FDA-Cleared Randox Immunoassay Control Simplifies Vitamin D Testing in Labs

Released: 24-Jul-2014 8:00 AM EDT
Source Newsroom: 2014 AACC Annual Meeting Press Program
Contact Information

Available for logged-in reporters only

Newswise — 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 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
________________________________________
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 1300 employees globally, Randox is dedicated to meeting your testing needs.
________________________________________
Contact Louise McVicker, Public Relations Exec for further information on +44 (0) 28 9445 1016, email louise.mcvicker@randox.com or visit I www.randox.com

Acusera Immunoassay Premium Plus contains:

17-OH-Progesterone
ACTH
Aldosterone
Alphafoetoprotein
Amikacin
β – 2 – Microglobulin
CA 15-3
CA 19-9
CA 125
Carbamazepine
Carcinoembryonic Antigen (CEA)
Cortisol
C Peptide
DHEA-Sulphate Digoxin
Estriol
Ethosuximide
Ferritin
Folate
Free T3
Free T4
FSH
Gentamicin
Growth Hormone (GH)
Human Chorionic Gonadotrophin (hCG)
IgE
Insulin Leuteinising Hormone (LH)
Oestradiol
Paracetamol (Acetaminophen)
Parathyroid Hormone (PTH)
Phenobarbital
Phenytoin
Primidone
Progesterone
Prolactin
PSA (Free)
PSA (Total)
Salicylate
SHBG
T Uptake Testosterone
Testosterone (Free)
Theophylline
Thyroglobulin
Thyroid Stimulating Hormone (TSH)
Tobramycin
Total T3
Total T4
Valprioc Acid
Vancomycin
Vitamin B12
I-25-(OH)2 – Vitamin D
25-OH-Vitamin D


Comment/Share