Department of Laboratory Medicine, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.
Int J Lab Hematol. 2023 Aug;45(4):449-459. doi: 10.1111/ijlh.14044. Epub 2023 Mar 13.
The erythrocyte sedimentation rate (ESR) is a nonspecific inflammatory indicator and is widely used in clinical diagnosis. Westergren is the gold standard method recommended by the International Committee for Standardization of Hematology (ICSH), but it is time-consuming and inconvenient and has biosafety risks. A new alternate method for ESR (Easy-W ESR) measurement was designed and integrated into the Mindray BC-720 series automated hematology analyzer to meet the clinical needs of hematology laboratories for efficiency, safety, and automation. In this study, the performance of the new ESR method was evaluated based on the ICSH recommendations on modified and alternate ESR methods.
Methodological comparisons using the BC-720 analyzer, TEST 1, and the Westergren method were performed to assess repeatability, carryover, sample stability, reference range validation, factors influencing the ESR, and clinical applicability in rheumatology and orthopedics.
The correlation between the BC-720 analyzer and the Westergren method was good (Y = 2.082 + 0.9869X, r = 0.9657, P > 0.0001, n = 342), carryover was <1%, the repeatability standard deviation was ≤1 mm/h, and the coefficient of variation (CV) was ≤5%. The reference range meets the manufacturer's claim. For rheumatology patients, the BC-720 analyzer showed a good correlation with the Westergren method (Y = 1.021X-1.941, r = 0.9467, n = 149). For orthopedic patients, the BC-720 analyzer also showed a good correlation with the Westergren method (Y = 1.037X + 0.981, r = 0.978, n = 97).
This study verified the clinical and analytical performance of the new ESR method, indicating that the results are very similar to those obtained using the Westergren method.
红细胞沉降率（ESR）是一种非特异性炎症指标，广泛应用于临床诊断。魏氏法是国际血液学标准化委员会（ICSH）推荐的金标准方法，但该方法耗时、不便，且存在生物安全风险。为满足临床对血液学实验室效率、安全性和自动化的需求，设计了一种新的红细胞沉降率（ESR）替代方法（Easy-W ESR），并将其集成到迈瑞 BC-720 系列全自动血液分析仪中。本研究根据 ICSH 关于改良和替代 ESR 方法的建议，对新 ESR 方法的性能进行了评估。
采用 BC-720 分析仪、TEST1 及魏氏法进行方法学比较，评估重复性、携带污染、样本稳定性、参考范围验证、影响 ESR 的因素及在风湿免疫科和骨科的临床适用性。
BC-720 分析仪与魏氏法相关性良好（Y=2.082+0.9869X，r=0.9657，P＞0.0001，n=342），携带污染＜1%，重复性标准差≤1mm/h，变异系数（CV）≤5%。参考范围符合厂家声称。对风湿免疫科患者，BC-720 分析仪与魏氏法相关性良好（Y=1.021X-1.941，r=0.9467，n=149）。对骨科患者，BC-720 分析仪与魏氏法相关性亦良好（Y=1.037X+0.981，r=0.978，n=97）。
本研究验证了新 ESR 方法的临床和分析性能，结果与魏氏法非常相似。
