Bio-Rad, CMVL201, Exact Diagnostics CMV 1E3 IU/m

INTENDED USE:
The Exact Diagnostics CMV 1E3 IU/mL Precision is calibrated against the 1 st WHO International Standard for Cytomegalovirus (09/162)1. The Exact Diagnostics CMV 1E3 IU/mL Precision is used to determine the accuracy of the assay for the presence of Cytomegalovirus (CMV) DNA at the target concentration of 1E3 IU/mL. Routine use of the Exact Diagnostics CMV 1E3 IU/mL Precision allows laboratories to evaluate their molecular assay and test for operator proficiency.

PRODUCT DESCRIPTION:
The Exact Diagnostics CMV 1E3 IU/mL Precision contains whole, intact virus. The Exact Diagnostics CMV 1E3 IU/mL Precision is developed using heat inactivated CMV Merlin strain. The Exact Diagnostics CMV 1E3 IU/mL Precision is intended to test the entire process of a molecular assay including extraction, detection, and amplification. The Exact Diagnostics CMV 1E3 IU/mL Precision is reported in International Units per milliliter (IU/mL). The Exact Diagnostics CMV 1E3 IU/mL Precision is formulated in True EDTA Plasma that is non-reactive for HBV DNA, HCV RNA, HIV-1 RNA, CMV DNA, HBsAg, and antibodies for HIV-1/2, and HCV.