Accuracy of HCV-RNA PCR tests for diagnosis or exclusion of vertically acquired HCV infection

Authors

  • Susanne Polywka,

    1. Institute for Infectious Diseases, University Hospital Eppendorf, Martinistraße, Hamburg, Germany
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  • Lucy Pembrey,

    1. Centre for Paediatric Epidemiology and Biostatistics, Institute of Child Health & Great Ormond Street Hospital for Children NHS Trust, University College London, London, UK
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  • Pier-Angelo Tovo,

    1. Dipartimento di Scienze Pediatriche e dell' Adolescenza, Università degli Studi di Torino, Piazza Polonia, Torino, Italy
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  • Marie-Louìse Newell

    Corresponding author
    1. Centre for Paediatric Epidemiology and Biostatistics, Institute of Child Health & Great Ormond Street Hospital for Children NHS Trust, University College London, London, UK
    • Centre for Paediatric Epidemiology & Biostatistics, Institute of Child Health (University College London), 30 Guilford Street, London WC1N 1EH.
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Abstract

The aim of the study was to estimate the sensitivity, specificity, positive (PPV) and negative (NPV) predictive values, and likelihood ratios for HCV-RNA PCR tests for the early diagnosis or exclusion of HCV infection in vertically exposed children. Data were included for children with confirmed HCV infection status from a European multi-center study. Confirmation was dependent on antibody status at or beyond 18 months, the ‘gold standard’ measure of infection status against which the use of qualitative HCV-RNA PCR tests was assessed. Of the 547 children included in this analysis, 193 were HCV-infected and 354 were not. Sensitivity of the HCV-RNA PCR test was low at birth (22%), but increased to 85% by 6 months. Specificity of RNA PCR was constant over age at 98%. The PPV of the PCR test rose from 33% at birth to 78% at 9 months of age, while NPV ranged from 96% to 99%. The high positive likelihood ratios from 1 month of age indicate strong evidence to diagnose infection but the negative likelihood ratios were consistent with weak evidence to exclude infection. The results suggest that the first qualitative HCV-RNA PCR test should be delayed until after the first month of life given the low sensitivity in the first few weeks. Although a negative test result after this time indicates probable absence of infection, this should be confirmed with a negative anti-HCV antibody test between 9 and 15 months of age as negative PCR results can be observed in infected children with fluctuations in viremia. J. Med. Virol. 78:305–310, 2006. © 2005 Wiley-Liss, inc.

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