Your molecular genetic test system for quantitative detection of polyomavirus BK from EDTA plasma and urine.
Polyomaviruses are spread worldwide among the human population with a seroprevalence of up to 80%. Primary infection with polyomavirus BK (BKV) in early childhood is usually asymptomatic. The virus establishes lifelong latency in cells of the urinary tract and kidneys. In immunosuppressed patients (e. g. after organ transplantation) however, virus reactivation may lead to severe complications and even renal failure. Close monitoring of BK viral load is of utmost importance in order to identify and evaluate potential virus reactivation at an early stage. Suitable therapeutic measures can thus be met before complications and irreversible organ damage occur. To date, the only known treatment is a controlled reduction in immunosuppression, which in turn has to be closely monitored, as it bears the risk of organ rejection. Therefore, a general BKV screening in regular intervals is advised after transplantation or complications.
FluoroType® BKV for fast and reliable quantification of BKV DNA from EDTA plasma or urine. Automated process steps minimize hands-on time for an efficient workflow. Viral DNA is extracted automatically with the GenoXtract® instrument 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. Test results are indicated directly in International Units (IU/ml according to NIBSC WHO International Standard), no additional calculation or conversion has to be performed by the user. Reliable BK viral load assessment requires only two quantification standards, which are determined only once per kit lot, eliminating the need for standard measurements with each run. Additionally, virus concentrations beyond the linear quantification range are evaluated as qualitative results. Interpretation of results is performed automatically by the intuitive and user-friendly FluoroSoftware®, for reliable test results within only three hours. FluoroType® BKV enables reliable viral load assessment, ensuring close patient monitoring.
Your benefits of using FluoroType® BKV
- Reliable quantification: Viral load assessment in IU/ml (WHO International Standard) requires only two quantification standards. Virus concentrations beyond the limit of quantification are evaluated as qualitative results.
- User-friendly: Minimal hands-on time with automated DNA extraction for an efficient workflow. Quantification standards need to be recorded only once per kit lot. 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. Reliable test results are available within only three hours.
- Maximum flexibility: A universal test protocol allows for combination with further parameters of our portfolio. Single samples as well as high sample numbers can be analyzed efficiently according to your needs.
- CE-marked: No need for elaborate validation studies.
Not all of our products are available in every country. Please contact your local sales representative for availability of this IVD product in your country.
At a glance
Molecular genetic test system for quantitative detection of BKV
EDTA plasma and urine
GXT NA Extraction Kit (with GenoXtract®)
Instrument for amplification and detection:
- 24 Tests No. 61524
- GXT NA Extraction Kit No. 12.08.02
- Proteinase K Set No. 405002