Automated systems have been developed for amplification and detection of nucleic acid ... Mailing address: Department of Labora- tory Medicine, Bouseidai ...
Quantitative Assay of Hepatitis C Virus RNA Using an Automated Extraction System for Specific Capture with Probes and Paramagnetic Particle Separation Hayato Miyachi,1* Atsuko Masukawa,2 Satomi Asai,1 Toshiaki Miura,3 Shigeru Tamatsukuri,3 Toru Hirose,3 and Yasuhiko Ando1 Department of Laboratory Medicine, Tokai University School of Medicine,1 and Clinical Laboratory, Tokai University Hospital,2 Bouseidai, Isehara, and Roche Diagnostics K. K., Tokyo,3 Japan Received 13 May 2002/Returned for modification 2 September 2002/Accepted 17 November 2002
A commercially available automated specimen preparation instrument for specific probe capture and paramagnetic separation has been developed (AmpliCap/GT-12; Roche Molecular Systems). We evaluated assay performance of the AmpliCap/GT-12 in the quantitative assay for hepatitis C virus (HCV) RNA with the AMPLICOR HCV MONITOR Test (version 2.0). Assay linearity using serial dilutions from a serum panel was observed in the range of 500 to 850,000 IU/ml, with a slightly compromised slope in the higher viral titers. The overall within-run and between-run reproducibility of the entire detection process for 3 and 5 log10 (IU/ml) of HCV RNA in samples had a standard deviation of
