FluoroType® HSV PCR CE/IVD

Herpes simplex viruses are spread worldwide and by now, genital herpes is one of the most prevalent sexually transmitted diseases in industrialized countries. The prevalence accounts for approximately 70-95% for HSV-1 and 10-20% for HSV-2, but can be considerably higher for risk groups. The primary infection occurs in more than 90% of cases without symptoms. However, reactivation of the virus in the nerve ganglia leads to a clinically manifest HSV recurrence or asymptomatic shedding. Because of the diversity and complexity of disease patterns, the clinical diagnosis is difficult. Besides typical blisters around the face, mouth, and genitals, both virus types can also cause severe infections of the central nervous system, such as aseptic meningitis or herpes simplex encephalitis in neonates or immune suppressed patients. Since for most disease patterns a specific therapy is available, severe progressive forms and transmission rates can be effectively prevented by an early and reliable diagnostics.

FluoroType® HSV enables the fast and reliable molecular diagnostics of HSV based on the innovative FluoroType® technology. HSV DNA is extracted from clinical swab specimens or liquor samples by the GenoXtract® system and analysed in the FluoroCycler®. The results are available within 3 hours only and are differentiated in HSV-1 and HSV-2. In comparison to culture or serology, elaborate and time-consuming steps are dispensed, furthermore a ready-to-use amplification mix containing the Taq polymerase is provided in each kit. Since the detection is carried out independently from the presence of specific antibodies, FluoroType® HSV is also applicable for children and neonates. This enables the immediate initiation of an antiviral therapy as well as adequate prevention measures.

Your benefits of using FluoroType® HSV

Fast results: Test procedure allows for rapid results within 3 hours and thereby enables the initiation of immediate therapy measures.
- Safety: The test system is characterized by a high sensitivity and specificity and the assay is monitored by an internal amplification control. Thus reliable results are guaranteed.
- Differentiation of HSV-1 and HSV-2: Because of the significant greater virulence of HSV-2, the determination of virus subtype provides additional prognostic information about the recurrence risk, the frequency of viral shedding and the risk of transmission.
- Maximum automation: The combination of a fully automated nucleic acid extraction with subsequent detection in the FluoroCycler® saves valuable time and enables optimal integration in your lab.
- CE-marked: No need for elaborate validation studies.

DNA Isolation:
GXT NA Extraction Kit (with GenoXtract®)

Instrument for Amplification and Detection:
FluoroCycler® 12, FluoroCycler® XT