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Analytical performance evaluation of the Biosystems BA400 Clinical Chemistry Analyzer |
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| รหัสดีโอไอ | |
| Creator | 1. Khanittha Taneyhill 2. Papatsorn Thanoosa 3. Suwatsin Kittikunnathum 4. Suruk Udomsom, Nannapas Inay 5. Natthita Seema |
| Title | Analytical performance evaluation of the Biosystems BA400 Clinical Chemistry Analyzer |
| Publisher | Faculty of Associated Medical Sciences, Chiang Mai University |
| Publication Year | 2558 |
| Journal Title | Journal of Associated Medical Sciences |
| Journal Vol. | 48 |
| Journal No. | 1 |
| Page no. | 34-48 |
| Keyword | BA400 analyzer, method validation, imprecision, inaccuracy, method comparison |
| ISSN | 1255347 |
| Abstract | Introduction: BA400 (Biosystems, Spain) is a new clinical chemistry analyzer for spectrophotometric,tubidimetric and ion-selective determination of biochemical analytes. Validation of method performancebefore routine operation is needed.Objective: The objective of this study was to perform the analytical evaluation of BA400 analyzer.Materials and methods: The evaluation was performed according to the guidelines of ClinicalLaboratory Improvement Amendments (CLIA). The evaluation included determination of within-run and between-runimprecision, linearity and method comparison with Cobas 6000 (Roche). The 39 test analytes including metabolites,enzymes, trace elements, proteins and electrolytes were evaluated.Results: All analytes met the required specifications for imprecision except opiates, amphetamines and Phenytoin.The result showed acceptable inaccuracy for all analytes except cholinesterase, AST, microalbumin and valproicacid. The linearity was in acceptable ranges for all analytes.Conclusions: BA400 analyzer has satisfactory accuracy, precision and linearity for majority of analytes.However, some analytes require more study and adjustment for routine operation. |
