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GeneProof Team
Product name | Catalog no. | Technology | Packaging |
GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit | HCVD/ISEX/025 | real-time PCR | 25 reactions |
GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit | HCVD/ISEX/100 | real-time PCR | 100 reactions |
Indication | in vitro diagnostic medical device |
Intended User | For professional use in laboratories with trained staff |
Technology | Real-time PCR |
Target Analysis | Qualitative and Quantitative |
Target Sequence | conservative region of 5' UTR sequence |
Analytical Specificity | HCV genotype 1–8, 100 % |
Analytical Sensitivity (LoD) |
53.505 IU/ml (on HCV NIBSC 14/150 using GeneProof PathogenFree RNA Isolation Kit) |
Diagnostic Specificity |
100 % (CI95 % : 99.07 % - 100 %) |
Diagnostic Sensitivity | 100 % (CI95 % : 95.39 % - 100 %) |
Linear Range | 108.5 – 102 IU/ml with precision of ± 0.5 log (GeneProof PathogenFree RNA Isolation Kit) 108.5 – 170.062 IU/ml with precision of ± 0.5 log (croBEE 201A Nucleic Acid Extraction System) 108.5 – 101.7 IU/ml with precision of ± 0.5 log (MagCore Automated NA Extractor) |
Dynamic Range | 108.5 – 53.505 IU/ml (GeneProof PathogenFree RNA Isolation Kit) 108.5 – 170.062 IU/ml (croBEE 201A Nucleic Acid Extraction System) 108.5 – 33.473 IU/ml (MagCore Automated NA Extractor) |
Reporting Units | IU/μl |
Metrological Traceability | HCV NIBSC 14/150 |
Extraction/Inhibition Control | PCR inhibition and RNA extraction efficiency control (ISEX version) |
Validated Specimen | plasma (EDTA, citrate), serum |
Storage | -20 ± 5 °C |
Validated Extraction Methods |
croBEE 201A Nucleic Acid Extraction System |
Instruments |
croBEE Real-Time PCR System |
Required Detection Channels | FAM, HEX |
Quality Control | quality management system is certified in compliance with the requirements of the standard ISO 13485 |
External Quality Assessment | Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels - results available at www.geneproof.com |
Regulatory Status | CE1023 IVD |
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