YY/T 1182-2020 PDF EnglishUS$165.00 · In stock · Download in 9 seconds
YY/T 1182-2020: Nucleic acids amplification test reagents (kits) Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid YY/T 1182: Historical versions
YY/T 1182-2020: Nucleic acids amplification test reagents (kits)---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/YYT1182-2020PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.100 C 44 Replacing YY/T 1182-2010 Nucleic acids amplification test reagents (kits) ISSUED ON: FEBRUARY 21, 2020 IMPLEMENTED ON: JANUARY 01, 2021 Issued by: National Medical Products Administration Table of ContentsForeword ... 3 1 Scope ... 5 2 Normative references ... 5 3 Terms and definitions ... 5 4 Classification ... 6 5 Technical requirements ... 7 6 Test method ... 12 7 Labels and instructions ... 15 8 Packaging, transportation and storage ... 15 References ... 16 Nucleic acids amplification test reagents (kits)1 ScopeThis Standard specifies the terms and definitions, classification technical requirements, test methods, labels and instructions, packaging, transportation and storage of nucleic acids amplification test reagents (kits) [hereinafter referred to as "reagents (kits)"]. This Standard applies to the quality control of nucleic acids amplification test reagents (kits). Nucleic acids amplification methods include polymerase chain reaction (PCR) technology and isothermal nucleic acid amplification technology. This Standard does not apply to the following products: a) reagents (kits) for blood source screening; b) reagents (kits) for gene sequencing. This Standard is a general standard for nucleic acids amplification test reagents (kits). For products or reagents (kits) with special standards, corresponding product standards or technical requirements should be formulated according to product characteristics and special standard requirements.2 Normative referencesThe following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document. 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 use3 Terms and definitionsThe following terms and definitions are applicable to this document. b) According to the principle of nucleic acid amplification, it can be divided into: variable temperature amplification detection kit and isothermal amplification detection kit; c) Classify according to methodologies; examples of common methodologies: PCR-fluorescent probe method, PCR-fluorescent dye method, PCR- melting curve method, multiple fluorescence PCR method, RT-PCR fluorescence method, nested-PCR method, gap-PCR method, loop- mediated constant temperature amplification method.5 Technical requirements5.1 General requirements 5.1.1 Appearance The reagents (kits) shall meet the appearance requirements that are specified by the manufacturer; the appearance requirements include but are not limited to the following: the reagents (kits) shall have complete components; the package shall be clean, free from leakage and damage; the signs and labels shall be clearly written. 5.1.2 Nucleic acid extraction function The nucleic acid extraction function shall meet the following requirements: a) For reagents (kits) that contain nucleic acid extraction components, the manufacturer shall make appropriate requirements for nucleic acid extraction, and verify the nucleic acid extraction function. For example: fully consider the interference factors in the sample extraction process and the possible impact on the subsequent sample amplification process; b) For reagents (kits) for which samples need to be extracted, but do not contain nucleic acid extraction components, the manufacturer shall state or specify the extraction reagents (kits) and provide verification or confirmation information; c) For reagents (kits) which are directly amplified without sample extraction, the manufacturer shall be able to provide sufficient evidence to prove the anti-interference of the enzymes in its products. 5.1.3 Internal standard and (or) control Manufacturers shall establish appropriate quality control procedures for the detection results of reagents (kits); they should reasonably set internal standard and (or) control in the reaction system according to the characteristics of their 5.2.6 Negative reference conformance rate When it is applicable, perform determination of the negative reference in the national reference or enterprise reference; the detection result shall be positive. The reference settings follow the following principles: a) Contain a certain number of samples without test substance; b) Fully consider factors such as possible interference, crossover, non- specific. For example: containing a certain number of other samples that are similar to the tested species, of the same infection site, or similar infection symptoms; c) When it is applicable, include a certain number of genotypes that are not within the declared detection range of the reagent (kit). 5.2.7 Detection limit The manufacturer shall specify and provide the detection limit of the reagent (kit); the establishing and verifying method of the detection limit of the reagent (kit) shall be scientific and feasible. Perform determination of the detection limit reference of the national reference or enterprise reference; the detection result shall meet the requirements of the national reference or enterprise reference. 5.2.8 Precision The precision within the batch shall meet that the coefficient of variation (CV, %) of the detected concentration log value is ≤ 5%. When the sample concentration is low, the coefficient of variation (CV, %) of the detected concentration log value is ≤10%. 5.2.9 Stability The following methods can be selected for verification: a) Stability of validity period: the manufacturer shall specify the validity period of the product. Under the storage conditions that are stipulated by the manufacturer, take samples of the nearest validity period to test 5.1, 5.2.2 ~ 5.2.8; the results shall meet the corresponding requirements; Note 1: generally, when the validity period is 1 year, select products no more than 1 month; when the validity period is half a year, select products no more than half a month, and so on. However, if it exceeds the prescribed time, the product can also be adopted when it meets the requirements. c) Genotyping or mutant products shall contain a certain number of genotypes that are not within the detection range of the reagent (kit). 5.3.3 Detection limit The manufacturer shall specify and provide the detection limit of the reagent (kit); the establishing and verifying method of the detection limit of the reagent (kit) shall be scientific and feasible. Perform a determination of the detection limit reference of the national reference or enterprise reference; the detection result shall meet the requirements of the national reference or enterprise reference. 5.3.4 Precision The precision within the batch shall meet the following requirements: a) The coefficient of variation of Ct value (CV, %) ≤5%. Or b) Test the same sample 10 times in parallel; the test results shall be consistent. 5.3.5 Stability The following methods can be selected to verify: a) Stability of validity period: the manufacturer shall specify the validity period of the product. Under the storage conditions that are stipulated by the manufacturer, take samples of the nearest validity period to test 5.1, 5.3.1 ~ 5.3.4; the results shall meet the corresponding requirements. Note 4: generally, when the validity period is 1 year, select products no more than 1 month; when the validity period is half a year, select products no more than half a month, and so on. However, if it exceeds the prescribed time, the product can also be adopted when it meets the requirements. b) Thermal stability test: under the thermal stability test conditions that are specified by the manufacturer, test 5.1, 5.3.1 ~ 5.3.4; the results shall meet the corresponding requirements. Note 5: thermal stability cannot be directly used to derive the product expiration date, unless a derivation formula that is based on a large amount of stability research data is used. Note 6: according to product characteristics, any combination of a), b) methods can be selected; but the selected method should be able to verify the stability of the product, so as to ensure that the product performance within the validity period meets the standard requirements. 6.2.8 Precision Operate according to the instructions of the reagent (kit); use at least two samples of high and low concentration levels to repeat the test 10 times; the concentration log value coefficient of variation (CV, %) shall meet the requirements of 5.2.8. 6.2.9 Stability The following methods can be selected for verification: a) Stability of the validity period: take samples of the near validity period for testing, which shall meet the requirements of 5.2.9a); b) Thermal stability test: take samples within the validity period for testing according to the method that is specified by the manufacturer, which shall meet the requirements of 5.2.9b). 6.3 Qualitative reagents 6.3.1 Positive reference conformance rate Operate according to the instructions of the reagent (kit); perform a detection of the positive reference in the national reference or enterprise reference; the detection result shall meet the requirements of 5.3.1. 6.3.2 Negative reference conformance rate Operate according to the instructions of the reagent (kit); perform a detection of the negative reference in the national reference or enterprise reference; the detection result shall meet the requirements of 5.3.2. 6.3.3 Limit of detection Operate according to the instructions of the reagent (kit); perform a detection of the detection limit reference in the national reference or enterprise reference; the result shall meet the requirements of 5.3.3. 6.3.4 Precision Operate according to the instructions of the reagent (kit); use at least two samples of high and low concentration levels to repeat the test 10 times; the Ct value coefficient of variation (CV, %) shall meet the requirements of 5.3.4a). Or Operate according to the instructions of the reagent (kit); take at least two negative and positive samples and repeat the test 10 times. The positive sample shall contain a weak positive sample; its measurement result shall meet the requirements of 5.3.4b). ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of YY/T 1182-2020 be delivered?Answer: The full copy PDF of English version of YY/T 1182-2020 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of YY/T 1182-2020_English with my colleagues?Answer: Yes. 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