Bio-Rad, HIVL201, Exact Diagnostics HIV-1 1E3 cp/mL Precision

INTENDED USE:
The Exact Diagnostics HIV-1 1E3 cp/mL Precision is calibrated against the 3 rd WHO International Standard for HIV-1 (10/152)1. The Exact Diagnostics HIV-1 1E3 cp/mL Precision is used to determine the accuracy of the assay for the presence of Human Immunodeficiency Virus (HIV-1) RNA at the target concentration of 1E3 cp/mL. Routine use of the Exact Diagnostics HIV-1 1E3 cp/mL Precision allows laboratories to evaluate their molecular assay and test for operator proficiency.

PRODUCT DESCRIPTION:
The Exact Diagnostics HIV-1 1E3 cp/mL Precision contains whole, intact virus that has been heat inactivated. The Exact Diagnostics HIV-1 1E3 cp/mL Precision is intended to test the entire process of a molecular assay including extraction, detection, and amplification.

The Exact Diagnostics HIV-1 1E3 cp/mL Precision is reported in copies per milliliter (cp/mL). The Exact Diagnostics HIV-1 1E3 cp/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.