GeneProof Parvovirus B19 PCR Kit
CE IVD
PRODUCT DETAIL
The PCR kit is intended for detection of the Parvovirus B19 DNA detection by the real-time Polymerase Chain Reaction (PCR) method. The method consists in the measurement of fluorophore labelled probes fluorescence increase. The Parvovirus B19 detection is based on the amplification of conservative DNA sequence of single-copy gene encoding VP1 protein (capsid protein). Parvovirus B19 presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is excluded from the reaction mix, controlling both PCR inhibition and nucleic acid extraction process efficiency. 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 | specific conservative DNA sequence of a single copy gene encoding VP1 protein (capsid protein) |
| Analytical Specificity | Parvovirus B19, 100 % |
| Analytical Sensitivity | 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 Traceability | Parvovirus B19 NIBSC 12/208 |
| Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control (ISEX version) |
| Validated Specimen | whole blood, plasma |
| 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 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 |
| Regulatory Status | CE IVD |
* Validated instruments
ORDER INFORMATION
| Product name | Cat. No. | Technology | Package |
| GeneProof Parvovirus B19 PCR Kit | B19/ISEX/025 | real-time PCR | 25 reactions |
| GeneProof Parvovirus B19 PCR Kit | B19/ISEX/050 | real-time PCR | 50 reactions |
| GeneProof Parvovirus B19 PCR Kit | B19/ISEX/100 | real-time PCR | 100 reactions |