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

Université Victor Segalen Bordeaux 2, Burdeos, Aquitaine, France
Journal of Clinical Microbiology (Impact Factor: 3.99). 10/2004; 42(9):4147-53. DOI: 10.1128/JCM.42.9.4147-4153.2004
Source: PubMed


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 (ANRS) 1201/1202 Ditrame Plus cohort developed for prevention of mother-to-child transmission of human immunodeficiency virus (HIV) infection in Côte d'Ivoire. A total of 1,039 specimens were retested by two commercial enzyme-linked immunosorbent assays (ELISAs). The following specimens were tested: 315 specimens found on-site to be infected with HIV type 1 (HIV-1), 8 specimens found on-site to be infected with HIV-2, 71 specimens found on-site to be infected with both HIV-1 and HIV-2, 40 specimens found on-site to have indeterminate results for HIV infection, and 605 specimens taken during a quality assurance program. For HIV discrimination, 99 positive serum samples (20 with HIV-1, 8 with HIV-2, and 71 with HIV-1 and HIV-2 on the basis of our rapid test algorithm) were retested by the Peptilav test, Western blot (WB) assays, and homemade monospecific ELISAs. Real-time DNA PCRs for the detection of HIV-1 and HIV-2 were performed with peripheral blood mononuclear cells from 35 women diagnosed on-site with HIV-1 and HIV-2 infections. Compared to the results of the ELISAs, the sensitivities of the Determine and Genie II assays were 100% (95% lower limit [95% LL], 99.1%) and 99.5% (95% confidence interval [95% CI], 98.2 to 99.9%), 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.

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Available from: Valeriane Leroy
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    • "Although human immunodeficiency virus type 1 (HIV-1) infection is responsible for most of the global AIDS pandemic, HIV type 2 (HIV-2) is not infrequent in West Africa and is an additional and important cause of burden of disease with a limited spread to other regions of the world [1–3]. Overall in West Africa, between 10 and 20% of HIV infections include HIV-2 with a significant proportion of dually infected or reactive HIV-1 + 2 individuals [4, 5]. Interestingly, the prevalence of HIV-2 infections seems to be declining in West Africa, although the reasons remain unclear [1, 6–9]. "
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    ABSTRACT: Background Few data are available on antiretroviral therapy (ART) response among HIV-2 infected patients. We conducted a systematic review on treatment outcomes among HIV-2 infected patients on ART, focusing on the immunological and virological responses in adults. Methods Data were extracted from articles that were selected after screening of PubMed/MEDLINE up to November 2012 and abstracts of the 1996–2012 international conferences. Observational cohorts, clinical trials and program reports were eligible as long as they reported data on ART response (clinical, immunological or virological) among HIV-2 infected patients. The determinants investigated included patients’ demographic characteristics, CD4 cell count at baseline and ART received. Results Seventeen reports (involving 976 HIV-2 only and 454 HIV1&2 dually reactive patients) were included in the final review, and the analysis presented in this report are related to HIV-2 infected patients only. There was no randomized controlled trial and only two cohorts had enrolled more than 100 HIV-2 only infected patients. The median CD4 count at ART initiation was 165 cells/mm3, [IQR; 137–201] and the median age at ART initiation was 44 years (IQR: 42–48 years). Ten studies included 103 patients treated with three nucleoside reverse transcriptase inhibitors (NRTI). Protease inhibitor (PI) based regimens were reported by 16 studies. Before 2009, the most frequent PIs used were Nelfinavir and Indinavir, whereas it was Lopinavir/ritonavir thereafter. The immunological response at month-12 was reported in six studies and the mean CD4 cell count increase was +118 cells/μL (min-max: 45–200 cells/μL). Conclusion Overall, clinical and immuno-virologic outcomes in HIV-2 infected individuals treated with ART are suboptimal. There is a need of randomized controlled trials to improve the management and outcomes of people living with HIV-2 infection.
    Full-text · Article · Aug 2014 · BMC Infectious Diseases
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    • ") . According to one of the reports , the two Korean products , GENEDIA ® HIV 1 / 2 Rapid 3 . 0 and SD BIOLINE HIV - 1 / 2 3 . 0 , showed greater efficacy compared with OraQuick ( WHO , 2004a ) . More recently , researchers published results of HIV testing based on the HIV testing strategy of UNAIDS / WHO ( Menard et al . , 2005 ; Rouet et al . , 2004 ; Stetler et al . , 1997 ) . These researchers proved that rapid tests were as affordable and as accurate as EIA for HIV - specific antibody detection ( Samdal et al . , 1996 ; Tribble et al . , 1997 ; Urassa et al . , 2002 ) . This testing strategy can be used in under - equipped laboratories in develop - ing countries or in high - pre"
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    ABSTRACT: This study aimed to provide evaluation information about rapid HIV kits by the anti-HIV External Quality Assessment Schemes (EQAS) panel of the Korea National Institute of Health (KNIH) and the rapid HIV test panel of the US Centers for Disease Control and Prevention (CDC). Each KNIH anti-HIV EQAS panel from 2003 to 2005 consisted of four or five samples of plasma obtained from blood donors with a strong positive or negative reaction to HIV. KNIH delivered each panel to public health centers for analysis of the HIV test results, and the reactivity of the five rapid HIV kits currently used in the Korean market were compared with that of a CDC reference. The analytic sensitivity and specificity of the rapid HIV kits for the KNIH anti-HIV EQAS in 2005 were 99.3 and 99.1%, respectively; in 2004, 98.8 and 97.1%; and in 2003, 94.8 and 95.9%. Five HIV kits from the CDC panel consistently showed positive reactivity for strong positive samples in all kits, but some showed erratic reactivity for weakly positive samples. This is the first report on post-evaluation of rapid HIV kits in the Korean market by an anti-HIV EQAS panel. It was found that the quality of performance of the rapid HIV tests had improved each year but should be interpreted with caution for weakly positive samples.
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    ABSTRACT: In Africa, single-dose nevirapine (NVPsd), short regimens of zidovudine (ZDV) or ZDV + lamivudine (3TC) are recommended to prevent peripartum mother-to-child HIV transmission (PMTCT). We evaluated the 6-week field efficacy of two more PMTCT drug combinations. An open-label intervention cohort in Abidjan. In 2001-2002, consenting women started oral ZDV 300 mg twice daily (bid) at > or =36 weeks of gestation, with 600 mg of ZDV + 200 mg NVPsd orally at beginning of labour. In 2002-2003, the antepartum regimen at > or =32 weeks comprised ZDV as previously + 3TC 150 mg bid; the labour dose comprised ZDV + NVPsd as previously + 300 mg 3TC orally. Neonates received ZDV syrup (2 mg/kg per 6 h) for 7 days + NVPsd syrup (2 mg/kg) on day 2 in both periods. Each woman was assisted to either use breast milk substitutes or breastfeed exclusively. Paediatric HIV infection was diagnosed by plasma HIV RNA viral load at 4 weeks, confirmed at 6 weeks. The reference group was a cohort receiving a short regimen of ZDV > or = 36-38 weeks in 1995-2000 in the same population. A total of 1144 HIV-infected pregnant women were included: 351 with ZDV, 420 with ZDV + NVPsd and 373 with ZDV + 3TC + NVPsd; 1010 livebirths were eligible for analysis; 79 children were HIV-infected peripartum. Six-week transmission probability was 6.5% [95% confidence interval (CI), 3.9-9.1%) with ZDV + NVPsd, a 72% reduction compared with ZDV alone (95% CI, 52-88%; P = 0.0002 adjusted on maternal CD4, clinical stage and breastfeeding). It was 4.7% (95% CI, 2.4-7.0%) with ZDV + 3TC + NVPsd (P = 0.34 compared with ZDV + NVPsd). A short-course of ZDV + NVPsd prevents most peripartum HIV transmission in Africa. This regimen could be added to international guidelines.
    Full-text · Article · Feb 2005 · AIDS
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