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Comparative evaluation of the Roche HIV Monitor Assay and the Organon Teknika Nuclisens NASBA Assay for determining HIV viral load

Comparative evaluation of the Roche HIV Monitor Assay and the Organon Teknika Nuclisens NASBA Assay for determining HIV viral load

Abstracts of the General Meeting of the American Society for Microbiology 101: 263

The goal of this research was to compare the Roche HIV Monitor Assay with the Organon Teknika Nuclisens NASBA Assay for quantitative HIV viral load determination. A total of 72 separate samples were analyzed. All samples were processed with the Organon Teknika Extractor system for automated extraction and isolation of nucleic acids. Quantitation standards supplied by the vendors were mixed with the samples prior to processing to control for extraction efficiency. Due to the different quantitation standards employed by the two tests, samples had to be separately processed through the extractor for the different methods. The isolated nucleic samples were subsequently processed for viral load determination according to the vendor's kit instructions. The final calculations for viral copies per ml were performed according to the manufacturer supplied protocol for the Roche assay. Viral load calculations using the Organon Teknika assay were provided with the print out from the Nuclisens ECL reader using the HIV QT protocol. The majority of the samples (69/72, 96%) demonstrated good correlation of the two methods (all less than 0.5 log difference, and the majority less than 0.25 log difference). Two samples had an approximate 0.5 log variance and in one sample there was a variance of slightly under 1 log (550,000 for Roche assay and 58,000 for the Organon method). These results indicate that the two methods provide essentially the same quantitative value for HIV viral load. This suggests that there may be limited need to "re-baseline" test patients when switching between these two methods.

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