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Journal of Clinical Microbiology, April 2002, p. 1447-1450, Vol. 40, No. 4
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.4.1447-1450.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Evaluation of an Automated Sample Preparation Protocol for Quantitative Detection of Hepatitis C Virus RNA

Evelyn Stelzl,1 Andrea Kormann-Klement,1 Josef Haas,2 Elisabeth Daghofer,1 Brigitte I. Santner,1 Egon Marth,1 and Harald H. Kessler1*

Molecular Diagnostics Laboratory, Institute of Hygiene, Karl-Franzens-University Graz, A-8010 Graz,1 Biometry Unit, Department of Obstetrics and Gynecology, Karl-Franzens-University Graz, A-8036 Graz, Austria2

Received 23 October 2001/ Returned for modification 24 December 2001/ Accepted 20 January 2002

The COBAS AMPLIPREP instrument for automated sample preparation has recently been introduced. In this study, the COBAS AMPLIPREP/COBAS AMPLICOR HCV MONITOR test, which includes this new molecular device, was evaluated and compared to the COBAS AMPLICOR HCV MONITOR test, which includes a manual extraction protocol. Interassay and intra-assay variation, precision, and linearity were determined, and a total of 130 clinical specimens were investigated. For determination of interassay variation, coefficients of variation were found to be between 9 and 59% for the COBAS AMPLIPREP/COBAS AMPLICOR HCV MONITOR test and between 13 and 69% for the COBAS AMPLICOR HCV MONITOR test. For determination of intra-assay variation, coefficients of variation were found to be between 7 and 13% for the COBAS AMPLIPREP/COBAS AMPLICOR HCV MONITOR test and between 8 and 16% for the COBAS AMPLICOR HCV MONITOR test. When precision of the COBAS AMPLIPREP/COBAS AMPLICOR HCV MONITOR test was tested, all results were found to be within ±0.5 log of the expected results. Determination of linearity resulted in a quasilinear curve over 3 logs. When clinical samples were tested with the COBAS AMPLIPREP/COBAS AMPLICOR HCV MONITOR test and compared with the COBAS AMPLICOR HCV MONITOR test, all results were found within ±0.5 log. In conclusion, the assay, which included the new molecular device, proved to be suitable for the routine molecular laboratory. It was found to be laborsaving and easy to handle.

* Corresponding author. Mailing address: Molecular Diagnostics Laboratory, Institute of Hygiene, KF-University Graz, Universitaetsplatz 4, A-8010 Graz, Austria. Phone: 43 (316) 380-7717. Fax: 43(316) 380-9649. E-mail: harald.kessler{at}uni-graz.at.

Journal of Clinical Microbiology, April 2002, p. 1447-1450, Vol. 40, No. 4
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.4.1447-1450.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.



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