affigene® VZV tracer

The CE-labelled in vitro diagnostic assay affigene® VZV tracer is a panel member of affigene® assays for detection of herpes viruses. The kit utilizes real-time Polymerase Chain Reaction (PCR) amplification for the qualitative determination of Varicella Zoster virus (VZV) DNA in human clinical samples. It is intended for the detection of VZV DNA in vesicle swabs stored in different media (e.g. saline, Virocult®) and CSF samples.

The kit includes all required reagents for the complete analysis of VZV, from amplification to analysis of results. The reagents are supplied in ready-to-use, single-use format.

For a complete CE-labelled process, from sample preparation to analysis, the kit shall be used in combination with affigene® DNA extraction.

The real-time PCR detection procedure is fully licensed and the affigene® VZV tracer test profile harmonises with other affigene® assays to enable multi-target runs.

The sensitivity of the assay is high (328 copies/ml in 200 ul saline). The kit is highly specific to VZV DNA and does not cross-react with any other herpes viruses.

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 vesicle swabs and BAL
• 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)