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GeneProof Team
Product name | Catalog no. | Technology | Packaging |
GeneProof Parvovirus B19 PCR Kit | B19/ISEX 025 | real-time PCR | 25 reactions |
GeneProof Parvovirus B19 PCR Kit | B19/ISEX/100 | real-time PCR | 100 reactions |
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 (ISEX version) |
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 SLAN® Real-Time PCR System |
Required Detection Channels | FAM, HEX |
Quality Control | quality management system is certified in compliance with the requirements of the standard ISO 13485 |
External Quality Assessment | Regularly tested by QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com |
Certification | CE IVD |
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