Xác nhận phương pháp xét nghiệm một số chỉ số sinh hóa và huyết học tại Viện Y học cổ truyền Quân đội

Abstract

Confronting the increasing  demands for laboratory quality assurance of the  Ministry of Public Health and ISO 15189, the verification of test methods has become more crucial than ever before. Objectives: To verify test methods of 8 biochemistry tests (Glucose, Urea, Cholesterol total, Triglyceride, Uric acid, GOT, GPT, GGT) using AU680;  as well as 4 hematology tests (RBC, WBC, PLT, Hb) using CD Ruby. A sigma rating is then calculated on that basis in order to promote quality within the laboratory. Objects andMethods: Evaluating the precision, accuracy, linear range and reference value of 8 biochemistry tests measured using AU680 and 4 hematology tests measured using CD Ruby. Results: The precision and accuracy of the 8 biochemistry tests and 4 hematology tests were qualified under the criteria of the Ministry of Public Health and ISO 15189. Linear range and reference value met all requirements of the manufacturer. There were  8 tests at above 6 sigma level, 2 tests at above 5 sigma level, 1 test at above 4 sigma level and 1 test at above 3 sigma level. Conclussions:8 biochemistry tests measured using AU680 and 4 hematology tests using CD Ruby of the Military Institute of Traditional Medicine are qualified under the criteria of the Ministry of Public Health and ISO 15189. The Sigma metric is a useful tool for evaluating and controling laboratory quality.