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YY/T 1249-2014 PDF in English

YY/T 1249-2014 (YY/T1249-2014, YYT 1249-2014, YYT1249-2014)
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YY/T 1249-2014: PDF in English (YYT 1249-2014)

YY/T  1249‐2014 
ICS 11.100
C 44
Free prostate specific antigen quantitative
labelling immunoassay kit
ISSUED ON. JUNE 17, 2014
Issued by. State Food and Drug Administration
Table of Contents
1  Scope ... 4 
2  Normative references ... 4 
3  Classification ... 4 
4  Requirements ... 5 
5  Test methods ... 7 
6  Marks, labels and instructions ... 8 
7  Packaging, transportation and storage ... 10 
Bibliography ... 11 
This Standard is drafted according to the rules specified in GB/T 1.1-2009.
Please note that some contents of this Document may involve patents. The issuing
authority of this Document 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. Huang Ying, Zhang Chuntao, Shen Shu, Yu Ting, and
Gao Shangxian.
Free prostate specific antigen quantitative labelling
immunoassay kit
1  Scope 
This standard specifies the classification, requirements, test method, marks, labels,
instructions, packaging, transportation, and storage of the free prostate specific antigen
quantitative labelling immunoassay kit.
This standard is applicable to the kit which quantitatively determines the free prostate
specific antigen (fPSA) by the principle of double antibody sandwich method (hereinafter
referred to as. fPSA kit). It includes the immunoassay kit of quantitative determination of
fPSA by using labelling methods such as enzyme labelling, (electrical) chemiluminescent
labelling, (time resolution) fluorescence labelling AS the capture antibody; and using
carriers such as microplates, pipes, magnetic particles, microbeads, and plastic beads AS
the coated antibody.
This standard does not apply to.
a) Reagent which is used to qualitatively or semi-quantitatively determine fPSA by
colloidal gold or other methods (such as. test paper strip, etc.);
b) Various types of fPSA radio-immunity or IRMA kit labelled with 125I and other
radioactive isotopes.
2  Normative references 
The articles contained in the following documents have become part of this Document
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
GB/T 191 Packaging - Pictorial marking for handling of goods
3  Classification 
According to different labelling method, fPSA kit can be divided into enzyme labelling fPSA
kit, (electric) chemiluminescence labelling fPSA kit, (time-resolved) fluorescence labelling
5  Test methods 
5.1 Appearance and physical examination
The visual inspection under the natural light shall be in compliance with the provisions of
4.1. The redissolving time of freeze-dried products is measured with timer.
5.2 Linearity
Dose - response curve linearity of the kit’s calibrator shall be in compliance with the
provisions of 4.4. For those kits not equipped with calibrator, USE fPSA national (or
international) standard materials (or other high concentration sample); PREPARE the
proper concentration points (generally no less than 5 points), according to the linear range
specified by the kit instructions. Establish a corresponding dose-response curve. The
linearity shall comply with provisions of 4.2.
5.3 Minimum detection limit
Repeatedly TEST zero-calibrator (or diluent of sample) for not less than 10 times.
Calculate the average value (x ) and standard deviation (SD) of reaction volume (A or
RLU or CPS, etc.). SUBSTITUTE the reaction volume of (x + 2SD) into dose-response
curve. Calculate the corresponding concentration value. It shall comply with provisions of
5.4 Accuracy
fPSA national (or international) standard materials shall be prepared to (generally not less
than 5 points) the concentration points corresponding with the calibrator in the kit, by using
the kit buffer system. Each point shall be determined for not less than 2 times in parallel.
CCALCULATE the slope rate and potency ratio of 2 dose-response curves. It shall comply
with provisions of 4.4.
For the kit that has not been equipped with a series of calibrators, within the measurement
range specified by the kit, SELECT an appropriate buffer system; USE national (or
international) standard materials of free prostate specific antigen to prepare 2 - 3
concentration points. Each point shall be determined for not less than 2 times in parallel.
The ratio of the average of determined values AND the theoretical value shall comply with
provisions of 4.4.
5.5 Precision
5.5.1 Within-analysis precision
2 ~ 3 control materials are set up in different areas of dose-response curves. Within a
same-analysis, repeatedly measure each control materials for not be less than 8 times.
The coefficient of variation (CV) of the measured results shall comply with provisions of
It shall contain at least the following contents.
a) Product name and specifications;
b) Name, address, contact information of manufacturing enterprise or after-sales
service organization;
c) Medical Device Registration Certificate Number;
d) Product standard number;
e) Product batch number;
f) Period of validity;
g) Storage conditions.
6.2 Marks and labels of each component package of kit
It shall contain at least the following contents.
a) Product name and specification;
b) Name or trademark of manufacturing enterprise;
c) Product batch number;
d) Period of validity;
e) Storage conditions.
6.3 Instructions of reagent (kit)
It shall generally contain the following contents.
a) Product name;
b) Packaging specifications;
c) Intended use;
d) Inspection principle;
e) Main compositions;
f) Storage conditions and period of validity;
g) Applicable instrument;
h) Sample requirements;
[1] GB/T 3358.1-2009 Statistical Terminology. Part 1. General Statistical Terminology
and Terminology Used in Probability
[2] JJF 1001-2011 General Measurement Terminology and Definition
[3] Ye Yingwu. National Clinical Laboratory Operation Specification. Version 3. Nanjing.
Southeast University Press. 2006
[4] YY/T 0316-2008 Medical Devices. The Application to Risk Management for Medical
[5] Chinese Pharmacopoeia Commission. The General Principles of the Radiation
Immunoassay Kit. 2005
[6] Council for the Standardization of Biological Products, China. Chinese Biological
Products Regulation Version 2000.
[7] Guo Zuchao. Medical Mathematical Statistics Method. Version 3. Beijing. People’s
Medical Publishing House. 1988
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.