Study on the Methodological Evaluation and Improvement for the Performance Verification of Inter-day Precision in Plasma Anticoagulant Protein S Activity Assay and Limits of Quantitative of Coagulation Factors Ⅷ and Ⅸ
10.3969/j.issn.1671-7414.2025.02.037
- VernacularTitle:临床实验室血浆抗凝蛋白S活性检测日间精密度与凝血因子Ⅷ,Ⅸ定量限的性能验证方法学评估及改善方案研究
- Author:
Xinghao WANG
1
;
Gaofeng HU
;
Chengshan XU
;
Mingting PENG
Author Information
1. 北京医院/国家老年医学中心,国家卫生健康委临床检验中心,中国医学科学院老年医学研究院,北京 100730;北京协和医学院/中国医学科学院,北京 100730
- Publication Type:Journal Article
- Keywords:
anticoagulant protein S(PS);
coagulation factor;
inter-day precision;
limit of quantification(LoQ);
performance verification
- From:
Journal of Modern Laboratory Medicine
2025;40(2):195-201
- CountryChina
- Language:Chinese
-
Abstract:
Objective To discuss the improvement for the verification of inter-day precision of PS activity assay and the verification protocol for limits of quantitative of FⅧ:C and FⅨ:C assay,aiming at the problems in the performance verification of anticoagulant protein S(PS),coagulation factor Ⅷ activity(F Ⅷ:C)and coagulation factor Ⅸ activity(F Ⅸ:C)assay.Methods SYSMEX CN-6000 and supporting reagents were used,and low-and high-value quality control(QCs)were used as the study samples.Following the American Clinical and Laboratory Standards Institute(CLSI)document EP15-A3,an inter-day precision verification study of the PS activity assay was performed with three reagent preparation methods designed(specification-required method,instrument's manual method and improved method).The specification-required method was carried out completely according to the specification,and the instrument manual method involved allowing the required reagents to stand in the device for 30 minutes based on the specification-required method,and the improved method mixed and dispensed the reagents needed to be based on the specification-required method.To study the bottle variation of the same batch of reagents for the same sample,the acceptable range of external quality assessment(EQA)of the National Center for Clinical Laboratories(NCCL)was used as the evaluation standard.Following the CLSI EP25 document,the PS activity assay reagent onboard stability verification was performed with the specification-required method and the improved method.Following the CLSI EP17-A2 document,WS/T 514-2017"Establishment and Verification of Detection Capability for Clinical Laboratory Measurement Procedures"and the International Committee for Standardization in Hematology(ICSH)guidelines,the LoQ for FVIII:C and FIX:C assays was verified.The verification results were passed if the requirements of the specification were met.Results The verification result of inter-day precision(CVWL:12.9%～21.6%)of PS activity assay according to the specification method and the instrumental manual method exceeded the requirements of the specification(<10%CVWL at high levels,<20%CVWL at low levels).The results of inter-day precision verification with the improved method(CVWL:2.9%and 4.5%)were consistent with the requirements of the specification.The bottle variation exceeded the acceptable range of EQA.The improved method corrected the reagent on-board stability verification results of reagents(relative deviations of-4.24%～9.97%)by the specifications(high levels<10%,low levels<20%).The LoQ verification results for FⅧ:C and FⅨ:C assay were by the product specifications(FⅧ:C:0.75%～1.46%and 0.74%～1.40%;FⅨ:C:0.71%～1.27%and 0.70%～1.32%).Conclusion An improved method to improve the inter-day precision of PS activity detection is provided,and LoQ verification protocol for F Ⅷ:C and FⅨ:C assay is provided for clinical laboratory reference.
