FDA Clears Randox Immunoassay for US Labs
News Sep 17, 2014
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 unique combination of analytes contained within this assayed control enables labs to effectively quality control a range of immunoassay tests, dramatically reducing the number of single controls required, thereby saving lab’s time and money.
Crucially, the Acusera Immunoassay Premium Plus is manufactured from 100% highest quality and highly screened human serum. Using 100% human serum is essential in immunoassay testing to minimize antibody cross reactivity, reducing the possibility of lot-to-lot variations when changing control batches.
An assayed control, instrument specific target values for each analyte are assigned using data from a global peer-group of over 25,000 laboratories, giving this product unsurpassed 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 this control will remain stable for 7 days at +2-8°c or 4 weeks at -20°c.
Randox US QC 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.”
*Source: 1 http://ods.od.nih.gov/factsheets/vitamind/; Holick MF "Vitamin D deficiency". N. Engl. J. Med. (2007) 357 (3): 266–81