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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Editorial Board Member: Gillery, Philippe / Kazmierczak, Steven / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Schlattmann, Peter / Whitfield, John B.

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Performance evaluation of the Abbott RealTime HCV Genotype II for hepatitis C virus genotyping

Yong-Hak Sohn1 / Sun-Young Ko2 / Myeong Hee Kim3 / Heung-Bum Oh2

1Department of Laboratory Medicine, Eulji University Hospital, Daejeon, South Korea

2Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, Seoul, South Korea

3Department of Laboratory Medicine, East-West Neo-Medical Center, Kyunghee University, College of Medicine, Seoul, South Korea

Corresponding author: Heung-Bum Oh, MD, Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, 388-1 Pungnap2-dong, Songpa-gu, Seoul 138-736, Korea Phone: +82-2-3010-4505, Fax: +82-2-478-0884,

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 48, Issue 4, Pages 469–474, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2010.093, February 2010

Publication History

Received:
2009-10-06
Accepted:
2009-11-24
Published Online:
2010-02-04

Abstract

Background: The Abbott RealTime hepatitis C virus (HCV) Genotype II (Abbott Molecular Inc.) for HCV genotyping, which uses real-time PCR technology, has recently been developed.

Methods: Accuracy and sensitivity of detection were assessed using the HCV RNA PHW202 performance panel (SeraCare Life Sciences). Consistency with restriction fragment mass polymorphism (RFMP) data, cross-reactivity with other viruses, and the ability to detect minor strains in mixtures of genotypes 1 and 2 were evaluated using clinical samples.

Results: All performance panel viruses were correctly genotyped at levels of >500 IU/mL. Results were 100% concordant with RFMP genotypic data (66/66). However, 5% (3/66) of the samples examined displayed probable genotypic cross reactivity. No cross reactivity with other viruses was evident. Minor strains in the mixtures were not effectively distinguished, even at quantities higher than the detection limit.

Conclusions: The Abbott RealTime HCV Genotype II assay was very accurate and yielded results consistent with RFMP data. Although the assay has the advantages of automation and short turnaround time, we suggest that further improvements are necessary before it is used routinely in clinical practice. Efforts are needed to decrease cross reactivity among genotypes and to improve the ability to detect minor genotypes in mixed infections.

Clin Chem Lab Med 2010;48:469–74.

Keywords: genotype; genotyping; HCV; method evaluation; real-time PCR

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