PERFORMANCE OF THE ABBOTT m2000SP/m2000RT REAL-TIME POLYMERASE CHAIN REACTION ASSAY FOR HEPATITIS C VIRUS RNA QUANTIFICATION

Quantification of hepatitis C virus (HCV) RNA is essential for the everyday management of chronic hepatitis C therapy. " Real-time " polymerase chain reaction (PCR) techniques are potentially more sensitive than classical PCR techniques, are not prone to carryover contamination, and have a consistently wider dynamic range of quantification. Thus they are rapidly replacing other technologies for routine quantification of HCV RNA. We extensively evaluated the intrinsic characteristics and clinical performance of m2000 SP /m2000 RT , the Abbott real-time PCR platform for HCV RNA quantification. The study shows that m2000 SP /m2000 RT is sensitive, specific, precise and reproducible, and has a broad dynamic range of quantification. When comparing HCV RNA levels measured in the same individuals with m2000 SP /m2000 RT and the third-generation branched DNA assay, a trend towards a modest overestimation of HCV RNA levels was observed in m2000 SP /m2000 RT in all genotypes except genotype 5. The differences were however unlikely to have any impact in clinical practice. In conclusion, our study shows that the Abbott m2000 real-time PCR system for HCV RNA quantification is sensitive, specific, precise and reproducible and that its broad dynamic range of quantification is well suited to HCV RNA monitoring in the clinical setting.