YY/T 1216-2020_English: PDF (YY/T1216-2020)
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(Alpha-fetoprotein determination kit)
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YY/T 1216-2020
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| YY/T 1216-2013 | English | 160 |
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Alpha-fetoprotein quantitative labelling immunoassay kit
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YY/T 1216-2013
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| Standard ID | YY/T 1216-2020 (YY/T1216-2020) | | Description (Translated English) | (Alpha-fetoprotein determination kit) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Word Count Estimation | 7,740 | | Date of Issue | 2020-06-30 | | Date of Implementation | 2021-06-01 | | Older Standard (superseded by this standard) | YY/T 1216-2013 | | Regulation (derived from) | Announcement No. 76 (2020) of the National Medical Products Administration | | Standard ID | YY/T 1216-2013 (YY/T1216-2013) | | Description (Translated English) | Alpha-fetoprotein quantitative labelling immunoassay kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 8,866 | | Quoted Standard | YY 0466.1 | | Drafting Organization | Chinese Academy of Food and Drug Testing | | Administrative Organization | National Medical clinical testing laboratories and in vitro diagnostic systems for Standardization Technical Committee | | Regulation (derived from) | State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies: a quantitative marker alpha-fetoprotein immunoassay kit classification, requirements, test methods, manual, marking, labeling and packaging, transportation and storage. This standard applies to: conduct quantitative determination |
YY/T 1216-2020
(Alpha-fetoprotein determination kit)
ICS 11:100
C44
People's Republic of China Pharmaceutical Industry Standard
Replace YY/T 1216-2013
Alpha-fetoprotein determination kit
2020-06-30 released
2021-06-01 implementation
Issued by the State Drug Administration
Preface
This standard was drafted in accordance with the rules given in GB/T 1:1-2009:
This standard replaces YY/T 1216-2013 "AFP Quantitative Labeling Immunoassay Kit", compared with YY/T 1216-2013,
Except for editorial changes, the main technical changes are as follows:
---Modified the standard name;
---Reagents applicable to the detection principle of "microfluidic chips, nanomaterials, etc: as carrier-coated antibodies" have been added to the scope of the regulations
Box (see Chapter 1);
---The traceability standards, packaging standards, and in vitro diagnostic reagent standards for in vitro diagnostic medical device calibrators have been added to the normative references:
Show label standard, delete "YY/T 0466:1" standard (see Chapter 2);
---Added traceability requirements (see 4:2);
---Modified the linear terms, requirements and corresponding detection methods (see 4:4 and 5:4);
---The accuracy requirements and corresponding testing methods have been modified (see 4:5 and 5:5);
---Modified the precision requirements, deleted the precision between analyses (see 4:6);
---Deleted specific requirements and detection methods;
---Added markings, labels, and instructions for use should comply with the requirements of GB/T 29791:2 (see Chapter 6);
---Modified the packaging should meet the requirements of GB/T 191 (see 7:1):
Please note that certain contents of this document may involve patents: The issuing agency of this document is not responsible for identifying these patents:
This standard was proposed by the State Drug Administration:
This standard is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee:
Drafting organizations of this standard: China Institute for Food and Drug Control, Beijing Institute of Medical Device Inspection, Beijing Huada Jibi Ai Biotechnology Co:, Ltd:
Co:, Ltd:, Boao Biological Group Co:, Ltd:, Xiamen Wantaicare Biotechnology Co:, Ltd:, Guangzhou Darui Biotechnology Co:, Ltd:
The main drafters of this standard: Wang Yumei, Wang Ruixia, Liu Licheng, Guo Jianfu, Sun Xudong, Wu Yingsong:
Alpha-fetoprotein determination kit
1 Scope
This standard specifies the classification, requirements, inspection methods, labeling, labeling, instructions for use, and packaging of alpha-fetoprotein labeled immunoassay reagent products:
Installation, transportation and storage:
This standard is applicable to the detection of alpha-fetoprotein (AFP) in human blood matrix or other body fluid components based on the principle of labeled immunoassay
Assay reagents, including labeling capture antibodies with enzymes, chemiluminescence, fluorescent substances, etc:, using microplates, tubes, magnetic particles, microbeads and plastic beads, and microfluidics
Control chips, nanomaterials, etc: are carrier-coated antibody immunoassay kits for quantitative determination of AFP:
This standard does not apply to:
a) Colloidal gold labeled AFP test strip;
b) Various types of radioimmunoassays labeled with radioisotopes such as 125I:
2 Normative references
The following documents are indispensable for the application of this document: For dated reference documents, only the dated version applies to this article
Pieces: For undated references, the latest version (including all amendments) applies to this document:
GB/T 191 Packaging, Storage and Transportation Graphic Mark
GB/T 21415-2008 Measurement of calibrator and control substance assignment in biological samples of in vitro diagnostic medical devices
Academic traceability
GB/T 29791:2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2: Professional in vitro diagnostic reagents
3 categories
AFP kits can be divided into enzyme-linked immunoassay, chemiluminescence, time-resolved immunofluorescence and other kits according to different labeling methods:
According to the different solid phase carriers, it can be divided into microplates, tubes, magnetic particles, microbeads and plastic beads, microfluidic chips, nanomaterials, etc: as the carrier AFP
Reagent kits: AFP kits can be divided into manual operation method and automatic instrument operation method according to the different operation process:
4 requirements
4:1 Appearance
The kit should have complete components, the inner and outer packaging should be complete, the label should be clear, the liquid reagent should not leak, and the lyophilized component should be loose, add and remove
After the resolving agent such as water, it should be completely dissolved within 20min:
Note: Manufacturers can specify appropriate appearance requirements based on the packaging characteristics of their products:
4:2 Traceability
The manufacturer shall provide the source of the AFP calibrator used, the traceability assignment method and the relative regulations in accordance with GB/T 21415-2008 and relevant regulations:
Should be indicators and uncertainties:
4:3 Detection limit
The detection limit should not be higher than 4:0IU/mL:
......
YY/T 1216-2013
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Alpha-fetoprotein quantitative labelling
immunoassay kit
ISSUED ON. OCTOBER 21, 2013
IMPLEMENTED ON. OCTOBER 1, 2014
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Classifications ... 4
4 Requirements ... 5
5 Test methods ... 6
6 Marks, labels and operating instructions ... 8
7 Packaging, transportation and storage ... 9
Bibliography ... 10
Foreword
This Standard is drafted according to the rules specified in GB/T 1.1-2009.
Please note that some contents of this Standard may involve patents. The issuing
authority of this Standard does not undertake the responsibility of identifying these
patents.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee (SAC/TC
136) on System of Medical Clinical Test Lab and in Vitro Diagnostic System of
Standardization Administration of China.
Drafting organization of this Standard. National Institutes for Food and Drug Control.
The main drafters of this Standard. Liu Yan, Huang Ying, and Gao Shangxian.
Alpha-fetoprotein quantitative labelling immunoassay kit
1 Scope
This Standard specifies the classification, requirements, test method, marks, labels,
operating instructions, packaging, transportation, and storage of the alpha-fetoprotein
quantitative labelling immunoassay kit.
This Standard is applicable to the quantitative detection of alpha-fetoprotein labelling
immunoassay kit (hereinafter referred to as AFP kit). It includes AFP immunoassay kit of
quantitative detection by using labelling methods such as enzyme labelling, (electrical)
chemiluminescent labelling, (time resolution) fluorescence labelling AS capture antibody;
and using microplates, pipes, magnetic particles, microbeads, plastic beads and others
AS the carrier coated antibody.
This Standard does not apply to.
a) Colloidal gold labelled AFP test strip;
b) Various types of radio-immunity or IRMA reagent kit labelled with 125I and other
radioactive isotopes.
2 Normative references
The articles contained in the following documents have become part of this Standard
when they are quoted herein. For the dated documents so quoted, all the modifications
(Including all corrections) or revisions made thereafter shall be applicable to this
document.
YY/T 0466.1-2009 Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1. General requirements
3 Classifications
The AFP kits can be divided into ELISA reagent kit, chemiluminescent reagent kit, time
resolution fluorescence reagent kit etc., according to the various labelling methods. It can
be divided into different kinds of AFP kits with carriers such as microplates, pipes,
magnetic particles, microbeads and plastic beads, according to the various solid-phase
carriers. The AFP kits can be divided into manual operation method and automatic
4.6 Specificity
DETECT at least 10 normal serums. The detection results shall not be higher than 20.0 ng
/ mL.
4.7 Measured value of quality control material
Within the linear range of the kit, SET 2 or 3 quality control materials with different
concentrations. The measured results shall be within the allowable interval of the
measured value of quality control products.
4.8 Stability
The following methods may be selected.
4.8.1 Stability at the end of validity
The reagent kit is preserved until the end of the validity under a specified condition. The
measured results shall comply with the provisions of 4.1, 4.2, 4.3, 4.4, 4.5.1, 4.5.2, 4.6
and 4.7.
4.8.2 Thermal stability
According to the period of validity of the kit, the kit is usually placed under the condition of
37°C for some time (usually 3 days - 7 days). The inspection results shall comply with the
provisions of 4.1, 4.2, 4.3, 4.4, 4.5.1, 4.5.2, 4.6, and 4.7.
Note 1. The thermal stability cannot be used to derive the period of validity of products, unless it uses the
derivation equation that is established based on a large number of stability study data;
Note 2. One of the above methods can be selected according to the product characteristics. However,
the selected method shall be capable of verifying the stability of the product, so as to ensure that the
performance of the product can comply with the standard requirements within the period of validity.
5 Test methods
5.1 Appearance
USE visual inspection method. Visually INSPECT under natural light and bright place. It
shall comply with the provision of 4.1.
5.2 Minimum detection limit
DETERMINE the signal values of zero-value calibrator or sample diluent for not less than
10 times. CALCULATE the mean ( ) and standard deviation (SD). And CALCULATE the
value of ( + 2SD). The sample concentration corresponding to that value is the
minimum detection limit of the kit. It shall comply with the provision of 4.2.
Bibliography
[1] GB 3100 The international system of units and its application
[2] GB/T 19702 In vitro diagnostic medical devices - Measurement of quantities in
samples of biological origin - Presentation of reference measurement procedures
[3] GB/T 19703 In vitro diagnostic medical devices - Measurement of quantities in
samples of biological origin -- Description of reference materials
[4] Ye Yingwu. National Clinical Test Operation Specification. Edition 3, Nanjing.
Southeast University Press, 2006
[5] WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro
diagnostic kits - General guideline
[6] GB/T 29791.1-2013 In vitro diagnostic medical devices - Information supplied by
the manufacturer (labelling) - Part 1. Terms, definitions and general requirements
......
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