Randox today announced that the Food and Drug Administration has approved the company’s Acusera Immunoassay Specialty 1 control for use in US laboratories.
I-25-(OH)2 –Vitamin D | Insulin | Parathyroid Hormone |
25-OH-Vitamin D | Insulin Like Growth Factor 1 | Anti-Thyroglobulin |
C Peptide | Procalcitonin | Anti-Thyroperoxidase |
A multi-analyte, lyophilised control, it contains nine complex immunoassays
Acusera Immunoassay Specialty Control 1 is an assayed Quality Control (QC), which is suitable for use with most immunoassay analysers. With assigned values are provided for all 9 immunoassay parameters, it is the only multi-analyte immunoassay QC in the market which contains clinically relevant levels of Vitamin D.
Lyophilized for enhanced stability, when reconstituted this control will remain stable for up to 5 days at +2-8°C or 4 weeks at -20°C.
The routine use of Randox’s 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’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.”
All Randox controls are true third party controls, manufactured independently using 100% human serum which has been highly screened to ensure quality. Using controls manufactured from 100% human serum minimizes antibody cross reactivity, reducing the possibility of lot to lot variations when changing control batches thereby saving laboratories time and money.
For enhanced laboratory performance, all of Randox QC products can be used in conjunction with Acusera 24.7 Live Online, an interlaboratory data management and peer group reporting package designed to help monitor analytical performance, interpret QC results and, ultimately, to improve patient diagnosis through accurate and reliable patient test results.
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For press enquiries please contact Louise McVicker on +44 (0) 28 9445 1016. Email [email protected] or [email protected]
About Randox Laboratories Ltd.
Randox is a global market leader within the in vitro diagnostics industry, developing innovative diagnostic solutions for hospitals, clinical, research and molecular labs, food testing, forensic toxicology, veterinary labs and life sciences. With offices and distribution in over 145 countries, Randox offers customers improved efficiency, quality, cost-effectiveness and flexibility. Randox is committed to revolutionising healthcare on a global scale. With over 1000 employees globally, Randox is dedicated to meeting your testing needs. Contact Public Relations for further information on +44 (0) 28 9445 1016 I www.randox.com