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YY/T 1221-2013 PDF English

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YY/T 1221-2013: Cardiac Troponin I (cTnI) Diagnostic Kit (Colloid Gold Method)
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YY/T 1221-2013: Cardiac Troponin I (cTnI) Diagnostic Kit (Colloid Gold Method)

---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/YYT1221-2013
YY PHARMACEUTICAL INDUSTRY STANDARD 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

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. This Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of National Technical Committee on System of Medical Clinical Test Lab and In Vitro Diagnostic System of Standardization Administration of China (SAC/TC 136). Drafting staffs of this Standard. National Institutes for Food and Drug Control. Chief drafting staffs of this Standard. Qu Shoufang, Huang Jie, and Gao Shangxian. 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. 3.5 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. 4.2 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. 4.5 Lowest detection limit Test the sensitivity control materials of the cardiac troponin I (cTnI), which shall be no higher than 1.0ng/mL. 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). 5.2 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 cardiac troponin I (cTnI); 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 cardiac troponin I (cTnI) with the same concentration; operate according to the instruction manual; and the result shall meet the requirements of 4.3. 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. 6.3 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 (kit) shall have at least the following contents. 7.2 The transportation and packaging of the reagent kit shall have the following contents. 7.3 The instruction manual shall have the following contents.

8 Transportation and Storage

8.1 Packaging 8.1.1 The reagent may be transported at the room temperature for a short period of time. Corresponding protective measures shall be enhanced in Winter or Summer, avoid becoming icy or at high temperature for a long time. 8.2 Storage 8.2.1 The reagent shall be stored in the environment at 4°C~30°C; no freezing storage is allowed. 8.2.2 Avoid heavy stress during the storage period. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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