FDA-Cleared Randox Immunoassay Control Simplifies Vitamin D Testing in Labs
30 Jul 2014The 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 tumor 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.”
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Immunoassay Premium Plus Control
Randox Laboratories Ltd.The Randox Acusera Immunoassay Premium Plus quality control covers an impressive 54 analytes with assayed instrument specific target values and ranges provided for up to 51 analytes. The unique combination of routine tumour markers, therapeutic drugs and Vitamin D allows laboratories to dramatically reduce the number of controls required while ultimately keeping costs to a minimum. Three levels of control are available with analytes present at clinically significant levels.Features & BenefitsLyophilised for enhanced stability100% human serumAssayed, instrument specific target values provided for up to 51 parametersFerritin and Vitamin B12 levels suitable for anaemia monitoringUltra low TSH levels in the level 1 controlStable to expiry date at 2°C – 8°CReconstituted stability of 7 days at 2°C – 8°C or 4 weeks at -20°CContains routinely run tumour markers: AFP/CA15-3/CA19-9/CA-125/CEA/PSA/Free-PSADescription - Size - Analytes - Cat NoImmunoassay Premium Plus Level 1 - 12 x 5ml - 54 - IA3109Immunoassay Premium Plus Level 2 - 12 x 5ml - 54 - IA3110Immunoassay Premium Plus Level 3 - 12 x 5ml - 54 - IA3111Immunoassay Premium Plus Tri-Level - 4 x 3 x 5ml - 54 - IA3112Analytes:ACTHAcetaminophenAFPAldosteroneAmikacinAndrostenedioneB2 MicroglobulinCA 15-3CA 19-9CA 125CEACarbamazepineC peptidehCGCortisolDHEA SulphateDigoxinEstriol*EthosuximideFerritinFolateFree T3Free T4FSHGentamicinGrowth HormoneIgEInsulinLeutinising HormoneOestradiolPhenobarbitalPhenytoinProgesteronePrimidoneProlactinPSA (Free)PSA (Total)17-OH-ProgesteroneSalicylateSHBGTestosteroneTestosterone (free)*TheophyllineThyroglobulinTotal T3Total T4TobramycinTSHT UptakeValproic AcidVancomycinVitamin B121-25-(OH)2 Vitamin D*25-OH-Vitamin D