GeneProof Hepatitis B Virus (HBV) PCR Kit
CE1023 IVD
PRODUCT DETAIL
The PCR kit is designed for detection of Hepatitis B virus (HBV) by the real-time Polymerase Chain Reaction (PCR) method.
The HBV detection consists in amplification of a specific conservative DNA sequence of an open reading frame X (ORFx) and in measurement of fluorescence increase. The HBV presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is included in the PCR kit, controlling the possible inhibition of the PCR and the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil DNA glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.
TECHNICAL SPECIFICATION
| 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, pre-core mutants HBV (HBeAg negative), 100% |
| Analytical Sensitivity (LoD) | reaches up to 36.9792 IU/ml with probability of 95 % (on HBV NIBSC 05/148 using manual extraction GeneProof PathogenFree DNA Isolation Kit) reaches up to 64.067 IU/ml with the probability of 95% (on HBV NIBSC 10/266 using automatic extractor croBEE NA16 Nucleic Acid Extraction System) |
| 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 (using manual extraction GeneProof PathogenFree DNA Isolation Kit or automatic extractor croBEE NA16 Nucleic Acid Extraction System) |
| Dynamic Range | 1010 – 36.9792 IU/ml (using manual extraction GeneProof PathogenFree DNA Isolation Kit) 1010 – 64.067 IU/ml (using automatic extractor croBEE NA16 Nucleic Acid Extraction System) |
| Reporting Units | IU/µl |
| Conversion Factor | 1 IU = 5.19 cp |
| Metrological Traceability | HBV NIBSC 10/264 |
| Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control (ISEX version) |
| Validated Specimen |
plasma, serum |
| Storage | -20 ± 5 °C |
| Validated Extraction Method | croBEE NA16 Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
| Instruments | croBEE Real-Time PCR System* Applied Biosystems 7300 / 7500 Real-Time PCR System AriaMx Real-Time PCR System CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System DTlite Real-Time PCR System LightCycler® 2.0 / 480 LineGene 9600 / 9600 Plus Mic qPCR Cycler QuantStudio™ 3 Real-Time PCR System |
QuantStudioTM 5 Real-Time PCR System
Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System
StepOne™ / StepOnePlus™ Real-Time PCR SystemRequired Detection ChannelsFAM, HEXExternal Quality Assessmentregularly tested by QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.comCertificationCE1023 IVD for in vitro Diagnostic Use
* Validated instruments
ORDER INFORMATION
| Product name | Cat. No. | Technology | Package |
| GeneProof Hepatitis B Virus (HBV) PCR Kit | HBV/ISEX/025 | real-time PCR | 25 reactions |
| GeneProof Hepatitis B Virus (HBV) PCR Kit | HBV/ISEX/050 | real-time PCR | 50 reactions |
| GeneProof Hepatitis B Virus (HBV) PCR Kit | HBV/ISEX/100 | real-time PCR | 100 reactions |