Field Evaluation of a Rapid Human Immunodeficiency Virus (HIV) Serial Serologic Testing Algorithm for Diagnosis and Differentiation of HIV Type 1 (HIV-1), HIV-2, and Dual HIV-1-HIV-2 Infections in West African Pregnant Women

Abstract

We evaluated a two-rapid-test serial algorithm using the Determine and Genie II rapid assays, performed on-site in four peripheral laboratories during the French Agence Nationale de Recherches sur le SIDA ( , respectively. The specificities were 98.4% (95% CI, 96.9 to 99.3%) and 100% (95% LL, 99.3%), respectively. All serological assays gave concordant results for infections with single types. By contrast, for samples found to be infected with dual HIV types by the Genie II assay, dual reactivity was detected for only 37 samples (52.1%) by WB assays, 34 samples (47.9%) by the Peptilav assay, and 23 samples (32.4%) by the monospecific ELISAs. For specimens with dual reactivity by the Genie II assay, the rates of concordance between the real-time PCR assays and the serological assays were 25.7% for the Genie II assay, 82.9% for the Peptilav assay, 74.3% for WB assays, and 80% for the homemade ELISAs. Our algorithm provided high degrees of sensitivity and specificity comparable to those of ELISAs. Even if they are rare, women identified by the Genie II assay as being infected with HIV-1 and HIV-2 mostly appeared to be infected only with HIV-2.Human immunodeficiency virus (HIV) antibody testing is a critical step that allows the implementation of effective prevention and care interventions in HIV-infected individuals. Simple voluntary counseling and testing (VCT) approaches are increasingly required, especially in situations in which the rapid identification of HIV infection is warranted, such as in pregnant women during gestation and in the peripartum period (3, 6, 13). For instance, among pregnant women attending antenatal clinics in Côte d'Ivoire, among whom the prevalence of HIV infection is estimated to be 10%, the increasing implementation of low-cost interventions to reduce mother-to-child transmission (MTCT) with short antiretroviral regimens has created new demands for VCT (22).For this purpose, the use of standard enzyme-linked immunosorbent assays (ELISAs), designed for batch testing, followed by confirmatory Western blot (WB) tests, if necessary, is now considered time-and money-consuming (5, 23). Sophisticated equipment (such as automatic pipettes, incubators, washers, and readers) must be available, is costly to purchase and maintain, and must be located near clean water and a reliable supply of electricity. The validity of the results obtained by these techniques strongly depends on the skills of the technicians, and their interpretation requires skills training and supervision. These conditions are often lacking in sub-Saharan Africa, at least in district-level hospitals. Finally, given the important delay between HIV antibody testing by standard procedures and the availability of results, a significant number of people do not return for posttest counseling (21).

Baseline characteristics, response to and outcome of antiretroviral therapy among patients with HIV-1, HIV-2 and dual infection in Burkina Faso

“…Different studies have shown that among individuals diagnosed as dually seropositive, often only HIV-1 or HIV-2 DNA is isolated (more often HIV-1), a phenomenon commonly thought to be explained by crossreactivity. 12,[36][37][38][39][40][41] In our study it is therefore possible that dual infection was overestimated, although to what extent is uncertain. Diagnosis of dual infection would ideally require the isolation of both viruses from an individual through the use of PCR techniques.…”

Evaluation of four rapid tests for diagnosis and differentiation of HIV-1 and HIV-2 infections in Guinea-Conakry, West Africa

“…Of the four rapid assays evaluated, the Genie II HIV1/HIV2 was found to be most accurate for discriminating between HIV-1 and HIV-2 (this finding has not always been confirmed in other settings 9 ) but did misidentify an HIV-2 sample as being HIV-1 which is a problem given the treatment issues around HIV-1 and HIV-2. However, use of the Genie II HIV1/HIV2 in Guinea-Conakry would be particularly compromised by the fact that the test requires sera (instead of whole blood) and is subject to cold chain availability, both of which are important operational considerations at peripheral facilities.…”

Susceptibility of Human Testis to Human Immunodeficiency Virus-1 Infection in Situ and in Vitro

“…Quantitative real-time RT-PCR was used to amplify a region with low degree of variability in the long terminal repeat (LTR) gene of the HIV-1 genome as previously described. 33 RT-PCR was performed as a one-step assay on 50 ng of RNA run in duplicate, using commercially available TaqMan one-step RT-PCR MasterMix (Applied Biosystems), with an internal standard for quantification. Amplification and data acquisition were performed with the ABI Prism 7000 sequence de-tection system (Applied Biosystems).…”