ViroGene BKV PCR Kit 1.0
- Dual Probe Assay
The highly mutable nature of pathogens often proves challenging in molecular assay design. Traditional qPCR assays are designed so that a single primer and probe set targets one location within the pathogen genome. However, these single-target assays often prove inadequate to detect and quantify viral targets. Sequence polymorphisms in the assay target region can cause impaired primer or probe binding, which may result in significant under-quantification or a false negative result. To eliminate this possibility, ViroGene BKV qPCR assay targets two regions within the pathogen genome, utilizing unique primer and probe sets for each target site. The driving principle behind our multiple-target assay design is that when a polymorphism occurs in one assay target, the additional sets of primers and probes for the alternate target region will still detect and accurately quantify the pathogen, and thus reduces the likelihood of under-quantification or a false negative result.
- All kit Components are Liquid Ready to use with enhanced freeze thaw stability (> 30 times)
- Using the highest standards for choice of enzymes on our kits which can tolerates all types of inhibitors found usually in clinical samples with no effect on result quality
- Common Internal control for more than 35 assays to ensure ease of use with limited samples resources.
- Common Reagents and common protocols which ensures running more than one test type on the same run
- Kit components enough to perform 110 Tests, to perform calibration and QC at no Extra cost
Technical specification
| Technology | Real-time PCR |
| Type of Analysis | qualitative and quantitative |
| Target Sequence | Two 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 0.6 cp/μl with the probability of 95 %. |
| Diagnostic Specificity | 100.00% (CI95%: 79.95%–100.00%) |
| Diagnostic Sensitivity | 96.5% (CI95%: 80.60%–97.51%) |
| Reporting Units | cp/μl |
| Extraction / Inhibition Control | PCR inhibition and DNA extraction efficiency control |
| Validated Specimen | CSF, plasma, urine, whole blood |
| Storage | -20 ± 5 °C |
| Validated Extraction Method | ViroGene Viral RNA/DNA Extraction Kit & NA16 MagCore NA Extractor |
| Instruments | Applied Biosystems 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System DTlite Real-Time PCR System LightCycler® 2.0 / 480 LineGene 9600 / 9600 Plus QuantStudio™ 5 Real-Time PCR System Rotor-Gene 3000 / 6000 / Q SLAN® Real-Time PCR System |
| Required Detection Channels | FAM, HEX |
| External Quality Assessment | regularly tested by QCMD and Instand e.V. External Quality Assessment panels |
| Certification | CE IVD for in vitro Diagnostics Use |
