Bio-Rad, HCVH202, Exact Diagnostics HCV 1E6 IU/mL Precision

INTENDED USE:
The Exact Diagnostics HCV 1E6 IU/mL Precision is calibrated against the 4 th WHO International Standard for Hepatitis C (06/102)1. The Exact Diagnostics HCV 1E6 IU/mL Precision is used to determine the accuracy of the assay for the presence of Hepatitis C Virus (HCV) RNA at the target concentration of 1E6 IU/mL. Routine use of the Exact Diagnostics HCV 1E6 IU/mL Precision allows laboratories to evaluate their molecular assay and test for operator proficiency.

PRODUCT DESCRIPTION:
The Exact Diagnostics HCV 1E6 IU/mL Precision contains whole, intact virus that is non-infectious. The Exact Diagnostics HCV 1E6 IU/mL Precision is developed using recombinant, non-infectious virus which contains the HCV 5’ UTR insertion. The Exact Diagnostics HCV 1E6 IU/mL Precision is intended to test the entire process of a molecular assay including extraction, detection, and amplification.

The Exact Diagnostics HCV 1E6 IU/mL Precision is reported in International Units per milliliter (IU/mL). The Exact Diagnostics HCV 1E6 IU/mL Precision is formulated in True EDTA Plasma that is non-reactive for HBV DNA, HCV RNA, HIV-1 RNA, HBsAg, and antibodies for HIV-1/2, and HCV.