OptiQual BKV Low and High Positive Controls

Increase your confidence in your molecular BK virus assay with the first and only standardized, full-process BK virus control!

Facilitating quality test results

· Closely mimics patient samples: the only unaltered, whole BK virus control in EDTA plasma

· Full process control for all test procedures including extraction

Helping you meet CAP and CLIA guidelines

· Designed for use on multiple combinations of extraction and amplification systems

· Configure your own combination of BK virus panels and controls to fit your specific validation needs. To learn more, visit our new Validation and Verification Webpage.

Manage costs and reduce downtime

· Controls yield consistent and reproducible results over time, independent of the lot

· Manufactured according to ISO 17511 for traceability to a higher in-house standard

Product Description

Designed and manufactured according to ISO 17511*, the OptiQual BKV Controls are assigned traceable values with uncertainty measurements and possess superior reproducibility and consistency in results from lot to lot. These controls also effectively mimic authentic patient samples, consisting of whole, unaltered virus in an EDTA-based plasma matrix. This ready-to-use, quality design allows labs to control for the full molecular testing process with confidence and ease. The OptiQual BKV Positive Controls are valuable tools for laboratories in optimizing BK virus assay performance.

Developed for use on multiple extraction and amplification systems, the OptiQual BKV Low and High Positive Controls are intended for use in assessing the performance of nucleic acid test procedures for the determination of human BK virus DNA (BKV DNA). Routine use of external quality controls enables laboratories to monitor day-to-day test variation, lot-to-lot performance of test kits, and operator variation, and can assist in identifying increases in random or systematic error.

The OptiQual BKV Controls contain human BK virus. The plasma was tested and found to be non-reactive for HCV RNA, HBV DNA, and HIV-1 RNA, as well as non-reactive for antibodies to HIV-1 and HIV-2, and HBsAg. The OptiQual BKV Low and High Positive Controls are for in vitro diagnostic use.

*ISO 17511: In vitro diagnostic medical devices—Measurement quantities in biological samples—Metrological traceability of values assigned to calibrators and control materials

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BKV Control Configurations

Description	Catalog Number
Low Positive Control (5 vials, 0.5 mL each)	96-0050
High Positive Control (5 vials, 0.5 mL each)	96-0051

Storage Instructions

The OptiQuant® BKV Low and High Positive Controls must be stored at -20°C or below to ensure highest quality. The controls may be refrozen after first use, thawed and used a second time with minimal loss of activity. Discard any unused material after the second use.