FluoroType® CMV qPCR CE/IVD

Human cytomegalovirus is spread worldwide with a prevalence of 60 – 100%. Infections are usually transmitted through bodily fluids, but transmission via organ transplantation might also occur. In healthy individuals, primary CMV infection is usually asymptomatic; however the virus remains within the body and establishes lifelong persistence. CMV infection during pregnancy can cause severe damage to the unborn child and is the most common viral cause for congenital disease.
In immunosuppressed patients, for example after organ transplantation, CMV infection or reactivation can lead to severe complications of different organs. Close monitoring of the viral load is therefore essential in immunosuppressed patients to identify and evaluate a potential virus reactivation at an early stage. Disease progression can thus be closely observed and suitable therapeutic measures can be met before complications or irreversible organ damage occur.

Viral DNA is extracted automatically from EDTA plasma or urine with the GenoXtract® followed by amplification, detection and quantification of characteristic target sequences with real-time PCR using FluoroCycler® XT instrument. Internal controls monitor test performance from sample preparation to test result. Reliable viral load assessment in International Units (IU/ml according to NIBSC WHO International Standard) requires only two quantification standards, which are determined just once per kit lot, eliminating the need for standard measurements with each run. Additionally, virus concentrations beyond linear quantification range are evaluated as qualitative results. Interpretation of results is performed automatically by the FluoroSoftware®, for reliable test results within only three hours.

Your benefits of using FluoroType® CMV

- Reliable quantification:Viral load assessment in IU/ml with two quantification standards, which are determined only once per kit lot. Virus concentrations beyond the limit of quantification are evaluated as qualitative results.
- User-friendly: Automated DNA extraction for minimal hands-on time and an efficient workflow. Interpretation of results is performed automatically by the FluoroSoftware®.
- Fast and dependable results: Internal controls monitor test performance from sample preparation to amplification and detection for reliable results within only three hours.
- Maximum flexibility: Combination with further viral parameters of our portfolio due to a universal test procedure. Single samples as well as high sample numbers can be analyzed efficiently according to your needs.
- CE-marked: No need for elaborate validation studies.

Molecular genetic test system for quantitative detection ofCMV

Starting material:
EDTA plasma and urine

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

Instrument for amplification and detection:
FluoroCycler® XT