YY/T 1256-2024 English PDF

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YY/T 1256-2024: Ureaplasma nucleic acid detection kit
Status: Valid

YY/T 1256: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1256-2024	259	Add to Cart	3 days	Ureaplasma nucleic acid detection kit	Valid
YY/T 1256-2015	209	Add to Cart	3 days	Ureaplasma nucleic acid amplification detection kit	Valid

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Basic data

Standard ID: YY/T 1256-2024 (YY/T1256-2024)
Description (Translated English): Ureaplasma nucleic acid detection kit
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100.10
Word Count Estimation: 12,159
Date of Issue: 2024-02-07
Date of Implementation: 2025-03-01
Older Standard (superseded by this standard): YY/T 1256-2015
Issuing agency(ies): State Drug Administration
Summary: This standard stipulates the classification, technical requirements, labels, instructions for use, packaging, transportation and storage of Ureaplasma nucleic acid detection kits, and describes the corresponding test methods. This document is applicable to nucleic acid detection kits for detecting Ureaplasma in the human urinary tract, reproductive tract and respiratory tract. The methodologies used include fluorescence PCR, isothermal amplification, and PCR membrane hybridization.

YY/T 1256-2024: Ureaplasma nucleic acid detection kit

---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.
ICS 11.100.10 CCSC44 Pharmaceutical Industry Standards of the People's Republic of China Replaces YY/T 1256-2015 Ureaplasma urealyticum nucleic acid detection kit Released on 2024-02-07 2025-03-01 Implementation The State Drug Administration issued

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 for standardization documents" Drafting. This document replaces YY/T 1256-2015 "Ureaplasma urealyticum nucleic acid amplification detection kit" and is different from YY/T 1256-2015 except In addition to structural adjustments and editorial changes, the main technical changes are as follows. a) Added normative references GB/T 29791.1 and GB/T 29791.2 (see Chapter 3 and Chapter 7); b) Deleted the naming and composition (see Chapter 4, Chapter 4 of the.2015 edition); c) Added general requirements for reagents, including appearance, nucleic acid extraction function, internal standards and/or controls (see 5.1, 5.1.1, 5.1.2, 5.1.3); d) Added traceability of Ureaplasma urealyticum nucleic acid quantitative reagent (see 5.2.1, 5.1 of the.2015 edition); e) Change the accuracy item of Ureaplasma urea nucleic acid quantitative reagent to divide it into two items. accuracy and positive reference conformity rate (See 5.2.4, 5.2.5, and 5.1.3 of the.2015 edition); f) Change the limit of quantification to the limit of detection (see 5.2.7, 5.1.6 of the.2015 edition); g) Increase the stability of the Ureaplasma urealyticum nucleic acid quantification reagent (see 5.2.9); h) Delete the genotyping test of Ureaplasma urealyticum nucleic acid qualitative reagent (see 6.2.3 of the.2015 edition); i) Increase the stability of the Ureaplasma urealyticum nucleic acid qualitative reagent (see 5.3.3); j) The test method has been adjusted accordingly based on the modification of the technical requirements (see Chapter 6, Chapter 6 of the.2015 edition); k) Deleted the specific requirements for identification, labeling and instructions for use (see Chapter 7 of the.2015 edition). Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Clinical Testing Laboratories and In Vitro Diagnostic Systems (SAC/TC136). This document was drafted by. China Food and Drug Inspection Institute, Henan Provincial Drug and Medical Device Inspection Institute, Chongqing Medical Device Quality Inspection Institute Center, Anhui Anlan Zhikong Biotechnology Co., Ltd., and Beijing Wantai Biological Pharmacy Co., Ltd. The main drafters of this document. Shen Shu, Liu Donglai, Wang Yumei, Zhang Juanli, Luo Wenguang, Ji Lei, Xian Yangling. The previous versions of this document and the documents it replaces are as follows. ---First published in.2015 as YY/T 1256-2015; ---This is the first revision. Ureaplasma urealyticum nucleic acid detection kit

1 Scope

This document stipulates the classification, technical requirements, labeling, instructions for use, packaging, transportation and storage of Ureaplasma urea nucleic acid detection kits. The corresponding test methods are described. This document is applicable to the nucleic acid detection kit for detecting ureaplasma in human urinary tract, reproductive tract and respiratory tract (hereinafter referred to as the kit). The methodologies include fluorescence PCR, constant temperature amplification, and PCR membrane hybridization.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB/T 29791.1 Information provided by the manufacturer of in vitro diagnostic medical devices (labeling) Part 1.Terms, definitions and general Require GB/T 29791.2 Information provided by the manufacturer of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents GB/T 21415 Metrological traceability of values assigned to calibrators and control materials for the measurement of quantities in biological samples of in vitro diagnostic medical devices Origin

3 Terms and definitions

The terms and definitions defined in GB/T 29791.1 and the following apply to this document. 3.1 Ureaplasma It belongs to a group of the smallest prokaryotic microorganisms without cell walls, and is an obligate parasite of eukaryotic organisms. It can use its own Urease breaks down urea. Note 1.Currently, the 14 standard serotypes of Ureaplasma are divided into two major biogroups (or completely independent species) based on phenotype and genotype. Ureaplasma microtypingi Note 2.Ureaplasma urealyticum (biogroup 1) includes serotypes 1, 3, 6 and 14; Ureaplasma urealyticum (biogroup 2) includes serotypes 2, 3, 6 and 14. serotype 1, serotype 4, serotype 5, serotype 7, serotype 8, serotype 9, serotype 10, serotype 11, serotype 12 and serotype 13. Note 3.The Ureaplasma urealyticum referred to in this document includes Ureaplasma urealyticum and Ureaplasma urealyticum.

4 Categories

Can be classified as follows. a) According to the determination of test results, it can be divided into quantitative detection kits and qualitative detection kits; 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) Classified according to methodology, common methodologies include. PCR fluorescent probe method, constant temperature amplification method, and PCR membrane hybridization method. ......

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