FDA Approves Randox Immunoassay Speciality Controls for US Market

Randox today announced that the Food and Drug Administration has approved the company’s Acusera Immunoassay Specialty 1 control for use in US laboratories.

A multi-analyte, lyophilized control, it contains nine complex immunoassays:

I-25-(OH)2 –Vitamin D
25-OH-Vitamin D
C Peptide
Insulin
Insulin Like Growth Factor 1
Procalcitonin
Parathyroid Hormone
Anti-Thyroglobulin
Anti-Thyroperoxidase

Acusera Immunoassay Specialty Control 1 is an assayed Quality Control (QC), which is suitable for use with most immunoassay analyzers. With assigned values are provided for all 9 immunoassay parameters, it is the only multi-analyze 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 inter-laboratory 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.