YY/T 1220-2013Creatine kinase isoenzyme MB (CK-MB) diagnostic kit (colloidal gold method) (English PDF)
肌酸激酶同工酶(CK-MB)诊断试剂(盒）(胶体金法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 21, 2013
Implementation date
October 1, 2014
Scope
YY/T 1220-2013 is the English-translated version of 肌酸激酶同工酶(CK-MB)诊断试剂(盒）(胶体金法）.
YY/T 1220-2013 is the Chinese pharmaceutical industry standard for the diagnostic kit that detects the MB isoenzyme of creatine kinase by the colloidal gold method, the marker used in myocardial infarction.
It specifies the terms and definitions, the requirements, the test methods, the inspection and judgement, the marking, the label, the instruction manual and the rules for packaging, transport and storage, covering the appearance of the strip, the detection limit, the agreement with reference materials, the specificity, the repeatability and the stability. Issued on 21 October 2013, it has applied since 1 October 2014.
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Document preview — YY/T 1220-2013
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative References4
- 3 Terms and Definitions4
- 4 Requirements5
- 5 Test Methods6
- 6 Inspection and Judgment8
- 7 Marking, Label and Instruction Manual8
- 8 Packaging, Transportation and Storage9
- Bibliography10
Foreword
This Standard was drafted as per the rules specified in GB/T 1.1-2009.
Please note some contents of this document may involve patents. The issuing agency of this document shall not assume the responsibility to identify these patents.
1 Scope
This Standard specifies the terms and definitions, requirements, test methods, inspection and judgment, marking, label, instruction manual, packaging, transportation and storage of the creatine kinase isoenzyme MB (CK-MB) diagnostic kit (colloid gold method).
This Standard is applicable to the creatine kinase isoenzyme MB (CK-MB) diagnostic kit (colloid gold method). This reagent is used to qualitatively detect the activity of creatine kinase isoenzyme MB (CK-MB) in human serum or plasma in vitro.
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.
YY/T 0466.1 Medical Devices - Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied - Part 1: General Requirements
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.
4 Requirements
4.1 Physical properties
4.2 Accuracy
Test the positive control materials of creatine kinase isoenzyme MB (CK-MB), 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 creatine kinase isoenzyme MB (CK-MB) 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 creatine kinase isoenzyme MB (CK-MB), the reaction result shall be negative.
4.6 Stability
Take the test papers of the same batch number and place them at 37°C for 20d. The result shall meet the requirements of 4.2~4.5.
5 Test Methods
5.1 Basis for result judgment (see Figure 1)
5.1.1 Positive. The color of the color band of the test line (T) is the same as or deeper than the control line (C).
5.1.2 Negative. Only the control line (C) appears.
5.2 Physical properties
5.2.1 Appearance
Randomly select 1 piece of test paper and visually observe it under natural light. It shall meet the requirements of 4.1.1.
5.3 Accuracy
Test the positive control materials of the creatine kinase isoenzyme MB (CK-MB); operate according to the instruction manual; and the results shall meet the requirements of 4.2.
5.4 Repeatability
Test the positive control materials of the creatine kinase isoenzyme MB (CK-MB) with the same concentration; and operate according to the instruction manual; the result shall meet the requirements of 4.3.
5.6 Lowest detection limit
Test the sensitivity control materials of the creatine kinase isoenzyme MB (CK-MB); and operate according to the instruction manual; the results shall meet the requirements of 4.5.
5.7 Stability
Take the test papers of the same batch number and place them at 37°C for 20d; and test according to the methods shown in 5.3 ~ 5.6. The result shall meet the requirements of 4.6.
6 Inspection and Judgment
6.1 Reagent (kit) inspection type
Reagent (kit) inspection is divided into exit-factory inspection and type inspection.
6.2 Exit-factory inspection
The exit-factory inspection items are 4.1~4.6; 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.
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.
7 Marking, Label and Instruction Manual
7.1 The outer packaging box of the reagent (box) shall have at least the following contents.
7.2 The product instruction manual shall have the following content.
8 Packaging, Transportation and Storage
8.1 Packaging
It shall be intact, no leakage, and without damage.
8.2 Transportation
The reagents (kits) shall be transported according to the requirements of the manufacturer. […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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