affigene® HSV 1/2 tracer

affigene® HSV 1/2 tracer is a CE-labelled in vitro diagnostic assay that utilizes real-time Polymerase Chain Reaction (PCR) amplification for the qualitative determination of Herpes Simplex virus (HSV) 1 and 2 DNA in human clinical samples. It is intended for the detection of HSV 1 and/or 2 DNA in CSF samples and vesicle swabs stored in different media (e.g. saline, Virocult®). The two viruses are detected simultaneously and separately with the assay.

The kit includes all required reagents for the complete analysis of HSV 1 and/or 2, 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® HSV 1/2 tracer test profile harmonises with other affigene® assays to enable multi-target runs.

The sensitivity of the assay is high (219 copies/ml in 200 ul saline). The kit is highly specific to HSV 1 and 2 DNA and does not cross-react with any other herpes virus.

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.