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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 / EC Directive 98/79/EC | |||||||
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) |
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Analytical Specificity |
Parvovirus B19, 100% |
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Analytical Sensitivity (LoD with 95% probability) |
Sample Processing | Plasma | Whole blood | Performed on | ||||
GeneProof PathogenFree DNA Isolation Kit | 90,29 IU/ml | 95,96 IU/ml | B19 NIBSC 12/208 | |||||
croBEE 201A Nucleic Acid Extraction Kit | 156,7 IU/ml | 100,47 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 |
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Applied Instruments | Instrument Name | |||||||
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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