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Basic data Standard ID | YY/T 1226-2022 (YY/T1226-2022) | Description (Translated English) | Detection and genotyping kits for human papillomavirus nucleic acid | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C44 | Word Count Estimation | 15,198 | Issuing agency(ies) | State Drug Administration |
YY/T 1226-2022: Detection and genotyping kits for human papillomavirus nucleic acid---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.
Detection and genotyping kits for human papillomavirus nucleic acid
ICS 11.100.10
CCSC44
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 1226-2014
Human papillomavirus nucleic acid (typing) detection kit
Published on 2022-05-18
2023-06-01 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.
This document replaces YY/T 1226-2014 "Human Papillomavirus Nucleic Acid (Type) Detection Reagents (Kits)", which is an
Basis for the quality of acid (typing) detection kits.
Compared with YY/T 1226-2014, except for structural adjustment and editorial changes, the main technical changes in this document are as follows.
a) Scope. Added the intended use of human papillomavirus nucleic acid for auxiliary diagnosis of HPV infection and/or cervical cancer screening (section
Type) detection kit, and supplemented with applicable methods.
b) Terminology. Changed the definition of "genotype" and updated HPV type in the note.
c) Requirements.
1) Added the requirements for "internal standard and/or control", "nucleic acid extraction function" and "stability" (see 4.1.2, 4.1.3, 4.1.8,
4.2.2, 4.2.3, 4.2.8, 4.3.2, 4.3.3, 4.3.8);
2) "4.1.2 Accuracy (positive coincidence rate)" is revised to "4.1.4 Positive reference product coincidence rate"; "4.1.3 Specificity (negative coincidence rate)"
rate)" was changed to "4.1.5 Negative reference product conformity rate"; "4.1.4 Repeatability (precision)" was changed to "4.1.6 Repeatability";
"4.1.5 Detection limit" is revised to "4.1.7 Detection limit";
3) "4.2.2 Accuracy (positive coincidence rate)" is revised to "4.2.4 Positive reference product coincidence rate"; "4.2.3 Specificity (negative coincidence rate)"
rate)" was changed to "4.2.5 Negative reference product conformity rate"; "4.2.4 Repeatability (precision)" was changed to "4.2.6 Repeatability";
"4.2.5 Detection limit" is revised to "4.2.7 Detection limit";
4) "4.3.2 Accuracy (positive coincidence rate)" is revised to "4.3.4 Positive reference product coincidence rate"; "4.3.3 Specificity (negative coincidence rate)"
rate)" was changed to "4.3.5 Negative reference product conformity rate"; "4.3.4 Repeatability (precision)" was changed to "4.3.6 Repeatability";
"4.3.5 Detection limit" is revised to "4.3.7 Detection limit";
5) Changed the content of "4.1.5 Negative Reference Conformance Rate" and "4.2.5 Negative Reference Conformance Rate". changed from "The cross-reaction rate is not
"More than 20%" is changed to "There should be no cross-reaction for high-risk types, and the cross-reaction rate for low-risk types should not be greater than
10.0%”, and make corresponding requirements for reference works;
6) Changed "4.3.5 Negative Reference Conformance Rate". from "Test results should meet the manufacturer's requirements" to "Cross-reaction"
The rate is not more than 20%”, and corresponding requirements are made for the reference;
7) Changed the content of "repeatability", and made corresponding requirements for the type selection and concentration of reference products;
8) Changed the content of "4.1.7 Detection Limit" and "4.2.7 Detection Limit". for two common high-risk types HPV16 and HPV18,
The detection limit is required to be no higher than 103copies/reaction;
9) The test method in Chapter 5 shall be adjusted according to the clauses required in Chapter 4.
d) Identification, labels and instructions for use. should comply with the corresponding provisions of GB/T 29791.2.
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. China National Institute for Food and Drug Control, Yaneng Biotechnology (Shenzhen) Co., Ltd., Hunan Shengxiang Biotechnology Co., Ltd.
Co., Ltd., Jiangsu Shuoshi Biotechnology Co., Ltd., Bidi Medical Equipment (Shanghai) Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd.
company.
The main drafters of this document. Tian Yabin, Xu Sihong, Tian Jie, Deng Zhongping, Zhang Rong, Tian Jing, Cai Xiaorong.
The previous versions of this document and its superseded documents are as follows.
---First published in.2014 as YY/T 1226-2014;
---This is the first revision.
Human papillomavirus nucleic acid (typing) detection kit
1 Scope
This document specifies the terms and definitions, technical requirements,
Test methods, identification, labels and instructions for use, packaging, transportation, storage, etc.
This document applies to the intended use for auxiliary diagnosis and/or uterine infection of human papillomavirus (HPV)
Human papillomavirus nucleic acid (typing) detection kit for cervical cancer screening, applicable detection methods include PCR fluorescence method, PCR-reverse hybridization
method, hybrid capture-chemiluminescence method, enzyme digestion signal amplification method, gene chip method, high-throughput sequencing, etc.
Note. This document is mainly for detection kits for the detection of HPV DNA. Among them, the use of cervical cancer screening includes clinical use for SARS of no clear significance
Primary screening.
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 191-2008 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
genotype
Genotype, also known as genotype, is the general term for all the genetic combinations of a biological individual, often referring specifically to the genotype of a certain trait, such as specific
genome of allelic loci.
Note 1.The difference between the human papillomavirus L1 gene or the whole genome sequence is more than 10% and a new type is identified; if the difference is less than 2%, it is called a new type.
It is a variant (variant); between the type and the variant, that is, the sequence difference between 2% and 10% is called the subtype (subtype).
Note 2.More than.200 HPV types have been identified.
Note 3.According to the carcinogenic potential of different HPV types, HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68 are listed as high-risk types.
HPV26, 53, 66, 73, and 82 were classified as potential high-risk types; HPV6, 11, 40, 42, 43, 44, 54, and 61 were classified as low-risk types.
4 Requirements
4.1 Requirements for Human Papillomavirus Nucleic Acid (Type) Detection Kit (PCR Fluorescence Method)
4.1.1 Appearance
The appearance should meet the following conditions.
a) The kit should meet the appearance requirements specified by the manufacturer;
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