Rapid HIV testing: A review of the literature and implications for the clinician

Abstract

HIV counseling and testing services are critical for individuals to access HIV prevention and treatment. Unfortunately, the standard HIV testing algorithm is complex and includes the use of a sensitive enzyme immunoassay (EIA), followed by a Western blot if the EIA is positive. This process can take 1 week or longer. Therefore, innovative approaches that incorporate simpler diagnostic algorithms are needed to reach the large number of individuals who are not aware that they are HIV-infected. Currently available rapid HIV tests have demonstrated sensitivities and specificities comparable to those of standard HIV testing without the requirements of sophisticated laboratory resources or highly trained personnel. These rapid HIV tests are increasingly being used in various clinical scenarios to decrease the number of missed opportunities for detection of HIV-infection. Their use is particularly applicable in specific clinical and nonclinical settings; public health settings; labor and delivery wards; in the management of occupational exposures; and in resource-constrained settings. The overarching goals of achieving wide implementation of rapid HIV tests are to increase the number of individuals who are aware of their serostatus, to improve entry of persons with HIV into prevention and care services, and to prevent further HIV transmission.

Rapid Detection and Differentiation of Antibodies to HIV-1 and HIV-2 Using Multivalent Antigens and Magnetic Immunochromatography Testing

“…The use of rapid HIV tests has now become routine in many areas of the world due to their simplicity, low cost, and excellent performance characteristics (8,24). In the United States, six rapid HIV assays are now approved by the U.S. Food and Drug Administration, and four of these have been categorized as "waived" testing under CLIA 1988, where the qualifications of the testers are minimal.…”

Saliva Testing as a Practical Tool for Rapid HIV Screening

“…They are simple to use and have high specificity, however, false positives do occur and they have been criticised in previous years for lacking in sensitivity relative to reference enzyme immunoassays (EIA/ELISA), particularly during primary HIV infection and infection by variant strains (Makuwa et al, 2002). There is, however, research evidence to indicate that rapid HIV tests produce results of comparable sensitivity and specificity to the ELISA test (Franco-Paredes et al, 2006;Greenwald et al, 2006;Branson, 2000a). Laboratory testing of 1266 specimens at rural peripheral laboratories of varied combinations of seven rapid HIV tests even showed a specificity of 100% (Stetler et al, 1997).…”

“…Debattista et al, 2007;Hamers et al, 2008;Delaney et al, 2006). Independent performance data for 4 FDA approved rapid HIV tests (Franco-Paredes et al, 2006) and a wider range of rapid tests (Branson, 2000a) highlight product testing with both sensitivity and specificity outcomes of 100% (Oraquick and Retrocell HIV-1/2) (Branson, 2000a). Data from 2006 showed that in testing, sensitivity and specificity exceeded 99% in 4 FDA approved tests (with the exception of Reveal G2 Plasma test where specificity is 98.6%) (Franco-Paredes et al, 2006).…”

“…It should be noted that although rapid tests using saliva have been shown to have high sensitivity and specificity parameters (Delaney et al, 2011), these are essentially brief screening tests and it has long been recognised that in cases where the first screening test utilised saliva, the diagnosis should be reconfirmed through a rapid test that involves blood testing (Andersson et al, 1997). In fact, it is now generally accepted that a second confirmatory test which detects the presence of a specific type of antibody to HIV 1/2 must follow (Franco-Paredes, et al, 2006). WHO recommends that for diagnostic purposes, two assays be used with a third test for discrepant results (Strategy II and III); the first test must have the highest sensitivity and the second test a similar or higher specificity (UNAIDS/WHO, 2004).…”

Assessment of Rapid Tests for Detection of Human Immunodeficiency Virus-Specific Antibodies in Recently Infected Individuals

“…This panel can serve a key function for the evaluation of antibody tests because it allows different HIV-specific antibody tests to be assessed for their sensitivities with specimens that may have relatively low anti-HIV immunoglobulin G (IgG) titers or that may contain only IgM. Previous studies have evaluated the sensitivities of various rapid tests, including analyses with seroconversion panels (1,5,8,10,12,16,19). However, no work to date has comprehensively evaluated the performance characteristics of all FDA-approved devices.…”