YY/T 1216-2020 in English

VALID

Alpha-fetoprotein testing kit

Issued on:2020-06-30
Implemented on:2021-06-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $120.00
$117.00

Standard No:	YY/T 1216-2020
Document status:	VALID
Title in English:	Alpha-fetoprotein testing kit
Title in Chinese:	甲胎蛋白测定试剂盒
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2020-06-30
Implemented on:	2021-06-01
Superseding:	YY/T 1216-2013 Alpha-fetoprotein quantitative labelling immunoassay kit
ICS Classification:	11.100-Laboratory medicine
Chinese Classification:	C44-Medical laboratory equipment
Professional Classification:	YY-Pharmaceutics
Related Keywords:	alpha-fetoprotein detection kit alpha-fetoprotein detection kits kit introduction analysis kit focus new standard
Related Topics:	protein bars the protein protein interaction Reagent test kit Formaldehyde detection box Protein identifier page+protein protein system many proteins protein sds protein histone Protein Assay Kit protein kit u6 kit dumas protein Protein identifier protein stealth Kit parameters The first quantitative kit in China transient detection protein protein + instant Kidney function test kit v6 kit q5 kit protein+sds protein instant protein + self egg white protein hand Hepatin protein agent Detection of Denatured Proteins rapid box assay Amidin Instant Kit protein denaturant t9 protein Assay Kit Kit Consumables protein assay brain protein protein assayd flow detection protein Formaldehyde detection box Histone protein opal Methanol cartridge protein of the week albumin bismuth kit unit Protein Assay Kit protein time How to identify proteins Protein diagnostic reagents protein from protein ketone blank test Amida protein Molecular protein detection Hey protein protein cluster program blank fixative formate protein specific protein reagent protein pcr porin specific protein reagent Guanidine Methanol detection kit Gold kit reagents Specific Protein Meter Reagents porin protein extractant in the kit Guanidine + protein Organic Reagent Protein egfr detection kit gold kit Methanol detection kit high-efficiency albumin manganese protein How to identify protein protein version extrinsic protein Proteobacteria detection manganese protein membrane kit Assay Kit flow kit target protein Photoprotein brain protein Photoprotein protein fixative Instruments for the determination of proteins Flow Cytometry+ Kits alpha-fetoprotein protein fixative A fetus Methanol detection kit afp alpha-fetoprotein UV protein Kurtosis Protein Kit protein assay flow protein multiparameter kit Gold Quantification Kit plant kit plant kit Test protein u6 protein Shihe Kit Shihe, kit protein denaturant Alpha-fetoprotein analysis Standard Box Reagent sds protein 12 specific proteins Pulse element kit protein+sds+ Domestic kit Protein Assay Principle r2 protein ms solvent cartridge e6, e7 protein detection specific protein egfr kit flow kit Specific Protein Assay Reagents protein + formic acid + Specific protein detection 12 items s6 protein burning seeds assay protein UV protein Denatured protein detection kit unit protein protein assay alpha-fetoprotein afp AFP+ t4 kit A fetus how to test protein formate protein Lithium Detection Kit Formic acid protein quantification protein ladder Lithium Detection Kit box protein Ultraviolet Determination of Protein Test Method alpha-fetoprotein 80 Lowry protein q7 kit semi-quantitative kit protein assay alpha-fetoprotein Mycoprotein detection Complexin protein stabilizer Albumin removal Apolipoprotein B Assay Kit Alpha-fetoprotein assay kit (chemiluminescence immunoassay) With 4.1 protein and adducin protein Urinary albumin 13.9 Reagent blank, solvent blank, sample blank ATP kit usage biochrom detects 565 proteins HEI10 protein Ki67 detection kit TaCPK5 protein Mouse interleukin 18 ELisa kit Reagent Blanks and Calibration Blanks atp detection kit BIAs proteins DNA methylation quantitative analysis kit Echdc1 protein LCAD protein pet28a protein PSD93 protein SR family proteins thbs1 protein function repressor protein Kit S/N MAMLD1 protein function Reagent blank and sample blank What reagents are used to detect proteins? dusp4 protein fis1 protein NanoTemPer his kit NICD protein Domestic interleukin detection kit Total chlorine determination kit detection Method for determination of effective concentration of albumin Alpha-fetoprotein detection kit industry Test kit testing standards disclosed Collagen kit detection method white test Albumin determination method Determination of protein soil White box testing international and domestic Protein determination standard curve kit bridge accepted Test kit industry Specific protein industry Determination of protein standard curve Methods for detecting alpha-fetoprotein

本标准规定了甲胎蛋白标记免疫测定试剂产品的分类、要求、检验方法、标示、标签、使用说明书、包装、运输和贮存等。本标准适用于以标记免疫测定为原理检测人血液基质或其它体液成分中的甲胎蛋白（AFP）定量测定试剂，包括以酶、化学发光、荧光物等方法标记捕获抗体，以微孔板、管、磁颗粒、微珠和塑料珠、微流控芯片、纳米材料等为载体包被抗体定量测定AFP的免疫测定试剂盒。本标准不适用于：胶体金标记AFP试纸条；用125I等放射性同位素标记的各类放射免疫。

Introduction

Analysis of the core content of the standard

This standard replaces YY/T 1216-2013, and mainly regulates the technical requirements, test methods and marking labels of alpha-fetoprotein detection kit. The key revisions include:

Technical dimensions	Requirements of the 2013 version	Updates to the 2020 version
Linear range	Lower limit not specified	Added a new detection limit of 4.0IU/mL
Accuracy	Recovery 80%-120%	Tightened to 90%-110%
Precision	CV≤15%	Intra-batch CV≤8% Inter-batch CV≤10%

Key technical requirements

1. Performance indicators

Linear correlation coefficient: required to be ≥0.9900 (Clause 4.4)
Detection limit: not higher than 16IU/mL (corresponding to 200ng/mL)
Intra-batch precision: CV≤8.0% after 10 tests

2. Traceability of standards

The international unit (IU) is clearly adopted as the measurement basis, and manufacturers are required to provide the conversion relationship between IU/mL and ng/mL (Clause 5.5). Reference standards include:

GB/T 21415-2008 Measurement of quantities in biological samples of in vitro diagnostic medical devices
GB/T 29791.2-2013 In vitro diagnostic medical device instructions

Implementation recommendations

Precautions for manufacturers

Case: During method validation, a manufacturer found that the inter-batch CV was 9.5%, and the following improvements were required to meet the ≤10% requirement:

Optimize the reconstitution process of calibrators
Increase the frequency of quality control product testing
Use more stable enzyme markers

Laboratory application guidelines

After the implementation of the new standard, it is recommended to revalidate the analytical performance of the kit
Focus on the detection accuracy in the low value range of 4.0-200IU/mL
Regularly participate in external quality assessment and compare the results of different methodologies

Analysis of standard evolution

This revision mainly responds to the following technological developments:

Increased demand for low-concentration AFP detection for early diagnosis of liver cancer
Increased precision of new technologies such as chemiluminescence
Updates to the requirements of in vitro diagnostic reagents in the international standard ISO 18113

After the implementation of the standard, it is expected that about 15% of ELISA kits that do not meet the accuracy requirements will be eliminated, and the market share of chemiluminescence alpha-fetoprotein detection kits will be increased to more than 80%.

More samples: JGJ 94-2008 NB/T 47013.2-2015 DL/T 368-2010

Sample only — not a preview of YY/T 1216-2020

Loading PDF document...

Error loading PDF. Please make sure the file is valid and try again.

We also recommend

YY/T 0688.2-2024 in English

Clinical laboratory testing and in vitro diagnostic systems - Performance evaluation of equipment for infectious pathogen susceptibility testing and antimicrobial susceptibility testing - Part 2: Performance evaluation of equipment for antimicrobial susce
2024-09-29
YY/T 0456.1-2014 in English

Reagents for hematology analyzer―Part 1:Rinse
2014-06-17
YY/T 0588-2017 in English

Flow cytometer
2017-12-05
YY/T 0996-2015 in English

Urine formed element analyzer(digital imaging automatic identification)
2015-03-02
YY/T 1303-2015 in English

Nucleic acid amplification reverse dot blot reagent(kit)
2015-03-02