GeneProof BK/JC Virus (BK/JC) PCR Kit

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 - 10cp/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

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