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Clinical Trial
. 2012 Jan;160(1):60-6.e1.
doi: 10.1016/j.jpeds.2011.06.053. Epub 2011 Aug 24.

Performance of HIV-1 DNA or HIV-1 RNA tests for early diagnosis of perinatal HIV-1 infection during anti-retroviral prophylaxis

Marianne Burgard  1 , Stéphane Blanche, Carine Jasseron, Philippe Descamps, Marie-Christine Allemon, Nicole Ciraru-Vigneron, Corinne Floch, Brigitte Heller-Roussin, Eric Lachassinne, Fabienne Mazy, Josiane Warszawski, Christine Rouzioux; Agence Nationale de Recherche sur le SIDA et les Hepatites virales French Perinatal Cohort
Collaborators, Affiliations
Clinical Trial

Performance of HIV-1 DNA or HIV-1 RNA tests for early diagnosis of perinatal HIV-1 infection during anti-retroviral prophylaxis

Marianne Burgard et al. J Pediatr. 2012 Jan.

Abstract

Objective: 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.

Study design: 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.

Results: 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.

Conclusion: 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.

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