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YY/T 1180-2021 English PDF

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YY/T 1180-2021: Typing kit for human leucocyte antigen(HLA)
Status: Valid

YY/T 1180: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 1180-2021English139 Add to Cart 3 days [Need to translate] Typing kit for human leucocyte antigen(HLA) Valid YY/T 1180-2021
YY/T 1180-2010English359 Add to Cart 3 days [Need to translate] Typing kit for human leucocyte antigen (HLA). Sequence specific primer. SSP Obsolete YY/T 1180-2010

PDF similar to YY/T 1180-2021


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Basic data

Standard ID YY/T 1180-2021 (YY/T1180-2021)
Description (Translated English) Typing kit for human leucocyte antigen(HLA)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Word Count Estimation 7,780
Issuing agency(ies) State Drug Administration

YY/T 1180-2021: Typing kit for human leucocyte antigen(HLA)

---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.
Typing kit for human leucocyte antigen(HLA) ICS 11:100:10 CCSC44 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 1180-2010 Human Leukocyte Antigen (HLA) Genotyping Detection kit 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: This document replaces YY/T 1180-2010 "Human Leukocyte Antigen (HLA) Genotyping Kit SSP Method", and YY/T 1180- Compared with:2010, in addition to editorial changes, the main technical changes are as follows: --- Scope adds the applicable methodology of this document, and examples; adds the inapplicable content of this document (see Chapter 1); --- Added normative references (see Chapter 2); --- Added terms and definitions (see 3:3, 3:4); ---The main revisions of technical indicators are as follows: ● Modified the appearance requirements by deleting item c) (see 4:1, 3:1 of the:2010 edition); ● Revised the main performance indicators, which are divided into two categories according to the intended use (see 4:2, 4:3, 3:2~3:7 of the:2010 edition); ● Modified the repeatability requirements (see 4:2:2, 4:3:3, 3:4 of the:2010 edition); ● Revised the effective detection range (see 4:2:3, 3:5 of the:2010 edition); ● Deleted the random failure rate requirement (see 3:6 of the:2010 edition); ● Modified the stability requirements (see 4:2:4, 4:3:5, 3:7 of the:2010 edition); --- Modified the test method to be compatible with the requirements of Chapter 4 (see Chapter 5, Chapter 4 of the:2010 edition); --- Modified identification, labels and instructions for use (see Chapter 6, Chapter 5 of the:2010 edition); --- Modified the packaging, transportation and storage (see Chapter 7, Chapter 6 of the:2010 edition): 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, China National Institute for Food and Drug Control, Thermo Fisher Scientific (China) Co:, Ltd: Company, Beijing Red Cross Blood Center, Shandong Yingsheng Biotechnology Co:, Ltd:, Jiangsu Weihe Biotechnology Co:, Ltd: The main drafters of this document: Wang Ruixia, Hu Zebin, Li Jiahao, Wang Dongmei, Jing Yesong, Chen Haoyuan: The previous versions of this document and its superseded documents are as follows: ---First published in:2010 as YY/T 1180-2010; ---This is the first revision: Human Leukocyte Antigen (HLA) Genotyping Detection kit

1 Scope

This document specifies the terms and definitions, requirements, test methods, standards of human leukocyte antigen (HLA) genotyping test kit products identification, labeling, instructions for use, packaging, transportation and storage, etc: This document applies to the quality control of human leukocyte antigen (HLA) genotyping detection kits (hereinafter referred to as kits): Should The kit is mainly used for multi-locus, single serological group or allele detection of HLA class I A, B and C sites and class II DRB and DQB: Genotyping: The kit methodology includes but is not limited to polymerase chain reaction-sequence-specific primer method (PCR-SSP), polymerase chain reaction response-sequence-specific oligonucleotide probe method (PCR-SSO), polymerase chain reaction-gene sequencing typing method (PCR-SBT), fluorescent PCR method, PCR melting curve method, etc: Clinical uses include matching of donor and recipient for transplantation or blood transfusion, auxiliary diagnosis of diseases, etc: This document does not apply to genotyping kits for the detection of human leukocyte antigen (HLA) using high-throughput sequencing methods:

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 human leukocyte antigen humanleucocyteantigen; HLA A group of glycoproteins that play an important role in the body's immune system is encoded by the genome on the short arm of human chromosome 6: Note: HLA genes are highly genetically polymorphic, with several to hundreds of alleles with different sequences per locus: 3:2 polymerase chain reaction-sequence specific primer method polymerase chain reaction-sequence specific primer; PCR-SSP A method of amplifying specific HLA alleles by PCR technology using multiple sets of allele-specific primers: 3:3 polymerase chain reaction-sequence specific oligonucleotide probe method polymerase chain reaction-sequencespecificoligonu- cleotide; PCR-SSO Use isotopically or non-radioactively labeled probes (sequence-specific oligonucleotides) to hybridize to the PCR-amplified target fragment products, according to A method for determining HLA alleles by positive signals: 3:4 polymerase chain reaction-sequence based genotyping; PCR-SBT Amplify the gene fragment to be analyzed by PCR, and sequence and analyze the DNA sequence to determine the genotype:

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