YY/T 1249-2014 English PDF (YYT1249-2014)

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.

YY/T  1249‐2014
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Free prostate specific antigen quantitative
labelling immunoassay kit
ISSUED ON. JUNE 17, 2014
IMPLEMENTED ON. JULY 1, 2015
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
Foreword
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 patents.
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 document.
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 4.3.
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;
Bibliography
[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 Device
[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