INTENDED USE:
The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma. The Alinity m HCV assay is intended for use in the clinical management of HCV-infected patients undergoing antiviral therapy in conjunction with clinical presentation and other laboratory markers. The Alinity m HCV assay may also be used as a diagnostic test to confirm active HCV infection. The results from the Alinity m HCV assay must be interpreted within the context of all relevant clinical and laboratory findings. This assay is not intended to be used in screening blood, blood products, tissue, or organ donors for HCV.
SPECIFICATIONS:
| ALINITY m HCV ASSAY PERFORMANCE | |
| Â Limit of Detection (LoD) | Plasma: Probit analysis determined that the concentration of HCV RNA in plasma detected with 95% probability was 5.11 IU/mL (95% CI 3.92 to 8.46 IU/mL). ermentum pharetra quam.
Serum: Probit analysis determined that the concentration of HCV RNA in serum detected with 95% probability was 5.11 IU/mL (95% CI 4.16 to 7.47 IU/mL). |
| Linear Range | 12 IU/mL to 200,000,000 IU/mL |
| Â Precision | < 0.18 Total SD |
| Specificity | Overall: 100.0% [95% CI: 99.2 to 100.0] |
|  Target Region | Dual Target targeting 5’UTR |
| Genotype Detection | 1, 2, 3, 4, 5, 6 |
| Confirmatory | Yes |
| Specimen Type | Plasma, Serum |
| Â Internal Control | Yes |
| Sample Input Volume | 600 µL |
