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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 |
Indication | in vitro diagnostic medical device | |
Regulatory Status | CE IVD | |
Intended User | For professional use in laboratories with trained staff | |
Test Principle | Real-time polymerase chain reaction (PCR) – amplification of the specific Target Sequence and detection using TaqMan probes with fluorophore-based detection | |
Type of Analysis | Qualitative and quantitative | |
Target Sequence |
Gene encoding VP1 protein (capsid protein) |
|
Analytical Specificity |
Parvovirus B19, 100% |
|
Analytical Sensitivity (LoD with 95% probability) |
Sample Processing | Plasma |
GeneProof PathogenFree DNA Isolation Kit | 90,29 IU/ml | |
croBEE 201A Nucleic Acid Extraction Kit | 156,7 IU/ml | |
Diagnostic Specificity | 100 % (CI95%: 90.40 % - 100 %) | |
Diagnostic Sensitivity | 100 % (CI95%: 90.77 % - 100 %) | |
Positive Predictive Value | 100 % (CI95%: 90.77 % - 100 %) | |
Negative Predictive Value | 100 % (CI95%: 90.40 % - 100 %) | |
Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control by Internal Standard (IS) | |
Reporting Units | IU/ml | |
Conversion Factor | IU = 1 cp | |
Metrological Traceability | Parvovirus B19 NIBSC 12/208 | |
Validated Specimen | Plasma, whole blood (EDTA) | |
Storage Conditions | (-20 ± 5 ) °C | |
Validated Extraction Methods | croBEE 201A Nucleic Acid Extraction Kit GeneProof PathogenFree DNA Isolation Kit |
|
Applied Instruments | croBEE Real-Time PCR System AMPLilab Real-Time PCR System Applied Biosystems 7300 / 7500 Real-Time PCR System AriaMx Real-Time PCR System BioQuant-96 Real-Time PCR System CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System Gentier 96E/96R Real-Time PCR System LightCycler® 480 LineGene 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 |
|
Detection Channels | FAM (B19), HEX/JOE/VIC (IS) | |
External Quality Assessment | Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com |
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GeneProof offers a unique PCR testing solution that provides differential diagnostics of many pathogens
Our products’ quality, safety, and performance are fully compliant with the new rules for in vitro…