Kuti Modupe Akinrele, Adeleye Jokotade Oluremilekun
Department of Chemical Pathology, College of Medicine, University of Ibadan, Ibadan, Nigeria.
Department of Medicine, College of Medicine, University of Ibadan, Ibadan, Nigeria.
Niger Med J. 2025 Apr 3;66(1):246-255. doi: 10.71480/nmj.v66i1.698. eCollection 2025 Jan-Feb.
For methods that report quantitatively, an assessment of their imprecision and bias should be assessed in the laboratory before their deployment into routine service. This study assessed these parameters of the HbA1C method on the STANDARD F2400® point of care analyzer. These parameters were further combined to generate sigma metrics for the method.
An external quality assurance (EQA) material from the Randox International Quality Assessment Scheme (RIQAS) was analysed according to the EP15 protocol of the Clinical Laboratory Standards Institute in SYNLAB Nigeria Laboratory Quality Assurance Department. Estimates of precision and an assessment of bias were determined from the data which consisted of 5 replicates per day for 5 consecutive days. Precision estimates were compared with manufacturer-provided information and estimates of bias were compared with the verification interval for the target value provided by RIQAS. Sigma metrics were determined for total allowable error (TAE) of 8% and 10%.
The grand mean (standard deviation) for the study was 4.95 (0.15) %. The Within-run CV and within laboratory CV were 1.28% and 1.86%, respectively. These were within the manufacturer claims of 1.70% and 1.90%, also respectively. The target value by RIQAS was 5.04(0.24) % with a calculated verification interval of 4.95 - 5.13%. The sigma metrics for the method at TAE of 8% and 10% were 4.8/3.3 and 6.3/4.3 within the run/within laboratory estimates respectively.
The HbA1C method on the STANDARD F2400® Analyzer displayed performance characteristics that are consistent with manufacturer specifications and are above industry standard quality for a point-of-care device for HbA1C. These suggest that may be used to support routine monitoring of persons with diabetes mellitus in Nigeria.
对于定量报告的方法，在将其投入常规服务之前，应在实验室评估其不精密度和偏倚。本研究评估了STANDARD F2400®即时检验分析仪上糖化血红蛋白（HbA1C）方法的这些参数。这些参数进一步合并以生成该方法的西格玛指标。
按照尼日利亚SYNLAB实验室质量保证部临床实验室标准协会的EP15协议，对来自朗道国际质量评估计划（RIQAS）的外部质量保证（EQA）材料进行分析。从连续5天每天5次重复的数据中确定精密度估计值和偏倚评估。将精密度估计值与制造商提供的信息进行比较，将偏倚估计值与RIQAS提供的目标值验证区间进行比较。确定了总允许误差（TAE）为8%和10%时的西格玛指标。
该研究的总体均值（标准差）为4.95（0.15）%。批内变异系数（CV）和实验室内CV分别为1.28%和1.86%。这些也分别在制造商声称的1.70%和1.90%范围内。RIQAS的目标值为5.04(0.24) %，计算出的验证区间为4.95 - 5.13%。TAE为8%和10%时，该方法在批内/实验室内估计的西格玛指标分别为4.8/3.3和6.3/4.3。
STANDARD F2400®分析仪上的HbA1C方法显示出与制造商规格一致的性能特征，并且高于糖化血红蛋白即时检验设备的行业标准质量。这些表明该方法可用于支持尼日利亚糖尿病患者的常规监测。
