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YY/T 1820-2021: Specific antinuclear antibody IgG detecting kit (immunoblotting)
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1820-2021 | English | 139 |
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Specific antinuclear antibody IgG detecting kit (immunoblotting)
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YY/T 1820-2021
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Basic data | Standard ID | YY/T 1820-2021 (YY/T1820-2021) | | Description (Translated English) | Specific antinuclear antibody IgG detecting kit (immunoblotting) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 7,769 | | Issuing agency(ies) | State Drug Administration | YY/T 1820-2021: Specific antinuclear antibody IgG detecting kit (immunoblotting)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Specific antinuclear antibody IgG detecting kit (immunoblotting)
ICS 11:100:10
CCSC44
People's Republic of China Pharmaceutical Industry Standard
Specific antinuclear antibody IgG detection kit
(Western blotting)
Published on 2021-12-06
2023-05-01 Implementation
Released by the State Drug Administration
foreword
This document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents"
drafted:
Please note that some content of this document may be patented: The issuing agency of this document assumes no responsibility for identifying patents:
This document is proposed by the State Drug Administration:
This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136):
This document is drafted by: Beijing Medical Device Inspection Institute, Beijing You'an Hospital Affiliated to Capital Medical University, Beijing Medical Device Technology
Evaluation Center, Oumen Medical Diagnostics (China) Co:, Ltd:, Hooman Diagnostics (Beijing) Co:, Ltd:
The main drafters of this document: Liu Yanchun, Yan Huiping, Sun Rong, Zhang Liuyan, Sun Dongna:
Specific antinuclear antibody IgG detection kit
(Western blotting)
1 Scope
This document specifies the requirements and test methods of the specific antinuclear antibody IgG detection kit (immunoblotting method) (hereinafter referred to as the kit):
law, labelling, labelling, instructions for use, packaging, transportation and storage:
This document is suitable for the qualitative detection of nuclear and cytoplasmic specific target antigens in human serum or plasma based on western blotting:
Anti-nuclear antibody specific autoantibody IgG kit, including manual operation method and instrument automatic operation method products:
This document does not apply to detection kits for total antinuclear antibodies:
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document:
GB/T 191 Graphical signs of packaging, storage and transportation
GB/T 29791:2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2: In vitro diagnostic reagents for professional use
3 Terms and Definitions
The following terms and definitions apply to this document:
3:1
specific antinuclear antibody
Antinuclear antibody (ANA), as an important biological marker of autoimmune disease, is the most widely used in clinical application:
The most basic group of autoantibodies: ANA is a general term for autoantibodies targeting various components of eukaryotic cells: ANA detection
It is divided into the detection of ANA total antibodies and the detection of specific autoantibodies against the target antigen: Specific antinuclear antibodies are those directed against a specific target antigen
antinuclear antibody-specific autoantibodies:
3:2
detection limit limitofdetection
The measured value obtained by a given measurement procedure, for which, given the probability of misjudgment of the presence of a component in the claimed substance as α, the sound
The misjudgment probability of the absence of this component is called β:
Note 1: IUPAC (International Union of Pure and Applied Chemistry), also translated as International Theory (Chemistry)
Science) and the Union of Applied Chemistry: It is recommended that the default values of α and β be equal to 0:05:
Note 2: It is used to describe a test procedure with a specific confidence level can be reported as the existence of the lowest measured value, is also used to refer to the minimum detectable concentration:
Note 3: It was also called "minimum detection limit", "minimum detection limit" and "detection limit":
[Source: YY/T 1713-2020, 3:6, with modifications]
3:3
cutoff
Used to identify a sample as a measure of the threshold for the presence or absence of a particular disease, condition, or measurand:
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