ISSN: 1859 - 2872
Validation of some analytical methods in Department of Biochemistry - 108 Military Central Hospital
Main Article Content
Abstract
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.
Article Details
References
2. Clinical Laboratory Standard Institute (2003) Evaluation of the linearity of quantitative measurement procedures: A statistical approache, approved guideline. 3rd edition. CLSI document EP06AE.
3. Clinical Laboratory Standard Institute (2012) Evaluation of detection capability for clinical laboratory measurement procedures. Approved guideline. 2nd edition. CLSI document EP17-A.
4. Clinical and Laboratory standards institute (2010) Evalution of precision performance of quantitative measurement methods; Approved Guideline. 2nd edition. CLSI document EP5-A2.
5. Clinical Laboratory Standard Institute (2010) Measurement procedure comparison and bias estimation using patient samples. Approved guideline. 3rd edition. CLSI document EP09.
6. Linnet K, Boyd JC (2006) Selection and analytical evaluation of methods - with statistical techniques. In: Burtis CA, Ashwood ER, Bruns DE, editors. Tietz textbook of clinical chemistry. 4thed. Philadelphia: Sauders.
7. International Organization for Standardization (2012) Medical laboratories particular requirements for quality and competence. ISO 15189. International Organization for Standardization (ISO), Geneva.
8. Jeffrey S, Jhang et al (2004) Evaluation of linearity in clinical laboratory. Arch Pathol Lab Med 128: 44-48.
9. Westgard JO et al (2008) Basic method validation. 3nd edition. Madison: Westgard QC Inc.
Article Sidebar
