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YY/T 1455-2016: Guidelines for values assignment of catalytic activity concentrations of enzymes using reference measurement procedures and evaluation of uncertainty
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YY/T 1455-2016: Guidelines for values assignment of catalytic activity concentrations of enzymes using reference measurement procedures and evaluation of uncertainty

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Guidelines for values assignment of catalytic activity concentrations of enzymes using reference measurement procedures and evaluation of uncertainty ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Applying the reference measurement procedure to assign the enzyme activity to the concentration And its uncertainty assessment guidelines 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued Directory Preface I 1 Scope 1 2 normative reference document 1 3 symbols and abbreviations 1 4 assignment 2 4.1 Selection of reference measurement program 2 4.2 to establish traceability 2 4.3 Evaluation of reference measurement procedures 2 4.4 Laboratory internal quality control 6 4.5 Sample Measurements 6 Evaluation of Measurement Uncertainty 6 5.1 Analysis of the sources of uncertainty 6 5.2 Establishment of measurement model 8 5.3 Evaluation of standard uncertainty 9 5.4 Calculation of synthetic standard uncertainty 10 5.5 Determination of expansion uncertainty 11 Report on measurement results and their assessment of uncertainty 11 Appendix A (informative) Enzyme reference measurement program information Table 12 Appendix B (informative) Limits Information given in other documents or activities 13 Appendix C (informative) LDH assignment process and uncertainty assessment method example 14 Appendix D (informative) Using the sensitivity factor for LDH measurement uncertainty Example 19 Reference 22

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized. The drafting of this standard. Beijing Medical Device Testing Institute, Sichuan Mike Technology Biology Co., Ltd., Shanghai Fuxing Changzheng Medical Department Ltd., Shenzhen Mindray Biomedical Electronics Co., Ltd., Ningbo Meikang Biotechnology Co., Ltd. The main drafters of this standard. Yang Zongbing, Lv Lei, Wu Jie, Wang Yingguo, Zou Jihua. Applying the reference measurement procedure to assign the enzyme activity to the concentration And its uncertainty assessment guidelines

1 Scope

This standard specifies the method of applying reference measurement procedures to assess the concentration of enzyme catalytically active concentrations and their uncertainties. This standard applies to the reference measurement of the in vitro diagnostic system. The laboratory uses the reference measurement procedure to assign the enzyme activity to its concentration and its uncertainty Fixed assessment work.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 15000.3 Standard sample work (3) General principles and statistical methods for standard sample setting YY/T 0638 In Vitro Diagnostic Medical Devices Quantitative Measurement of Biological Samples Accumulated Concentrations of Enzyme Concentration in Calibrated and Controlled Substances Metrological traceability WS/T 403-2012 Clinical biochemical tests General project analysis Quality indicators

3 symbols and abbreviations

3.1 symbols The following symbols apply to this document. U. Extended Uncertainty. Urel. relative expansion uncertainty. uc, rel. synthetic uncertainty. α1; α2. pre-selected adjustment value. 3.2 abbreviations The following abbreviations apply to this document. ALP. alkaline phosphatase (AlkalinePhosphatase) ALT. Alanine aminotransferase (AlanineAminotransferase) AMY. Amylase (α-amylase) AST. Aspartate aminotransferase (AspartateAminotransferase) BIPM. Bureau of International Statistics (BureauInternationaldesPoidsetMesures) CK. creatine kinase (CreatineKase) CNAS. China National Accreditation Committee for Conformity Assessment (ChinaNationalAccreditationServiceforConformity Assessment CRM. Certified Reference Information (CertifiedReferenceMaterial) CV. coefficient of variation (CoefficientofVariance) ...