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GeneProof Team
PCR Kit detects both viruses in a single reaction tube
| Product name | Catalog no. | Technology | Packaging |
| GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit | HHV/ISEX/025 | real-time PCR | 25 reactions |
| GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit | HHV/ISEX/100 | real-time PCR | 100 reactions |
| Indication | in vitro diagnostic medical device | |||
| Regulatory Status | CE IVD / EC Directive 98/79/EC | |||
| Intended User | For professional use in laboratories with trained staff | |||
| Technologie | Real-time PCR | |||
| Type of Analysis | Qualitative and quantitative | |||
| Target Sequence |
U94 gene (HHV-6A/B), U57 gene (HHV-7) |
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| Analytical Specificity | Human Herpesvirus 6/7 (HHV-6/7), 100 % | |||
| Analytical Sensitivity (LoD with 95% probability) |
Sample Processing |
Plasma | Whole blood | CSF |
| GeneProof PathogenFree DNA Isolation Kit | 134.9 IU/ml | 169.0 IU/ml | 152.3 IU/ml | |
| croBEE 201A Nucleic Acid Extraction Kit | 312.9 IU/ml | 448.4 IU/ml | 793.4 IU/ml | |
| Diagnostic Specificity | 97.73 % (CI95%: 92,99 % - 99,41 %) | |||
| Diagnostic Sensitivity | 98.72 % (CI95%: 92,09 % - 99,93 %) | |||
| Positive predictive value | 96.25 % (CI95%: 88,68 % - 99,03 %) | |||
| Negative predictive value | 99.23 % (CI95%: 95,16 % - 99,96 %) | |||
| Linear Range | 108 – 102.5 IU/ml with precision of ± 0.5 log | |||
| Dynamic Range |
108 – LoD IU/ml (LoD varying according to the extraction and material used) |
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| Trueness (of expected concentration) |
0,005 log (CI95%: -0,05 – 0,06) using manual extraction GeneProof PathogenFree DNA Isolation Kit -0,002 log (CI95%: -0,08 – 0,07) using automatic extraction croBEE 201A Nucleic Acid Extraction Kit |
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| Reporting Units | IU/ml | |||
| Conversion Factor | IU = 0.6 cp / 1 cp = 1.8 IU | |||
| Metrological Traceability | NIBSC HHV6B 15/266 | |||
| Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control by Internal Standard (IS) | |||
| Validated Specimen |
CSF, plasma, whole blood (EDTA)* |
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| Storage | -20 ± 5 °C | |||
| Validated Extraction Methods | croBEE 201A Nucleic Acid Extraction Kit GeneProof PathogenFree DNA Isolation Kit |
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| Applied Instruments |
croBEE Real-Time PCR System |
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| Detection Channels | FAM (HHV-6), HEX/JOE/VIC (IS), Cy5* (HHV-7) | |||
| External Quality Assessment |
Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels – results at www.geneproof.com |
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*NOTE: Due to the availability of international reference standard only for HHV-6, it is possible to monitor HHV-7 in cp/ml reporting units.
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