Oral fluid-based rapid HIV testing: Issues, challenges and research directions

Expert Review of Molecular Diagnostics (Impact Factor: 4.27). 08/2007; 7(4):325-8. DOI: 10.1586/14737159.7.4.325
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Available from: Nitika Pai, Oct 21, 2014
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    ABSTRACT: Testing pregnant women for HIV at the time of labor and delivery is the last opportunity for prevention of mother-to-child HIV transmission (PMTCT) measures, particularly in settings where women do not receive adequate antenatal care. However, HIV testing and counseling of pregnant women in labor is a challenge, especially in resource-constrained settings. In India, many rural women present for delivery without any prior antenatal care. Those who do get antenatal care are not always tested for HIV, because of deficiencies in the provision of HIV testing and counseling services. In this context, we investigated the impact of introducing round-the-clock, rapid, point-of-care HIV testing and counseling in a busy labor ward at a tertiary care hospital in rural India. After they provided written informed consent, women admitted to the labor ward of a rural teaching hospital in India were offered two rapid tests on oral fluid and finger-stick specimens (OraQuick Rapid HIV-1/HIV-2 tests, OraSure Technologies). Simultaneously, venous blood was drawn for conventional HIV ELISA testing. Western blot tests were performed for confirmatory testing if women were positive by both rapid tests and dual ELISA, or where test results were discordant. Round-the-clock (24 h, 7 d/wk) abbreviated prepartum and extended postpartum counseling sessions were offered as part of the testing strategy. HIV-positive women were administered PMTCT interventions. Of 1,252 eligible women (age range 18 y to 38 y) approached for consent over a 9 mo period in 2006, 1,222 (98%) accepted HIV testing in the labor ward. Of these, 1,003 (82%) women presented with either no reports or incomplete reports of prior HIV testing results at the time of admission to the labor ward. Of 1,222 women, 15 were diagnosed as HIV-positive (on the basis of two rapid tests, dual ELISA and Western blot), yielding a seroprevalence of 1.23% (95% confidence interval [CI] 0.61%-1.8%). Of the 15 HIV test-positive women, four (27%) had presented with reported HIV status, and 11 (73%) new cases of HIV infection were detected due to rapid testing in the labor room. Thus, 11 HIV-positive women received PMTCT interventions on account of round-the-clock rapid HIV testing and counseling in the labor room. While both OraQuick tests (oral and finger-stick) were 100% specific, one false-negative result was documented (with both oral fluid and finger-stick specimens). Of the 15 HIV-infected women who delivered, 13 infants were HIV seronegative at birth and at 1 and 4 mo after delivery; two HIV-positive infants died within a month of delivery. In a busy rural labor ward setting in India, we demonstrated that it is feasible to introduce a program of round-the-clock rapid HIV testing, including prepartum and extended postpartum counseling sessions. Our data suggest that the availability of round-the-clock rapid HIV testing resulted in successful documentation of HIV serostatus in a large proportion (82%) of rural women who were unaware of their HIV status when admitted to the labor room. In addition, 11 (73%) of a total of 15 HIV-positive women received PMTCT interventions because of round-the-clock rapid testing in the labor ward. These findings are relevant for PMTCT programs in developing countries.
    PLoS Medicine 06/2008; 5(5):e92. DOI:10.1371/journal.pmed.0050092 · 14.00 Impact Factor
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    ABSTRACT: The human immunodeficiency virus (HIV) pandemic mainly affects developing countries, where the Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates suggest that less than 1 in 10 people are aware of their HIV sero-status. In order to enhance epidemiological surveys, prevention programs, and therapeutic interventions, development of specific, rapid, and convenient diagnostic detection systems is still warranted. Here we report the direct detection of HIV particles using broadly HIV-1 neutralizing gp120 monoclonal antibody (gp120MAbs)-conjugated magnetic beads (MBs) and fluorescent nanosized polymeric beads (FNBs). The HIV-1 envelope glycoprotein gp120 is anchored to the viral surface through gp41 and mediates entry into target cells by interaction with the main cellular receptor (CD4) and coreceptors (e.g., CCR5 and CXCR4). FNBs conjugated to gp120MAbs (gp120MAbs-FNBs) were used to generate fluorescent signals, whereas MBs conjugated to gp120MAbs (gp120MAbs-MBs) were employed to isolate HIV-1 particles. In presence of HIV-1 particles, addition of gp120MAbs-FNBs and gp120MAbs-MBs leads to the formation of a MBs/HIV-1 particles/FNB complex, which can be easily isolated and concentrated by common magnet separation. We demonstrate the ability of detecting HIV-1 particles specifically and directly using MBs and FNBs with low sample volume (less than 100 microL) and rapidity (less than 1.5 h) without any pretreatment of test samples. The specific binding of FNBs with HIV-1 particles on the surface of MBs was confirmed by fluorescence microscopy and fluorescence-activated cell sorting (FACS). Imaging and FACS analysis revealed the specific and quantitative detection of HIV-1 particles. These results provide proof-of-principle that broadly HIV-1 neutralizing gp120 antibodies coupled to nanobeads can be employed for the direct detection of HIV-1 particles with potential implication for the development of specific, rapid, and convenient diagnostic systems.
    Analytical Chemistry 03/2009; 81(6):2388-93. DOI:10.1021/ac802267u · 5.83 Impact Factor
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    ABSTRACT: The objective of this study was to validate the use of OraQuick ADVANCE Rapid HIV-1/2 Antibody test (OraSure Technologies Inc., Bethlehem, PA) on oral fluid for a population-based HIV prevalence survey of rural youth in southeast Zimbabwe. The evaluation was conducted in patients presenting for voluntary counseling and testing at rural clinics. Each participant provided an oral fluid sample tested using OraQuick ADVANCE. In addition, dried blood specimens were collected and tested blind at the National Microbiology Reference Laboratory in Harare using two enzyme-linked immunosorbent assays (ELISA; Vironostika, Biomérieux BV, Boxtel, The Netherlands and Ani Labsystems, Ltd., Vantaa, Finland) with confirmatory Western blot (MP Diagnostics [formerly Genelabs Diagnostics], Medical Technology Promedt Consulting GMBH, St. Ingbert, Germany) for samples with discrepant results. Diagnostic accuracy of the oral fluid assay was determined against the ELISA/Western blot algorithm as gold standard. Five hundred and ninety-one participants took part in the study between February and July 2006. Sensitivity of the test on oral fluid was 100% (95% confidence interval [CI]: 97.9-100), and specificity was 100% (95% CI: 99.1-100). HIV prevalence based on the reference standard was 29.8% (95% CI: 26.1-33.5). This is one of the first validations of this rapid assay on oral fluid conducted in a general population to be reported in Africa. While there are some limitations with the assay (e.g., unlikely to detect those in early stages of HIV infection or with reduced viral load; altered accuracy in pregnancy) these limitations also apply to other rapid assays. The results showed the assay to be 100% accurate in determining HIV status, performed well in field settings, and can be considered suitable for use in epidemiologic surveys aiming to estimate HIV prevalence in general populations.
    AIDS patient care and STDs 07/2009; 23(7):571-6. DOI:10.1089/apc.2008.0225 · 3.58 Impact Factor
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