HCV Confirmation
The Confirmatory PCR Kit HCV is designed for the automated or manual confirmation testing of positive screening results.
Confirmatory PCR Kit HCV
The Confirmatory PCR Kit HCV is an in vitro diagnostic test kit for the qualitative analysis of Hepatitis C Virus (HCV) RNA in human EDTA plasma to confirm results from blood screening.
| Analyte Reference material | Individual samples sample volume 400 μl |
| HCV WHO 2nd Int. Std. 96/798 (Applied BiosystemsTM 7500) WHO 3rd Int. Std. 06/100 (Roche LightCycler® 480) | Applied BiosystemsTM 7500: 23 IU/ml Roche LightCycler® 480: 46 IU/ml |
| Analyte Reference material | Individual samples sample volume 380 μl Roche LightCycler® 480 / MinElute (manual handling) |
| HCV WHO 4th Int. Std. 06/102 | 2.9 IU/ml |
| Analyte | Specificity |
| Pooled plasma samples | 100% |
| Individual samples | 100% |
| Virus | Genotype / Subtype |
| HCV | 1 – 6 |
For details please refer to the product information document.
| Confirmatory PCR Kit HCV (version 1.0) GFE order number Number of reactions per kit | Automated handling (autoX-System) Manual handling | packing unit = 20 kits 003-08-20 8 analyses for 1 viruses 12 analyses for 1 viruses |
| Kit components: Basismix Oligomix HCV | Volume [µl] 810 100 | Label BM O_C |
Intended Use
The Confirmatory PCR Kit HCV is designed for the qualitative detection of Hepatitis C‑Virus (HCV) RNA in human EDTA plasma from blood donations. The kit allows for a highly sensitive analysis in accordance with Votum 34 of the German National Advisory Committee Blood (Arbeitskreis Blut) of the German Federal Ministry of Health.
The kit is intended to confirm HCV positive screening results in human EDTA plasma samples by analysis of repository samples or consecutive blood samples of individual donors.
The Confirmatory PCR Kit HCV is intended for use with the Applied BiosystemsTM 7500 Real-Time PCR System or the Roche LightCycler® 480 II Real-Time PCR System in conjunction with the GFE autoX‑System and the respective GFE accessory and control kits.
The Confirmatory PCR Kit HCV is also intended for use with the Roche LightCycler® 480 II Real-Time PCR System in conjunction with the QIAamp® MinElute® Virus Spin Kit for nucleic acid extraction and the respective GFE control kits (IC Kit, PCR Positive Control Kit, NTC Kit).
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