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YY/T 1216-2013 (YYT 1216-2013)

YY/T 1216-2013_English: PDF (YYT1216-2013)
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YY/T 1216-2013English160 Add to Cart 0--3 minutes. Auto-delivered. Alpha-fetoprotein quantitative labelling immunoassay kit YY/T 1216-2013 Obsolete YY/T 1216-2013

Standard ID YY/T 1216-2013 (YY/T1216-2013)
Description (Translated English) Alpha-fetoprotein quantitative labelling immunoassay kit
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 8,866
Quoted Standard YY 0466.1
Drafting Organization Chinese Academy of Food and Drug Testing
Administrative Organization National Medical clinical testing laboratories and in vitro diagnostic systems for Standardization Technical Committee
Regulation (derived from) State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Proposing organization State Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies: a quantitative marker alpha-fetoprotein immunoassay kit classification, requirements, test methods, manual, marking, labeling and packaging, transportation and storage. This standard applies to: conduct quantitative determination

YY/T 1216-2013
ICS 11.100
C 44
Alpha-fetoprotein quantitative labelling
immunoassay kit
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3 
1  Scope ... 4 
2  Normative references ... 4 
3  Classifications ... 4 
4  Requirements ... 5 
5  Test methods ... 6 
6  Marks, labels and operating instructions ... 8 
7  Packaging, transportation and storage ... 9 
Bibliography ... 10 
This Standard is drafted according to the rules specified in GB/T 1.1-2009.
Please note that some contents of this Standard may involve patents. The issuing
authority of this Standard does not undertake the responsibility of identifying these
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee (SAC/TC
136) on System of Medical Clinical Test Lab and in Vitro Diagnostic System of
Standardization Administration of China.
Drafting organization of this Standard. National Institutes for Food and Drug Control.
The main drafters of this Standard. Liu Yan, Huang Ying, and Gao Shangxian.
Alpha-fetoprotein quantitative labelling immunoassay kit
1  Scope 
This Standard specifies the classification, requirements, test method, marks, labels,
operating instructions, packaging, transportation, and storage of the alpha-fetoprotein
quantitative labelling immunoassay kit.
This Standard is applicable to the quantitative detection of alpha-fetoprotein labelling
immunoassay kit (hereinafter referred to as AFP kit). It includes AFP immunoassay kit of
quantitative detection by using labelling methods such as enzyme labelling, (electrical)
chemiluminescent labelling, (time resolution) fluorescence labelling AS capture antibody;
and using microplates, pipes, magnetic particles, microbeads, plastic beads and others
AS the carrier coated antibody.
This Standard does not apply to.
a) Colloidal gold labelled AFP test strip;
b) Various types of radio-immunity or IRMA reagent kit labelled with 125I and other
radioactive isotopes.
2  Normative references 
The articles contained in the following documents have become part of this Standard
when they are quoted herein. For the dated documents so quoted, all the modifications
(Including all corrections) or revisions made thereafter shall be applicable to this
YY/T 0466.1-2009 Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1. General requirements
3  Classifications 
The AFP kits can be divided into ELISA reagent kit, chemiluminescent reagent kit, time
resolution fluorescence reagent kit etc., according to the various labelling methods. It can
be divided into different kinds of AFP kits with carriers such as microplates, pipes,
magnetic particles, microbeads and plastic beads, according to the various solid-phase
carriers. The AFP kits can be divided into manual operation method and automatic
4.6 Specificity
DETECT at least 10 normal serums. The detection results shall not be higher than 20.0 ng
/ mL.
4.7 Measured value of quality control material
Within the linear range of the kit, SET 2 or 3 quality control materials with different
concentrations. The measured results shall be within the allowable interval of the
measured value of quality control products.
4.8 Stability
The following methods may be selected.
4.8.1 Stability at the end of validity
The reagent kit is preserved until the end of the validity under a specified condition. The
measured results shall comply with the provisions of 4.1, 4.2, 4.3, 4.4, 4.5.1, 4.5.2, 4.6
and 4.7.
4.8.2 Thermal stability
According to the period of validity of the kit, the kit is usually placed under the condition of
37°C for some time (usually 3 days - 7 days). The inspection results shall comply with the
provisions of 4.1, 4.2, 4.3, 4.4, 4.5.1, 4.5.2, 4.6, and 4.7.
Note 1. The thermal stability cannot be used to derive the period of validity of products, unless it uses the
derivation equation that is established based on a large number of stability study data;
Note 2. One of the above methods can be selected according to the product characteristics. However,
the selected method shall be capable of verifying the stability of the product, so as to ensure that the
performance of the product can comply with the standard requirements within the period of validity.
5  Test methods 
5.1 Appearance
USE visual inspection method. Visually INSPECT under natural light and bright place. It
shall comply with the provision of 4.1.
5.2 Minimum detection limit
DETERMINE the signal values of zero-value calibrator or sample diluent for not less than
10 times. CALCULATE the mean ( ) and standard deviation (SD). And CALCULATE the
value of ( + 2SD). The sample concentration corresponding to that value is the
minimum detection limit of the kit. It shall comply with the provision of 4.2.
[1] GB 3100 The international system of units and its application
[2] GB/T 19702 In vitro diagnostic medical devices - Measurement of quantities in
samples of biological origin - Presentation of reference measurement procedures
[3] GB/T 19703 In vitro diagnostic medical devices - Measurement of quantities in
samples of biological origin -- Description of reference materials
[4] Ye Yingwu. National Clinical Test Operation Specification. Edition 3, Nanjing.
Southeast University Press, 2006
[5] WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro
diagnostic kits - General guideline
[6] GB/T 29791.1-2013 In vitro diagnostic medical devices - Information supplied by
the manufacturer (labelling) - Part 1. Terms, definitions and general requirements