HEPATITIS C
Alinity m HCV Assay
For more information, contact Abbott.
For more information, contact Abbott.
| PRODUCT NAME | UNIT SIZE | ORDER NUMBER | GTIN |
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Accurate quantitation is critical to guide diagnosis to cure Hepatitis C. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.
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.
To learn more about Alinity m HCV Assay please visit: https://www.molecular.abbott/int/en/products/infectious-disease/alinity-m-hcv-assay
| ALINITY m HCV ASSAY PERFORMANCE | |
| Technology | RT-PCR |
| Claim | Monitoring and Confirmatory |
| Time to first result | <115 min |
| Standardization | 4th World Health Organization (WHO) International Standard for Hepatitis C Virus |
| Probe Design | Dual probe design; robust genotyping detection and quantitation |
| Target Region | Conserved 5’ UTR Region |
| Genotypes | 1,2,3,4,5,6 |
| Specimen types | Plasma: Acid Citrate Dextrose (ACD); K2 EDTA; K3 EDTA; Plasma Preparation Tubes (PPT) Serum: Serum, Serum Separator Tubes (SST) |
| Sensitivity Limit of Detection (LoD) | 12 IU/mL Plasma: Probit Analysis determined that the concentration of HCV RNA detected with 95% probability was 5.11 IU/mL (95% CI: 3.92 to 8.46 IU/mL) Serum: Probit Analysis determined that the concentration of HCV RNA detected with 95% probability was 5.11 IU/mL (95% CI: 4.16 to 7.47 IU/mL) |
| Linearity | 12 IU/mL to 200,000,000 IU/mL |
| Result Units | IU/mL or Log (IU/mL) |
| Precision | ≤ 0.18 Total SD |
| Sample input volume | 600μL |
| Specificity | Overall: 100.0% (95% CI: 99.2 to 100.0%) |
| Controls | Negative, Low Positive, and High Positive controls–single use tubes |
| Calibrator | 2 Calibrator levels–single use tubes |
| Internal Control | Internal Control Armored RNA (Pumpkin) |
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Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.