Standard Number: YY/T 1789.2-2021(YY/T1789.2-2021)
Chinese:体外诊断检验系统 性能评价方法 第2部分：正确度
English:In vitro diagnostic test systems Evaluation method of performance Part 2: Trueness
Effective Date:2023-05-01
ICS:11.100.10
Standard Applicability:This standard specifies the in vitro diagnostic test system correctness performance evaluation method. This standard applies to the manufacturer of quantitative tests for in vitro diagnostic test system performance evaluation. This standard does not apply to the results reported as nominal scale and ordinal scale in vitro diagnostic test system, such as for blood cell identification, microbial typing, nucleic acid sequence identification, urine particle identification, the results reported as negative, positive or 1 +, 2 +, 3 + in vitro diagnostic test system performance evaluation. This standard also does not apply to qualitative in vitro diagnostic test systems based on quantitative measurements and determine the results through the threshold (such as enzyme-linked immunosorbent assay of pathogenic microorganisms antigen or antibody detection kit) performance evaluation. This standard does not apply to the performance verification of the correctness of medical laboratories, nor does it apply to product type testing.
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