Performance of HIV-1 DNA or HIV-1 RNA tests for early diagnosis of perinatal HIV-1 infection during anti-retroviral prophylaxis.
ABSTRACT To compare performance of testing for human immunodeficiency virus (HIV)-1 DNA and HIV-1 RNA for diagnosis of HIV-1 infection in infants receiving preventive antiretroviral therapy.
This substudy of the French multicenter prospective cohort of neonates born to HIV-infected mothers, included 1567 infants tested for HIV with polymerase chain reaction (PCR) in a single laboratory, receiving post-natal prophylaxis, not breastfed, and having simultaneous HIV-1 DNA and RNA results before 45 days. The performance of PCR was assessed in reference to the 6-month HIV-1 RNA result.
Specificity of both HIV-1 RNA and HIV-1 DNA PCR was 100% at all ages (except 99.8% for DNA at birth); sensitivity was 58% (RNA) and 55% (DNA) at birth, and 89% at 1 month, 100% at 3 months for both, and 100% at 6 months (DNA). Concordance between HIV-1 DNA and RNA results was 0.78 and 0.81 (Kappa) at birth and 1 month and 100% at 3 and 6 months. Type of maternal and neonatal prophylaxis had no effect on sensitivity, but influenced viral load.
The performances of testing for HIV-1 DNA and RNA were similar with 100% sensitivity at 3 months. At 1 month during prophylaxis, 11% of infected children had negative PCR results.
- The Pediatric Infectious Disease Journal 02/2013; 32(2):e54-e61. DOI:10.1097/INF.0b013e3182787c29 · 3.14 Impact Factor
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ABSTRACT: BACKGROUND:: Early initiation of antiretroviral therapy (ART) depends on an early infant diagnosis (EID) and is critical to reduce HIV-related infant mortality. We describe the implementation of a routine Prevention of Mother-to-Child Transmission (PMTCT) program and focus on EID to identify opportunities to improve outcomes. METHODS:: HIV-exposed infants and their mothers were enrolled in a prospective, observational cohort study at a routine, hospital-based PMTCT and HIV treatment service in Johannesburg, South Africa. Infant HIV status was determined by testing samples collected between birth and 6 weeks and searching the national laboratory information system for PCR results of defaulting infants who accessed testing elsewhere. RESULTS:: Of 838 enrolled infants, HIV status was determined for 606 (72.3%) by testing at the study site, 85 (10.1%) by accessing test results from other facilities, 19 (2.3%) by testing stored samples and remained unknown in 128 (15.3%) infants. In total, 38 perinatally HIV-infected infants were identified. Thirty (79%) HIV-infected infants accessed 6-week testing and initiated ART at a median age of 16.0 weeks, but only 14 were in care a median of 68 weeks later and 4 had died. Eight (21%) HIV-infected infants, 2 of whom died, escaped identification by routine testing. Their mothers were younger, more likely to be foreign and accessed less optimal antenatal care. CONCLUSIONS:: Six-week testing delayed ART initiation beyond the time of early HIV-related infant mortality and missed one-fifth of perinatally HIV-infected infants. Earlier diagnosis and improved retention in care are required to reduce infant mortality and accurately measure elimination of MTCT.The Pediatric Infectious Disease Journal 04/2013; 32(10). DOI:10.1097/INF.0b013e318290622e · 3.14 Impact Factor
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ABSTRACT: This study evaluates HIV infant diagnosis on DBS using Biocentric HIV1-DNA and HIV1-RNA assays, in field conditions in Côte d'Ivoire. Paediatric screening was offered to children ≤ 3 years in clinical sites in Côte d'Ivoire in 2008. For each HIV-infected child, two non-infected children were included and blood samples were collected. HIV-DNA results obtained on EDTA blood samples with Biocentric assay were the reference for HIV infant diagnosis. Plasma and DBS viral loads were measured using HIV-RNA Biocentric assay. DBS samples were also tested for HIV-DNA detection using both Biocentric and Amplicor Roche assays. Sensitivity, specificity and concordance between tests were calculated. Overall samples from 138 HIV-exposed children, 46 infected, 92 non-infected were included. All tests were 100% sensitive and specific including 100% concordance with the two HIV-DNA assays. The median level of HIV-DNA on EDTA samples was 3.15 log10 copies/10(6) PBMCs; the median level of HIV RNA in plasma and DBS were respectively 5.82 and 5.17 log10 copies/ml (Pearson's correlation R(2)=0.92, p<0.0001). The threshold for detectable HIV-RNA on DBS was 3.3 log10. Although there are differences between viral load measured on DBS and plasma, the two Biocentric assays present very good performances for HIV infant diagnosis on DBS while cheap and feasible.Journal of virological methods 07/2013; 193(2). DOI:10.1016/j.jviromet.2013.07.011 · 1.88 Impact Factor