The FDA has cleared Randox’s Immunoassay Premium Plus quality control for use in US laboratories.
A multi-analyte control, the Acusera Immunoassay Premium Plus combines 52 analytes including tumour markers, hormones, therapeutic drugs and Vitamin D.
One billion people globally – up to 77% of American adults - are thought to be vitamin D deficient. Randox offers the only third party multi-analyte immunoassay QC in the US which contains clinically relevant levels of Vitamin D.
The combination of analytes contained within the assayed control enables labs to effectively quality control a range of immunoassay tests, reducing the number of single controls required, thereby saving time and money.
The Acusera Immunoassay Premium Plus is manufactured from 100% high quality and highly screened human serum to minimise antibody cross reactivity - reducing the possibility of lot-to-lot variations when changing control batches.
Instrument specific target values for each analyte are assigned using data from a global peer-group of more than 25,000 laboratories to give accuracy and reliability.
Three levels of control are available with analytes present at clinically significant levels. This includes Ferritin and Vitamin B12 at levels suitable for anaemia monitoring. The level 1 control contains ultra-low TSH levels.
Lyophilised for enhanced stability, when reconstituted the control will remain stable for 7 days at 2-8°c or 4 weeks at -20°c.
Randox US quality control sales director John Schaefering said: “We are delighted to receive FDA clearance of a product which will help laboratories significantly streamline QC in immunoassay testing, while ensuring the highest possible standards of accuracy and precision.
“As laboratory budgets are increasingly under pressure, consolidated QC products offer major savings in both lab time and money.”
