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GeneProof Team
Product name | Catalog no. | Technology | Packaging |
GeneProof Hepatitis B Virus (HBV) PCR Kit | HBV/ISEX/025 | real-time PCR | 25 reactions |
GeneProof Hepatitis B Virus (HBV) PCR Kit | HBV/ISEX/100 | real-time PCR | 100 reactions |
Indication | in vitro diagnostic medical device |
Regulatory Status | CE1023 IVD |
Intended User | For professional use in laboratories with trained staff |
Technology | real-time PCR |
Type of Analysis |
qualitative and quantitative |
Target Sequence |
DNA conservative sequence of open reading frame X (ORFx) |
Analytical Specificity |
HBV genotype A-H, precore mutants HBV (HBeAg negative), 100 % |
Analytical Sensitivity (LoD with the probability of 95 %) |
36.9792 IU/ml (on HBV NIBSC 05/148 using GeneProof PathogenFree DNA Isolation Kit), 64.067 IU/ml (on HBV NIBSC 10/266 using croBEE 201A Nucleic Acid Extraction Kit), croBEE NA16 Nucleic Acid Extraction System) 13.9 IU/ml (on HBV NIBSC 10/266 using manual extraction SpinStar Viral Nucleic Acid Kit 1.0 with SpinStar Pretreatment Solution) |
Diagnostic Specificity |
100% (CI95% : 99.06% – 100%) |
Diagnostic Sensitivity | 100% (CI95% : 95.90% – 100%) |
Linear Range |
1010 – 102 IU/ml with precision of ± 0.5 log |
Dynamic Range |
1010 – 36.9792 IU/ml (using GeneProof PathogenFree DNA Isolation Kit) |
Reporting Units |
IU/µl |
Metrological Traceability |
HBV NIBSC 10/266 (4th WHO International Standard) |
Validated Specimen | plasma, serum |
Storage | -20 ± 5 °C |
Validated Extraction Method | croBEE NA16 Nucleic Acid Extraction Kit GeneProof PathogenFree DNA Isolation Kit |
Validated Instruments |
croBEE Real-Time PCR System |
Required Detection Channels | FAM, HEX |
External Quality Assessment | Regularly tested by QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com |
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