claimed to be 99.9% and 99.7%, respectively by the manufacturer. Similar observations have been reported in previous studies [23][24][25]. Subtyping of currently prevailing HIV-1 isolates is considered crucial for understanding the genetic evolution of this virus around the globe [26], and, for this particular purpose, the pol gene is considered an important marker for accurate delineation of HIV-1 subtypes [15][16][17][27][28][29].…”

Peer Mobilization and Human Immunodeficiency Virus (HIV) Partner Notification Services Among Gay, Bisexual, and Other Men Who Have Sex With Men and Transgender Women in Coastal Kenya Identified a High Number of Undiagnosed HIV Infections

“…They distributed OraQuick HIV oral self-tests within their networks and referred clients for study screening, regardless of the self-test result. Since the antibody-based self-test performs poorly in diagnosing AEHI [ 14 ], peer mobilizers gave clients with AEHI symptoms a symptom referral card and immediately referred them for enrollment and further testing. Peer mobilizers were compensated with US$15 in each week that they achieved their target of mobilizing 5 clients for study screening.…”

“…Community-led HIV testing and counseling services (HTC), including provision of self-tests, combined with HPN, proved feasible and effective in diagnosing HIV and linking clients to HPN and care among key populations in Thailand [ 13 ]. However, HIV oral self-tests and other antibody-based HIV self-tests will miss acute or early HIV infection (AEHI) [ 14 ], while undiagnosed AEHI could be an important driver of the ongoing HIV epidemic among GBMSM and TGW in SSA [ 15–17 ].…”

2021 European guideline on HIV testing in genito‐urinary medicine settings

“…Patients presenting for PEPSE however should be tested at the start of PEPSE 109 . In individuals using PrEP or PEP/PEPSE, seroconversion can be delayed; thus, rapid HIV tests are not recommended as the sole mode of HIV testing in this context 110,111 . (2 B) If a patient presents with clinical symptoms suggestive of HIV infection or AIDS and the HIV screening tests are repeatedly negative, then referral of the specimen to a specialized laboratory for analysis using alternative tests to exclude uncommon HIV strains is recommended.…”