affigene® BKV trender
For the monitoring of the polyomavirus BK the affigene® BKV trender has been developed. The kit is a CE-labelled in vitro diagnostic assay that utilizes real-time Polymerase Chain Reaction (PCR) amplification for the quantitative measurement of BK virus (BKV) DNA in human clinical samples. It is intended for the measurement of BKV in human serum samples. Applications for whole blood and urine are available.
The kit includes all required reagents for the complete analysis of BKV, from amplification to analysis of results. The reagents are supplied in ready-to-use, single-use format.
The complete process, from sample preparation to results is CE labelled when using the affigene® DNA extraction kit.
The real-time PCR detection procedure is fully licensed including user license. The affigene® BKV trender test profile harmonises with other affigene® assays to enable multi-target runs.
The sensitivity of the assay is high (223 copies/ml in 200 µl serum). The kit is highly specific for BKV DNA and does not cross-react with any other known viruses including JCV and SV-40.
False negative results are prevented through a built-in internal control and the risk of getting false negative results with the assay has been determined to <1%.
False positive results are prevented through selective UDG amplification, closed-tube reactions and single-use reagents.
Flexibility
- CE labelled flexible solution for sample preparation from different sample matrices such as cell free body fluids and whole blood
- CE labelled for manual as well as automated sample preparation (validated in combination with the NucliSens easyMAG system)
- CE label valid on multiple real-time PCR platforms for flexible detection possibilities:
- Mx3000P/3005P (Stratagene, La Jolla, USA)
- iCycler iQ/iQ5 (BioRad Laboratories Inc, Hercules, CA, USA)
- Rotor-Gene 3000/6000 (Corbette Research, Sydney, Australia)
- ABI 7300(Applied Biosystems, Foster City, USA)
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