YY/T 1183-2024 PDF English
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| YY/T 1183-2024 | English | 200 |
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Detection reagent kit for enzyme-linked immunoabsorbent assay
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| YY/T 1183-2010 | English | 150 |
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Detection reagent (kit) for enzyme-linked immunoabsorbent assay (ELISA)
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YY/T 1183-2024: Detection reagent kit for enzyme-linked immunoabsorbent assay---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1183-2024
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.100.10
CCS C 44
YY/T 1183-2024
Replacing YY/T 1183-2010
Detection reagent kit for enzyme-linked immunoabsorbent
assay
Issued on. SEPTEMBER 29, 2024
Implemented on. OCTOBER 15, 2025
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 6
2 Normative references... 6
3 Terms and definitions... 6
4 Requirements... 7
5 Test methods... 12
6 Identification, labeling and instructions for use... 16
7 Packaging, transportation and storage... 16
Bibliography... 17
Foreword
This document was drafted in accordance with the provisions of GB/T 1.1-2020
“Directives for standardization - Part 1.Rules for the structure and drafting of
standardizing documents”.
This document replaces YY/T 1183-2010 “Detection reagent (kit) for enzyme-linked
immunoabsorbent assay (ELISA)”. Compared with YY/T 1183-2010, in addition to
structural adjustments and editorial changes, the main technical changes are as follows.
- ADD “analytical specificity”; DELETE the terms and definitions of “immediate
container, primary container”, “outer container (sales packaging)”, “label”, “batch
(lot)”, “batch code, lot number”, “metrological traceability”, “accuracy”,
“recovery”, “detection limit, limit of detection”, “linearity of a measuring system”,
“repeatability”, “expiry date”, “stability” and “cutoff value” (see 3.3 of this
document, 3.3 ~ 3.16 of the 2010 edition);
- DELETE the classification (see Clause 4 of the 2010 edition);
- MODIFY the requirements for the accuracy of quantitative detection and the
corresponding detection methods (see 4.1.3 and 5.1.3 of this document, 5.1.3 and
6.1.3 of the 2010 edition);
- MODIFY the requirements for the detection limit of quantitative detection and the
corresponding detection methods (see 4.1.4 and 5.1.4 of this document, 5.1.4 and
6.1.4 of the 2010 edition);
- MODIFY the requirements for the linearity of quantitative detection and the
corresponding detection methods (see 4.1.5 and 5.1.5 of this document, 5.1.5 and
6.1.5 of the 2010 edition);
- ADD the requirements for the analytical specificity of quantitative detection and
the corresponding detection methods (see 4.1.6 and 5.1.6 of this document);
- MODIFY the requirements for the repeatability of quantitative detection and the
corresponding detection methods (see 4.1.7 and 5.1.7 of this document, 5.1.6 and
6.1.6 of the 2010 edition);
- MODIFY the requirements for the inter-batch variability of quantitative detection
and the corresponding detection methods (see 4.1.8 and 5.1.8 of this document,
5.1.7 and 6.1.7 of the 2010 edition);
- MODIFY the requirements for the stability of quantitative detection and the
corresponding detection methods (see 4.1.9 and 5.1.9 of this document, 5.1.8 and
6.1.8 of the 2010 edition);
- MODIFY the requirements for the conformity rate of negative references for
qualitative detection and the corresponding detection methods (see 4.2.2 and 5.2.2
of this document, 5.2.2 and 6.2.2 of the 2010 edition);
- MODIFY the requirements for the conformity rate of positive references for
qualitative detection and the corresponding detection methods (see 4.2.3 and 5.2.3
of this document, 5.2.3 and 6.2.3 of the 2010 edition);
- ADD the requirements for the analytical specificity of qualitative detection and the
corresponding detection methods (see 4.2.4 and 5.2.4 of this document);
- MODIFY the requirements for the detection limit of qualitative detection and the
corresponding detection methods (see 4.2.5 and 5.2.5 of this document, 5.2.4 and
6.2.4 of the 2010 edition);
- MODIFY the requirements for the repeatability of qualitative detection and the
corresponding detection methods (see 4.2.6 and 5.2.6 of this document, 5.2.5 and
6.2.5 of the 2010 edition);
- MODIFY the requirements for the inter-batch variability of qualitative detection
and the corresponding detection methods (see 4.2.7 and 5.2.7 of this document,
5.2.6 and 6.2.6 of the 2010 edition);
- MODIFY the requirements for the stability of qualitative detection and the
corresponding detection methods (see 4.2.8 and 5.2.8 of this document, 5.2.7 and
6.2.7 of the 2010 edition);
- MODIFY the identification, labeling and instructions for use (see Clause 6 of this
document, Clause 7 of the 2010 edition);
- MODIFY the packaging, transportation and storage (see Clause 7 of this document,
Clause 8 of the 2010 edition).
Attention is drawn to the possibility that some of the elements of this document may be
the subject of patent rights. The issuing authority of this document shall not be held
responsible for identifying any or all such patent rights.
This document was proposed by National Medical Products Administration.
This document shall be under the jurisdiction of National Technical Committee on
Medical Clinical Laboratory and In Vitro Diagnostic System of Standardization
Administration of China (SAC/TC 136).
Drafting organizations of this document. Beijing Institute of Medical Device Inspection
(Beijing Medical Biological Protection Equipment Inspection and Research Center),
Beijing Medical Device Review and Inspection Center, Science and Technology
Research Center of China Customs, Beijing Wantai Biopharmaceutical Co., Ltd.,
Zhengzhou Antubio Diagnostics Co., Ltd.
Main drafters of this document. Li Xiao, Xu Songyan, Zhao Qiang, Wang Yikai, Liu
Xin, Shi Qiaoyun, Jin Lindan.
This document was first issued in 2010, and this is the first revision.
Detection reagent kit for enzyme-linked immunoabsorbent
assay
1 Scope
This document specifies the requirements, identification, labeling and instructions for
use, packaging, transportation and storage of detection reagent kits for enzyme-linked
immunoabsorbent assay, and describes the corresponding test methods.
This document applies to quantitative or qualitative detection reagent kits (hereinafter
referred to as “reagent kits”) based on the principle of enzyme-linked immunoabsorbent
assay in medical laboratories.
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 191 Packaging - Pictorial marking for handling of goods
GB/T 21415 In vitro diagnostic medical devices - Measurement of quantities in
biological samples - Metrological traceability of values assigned to calibrators and
control materials
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
3.1
enzyme-linked immunoabsorbent assay; ELISA
A solid phase adsorption test method that uses enzymes as marker indicators, antigen-
antibody reactions as the basis, and the results are judged by the degree of color
development of the chromogen.
3.2
detection reagent kit for enzyme-linked immunoabsorbent assay
A set of components used to complete specific in vitro diagnostic tests based on the
principle of enzyme-linked immunoabsorbent assay.
4 Requirements
4.1 Requirements for quantitative detection reagent kits for enzyme-linked
immunoabsorbent assay
4.1.1 Appearance
The appearance shall meet the following requirements.
4.1.2 Traceability
The manufacturer shall provide the source, assignment process and uncertainty of the
calibration standards used in accordance with GB/T 21415 and relevant regulations.
4.1.4 Detection limit
It shall comply with manufacturer claims.
4.1.5 Linearity
Within the linear range specified by the manufacturer, the correlation coefficient (r) of
reagent kits shall not be less than 0.9900.
4.1.6 Analytical specificity
Test negative samples containing cross-reactants/degradation products/impurities at a
certain concentration/level 3 times, and the test results shall be consistent with their
claimed values.
4.1.7 Repeatability
Repeat the test 10 times using references/samples with high and low
concentrations/levels respectively, and the coefficient of variation (CV) of the test
results shall not be higher than 10 %.
4.2 Requirements for qualitative detection reagent kits for enzyme-linked
immunoabsorbent assay
4.2.1 Appearance
The appearance shall meet the following requirements.
4.2.2 Conformity rate of negative references
Test different references/samples that are used to evaluate the negative conformity rate
of reagents once each, and the test results shall all be negative.
The setting of negative references follows the following principles (taking pathogenic
microorganisms as an example).
4.2.5 Detection limit
The manufacturer shall specify the detection limit level of reagent kits. Test
references/samples with different concentrations/level gradients respectively, and the
results shall comply with manufacturer claims.
The concentration/level setting and preparation of references/samples shall follow the
following principles.
4.2.6 Repeatability
Test negative and weak positive references/samples with indicated
concentrations/levels at least 10 times, and the conformity rate of positive and negative
results shall be 95 %.
4.2.8 Stability
The shelf life stability and thermal stability can be verified.
5 Test methods
5.1 Test methods for quantitative detection reagent kits for enzyme-linked
immunoabsorbent assay
5.1.1 Appearance
Visually inspect with corrected vision under natural light.
5.1.2 Traceability
The manufacturer shall provide traceability information.
5.1.4 Detection limit
According to the information such as blank limit, detection limit and reference range of
reagent kits provided by the manufacturer, test 5 low-value samples with concentrations
close to the detection limit. Each sample is tested 5 times. The test results are sorted by
size. If the following conditions are met, the blank limit and detection limit provided
by the manufacturer can be considered to be basically reasonable.
5.1.5 Linearity
The high-value samples close to the upper limit of the linear range are diluted to at least
5 concentrations in a certain proportion, among which the low-value concentration
samples shall be close to the lower limit of the linear range. Operate according to the
instructions of the reagent kit, test the sample of each concentration 3 times, calculate
the average value of its concentration, linearly fit the average value of the result and the
dilution ratio by the least squares method, and calculate the linear correlation coefficient
(r). In special cases, such as the determination of bound and free states where dilution
may cause changes in binding, dilution linear detection should not be used.
5.1.6 Analytical specificity
Test negative samples containing cross-reactants/degradation products/impurities with
indicated concentrations/levels 3 times.
5.1.9 Stability
5.1.9.1 Shelf life stability
After a reagent kit is stored under the conditions specified in 4.1.9 a), test it according
to methods of 5.1.3 to 5.1.7.
5.1.9.2 Thermal stability
Take a reagent kit within the shelf life, based on the thermal stability conditions claimed
by the manufacturer, test it according to methods of 5.1.3 to 5.1.7.
5.2 Test methods for qualitative detection reagent kits for enzyme-linked
immunoabsorbent assay
5.2.1 Appearance
Visually inspect with corrected vision under natural light.
5.2.2 Conformity rate of negative references
Test negative references once each.
5.2.3 Conformity rate of positive references
Test positive references once each.
5.2.4 Analytical specificity
Test specificity samples containing cross-reactants/degradation products/impurities
with indicated concentrations/levels.
5.2.5 Detection limit
Test references/samples with different gradients and indicated concentrations/levels at
least once each.
6 Identification, labeling and instructions for use
The identification, labeling and instructions for use shall comply with the provisions of
GB/T 29791.2.
7 Packaging, transportation and storage
7.1 Packaging
The pictorial marking for packaging, storage and transportation shall comply with the
provisions of GB/T 191.The packaging container shall be well sealed, complete, leak-
free and undamaged.
7.2 Transportation
The reagent kits shall be transported according to the manufacturer’s requirements.
During transportation, it shall be prevented from moisture and heavy objects, direct
sunlight, rain and snow, contact with acidic and alkaline substances and damage to the
inner and outer packaging.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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