GeneProof Hepatitis B Virus (HBV) PCR Kit
Kat.: HBV/ISEX/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
Minden HBV A – H genotípus detektálására alkalmas, ‘Ready-To-Use’ master mix. Az ORFx konzervatív DNS szekvenciát célozza. (25 reakció)
Leírás
PRODUCT ADVANTAGES
HIGH SPECIFICITY
- Secured by targeting the DNA conservative sequence of ORFx
- Prevents analysis failure caused by the occurrence of mutations (including safe detection of core and pre-core mutants)
- Detection of all HBV genotypes A – H
PRECISE QUANTITATIVE DETECTION
- Precise and fully traceable quantification according to WHO International HBV DNA Standard NIBSC 10/266
- Excellent results in EQA panel testing (QCMD, INSTAND)
CONTAMINATION ELIMINATION
- Single tube Ready to use Master Mix contains Uracil DNA N-glycosylase (UNG) and dUTPs eliminating possible contamination with amplification product
HIGH SENSITIVITY
- Sensitivity was established with certified strain (HBV NIBSC 10/266)
- Ensures excellent sensitivity reaches up to 13.9 IU/ml
SINGLE TUBE READY-TO-USE MASTER MIX
- Contains all components for PCR amplification
- No additional pipetting of PCR reagents necessary
- Reduces the need for qualified laboratory staff
- Ensures reproducibility of results
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CE IVD CERTIFIED DIAGNOSTIC TEST
Technical specification
| Indication | in vitro diagnostic medical device |
| 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, pre-core mutants HBV (HBeAg negative), 100% |
| Analytical Sensitivity (LoD) | reaches up to 36.9792 IU/ml with the 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) reaches up to 13.9 IU/ml with the probability of 95% (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% : 99.90% – 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 |
| Metrological Traceability | HBV NIBSC 10/266 |
| Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control |
| 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 DT lite Real-Time PCR System LightCycler® 2.0 / 480 LineGene 9600 / 9600 Plus Mic qPCR Cycler QuantStudioTM 3 / 5 Real-Time PCR System Rotor-Gene 3000 / 6000 / Q SLAN® Real-Time PCR System StepOneTM/StepOne PlusTM 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 |
| Regulatory Status | CE1023 IVD |
