Intended UseThis diagnostic kit is an in vitro nucleic acid(NA) amplification test for the quantitation of Human Hepatitis C Virus (HCV) RNA in human plasma or serum. The test is intended for use in c...
Intended Use
This diagnostic kit is an in vitro nucleic acid(NA) amplification test for the quantitation of Human Hepatitis C Virus (HCV) RNA in human plasma or serum. The test is intended for use in conjunction with clinical presentation and other laboratory markers of HCV infection for the clinical management of patients with chronic HCV. The test can be used to assess the probability of a sustained viral response early in a course of antiviral therapy and to assess viral response to antiviral treatment as measured by changes in serum or plasma HCV RNA levels.
Features
Methodology | Magnetic bead method |
Sample volume | 50ul(Semi-automated); 1200ul(automated) |
Sample type | Serum or plasma |
Subtype coverage | 1a,1b,2,2a,2b,2a/c,3a, 4,4a,4c,4acd,4d,4p,4q,5a,6,6a/b,6c |
Linear range | 5.0E+01~1.0E+09 IU/ml; |
Sensitivity | 50 IU/ml(semi-automated); 12.5IU/ml(Automated) |
