GeneProof BK/JC Virus (BK/JC) PCR Kit
CE IVD
PRODUCT DETAIL
The PCR kit is designed for BK/JC viruses detection and differentiation by the real-time Polymerase Chain Reaction (duplex PCR) method.
The BK/JC viruses detection and differentiation consists in amplification of a specific conservative DNA sequence overlapping the boundary between the gene for the VP1 and VP2 proteins and in measurement of fluorescence increase. The BK virus presence is indicated by the FAM fluorophore fluorescence growth and the JC virus presence is indicated by the Cy5 fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). 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 | the specific conservative DNA sequence overlapping the boundary between the gene for the VP1 and VP2 proteins |
Specificity | BK virus, 100%
JC virus, 100 % |
Sensitivity (LoD) | for BKV reaches up to 180.687 IU/ml with the probability of 95 % (on BKV NIBSC 14/212 using manual extraction GeneProof PathogenFree DNA Isolation Kit) for JCV reaches up to 180.81 IU/ml with the probability of 95 % (on JCV NIBSC 14/114 using manual extraction GeneProof PathogenFree DNA Isolation Kit) |
Linear Range | 1010 - 102 cp/ml with precision of ± 0.5 log |
Reporting Units | cp/μl |
Metrological Traceability | BKV Molecular 'Q' Panel (Qnostics BKV) JCV Molecular 'Q' Panel (Qnostics JCV) |
Extraction/Inhibition Control | PCR inhibition control (ISIN version) PCR inhibition and DNA extraction efficiency control (ISEX version) |
Validated Specimen | CSF, plasma, urine, whole blood |
Storage | -20 ± 5 °C |
Validated Extraction Method | croBEE NA16 Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
Validated Instruments | croBEE Real-Time PCR System Applied Biosystems 7500 Real-Time PCR System AriaMx Real-Time PCR System CFX96™ / Dx Real-Time PCR Detection System LightCycler® 480 LineGene 9600 / 9600 Plus |
Mic qPCR Cycler
QuantStudio™ 5 Real-Time PCR System
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR SystemRequired Detection ChannelsFAM, HEX, Cy5Quality controlquality management system is certified in compliance with the requirements of the standard ISO 13485External quality assessmentregularly tested by QCMD and Instand e.V. External Quality Assessment panels - results at www.geneproof.comCertificationCE IVD, for in vitro Diagnostic Use
ORDER INFORMATION
Product name | Cat. No. | Technology | Package |
GeneProof BK/JC Virus (BK/JC) PCR Kit | BKJC/ISIN/025 | real-time PCR | 25 reactions |
GeneProof BK/JC Virus (BK/JC) PCR Kit | BKJC/ISIN/050 | real-time PCR | 50 reactions |
GeneProof BK/JC Virus (BK/JC) PCR Kit | BKJC/ISIN/100 | real-time PCR | 100 reactions |
GeneProof BK/JC Virus (BK/JC) PCR Kit | BKJC/ISEX/025 | real-time PCR | 25 reactions |
GeneProof BK/JC Virus (BK/JC) PCR Kit | BKJC/ISEX/050 | real-time PCR | 50 reactions |
GeneProof BK/JC Virus (BK/JC) PCR Kit | BKJC/ISEX/100 | real-time PCR | 100 reactions |