ĐÁNH GIÁ TÍNH ĐỒNG NHẤT VÀ ĐỘ ỔN ĐỊNH CỦA CHỈ SỐ APTT (ACTIVATED PARTIAL THROMBOPLASTIN TIME) TRONG HUYẾT TƯƠNG ĐÔNG KHÔ ỨNG DỤNG CHO CHƯƠNG TRÌNH NGOẠI KIỂM ĐÔNG MÁU

Abstract

Objective: Research to evaluate the uniformity and stability of the aPTT (Activated Partial Thromboplastin Time) index in freeze-dried plasma applied to the coagulation external control program according to ISO 13528:2015¹ and ISO guide 35² standards. Methods: Experimental research. Fresh frozen plasma provided by Ho Chi Minh City Blood Transfusion Hematology Hospital was screened negative for HBV, HCV, HIV, malaria, and syphilis. One-way ANOVA was used to evaluate the homogeneity and stability of freeze-dried plasma over different time points and temperatures using the t-test. Results: Lyophilized plasma containing the aPTT index achieved uniformity that met the proficiency testing program with p > 0.05. Lyophilized plasma containing aPTT index is stable when stored at temperatures of 2-8⁰C and -20⁰C for up to 3 months and is stable for transportation for a maximum of 7 days. Conclusion: Lyophilized plasma containing the aPTT index achieved uniformity that met the proficiency testing program with p > 0.05. Lyophilized plasma containing the APTT index is stable when stored at temperatures of 2-8⁰C and -20⁰C for up to 3 months and is stable for transportation for up to 7 days according to the criteria of ISO 13528:2015 and ISO guide 35 responses to the external audit program