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

Yong Hak Sohn, Sun Young Ko, Myeong Hee Kim, Heung Bum Oh

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    18 Citations (Scopus)


    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.

    Original languageEnglish
    Pages (from-to)469-474
    Number of pages6
    JournalClinical Chemistry and Laboratory Medicine
    Issue number4
    Publication statusPublished - 2010 Apr

    Bibliographical note

    Funding Information:
    This research was supported by the Pioneer R&D program for converging technology through the Korea Science and Engineering Foundation funded by the Ministry of Education, Science and Technology (Grant number: M10711270001-08M1127-00110).


    • Genotype
    • Genotyping
    • HCV
    • Method evaluation
    • Real-time PCR

    ASJC Scopus subject areas

    • Clinical Biochemistry
    • Biochemistry, medical


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