Objective Goal by verifying the performance indicators of16 items such as alanine aminotransferase (ALT), the performance of thedetection system of BS-2800M, a fully automatic biochemical analyzerproduced by Mindray manufacturer, which was newly put into use in thislaboratory was evaluated, so as to improve the work quality of thelaboratory and ensure the accuracy and reliability of the test results. Methods According to the accuracy, precision, linear range and referenceinterval of the test items, the performance of 16 test items such asalanine aminotransferase (ALT) was evaluated. No unacceptableperformance was found in the evaluation process, indicating that theanalytical performance of the test method was accepted and met therequirements of clinical specimen detection. The entire validationprocess is based on the Requirements of the Guidelines for theAccreditation of Quality and Competence of Medical Laboratories in theField of Clinical Chemistry Examination, referring to the requirementsof CLSI EP15-A3, EP6, C28-A2 and EP15-A23 documents. Results Therelative bias of 16 items was $<1/2$ total allowable error (TEa). The coefficient of variation(CV) in precision batch was $<1/4$ tea, the total CV was $<1/3$ tea, the b values of 16 items were in the range of ${1.00}\pm {0.03}$ , and ${r}^{2}$ was $\geq {0.95}$ . The maximum dilution andclinical reportable range were verified and met the requirements. Conclusion The accuracy, precision, linearity and clinical reportablerange of the 16 tested items meet the requirements of quality objectivesand can be used for clinical detection.
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |