Homogeneity and Stability Evaluation of External Quality Assessment Control Materials for Four Coagulation Tests. 2021

Huimin Yuan, and Zhiqi Gao, and Jianping Zhang, and Yuhong Yue, and Shunli Zhang, and Rui Zhang

BACKGROUND This study assessed the homogeneity and stability of control materials used in external quality assessment (EQA) of four coagulation tests, aiming to verify that these materials meet clinical testing requirements and to provide an evidence base for future improvement of laboratory coagulation test quality. METHODS The homogeneity and stability of control materials were assessed according to the relevant guidance. Homogeneity assessment involved 10 vials of samples obtained from 2 batches (each vial tested twice). The homogeneity of control materials in four coagulation tests was assessed using one-way analysis of variance, with standard deviation of uniformity (Ss) 0.3 σ as an assessment criterion. Stability assessment involved two vials of sam-ples obtained from two batches (each vial tested twice). The stability of control materials was assessed at cold storage, room temperature, temperature of 37°C. Reconstitution stability of control materials placed in cold storage and at room temperature, and long-term stability of reconstituted control materials stored frozen (-20°C and -80°C) were observed. Linear regression analysis was performed to assess long-term stability. RESULTS The Ss values of EQA control materials for four coagulation tests were PT L1 Ss = 0.084, PT L2 Ss = 0.889, APTT L1 Ss = 0.164, APTT L2 Ss = 0.223, Fbg L1 Ss = 6.256, Fbg L2 Ss = 2.251, TT L1 Ss = 0.552, TT L2 Ss = 0.3111. PT, APTT, Fbg, and TT were associated with the standard deviation of uniformity values of 0.3 σ. Non-reconstituted samples were observed at 37°C for 2 hours and 4 hours, and at room temperature for 1 day. Reconstituted samples were observed when stored at 4°C for 4 hours and 8 hours, at room temperature for 4 hours, and at -20°C and -80°C for 6 months. Instability of reconstituted samples was observed in PT and APTT tests at 4°C for 8 hours and at -20°C for 5 months. CONCLUSIONS EQA control materials presented with satisfactory homogeneity in four coagulation tests. Non-reconstituted samples presented with satisfactory stability at 37°C for 2 hours and 4 hours and at room temperature for 1 day, while reconstituted samples presented with satisfactory stability when refrigerated at 4°C for 4 hours, when kept at room temperature for 4 hours, and when frozen at -80°C for 6 months.

UI MeSH Term Description Entries
D001777 Blood Coagulation The process of the interaction of BLOOD COAGULATION FACTORS that results in an insoluble FIBRIN clot. Blood Clotting,Coagulation, Blood,Blood Clottings,Clotting, Blood
D001780 Blood Coagulation Tests Laboratory tests for evaluating the individual's clotting mechanism. Coagulation Tests, Blood,Tests, Blood Coagulation,Blood Coagulation Test,Coagulation Test, Blood,Test, Blood Coagulation
D005615 Freezing Liquids transforming into solids by the removal of heat. Melting
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D013696 Temperature The property of objects that determines the direction of heat flow when they are placed in direct thermal contact. The temperature is the energy of microscopic motions (vibrational and translational) of the particles of atoms. Temperatures
D013997 Time Factors Elements of limited time intervals, contributing to particular results or situations. Time Series,Factor, Time,Time Factor

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