Leírás
PRODUCT ADVANTAGES
HIGH SENSITIVITY AND TRACEABILITY
- Sensitivity was established with certified strain (NIBSC 3rd WHO International standard 12/208)
PRECISE QUANTITATIVE DETECTION
- Precise and fully traceable quantification according NIBSC 3rd WHO International standard 12/208
CONTAMINATION ELIMINATION
- Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating contamination with amplification products
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 | specific conservative DNA sequence of a single copy gene encoding VP1 protein (capsid protein) |
| Analytic Specificity | Parvovirus B19, 100 % |
| Analytic Sensitivity (LoD) | reaches up to 90.29 IU/ml with the probability of 95 % (on Parvovirus B19 NIBSC 12/208 using manual extraction GeneProof PathogenFree DNA Isolation Kit) reaches up to 156.7 IU/ml with the probability of 95 % (on Parvovirus B19 NIBSC 12/208 using automatic extraction croBEE NA16 Nucleic Acid Extraction System) |
| Linear Range | 108 – 102.5 IU/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree DNA Isolation Kit or automatic extraction croBEE NA16 Nucleic Acid Extraction System) |
| Dynamic Range | 108 – 90.29 IU/ml (using manual extraction GeneProof PathogenFree DNA Isolation Kit) 108 – 156.7 IU/ml (using automatic extraction croBEE NA16 Nucleic Acid Extraction System) |
| Reporting Units | IU/μl |
| Conversion Factor | 1 IU = 1.6 cp |
| Metrological Tracebility | Parvovirus B19 NIBSC 12/208 |
| Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control |
| Validated Specimen | plasma, whole blood |
| 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 CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System LightCycler 480 LineGene 9600 Plus Mic qPCR Cycler Rotor-Gene 3000 / 6000 / Q QuantStudio™ 3 / 5 Real-Time PCR System StepOne™ / StepOnePlus™ Real-Time PCR System SLAN® 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 |
| Certification | CE IVD |
