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Nucleic Acids Research, 2002, Vol. 30, No. 24 e137
© 2002 Oxford University Press

Stochastic processes defining sensitivity and variability of internally calibrated quantitative NASBA-based viral load assays

Jos J. A. M. Weusten, Pieter A. W. M. Wouters*, Martien C. A. van Zuijlen2 and Paul A. van de Wiel1

Departments of Biomathematics and 1 Department of Molecular Diagnostics, BioMérieux, Boxtel, The Netherlands and 2 Department of Mathematics, Catholic University of Nijmegen, Nijmegen, The Netherlands

*To whom correspondence should be addressed at BioMérieux, PO Box 84, 5280 AB Boxtel, The Netherlands. Tel: +31 411 65 46 25; Fax: +31 411 65 43 11; Email: pieter.wouters{at}eu.biomerieux.com

For quantitative assessment of virus particles in patient plasma samples various assays are commercially available. Typical performance characteristics for such assays are sensitivity, precision and the range of linearity. In order to assess these properties it is common practice to divide the range of inputs into subranges in order to apply different statistical models to evaluate these properties separately. We developed a general statistical model for internally calibrated amplification based viral load assays that combines these statistical properties in one powerful analysis. Based on the model an unambiguous definition of the lower limit of the linear range can be given. The proposed method of analysis was illustrated by a successful application to data generated by the NucliSens EasyQ HIV-1 assay.


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