False positive ultrasensitive HIV bDNA viral load results in diagnosis of perinatal HIV-infection in the era of low transmission

Janak A. Patel, Erika Anderson, Jianli Dong

Research output: Contribution to journalArticle

5 Scopus citations


Background: The performance of ultrasensitive, quantitative assays in the diagnosis of perinatal HIV has not been documented in a population with low perinatal transmission due to use of antiretroviral therapy. Methods: We studied 205 plasma samples from 71 perinatally-exposed infants for HIV diagnosis using a quantitative branched DNA (bDNA) assay with a detection range of 75-500,000 copies/mL. Results: Twelve (16.9%) infants had at least 1 positive bDNA result. Two (2.8%) infants had confirmed HIV-infections as determined by ≥2 subsequent positive bDNA results (range=1,818-500,000 copies/mL). The remaining 10 (14.5%) infants had 1 positive bDNA test (range=81-440 copies/mL) with 2 subsequent negative bDNA tests and/or a negative HIV ELISA test; these infants were considered to have a false-positive result. The performance of internal assay standards was within acceptable limits. Conclusions: Our study suggests caution is needed in the interpretation of single, low-level, positive results of the ultrasensitive, quantitative bDNA test for HIV diagnosis of perinatallyexposed infants.

Original languageEnglish (US)
Pages (from-to)611-614
Number of pages4
JournalLaboratory medicine
Issue number10
StatePublished - Oct 1 2009


ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

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