TABLE 2.

Nonquantitative HCV RNA detection rates using the COBAS HCV TM-ASR assay^a

Virus level (HCV RNA IU/ml)b	HCV RNA detectedc	Total no. of valid resultsd	% Detection
100	79	80	98.8
50	72	80	90.0
35	69	79	87.3
25	54	79	68.4
10	39	80	48.8
0	0	75	0.0

^aA panel consisting of a diluted HCV specimen of genotype 1a and an HCV RNA-negative member containing predefined concentration levels at 0, 10, 25, 35, 50, and 100 IU/ml were processed in replicate across multiple runs. Five runs were performed using the Qiagen BioRobot 9604 and QiaAmp virus kit for HCV RNA extraction and COBAS HCV TaqMan ASR reagents and the COBAS TaqMan analyzer for RNA amplification and detection. HCV RNA-positive members were processed in replicates of 16 on each run, and the HCV RNA-negative member was processed in replicates of 15 on each run.

^bVirus level was predefined by Roche Molecular Systems.

^cHCV RNA detected results considered detected as any quantitative result (≥10 IU/ml) and any result with a value of “<10 IU/ml.”

^dA valid result was defined as any result with a valid QS elbow value result and not called “invalid” by the COBAS TaqMan Analyzer and TaqLink software.