Department of Clinical Laboratory Center, Beijing AnZhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing, China.
Department of Cardiac Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.
J Clin Lab Anal. 2021 Mar;35(3):e23660. doi: 10.1002/jcla.23660. Epub 2020 Dec 29.
We validated the performance of seven different reagents of peroxidase method for sdLDL-C in two automatic analyzers that are common in Chinese laboratories.
Seven commercially available sdLDL-C assays were analyzed with the Beckman AU5400 and Mindray BS2000 automatic analyzers. A total of 336 blood samples were collected and the reference interval was also validated in 298 apparently healthy individuals. Serum samples were used for method comparison of precision, recovery, lower limit of detection, comparison and concurrence analysis, as well as reference interval for the Mindray reagent.
The repeatability CV% of the seven sdLDL-C assays were 0.81%3.66% for Mindray BS2000 and 0.76%3.91% for Beckman AU5400, while Total CVs for Mindray BS2000 sdLDL-C assay were 1.34%4.81%, and that of Beckman AU5400 were 2.25%10.33%. The measured recovery rates of sdLDL-C assays were within the allowable ±10% deviation range. There was no obvious difference between the reagents in the lower limit detection. There was a difference between the validation results of the reference range and the manufacturer's.BSBE, Mindray, and Dongou had a high degree of association with DENKA SEIKEN on Mindray BS2000, while BSBE, Mindray, Dongou and Merit Choice had a high degree of association with DENKA SEIKEN on Beckman AU5400. Passing-Bablok regression showed excellent linear correlation between BSBE and Mindray and DENKA SEIKEN and on Beckman AU5400.
Our results indicate that the basic performance can meet the testing requirements, but the comparability between them is still insufficient.
我们在两种常见于中国实验室的自动分析仪上验证了七种不同过氧化物酶法试剂检测 sdLDL-C 的性能。
使用贝克曼 AU5400 和迈瑞 BS2000 自动分析仪分析了七种市售的 sdLDL-C 检测试剂。共采集了 336 份血样，并在 298 名健康个体中验证了参考区间。使用血清样本进行精密度、回收率、检测下限比较和一致性分析以及迈瑞试剂参考区间的方法比较。
七种 sdLDL-C 检测试剂在迈瑞 BS2000 上的重复性 CV%为 0.81%3.66%，在贝克曼 AU5400 上为 0.76%3.91%，而迈瑞 BS2000 sdLDL-C 检测试剂的总 CV 为 1.34%4.81%，贝克曼 AU5400 的为 2.25%10.33%。sdLDL-C 检测试剂的测定回收率在允许的±10%偏差范围内。检测下限无明显差异。参考范围的验证结果与制造商提供的结果存在差异。BSBE、迈瑞和东瓯在迈瑞 BS2000 上与 DENKA SEIKEN 高度相关，而 BSBE、迈瑞、东瓯和 Merit Choice 在贝克曼 AU5400 上与 DENKA SEIKEN 高度相关。Passing-Bablok 回归显示 BSBE 和 Mindray 与 Beckman AU5400 上的 DENKA SEIKEN 之间具有极好的线性相关性。
我们的结果表明，基本性能可以满足检测要求，但它们之间的可比性仍然不足。
