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J Clin Virol. 2007 Feb;38(2):96-100. Epub 2006 Dec 20.

Evaluation of the Abbott RealTime HCV assay for quantitative detection of hepatitis C virus RNA.

Author information

1
Institute of Hygiene, Medical University of Graz, Universitaetsplatz 4, 8010 Graz, Austria. birgit.michelin@meduni-raz.at

Abstract

BACKGROUND:

The Abbott RealTime HCV assay for quantitative detection of HCV RNA has recently been introduced.

OBJECTIVES:

In this study, the performance of the Abbott RealTime HCV assay was evaluated and compared to the COBAS AmpliPrep/COBAS TaqMan HCV test.

STUDY DESIGN:

Accuracy, linearity, interassay and intra-assay variations were determined, and a total of 243 routine clinical samples were investigated.

RESULTS:

When accuracy of the new assay was tested, the majority of results were found to be within +/-0.5 log(10) unit of the results obtained by reference laboratories. Determination of linearity resulted in a quasilinear curve up to 1.0 x 10(6)IU/ml. The interassay variation ranged from 15% to 32%, and the intra-assay variation ranged from 5% to 8%. When clinical samples were tested by the Abbott RealTime HCV assay and the results were compared with those obtained by the COBAS AmpliPrep/COBAS TaqMan HCV test, the results for 93% of all samples with positive results by both tests were found to be within +/-1.0 log(10) unit. The viral loads for all patients measured by the Abbott and Roche assays showed a high correlation (R(2)=0.93); quantitative results obtained by the Abbott assay were found to be lower than those obtained by the Roche assay.

CONCLUSIONS:

The Abbott RealTime HCV assay proved to be suitable for use in the routine diagnostic laboratory. The time to results was similar for both of the assays.

PMID:
17185031
DOI:
10.1016/j.jcv.2006.11.007
[Indexed for MEDLINE]

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