Assayed Quality Control Suitable for Most Immunoassay Analyzers

An assayed Quality Control (QC) is suitable for use with most immunoassay analyzers. Assigned values are provided for nine immunoassay parameters, and it is the only multianalyte immunoassay QC in the market which contains clinically relevant levels of Vitamin D.

Randox’s (Crumlin, United Kingdom) Acusera Immunoassay Speciality 1 control will provide laboratories with the means to monitor the precision of their testing methods and is an aid to ensuring quality patient results on an ongoing basis.

Randox controls are true third party controls, manufactured independently using 100% human serum, which has been highly screened to ensure quality. This minimizes antibody cross reactivity, reducing the possibility of lot to lot variations when changing control batches thereby saving laboratories time and money.

Lyophilized for enhanced stability, when reconstituted the control will remain stable for up to 5 days at 2–8 °C or 4 weeks at -20 °C.

Randox announced that the US Food and Drug Administration (FDA; Silver Spring, MD, USA) has approved the company’s Acusera Immunoassay Specialty 1 control for use in US laboratories. Randox’s global QC manager Steven Jordan said, “We are delighted to receive FDA clearance. It will allow our US customers to benefit from improved accuracy in patient testing, whilst reducing the laboratory’s need to run multiple control tests.”

Related Links:
Randox
US Food and Drug Administration