Randox Laboratories has this month announced its achievement in being awarded the Manufacturer Certification by the National Glycohemoglobin Standardization Program (NGSP); for direct HbA1c testing on three of its clinical chemistry analysers; the RX modena, RX imola and RX daytona+.
NGSP is recommended for laboratories conducting diabetes-related clinical trials and is only granted on the basis of 98% accuracy. With the global prevalence of diabetes mellitus increasing rapidly, affecting roughly 8% of the total population, the achievement of this certification emphasises that Randox RX series clinical chemistry analysers correlate with global standards and deliver accurate, reliable and precise results for direct HbA1c testing; helping clinicians make informed decisions for patients with diabetes.
The Randox automated immunoturbidmetric HbA1c test exhibits high accuracy and reproducibility with the added advantages of using liquid reagents with good stability, and on-board pre-treatment of samples; therefore, offering an improved method for the rapid direct measurement of HbA1c in human blood.
Randox Direct HbA1c Assay Features
- Sample type – suitable for use with whole blood samples
- Latex enhanced immunoassay method – the Randox assay utilises an immunoassay method making it simple and quick to perform
- Liquid ready to use reagents – for ease of use and convenience
- Excellent stability – all reagents are stable to expiry date when stored at +2-8ºC or 28 days on board the analyser at approximately 10°C
Advantages of the RX series Direct HbA1c Testing
- Fully automated on-board haemolysis function for HbA1c testing
- Continuous loading and STAT sample functionality to enhance productivity in the laboratory (analyser dependent)
- Low sample volumes required
- 1200 tests per hour including ISE (RX modena)
Randox was awarded NGSP Certification for Direct HbA1c testing on 1st July 2019.