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Mindray Receives CE Mark for HIV and HBV Test Kits

NEW YORK (360Dx) – Shenzhen, China-based Mindray said today that it has received CE marking for its HIV and HBV test kits for HBsAg, Anti-HBs, Anti-HBc, HBeAg, and Anti-HBe.

The firm noted that its CL-series HIV chemiluminescence immunoassay performs simultaneous qualitative determination of HIV p24 antigen prior to seroconversion and of antibodies to HIV-1 and HIV-2 in human serum or plasma. Mindray said that the assay shortens the detection window and improves sensitivity in the early detection of HIV infection, and added that it can be used as an aid in the diagnosis of HIV-1/HIV-2 infection and as a screening test for donated blood.

Zhaoyang Li, general manager of Mindray's in vitro diagnostics business unit, said that the firm has "applied a number of patented technologies in the infectious disease assays to shorten the window period and reduce the endogenous interference of samples from pregnant women, the elderly, and patients with hepatic or renal diseases."