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Analytical Performance Evaluation of theMaccura IS 1200Clinical Chemistry Analyzer forHormones and Tumor Markers |
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| รหัสดีโอไอ | |
| Creator | Thunwarut Kaingam |
| Title | Analytical Performance Evaluation of theMaccura IS 1200Clinical Chemistry Analyzer forHormones and Tumor Markers |
| Contributor | Narisa Kengtrong Bordeerat |
| Publisher | Thammasat University |
| Publication Year | 2564 |
| Journal Title | Thai Journal of Science and Technology |
| Journal Vol. | 10 |
| Journal No. | 5 |
| Page no. | 602-620 |
| Keyword | Method validation, Maccura IS 1200, Hormone, Tumor marker |
| URL Website | https://www.tci-thaijo.org/ |
| Website title | THAIJO |
| ISSN | 2286-7333 |
| Abstract | Currently, the automation system for laboratory has developed a new technology used to make a short turnaround time and quick whether it is a diagnosis or follow up with a doctor's treatment. Therefore, the test results should be accurate and reliable. The purpose of this study was to assess the diagnostic efficacy of Maccura IS 1200based on enhanced chemiluminescence enzyme immunoassay (ECLEIA)in the determination of thyroid hormone (TSH, T3, T4, FT3, FT4) and tumor markers (AFP, CEA, PSA, CA19-9, CA15-3, CA125). The assessment consisted of testing precision, accuracy, linearity, and recovery test according to the requirements of CLSI EP5-A2using a method validation. For a method validation result, Automation Maccura IS 1200were presented a good reliability within the specified range. The quality control materials with low and high concentrations had within-day imprecision (% CVwd) value 0.99-7.19% and between-day imprecision (% CVbd) 1.9014.27%. The measurement error was within the acceptable range. Comparative measurements with reference instruments, including the Architect i4000SR, showed that the regression curve shows the slope between 0.1150.956, the correlation coefficient (r) is between 0.113-0.996. The recovery in the range of 73% -163%, with an average equal to 106%.Measurement values were in the range specified by the manufacturer. The results of this study show that the Maccura IS 1200analyzer can measure thyroid hormone levels. and tumor markers in the range of acceptable according to the criteria set by the standard organization and further testing should be done before it is put into practice in the laboratory. |
