Validation of some analytical methods in Department of Biochemistry - 108 Military Central Hospital

Tóm tắt

Objective: Validation method and homogeneity assessment of 6 biochemistry tests. Which were measured with AU 5,800 with these tests were performed on 5 other biochemistry instruments and 2 immuno biochemistry tests were performed on two Cobas e601 that were analyzed at Department of Biochemistry, 108 Military Central Hospital. Subject and method: Evaluating within-run precision, day-to-day precision, accuracy, LOQ, linear range, uncertainty of the assigned value of 8 biochemistry tests in 8 bio-chemistry equipments. Result: 8 tests which have within-run precision, day-to-day precision, accuracy, liner range are absolute by the manufacturer’s announcement, promulgate uncertainty and realistic LOQ of each bio-chemistry test, 6 devices ensure the similarity. Conclusion: 6 tests - glucose, cholesterol, triglyceride, AST, ALT, ure on 6 AU and 2 test - TSH, FT4 in 2 Cobas e601, which are currently analyzed at Department of Biochemistry in 108 Military Central Hospital, are accepted by within-run precision, day-to-day precision, accuracy, limit of determinative, linear range, and equipment similarities according to manufacturer’s claims and 5.5.3 and 5.6.4 clauses of ISO standard 15189:2012.

Keywords: AU5800, Cobas e601, validation method, 108 Military Central Hospital.