Bio-Rad, BKVB201, Exact Diagnostics BKV Verification Bundle

The EDX BKV Verification Panel 1.4mL contains whole, intact virus that has been heat inactivated. EDX BKV Verification Panel 1.4mL is intended to test the entire process of a molecular assay including extraction, detection, and amplification. The EDX BKV Verification Panel 1.4mL is reported in International Units per milliliter (IU/mL). EDX BKV Verification Panel 1.4mL is manufactured according to ISO 17511:2003. EDX BKV Verification Panel 1.4mL is formulated in True EDTA Plasma that is non-reactive for HBV DNA, HCV RNA, HIV-1 RNA, BKV DNA, HBsAg and antibodies for HIV-1/2 and HCV.

INTENDED USE:

The EDX BKV Verification Panel 1.4mL is a standard for various molecular assays. EDX BKV Verification Panel 1.4mL is calibrated against the 1st WHO International Standard for BK Virus (BKV) (14/212) 1 . EDX BKV Verification Panel 1.4mL is used to establish points of reference (qualitative and quantitative) for the measurement of Polyomavirus BK Virus (BKV) DNA. EDX BKV Verification Panel 1.4mL allows laboratories to evaluate their molecular assay and test for operator proficiency.

LIMITATIONS:

For In Vitro Diagnostic Use.