YY/T 1249-2014 PDF English
US$150.00 · In stock · Download in 9 secondsYY/T 1249-2014: Free prostate specific antigen quantitative labelling immunoassay kit Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 1249-2014 | English | 150 |
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Free prostate specific antigen quantitative labelling immunoassay kit
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YY/T 1249-2014: Free prostate specific antigen quantitative labelling immunoassay kit---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1249-2014
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
YY/T 1249-2014
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
fPSA kit, etc.
4 Requirements
4.1 Appearance and physical examination
The kits shall be completed in components. The internal and external package shall be
intact. The label shall be clear.
4.2 Linearity
Within the interval of 0.5 g/L~10 g/L, USE double logarithmic or other appropriate
mathematical model for fitting. The linear correlation coefficient (r) of dose-response curve
shall not be less than 0.9900.
4.3 Minimum detection limit
It shall not be higher than 0.20 g/L.
4.4 Accuracy
Calibrator in the kit AND fPSA national (or international) standard materials with
corresponding concentrations are tested at the same time. USE double logarithmic or
other appropriate mathematical model for fitting.
4.5 Precision
4.5.1 Within-analysis precision
Coefficient of variation (CV) of measured results of control material of manual operation kit
shall not be more than 15.0%; the coefficient of variation (CV) of measured results of
control materials of full-automatic immune analysis system kit shall not be more than
8.0%.
4.6 The measured value of control materials
For the kit equipped with fixed-value control materials, its determination result shall be in
the range specified by the kit.
4.7 Specificity
USE national (or international) standard materials of free prostate specific antigen taken
AS the comparison materials. The determination result of national (or international)
standard materials prostate specific antigen in this kit shall be consistent with its labelled
ratio content.
4.8 Stability
4.8.1 Stability at the end of validity
The kit is preserved until the end of the validity under a stated condition. The measured
results shall comply with provisions of 4.1, 4.2, 4.3, 4.4, 4.5.1 and 4.6.
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.
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.
5.5 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
4.5.1.
5.6 The measured value of control materials
Control materials (usually 2-3) are set up in different areas of dose-response curves. The
measured results of the kit shall comply with the provisions of 4.6.
5.7 Specificity
National (or international) standard materials of free prostate specific antigen (fPSA) AND
national (or international) standard materials of prostate specific antigen (fPSA) are
prepared to solutions with appropriate series of concentrations.
5.8 Stability
After the kit is preserved at conditions specified by provisions of 4.8.1, 4.8.2 or 4.8.3,
MEASURE 4.1, 4.2, 4.3, 4.4, 4.5.1 and 4.6.The results shall comply with related
provisions.
6 Marks, labels and instructions
6.1 Marks, labels of outer package of kit
It shall contain at least the following contents.
6.2 Marks and labels of each component package of kit
It shall contain at least the following contents.
6.3 Instructions of reagent (kit)
It shall generally contain the following contents.
7 Packaging, transportation and storage
7.1 Packaging
The kit shall be packed according to the requirements of product enterprise, and satisfy
the requirements of GB/T 191.
7.2 Transportation
Reagent (kit) shall be transported according to the requirements of manufacturing
enterprise.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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