EKF Diagnostics, Cardiff, UK, has announced the successful evaluation of its Quo-Lab point-of-care HbA1c analyzer by the European Reference Laboratory for Glycohemoglobin. The reference laboratory’s study assessed four point-of-care (POC) devices for measuring glycated hemoglobin (HbA1c) using international quality targets. Out of 30 devices available on the market, and four that agreed to participate, only EKF’s Quo-Lab and one other analyzer passed the same stringent quality criteria as laboratory analyzers, achieving excellent analytical performance.1
The study aimed to evaluate the four POC HbA1c instruments based on Clinical and Laboratory Standards Institute (CLSI) protocols and how they performed when different criteria were applied, using four secondary reference measurement procedures (SRMPs) certified by the International Federation of Clinical Chemistry (IFCC) and the National Glycohemoglobin Standardization Program (NGSP). The study confirmed that there was minimal bias between Quo-Lab and the mean of four SRMPs. The analyzer also satisfied all relevant performance criteria, exceeding the requirements for IFCC and NGSP certifications.
Gavin Jones, EKF Diagnostics.
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 Diabetes Control and Complications Trial (DCCT) units, both results representing a significant improvement over previous studies.
The evaluation success follows last year’s similarly excellent evaluation of EKF’s Quo-Test HbA1c analyzer, which was again confirmed to meet IFCC performance criteria.2 Although the Quo-Test analyzer was not included in the latest study, the study authors noted in their conclusion that Quo-Test’s improved performance also showed no bias compared to the mean of three SRMPs.
“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,” says Gavin Jones, diabetes product manager for EKF Diagnostics. “This study also highlights the performance improvements that we have made to both our Quo-Lab and Quo-Test HbA1c analyzers to fulfill increasingly tough requirements from the IFCC. This means that both analyzers meet the same rigorous quality criteria as laboratory analyzers.”
Quo-Lab HbA1c is a desktop analyzer designed specifically to meet the needs of diabetes clinics and laboratories in settings that demand low-cost operation and ease of use. From a simple semiautomated procedure, Quo-Lab provides test results within 4 minutes from a venous or fingerstick blood sample of just 4 ?L. Quo-Lab uses the same boronate affinity methodology as Quo-Test, which is also unaffected by Hb variants. A clear, multilingual display shows step-by-step instructions, minimizing staff training time and reducing opportunity for error. Quo-Lab is CE marked and available for sale in most global markets, subject to local registration requirements.
For more information, visit EKF Diagnostics.
References
- Lenters-Westra E, English E. Evaluation of four HbA1c point-of-care devices using international quality targets: are they fit for purpose? J Diabetes Sci Technol. 2018;12(4):762–770; doi: 10.1177/1932296818785612.
- Lenters-Westra E, English E. Understanding the use of sigma metrics in hemoglobin A1c analysis. Clin Lab Med. 2017;37(1):57–71; doi: 10.1016/j.cll.2016.09.006.
