YY/T 1221-2013 English PDF (YYT1221-2013)

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YY/T 1221-2013: Cardiac troponini I (cTnI) diagnostic kit (Colloid gold method)
YY/T 1221-2013
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
Cardiac Troponin I (cTnI) Diagnostic Kit (Colloid Gold
Method)
ISSUED ON: OCTOBER 21, 2013
IMPLEMENTED ON: OCTOBER 01, 2014
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 4
4 Requirements ... 5
5 Test Methods ... 6
6 Inspection and Judgment ... 7
7 Marking, Label and Instruction Manual ... 8
8 Transportation and Storage ... 9
Bibliography ... 11
Cardiac Troponin I (cTnI) Diagnostic Kit (Colloid Gold
Method)
1 Scope
This Standard specifies the terms and definitions, requirements, test methods,
inspection and judgment, marking, label, instruction manual, packaging, transportation
and storage of cardiac troponin I diagnostic kit (colloid gold method).
This Standard is applicable to the cardiac troponin I diagnostic kit (colloid gold method).
This reagent is used to qualitatively detect the cardiac troponin I (cTnI) in human serum
or plasma.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) is applicable to this document.
GB/T 191 Packaging – Pictorial Marking for Handling of Goods
3 Terms and Definitions
For the purpose of this document, the following terms and definitions apply.
3.1 Colloid gold technique
A labeling technique that uses colloidal gold particles as a tracer or chromogenic
substance for antigen-antibody reaction or other molecular detection.
3.2 Lowest detection limit
The lowest measured value in a sample that can be declared different from zero with
a certain probability.
3.3 Analytical specificity
The measurement program only measures the ability to be measured.
3.4 Control materials
Substances, materials or articles that are used to verify the performance and
characteristics of in vitro diagnostic reagents (kits).
3.5 Repeatability
Under the same measurement conditions, the consistency between the results
obtained by consecutive multiple measurements on the same measured object.
4 Requirements
4.1 Physical properties
4.1.1 Appearance
It shall meet the normal appearance requirements specified by the manufacturer.
4.1.2 Width of the film strip
It shall be no less than 2.5mm.
4.1.3 Liquid moving speed
The liquid moving speed shall be no less than 10mm/min.
4.2 Accuracy
Test the positive control materials of cardiac troponin I (cTnI), all the results shall be
positive.
4.3 Repeatability
Take 10 pieces of test papers of the same batch number to test the positive control
materials of cardiac troponin I (cTnI) with the same concentration; the reaction results
shall be consistent, the color shall be uniform, and all shall be positive.
4.4 Analytical specificity
Test the specificity control materials of cardiac troponin I (cTnI), the reaction result shall
be negative.
NOTE: The specificity control materials of the cardiac troponin I (cTnI) are normal negative
plasma or serum samples; troponin T control materials and troponin C control materials.
4.5 Lowest detection limit
Test the sensitivity control materials of the cardiac troponin I (cTnI), which shall be no
higher than 1.0ng/mL.
The exit-factory inspection items are 4.1~4.5; and the products may leave the factory
only after the inspection is qualified; if any of the inspection results does not meet the
requirements, a re-inspection shall be carried out. If the re-inspection is still unqualified,
the batch of products shall be determined as unqualified.
6.3 Type inspection
Type inspection items are all items; and each batch of products shall be all-item
inspected according to this Standard. Type inspection shall be carried out in one of the
following situations:
a) The new product is put into production;
b) Major changes in materials, processes, and formulas may affect product
performance;
c) No less than once a year in continuous production;
d) Resume production after stopping production for rectification;
e) Contract provisions or departmental requirements.
If all inspection items are qualified, then the products pass the type inspection. If the
type inspection fails, mass production is not allowed.
7 Marking, Label and Instruction Manual
7.1 The outer packaging box of the reagent (kit) shall have at least the following
contents:
a) Product name and specifications;
b) The name and address of the manufacturer;
c) Production batch number or production date;
d) Validity period;
e) Product standard number;
f) Production license number;
g) Product registration number;
h) Storage methods;
i) Precautions.