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GeneProof Team
Product name | Catalog no. | Technology | Packaging |
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/100 | real-time PCR | 100 reactions |
Indication | in vitro diagnostic medical device |
Intended User | For professional use in laboratories with trained staff |
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 |
Analytical Specificity |
BK virus, 100 % |
Analytical Sensitivity (LoD) |
reaches up to 0.684 cp/μl with the probability of 95 % |
Linear Range |
1010 – 102 cp/ml with precision of ± 0.5 log |
Reporting Units | cp/μl |
Metrological Traceability |
BKV Molecular ‚Q‘ Panel (Qnostics BKV) |
Extraction / Inhibition Control |
PCR inhibition and DNA extraction efficiency control |
Validated Specimen | CSF, plasma, urine, whole blood |
Storage | -20 ± 5 °C |
Validated Extraction Method |
croBEE NA16 Nucleic Acid Extraction System |
Instruments |
croBEE Real-Time PCR System |
Required Detection Channels | FAM, HEX, Cy5 |
External Quality Assessment | regularly tested by QCMD and Instand e.V. External Quality Assessment panels – results at www.geneproof.com |
Regulatory Status | CE IVD |
+420 543 211 679
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