Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the National Medical Products Administration.
This standard is under the jurisdiction of SAC/TC 136 National Technical Committee on Medical Clinical Laboratory Testing and Invitro Diagnostic Test Systems Standardization Administration of China.
Drafting organizations of this standard: Beijing Institute of Medical Device Testing, Suzhou Sym-Bio Lifescience Co., Ltd. and Diasorin Diagnostic Medical Equipment (Shanghai) Co., Ltd.
Chief drafters of this standard: Wang Ruixia, Tu Xianju and Wang Chengmei.
Free thyroxine (FT4) testing kit
1 Scope
This standard specifies the classification, requirements, test methods, labeling, instructions for use, and packaging, transportation and storage of free thyroxine (FT4) testing kit (hereinafter referred to as “FT4 kit”).
This standard is applicable to the immunoassay kits for the in vitro quantitative determination of free thyroxine (FT4) in line with the principle of double antibody sandwich method or competition method by using methods such as enzyme labeling, (electro) chemiluminescence labeling and (time-resolved) fluorescent labeling.
This standard is not applicable to:
a) Reagents (such as test strips and biochips) for qualitative or semi-quantitative determination of the human free thyroxine labeled with colloidal gold or other methods;
b) All kinds of radioimmunoassay or immunoradioassay kits labeled with 125I and other radioisotopes;
c) The free thyroxine calibrators and controls that are to be sold separately, or the calibrators and controls in FT4 kits;
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
GB/T 29791.2 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
3 Classification
The FT4 kits may be classified into: enzyme labeling, (electro) chemiluminescence labeling, (time-resolved) fluorescent labeling, etc. according to different labeling methods; microplate type, tubular type, magnetic particle type, microsphere bead type, plastic bead type, etc. according to different solid phase carriers; manual operation method and automatic instrument operation method according to different operation process.
4 Requirements
4.1 Appearance
The appearance shall meet the following requirements:
a) Each component of the reagent (kit) shall be complete and intact, without liquid leakage;
b) The marks shall be clear and easy to identify.
4.2 Traceability
Manufacturers shall provide the source, value assignment process, uncertainty and other relevant contents of the calibrator used in accordance with GB/T 21415-2008 and related requirements.
4.3 Linearity
The linear interval shall not be narrower than [6.4, 77.2] pmol/L. Within the linear interval given by the manufacturer, the correlation coefficient (r) shall not be less than 0.9900.
4.4 Limit of detection
It shall be less than or equal to 6.4 pmol/L.
4.5 Accuracy
The accuracy shall meet the following requirements:
a) Using the certified reference materials (CRM) or other recognized reference materials that can be used to evaluate conventional methods as samples for testing, the relative deviation of the measurement results shall not exceed ±15%. and/or
b) Using the enterprise's reference product for determination, the relative deviation between the measured value and the labeled value shall be within ±15%.
4.6 Repeatability
Within the linear interval of the FT4 kit, (2 to 3) quality control samples of different concentrations are tested 10 times respectively, and the coefficient of variation (CV) shall not be greater than 15%.
Foreword II
1 Scope
2 Normative references
3 Classification
4 Requirements
5 Test methods
6 Labelling and instructions for use
7 Packaging, transportation and storage
Bibliography
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the National Medical Products Administration.
This standard is under the jurisdiction of SAC/TC 136 National Technical Committee on Medical Clinical Laboratory Testing and Invitro Diagnostic Test Systems Standardization Administration of China.
Drafting organizations of this standard: Beijing Institute of Medical Device Testing, Suzhou Sym-Bio Lifescience Co., Ltd. and Diasorin Diagnostic Medical Equipment (Shanghai) Co., Ltd.
Chief drafters of this standard: Wang Ruixia, Tu Xianju and Wang Chengmei.
Free thyroxine (FT4) testing kit
1 Scope
This standard specifies the classification, requirements, test methods, labeling, instructions for use, and packaging, transportation and storage of free thyroxine (FT4) testing kit (hereinafter referred to as “FT4 kit”).
This standard is applicable to the immunoassay kits for the in vitro quantitative determination of free thyroxine (FT4) in line with the principle of double antibody sandwich method or competition method by using methods such as enzyme labeling, (electro) chemiluminescence labeling and (time-resolved) fluorescent labeling.
This standard is not applicable to:
a) Reagents (such as test strips and biochips) for qualitative or semi-quantitative determination of the human free thyroxine labeled with colloidal gold or other methods;
b) All kinds of radioimmunoassay or immunoradioassay kits labeled with 125I and other radioisotopes;
c) The free thyroxine calibrators and controls that are to be sold separately, or the calibrators and controls in FT4 kits;
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
GB/T 29791.2 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
3 Classification
The FT4 kits may be classified into: enzyme labeling, (electro) chemiluminescence labeling, (time-resolved) fluorescent labeling, etc. according to different labeling methods; microplate type, tubular type, magnetic particle type, microsphere bead type, plastic bead type, etc. according to different solid phase carriers; manual operation method and automatic instrument operation method according to different operation process.
4 Requirements
4.1 Appearance
The appearance shall meet the following requirements:
a) Each component of the reagent (kit) shall be complete and intact, without liquid leakage;
b) The marks shall be clear and easy to identify.
4.2 Traceability
Manufacturers shall provide the source, value assignment process, uncertainty and other relevant contents of the calibrator used in accordance with GB/T 21415-2008 and related requirements.
4.3 Linearity
The linear interval shall not be narrower than [6.4, 77.2] pmol/L. Within the linear interval given by the manufacturer, the correlation coefficient (r) shall not be less than 0.9900.
4.4 Limit of detection
It shall be less than or equal to 6.4 pmol/L.
4.5 Accuracy
The accuracy shall meet the following requirements:
a) Using the certified reference materials (CRM) or other recognized reference materials that can be used to evaluate conventional methods as samples for testing, the relative deviation of the measurement results shall not exceed ±15%. and/or
b) Using the enterprise's reference product for determination, the relative deviation between the measured value and the labeled value shall be within ±15%.
4.6 Repeatability
Within the linear interval of the FT4 kit, (2 to 3) quality control samples of different concentrations are tested 10 times respectively, and the coefficient of variation (CV) shall not be greater than 15%.
Contents of YY/T 1721-2020
Foreword II
1 Scope
2 Normative references
3 Classification
4 Requirements
5 Test methods
6 Labelling and instructions for use
7 Packaging, transportation and storage
Bibliography
