Method: Quantitative Reverse Transcription Polymerase Chain Reaction
Analytical Sensitivity: 98% (n = 1760 across reportable range)
Analytical Specificity: No cross reactivity was observed in samples spiked with other common pathogenic viruses, bacteria, or yeast.
Limit of Detection: 10 IU/mL
Quantitative Range: 15 - 100,000,000 IU/mL (1.2 - 8.0 Log)
A negative result (“Not Detected”) does not rule out the presence of HCV below the limit of detection of the assay or the presence of inhibitory substances. HCV viral loads detected at less than 15 IU/mL are not quantitated. Assay is the FDA-approved Roche AmpliPrep/COBAS® TaqMan® HCV Test, v2.0.