Chaiwong Kwanlada, Naksith Rujira, Laiklang Waroonkarn, Yeekaday Manissara, Wongkamchai Suppakorn, Limpornpukdee Orakan, Ketloy Chutitorn, Prompetchara Eakachai
Division of Laboratory Medicine, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Department of Laboratory Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Diagnosis (Berl). 2024 Dec 12;12(2):268-276. doi: 10.1515/dx-2024-0158. eCollection 2025 May 1.
Validation and performance assessment of novel ESR analyzer is required before implementation. The objective of this study was to assess the correlation between three ESR measurement methods. Full validation and performance assessment of an alternate method (TEST1) were also evaluated.
Three-way correlation assessment for the Westergren (WG), modified Westregren (Mixrate), and alternate (TEST1) methods were performed. Analytical performance of TEST1 including precision, carryover, sample stability, potential interferences as well as effect of hematocrit (Hct) and mean corpuscular volume (MCV) were also determined.
Strong correlation between three ESR measurement methods were observed. Correlation coefficient (r) was 0.902, 0.977, and 0.949 for WG vs. TEST1, WG vs. Mixrate, and TEST1 vs. Mixrate, respectively with absolute bias <5 mm. For TEST1, precision and carryover were within the manufacturer's claim. Samples were stable upto 24 h and 48 h when they were stored at room temperature or 2-8 °C, respectively. No effect of trigyceride and cholesterol was observed. In low Hct samples, no significant different between the results obtained from Fabry's formula corrected WG values and from TEST1.
Three-way comparison study yielded a strong correlation between methods. As part of the method validation before implementing a new analyzer, full validation of TEST1 showed that all validated parameters met the manufacturer's specifications. A negative bias was observed but remains within the acceptable criteria. Difference in values for samples with low hematocrit were noted, but these can be corrected by Fabry's formula applied to the values from WG method.
在新型红细胞沉降率（ESR）分析仪投入使用前，需要对其进行验证和性能评估。本研究的目的是评估三种ESR测量方法之间的相关性。同时还对另一种方法（TEST1）进行了全面验证和性能评估。
对魏氏（WG）法、改良魏氏（Mixrate）法和另一种方法（TEST1）进行了三方相关性评估。还测定了TEST1的分析性能，包括精密度、携带污染、样本稳定性、潜在干扰以及血细胞比容（Hct）和平均红细胞体积（MCV）的影响。
观察到三种ESR测量方法之间具有很强的相关性。WG与TEST1、WG与Mixrate、TEST1与Mixrate的相关系数（r）分别为0.902、0.977和0.949，绝对偏差<5毫米。对于TEST1，精密度和携带污染在制造商规定的范围内。样本分别在室温或2-8°C下储存时，在24小时和48小时内保持稳定。未观察到甘油三酯和胆固醇的影响。在低Hct样本中，经法布里公式校正的WG值与TEST1所得结果之间无显著差异。
三方比较研究表明各方法之间具有很强的相关性。作为新分析仪投入使用前方法验证的一部分，TEST1的全面验证表明所有验证参数均符合制造商的规格。观察到存在负偏差，但仍在可接受标准范围内。注意到低血细胞比容样本的值存在差异，但可通过将法布里公式应用于WG法的值进行校正。
