Department of Laboratory Diagnostics, University Hospital Centre Zagreb, Zagreb, Croatia.
Laboratory for Medical Biochemistry, General Hospital Varaždin, Varaždin, Croatia.
Clin Chem Lab Med. 2023 Feb 20;61(8):1463-1469. doi: 10.1515/cclm-2023-0033. Print 2023 Jul 26.
Analytical validation of automated erythrocyte sedimentation rate (ESR) analyzers is necessary prior to their implementation into routine practice. Our aim was to perform the analytical validation of the modified Westergren method applied on the CUBE 30 touch analyzer (Diesse, Siena, Italy).
Validation included determination of within-run and between-run precision following the Clinical and Laboratory Standards Institute EP15-A3 protocol, comparison with the reference Westergren method, sample stability assessment at both room temperature and 4 °C, after 4, 8 and 24-h storage, and checking the extent of hemolysis and lipemia interference.
Coefficients of variation (CVs) for within-run precision were 5.2% for the normal and 2.6% for the abnormal range, while between-run CVs were 9.4 and 2.2%, respectively. Comparison with the Westergren method (n=191) yielded Spearman's correlation coefficient of 0.93, no constant nor proportional difference [y=0.4 (95% CI: -1.7-1.0) + 1.06 (95% CI: 1.00-1.14)x] and a non-significant mean absolute bias of -2.6 mm (95% CI: -5.3-0.2). Lower comparability was evidenced with increasing ESR values, with both constant and proportional differences for ESR values between 40 and 80 mm, and above 80 mm. Sample stability was not compromised up to 8-h storage both at room temperature (p=0.054) and 4 °C (p=0.421). Hemolysis did not affect ESR measurement up to 1.0 g/L of free hemoglobin (p=0.089), while lipemia index above 5.0 g/L affects the ESR result (p=0.004).
This study proved that CUBE 30 touch provides reliable ESR measurement and satisfactory comparability with the reference Westergren methods, with minor variation related to methodological differences.
在将自动红细胞沉降率（ESR）分析仪投入常规使用之前，需要对其进行分析验证。我们的目的是对应用于 CUBE 30 触摸分析仪（意大利锡耶纳的 Diesse）的改良 Westergren 方法进行分析验证。
验证包括根据临床和实验室标准协会 EP15-A3 协议进行批内和批间精密度测定、与参考 Westergren 方法比较、在室温（4°C）下分别在 4、8 和 24 小时储存后的样本稳定性评估，以及检查溶血和脂血干扰的程度。
批内精密度的变异系数（CV）分别为正常范围的 5.2%和异常范围的 2.6%，而批间 CV 分别为 9.4%和 2.2%。与 Westergren 方法（n=191）的比较得出斯皮尔曼相关系数为 0.93，无常数和比例差异[y=0.4（95%CI：-1.7-1.0）+1.06（95%CI：1.00-1.14）x]，平均绝对偏差无统计学意义为-2.6mm（95%CI：-5.3-0.2）。随着 ESR 值的增加，可比性降低，ESR 值在 40 至 80mm 之间以及 80mm 以上时，存在常数和比例差异。在室温（p=0.054）和 4°C（p=0.421）下，标本稳定性在 8 小时储存内不受影响。溶血程度达到 1.0g/L 游离血红蛋白时，不会影响 ESR 测量（p=0.089），而脂血指数超过 5.0g/L 时会影响 ESR 结果（p=0.004）。
本研究证明 CUBE 30 触摸提供了可靠的 ESR 测量值，与参考 Westergren 方法具有良好的可比性，方法学差异导致的差异较小。
