Zhou Wenbin, Li Chenbin, Zhang Haipeng, Cheng Fei, Peng Mingting
National Center for Clinical Laboratories, Beijing Hospital, Beijing 100730, China.
National Center for Clinical Laboratories, Beijing Hospital, Beijing 100730, China; Email:
Zhonghua Yi Xue Za Zhi. 2015 Sep 8;95(34):2754-9.
To evaluate the comparability of measurement results for coagulation factor VIII (FVIII)and factor IX (FIX) activity and the commutability of reference materials on different measurement systems.
The study was performed according to CLSI guideline EP30 and China health standard WS/T 356-2011. Clinical samples with different levels of FVIII and FIX which covered over the clinical analytical range, five lots of homemade reference materials (F20140601-F20140605) and a coagulation reference material (SSCLOT4) provided by NIBSC were detected for FVIII and FIX activity on three popular measurement systems in China, which including Stago STA-R Evolution, IL ACL TOP700 and Sysmex CA7000 automatic coagulation analyzers using supplementary reagents. The results between measurement systems were analyzed pairwise. To evaluate the comparability, the linear regression and the biases between the results of clinical samples from two measurement systems were calculated. The comparability was evaluated by the regression coefficient and the biases inside the acceptable range. After eliminated outliers from the results, linear regressions were run again and the 95% confidence intervals were calculated. The commutability of the homemade reference materials and NIBSC reference material were evaluated by comparing the results with the limits of the intervals.
The ranges of FVIII and FIX level of clinical samples were 0.5%-218.0% and 1.6%-156.5%, which covered the sample levels in routine work and fit the requirements for commutability evaluation. The square of correlation coefficients (R²) of measurement results of clinical samples for FVIII and FIX activity assays were 0.89-0.94 and 0.81-0.93. The proportions of outliers were all less than 10%. The comparability of measurement results of FVIII and FIX in different measurement systems was acceptable.According to the acceptable criteria for bias, the measurement results of 42, 41 and 45 clinical samples for FVIII and 44, 42 and 41 clinical samples for FIX were used in the commutability evaluation for homemade reference materials and NIBSC reference material after deleting the outliers. The five lots homemade reference materials and NIBSC reference material were all within the 95% prediction intervals from the linear regression of clinical samples' results.
Good correlation and comparability are found for FVIII assay and those for FIX assay are acceptable. All homemade reference materials and NIBSC reference material are commutable for the three measurement systems.
评估凝血因子VIII（FVIII）和因子IX（FIX）活性测量结果的可比性以及不同测量系统上参考物质的互换性。
本研究按照CLSI指南EP30和中国卫生标准WS/T 356 - 2011进行。使用补充试剂，在中国三种常用的测量系统（包括Stago STA - R Evolution、IL ACL TOP700和Sysmex CA7000自动凝血分析仪）上，对覆盖临床分析范围的不同FVIII和FIX水平的临床样本、五批自制参考物质（F20140601 - F20140605）以及由NIBSC提供的一种凝血参考物质（SSCLOT4）进行FVIII和FIX活性检测。对测量系统之间的结果进行两两分析。为评估可比性，计算两个测量系统临床样本结果之间的线性回归和偏差。通过回归系数和偏差在可接受范围内来评估可比性。在去除结果中的异常值后，再次进行线性回归并计算95%置信区间。通过将结果与区间限值进行比较来评估自制参考物质和NIBSC参考物质的互换性。
临床样本的FVIII和FIX水平范围分别为0.5% - 218.0%和1.6% - 156.5%，涵盖了日常工作中的样本水平，符合互换性评估要求。FVIII和FIX活性检测临床样本测量结果的相关系数平方（R²）分别为0.89 - 0.94和0.81 - 0.93。异常值比例均小于10%。不同测量系统中FVIII和FIX测量结果的可比性可接受。根据偏差可接受标准，在去除异常值后，42、41和45份FVIII临床样本以及44、42和41份FIX临床样本的测量结果用于自制参考物质和NIBSC参考物质的互换性评估。五批自制参考物质和NIBSC参考物质均在临床样本结果线性回归的95%预测区间内。
FVIII检测具有良好的相关性且可比性良好，FIX检测的可比性可接受。所有自制参考物质和NIBSC参考物质在这三种测量系统上具有互换性。
