In Q3 of 2013, Randox announced that the Food and Drug Administration has approved the company's Acusera Immunoassay Speciality 1 quality control for use in US laboratories.
As a multi-analyte, lyophilized control, nine complex immunoassays are present at clinically significant levels:
I-25-(OH)2 -Vitamin DInsulin Parathyroid Hormone
25-OH-Vitamin DInsulin Like Growth Factor 1Anti-Thyroglobulin
C Peptide Procalcitonin Anti-Thyroperoxidase
Acusera Immunoassay Speciality Control 1 is an assayed quality control (QC), which is suitable for use with most immunoassay analyzers. 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're 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 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, a web-based interlaboratory data management package designed to monitor analytical performance, interpret QC results and, ultimately, help improve accuracy of test results. With peer group data uniquely updated every 24 hours, Acusera 24•7 Live Online will eliminate the need for costly retests and provides confidence in assigned target values and therefore patient diagnosis.