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YY/T 1713-2020 PDF English

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YY/T 1713-2020: Diagnostic kit for colloidal gold immunochromatographic assay
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YY/T 1713-2020: Diagnostic kit for colloidal gold immunochromatographic assay

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YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.100 C 44 Diagnostic kit for colloidal gold immunochromatographic assay Issued on. SEPTEMBER 27, 2020 Implemented on. JUNE 01, 2022 Issued by. National Medical Products Administration

Table of Contents

Foreword... 3 1 Scope... 4 2 Normative references... 4 3 Terms and definitions... 4 4 Requirements... 7 5 Test methods... 18 6 Labels and instructions for use... 24 7 Packaging, transportation and storage... 25 Bibliography... 26

Foreword

This Standard was drafted 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 Standard may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights. This Standard was proposed by National Medical Products Administration. This Standard 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). The drafting organizations of this Standard. Beijing Medical Device Technology Review Center, Beijing Medical Device Inspection Institute, China Institute of Food and Drug Test, Zhengzhou Antu Biological Engineering Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd., Jidan Biotechnology Co., Ltd. Main drafters of this Standard. Sun Rong, Liu Yanchun, Shen Shu, Li Xiaoxia, Tian Wei, Wang Luhai. Diagnostic kit for colloidal gold immunochromatographic assay

1 Scope

This Standard specifies relevant terms and definitions, requirements, test methods, labels and instructions for use, packaging, transportation and storage of diagnostic kit for colloidal gold immunochromatographic assay. This Standard is applicable to diagnostic kit that uses the colloidal gold immunochromatographic assay as the principle to conduct quantitative, semiquantitative, qualitative examinations to human sample (blood, urine, feces, saliva and so on).

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, 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 Terms and definitions

For the purposes of this document, the following terms and definitions apply. 3.1 qualitative examination a set of operations that identify or classify substances based on their chemical or physical properties 3.2 semiquantitative examination essentially, it is a qualitative test that adds options for the degree of response (positive degree, dilution to obtain a positive result, or comparison with the color card); the reaction results can be presented using ordinal tables and so on Example. The examination result can be reported as "-" "±" "+" "++". 3.3 quantitative examination a set of operations that measure the amount or concentration of an analyte and express it in a digital value of the appropriate measurement unit [GB/T 29791.1-2013, definition A.3.45] 3.5 c5-c95 interval the concentration range of the analyte near the cutoff can be considered that more than 95% of the examination results of the analyte outside this concentration range are negative (concentration< c5) or more than 95% are positive (concentration >c95) 3.6 limit of detection the measured value obtained from a given measurement program; for this value, given that the false positive probability of a certain component in the claimed substance is α, the false positive probability of the non-existent component is β 3.8 analytical specificity the ability of the examination procedure to only examine or measure the presence of the measurand when there are other quantities in the sample [GB/T 29791.1-2013, definition A.2.6]

4 Requirements

4.1 Diagnostic kit for qualitative examination 4.1.1 Appearance Meet the normal appearance requirements specified by the manufacturer. 4.1.2 Net content (when applicable) If the kit contains liquid components, the volume shall meet the following requirements. 4.1.3 Film strip width The manufacturer shall specify the width of the film strip (lower limit or deviation). The random test shall be no less than the manufacturer's claim. 4.1.6 Compliance rate of negative reference products (when applicable) Separately examine different reference products/samples used to evaluate the negative coincidence rate of reagents once each. The examination results shall all be negative. 4.1.8 Analytical specificity (when applicable) Examine the negative reference product/sample containing a certain concentration/level of cross-reactant 3 times. The examination result shall not be positive. 4.1.9 High dose hook effect (when applicable) Examine the high concentration/level positive reference product/sample claimed by the manufacturer 3 times. There shall be no false negatives in the examination results. 4.1.10 Repeatability Test the negative and weakly positive reference products/samples with the indicated concentration/level at least 10 times. The coincidence rate of negative and positive results shall not be less than 95%. The repeatability concentration/level setting and result judgment shall follow the following principles. 4.2.6 Analytical specificity (when applicable) Examine the negative reference product/sample containing a certain concentration/level of cross-reactant 3 times. The result shall not be positive. 4.2.7 High dose hook effect (when applicable) Examine the high concentration/level positive reference product/sample claimed by the manufacturer 3 times. The result shall be no false negatives. 4.3 Diagnostic kit for quantitative examination 4.3.1 Appearance Meet the normal appearance requirements specified by the manufacturer. 4.3.6 Accuracy It can use one of the following methods to verify. The relative deviation method is preferred.

5 Test methods

5.1 Diagnostic kit for qualitative examination 5.1.1 Appearance Visually inspect with normal vision or corrected vision under natural light, which shall be in accordance with the requirements in 4.1.1. 5.1.5 Limit of detection Respectively examine the reference product/sample of different gradients with the indicated concentration/level once each. The result shall meet the requirements of 4.1.5. 5.1.6 Negative coincidence rate (when applicable) Respectively examine different reference products/samples used to evaluate the specificity of reagents once each. The result shall meet the requirements of 4.1.6. 5.1.7 Positive coincidence rate (when applicable) Respectively examine different reference products/samples used to evaluate the sensitivity of reagents once each. The result shall meet the requirements of 4.1.7. 5.1.10 Repeatability Examine the negative and weakly positive reference products/samples with the indicated concentration/level at least 10 times. The result shall meet the requirements of 4.1.10. 5.1.11 Batch-to-batch difference Extract 3 batches of kits. Respectively examine each batch of weakly positive reference products/samples with indicated concentrations/levels at least 10 times. The result shall meet the requirements of 4.1.11. 5.1.12 Stability 5.2 Diagnostic kit for semiquantitative examination 5.2.1 Appearance Visually inspect with normal vision or corrected vision under natural light, which shall meet the requirements in 4.1.1. 5.2.2 Net content (when applicable) Use a universal measuring tool to measure the number of liquid reagents, which shall meet the requirements in 4.2.2. 5.2.8 Repeatability Respectively examine the concentration/level of different levels of concentration reference products/samples at least 10 times each. The result shall meet the requirements of 4.2.8. 5.2.9 Batch-to-batch difference Extract 3 batches of kits. Each batch shall be tested respectively at least 10 times for the reference product/sample with the indicated concentration/level. The result shall meet the requirements of 4.2.9. 5.2.10 Stability 5.2.10.1 Stability of validity period The diagnostic kit is stored under the specified storage conditions until the end of the validity period. Examine according to 5.2.5, 5.2.6, 5.2.7, 5.2.8.The result shall meet the requirements of 4.2.10a). 5.3.8 Linear Dilute high-value samples close to the upper limit of the linear interval to at least 5 concentrations in a certain proportion, where the samples with low concentration must be close to the lower limit of the linear interval. 5.3.12 Stability 5.3.12.1 Stability of validity period The diagnostic kit is stored under the specified storage conditions until the end of the validity period. Examine according to 5.3.6, 5.3.7, 5.3.8, 5.3.9, 5.3.10. The result shall meet the requirements of 4.3.12a).

6 Labels and instructions for use

Shall meet the requirements of GB/T 29791.2.

7 Packaging, transportation and storage

7.1 Packaging The packaging shall meet the following requirements. 7.2 Transportation Transport in accordance with the conditions stipulated in the contract. 7.3 Storage Store in accordance with the conditions specified by the manufacturer. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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