YY/T 1256-2024 in English

VALID

Ureaplasma nucleic acid detection kit

Issued on:2024-02-07
Implemented on:2025-03-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $190.00
$185.00

Standard No:	YY/T 1256-2024
Document status:	VALID
Title in English:	Ureaplasma nucleic acid detection kit
Title in Chinese:	解脲脲原体核酸检测试剂盒
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2024-02-07
Implemented on:	2025-03-01
Superseding:	YY/T 1256-2015 Ureaplasma nucleic acid amplification detection kit
Professional Classification:	YY-Pharmaceutics
Related Keywords:	nucleic acid detection test results single detection limit set detection limits acid extraction function verification subtype detection analysis detection
Related Topics:	Detection kit Detection Reagent Hydrolysis of urea Urea detection Urea detection Detection Reagent Detection kit u6 kit Time to test uretone in vitro testing Urazine hu in situ kit Seven autoantibody detection kits Kidney function test kit v6 kit q5 kit acid detection Crystal Kit Automatic Nucleic Acid Detection acid detection Instant Kit Mycoplasma detection kit Kit Consumables Dimethylurea detection Urea hydrolysis test agent Uric acid assay kit Nucleic acid detection kit Urea Tester Nucleic acid detection box Collagen Kit Mycoplasma kit In Situ Detection Kit nucleic acid agent Test box specification Gold kit reagents Liquid Detection Principle Molecular detection Nucleic acid detection Test box specification Molecular nucleic acid detection Mycoplasma aureus Kit in the kit nucleic acid principle stock solution box Uric acid kit egfr detection kit A kind of antibody detection kit membrane kit Raw sand detection Nucleic acid detection kit quadruplex nucleic acid Reagent raw materials Micro nucleic acid detection Liquid Detection Principle multiparameter kit plant kit plant kit Urea hydrolysis Principles of Nucleic Acid Analysis Shihe Kit Shihe, kit Principles of Nucleic Acid Analysis Standard Box Reagent Nucleic acid detection window period Pulse element kit Urea bond About nucleic acid testing abroad Type Collagen Kit Urea bond Micro nucleic acid detection de02 original box Type Collagen Kit Autoantibody Detection Kit nucleic acid secretion Nucleic acid detection window period Nucleic acid detection pcr kit How to detect nucleic acid Violet acid Principles of Nucleic Acids egfr kit Forensic Test Kit Urea degradation Gas phase detection of methyl urea secretory nucleic acid Benzene test kit Nucleic acid detection pcr kit Urea group detection method t4 kit Nucleic acid system Lithium Detection Kit Lithium Detection Kit Kit detection system q7 kit Nucleic acid principle analysis Phenylurea pyrolysis Nucleic acid UV principle Quality inspection of thiourea Biuret reagent Hepatitis C core antigen detection kit steps Biuret reagent preparation Principle of water quality testing kit ATP kit usage Ki67 detection kit Glycolysis/OXPHOS Assay Kit Detection method of brucellosis detection kit atp detection kit ATP kit principle Covid test kit results hiv nucleic acid detection method HIV testing kit sales cod detection premade reagents Kit S/N diphenylurea reagent Urine RNA nucleic acid detection NanoTemPer his kit Aquatic products special testing kit Abscisic acid elisa detection kit Total chlorine determination kit detection Principle and method of urine testing kit Test kit testing standards disclosed Cadmium kit detection method principle Testing kit Methods for breaking down nucleic acids International nucleic acid testing Nucleic acid detector industry Detection method of thiourea yy/t 1902-2024 t/cesa 1256 Test kit industry Test kit group yy/t 1922-2024 yy/t1937-2024

本文件规定了解脲脲原体核酸检测试剂盒的分类、技术要求、标签、使用说明书、包装、运输和贮存，描述了相应的试验方法。
本文件适用于检测人泌尿道、生殖道和呼吸道脲原体的核酸检测试剂盒，采用的方法学有荧光PCR法、恒温扩增法、PCR膜杂交法。

Introduction

Core changes in the standard revision

2015 version	2024 version	Clinical significance
Qualitative testing only	Quantitative/qualitative dual system	Meet the needs of precision medicine
No traceability requirements	Added GB/T21415 traceability requirements	Improve comparability of test results
Single detection limit	Set detection limits by biota	Improve sensitivity of subtype detection

Analysis of key technical requirements

5.1 General requirements

Newly added Nucleic acid extraction function verification hierarchical management:

Reagents containing extraction components need to be fully verified
Specified extraction reagents need to provide cross-validation data
Direct amplification reagents need to prove enzyme anti-interference

5.2 Core indicators of quantitative reagents

Case: Verification of a fluorescent PCR reagent showed:

When the linear range is 10²-10⁷ copies/mL, |r|=0.995
Repeatability CV ≤3.2% (high value), ≤8.7% (low value)
Thermal stability accelerated at 37℃ for 7 days to meet the performance standard

Implementation suggestions

Corporate response strategies

Links	Key actions
R&D and design	Optimize primer and probe design according to the new regulations, covering 14 serotypes
Performance verification	Establish a secondary reference system to ensure the integrity of the traceability chain
Quality control	Increase biota-specific verification (such as the difference between Uu and Up)

Clinical laboratory precautions

Give priority to products that meet the labeling requirements of GB/T29791.2
Regularly participate in external quality assessments including Uu/Up typing
Pay attention to reagent transportation temperature records (new regulations require cold chain verification)

More samples: DL/T 368-2010 QC/T 942-2021 GB 50021-2001(2009)

Sample only — not a preview of YY/T 1256-2024

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