Excellent performance of POC HbA1c analyser demonstrated
EKF Diagnostics has announced the successful evaluation of its Quo-Lab® point-of-care HbA1c analyser by the European Reference Laboratory for Glycohemoglobin. In a recently published paper. The reference laboratory’s evaluation study assessed HbA1c (glycated hemoglobin) POC devices using international quality targets, posing the question ‘Are they fit for purpose?’ Out of 30 available on the market and the four that agreed to participate, only EKF’s Quo-Lab and one other analyser passed the same stringent quality criteria as laboratory analysers, achieving excellent analytical performance.
The study aimed to evaluate the four POC HbA1c instruments according to Clinical and Laboratory Standards Institute (CLSI) protocols and how they performed when different criteria were applied using four certified IFCC and NGSP secondary reference measurement procedures (SRMPs). The reference laboratory study confirmed there was minimal bias between Quo-Lab and the mean of four SRMPs, it also passed all relevant performance criteria going far beyond what is required for NGSP and IFCC certification.
Notably, Quo-Lab showed no consistent clinically significant interference from the common hemoglobin (Hb) variants HbAS, HbAC, HbAD, HBAE and elevated A2. It also easily met imprecision criteria, achieving a ≤2.4% CV in IFCC SI units and ≤1.7% CV in DCCT units which represents a significant improvement on previous studies.
Commenting on the successful European Reference Laboratory for Glycohemoglobin evaluation, Gavin Jones, Diabetes Product Manager, EKF Diagnostics said, “The excellent performance that Quo-Lab has demonstrated in this latest study confirms that it is very definitely fit for purpose, delivering reliable HbA1c results in a range of settings. Quo-Lab® HbA1c is a desktop analyser designed specifically to meet the needs of diabetes clinics and laboratories in settings that demand low cost of operation and ease of use. From a simple semi-automated procedure, Quo-Lab provides test results within four minutes from a venous or finger prick blood sample of just 4 μL