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YY/T 1235-2014 PDF English

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YY/T 1235-2014: Rubella virus IgG / IgM antibody detection kit
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YY/T 1235-2014English150 Add to Cart 0-9 seconds. Auto-delivery Rubella virus IgG / IgM antibody detection kit Valid

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YY/T 1235-2014: Rubella virus IgG / IgM antibody detection 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/YYT1235-2014
YY ICS 11.100 C 44 Pharmaceutical Industry Standard of the People’s Republic of China Rubella IgG / IgM antibody detection kit Issued on. JUNE 17, 2014 Implemented on. JULY 1, 2015 Issued by. State Food and Drug Administration

Table of Contents

Foreword... 3 1 Scope... 4 2 Normative references... 4 3 Requirements... 4 4 Test methods... 6 5 Marking, labeling, and instructions... 7 6 Packaging, transportation, and storage... 9 References... 10

Foreword

This Standard was drafted according to the rules given by 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 for the identification of these patents. This Standard was proposed by State Food and Drug Administration. This Standard shall be under the jurisdiction of the Standardization Technical Committee of National Medical Clinical Test Laboratory and in Vitro Diagnostic System (SAC/TC 136). Drafting organizations of this Standard. National Institutes for Food and Drug Control. Main drafters of this Standard. Huang Jie, Qu Shoufang, and Gao Shangxian. Rubella IgG / IgM antibody detection kit

1 Scope

This Standard specifies the requirements, test methods, marking, labeling, instructions manual, packaging, transportation, and storage of rubella IgG / IgM antibody detection kit (hereinafter referred to as "reagents (kit)"). This Standard applies to the qualitative detection of rubella IgG / IgM antibody in human serum/plasma detection kit (enzyme-linked immunosorbent assay method), rubella IgG / IgM antibody detection kit (chemiluminescence method), rubella IgG / IgM antibody detection kit (immunofluorescence method), rubella IgG / IgM antibody detection kit (Immunoblotting method), etc.

2 Normative references

The provisions in following documents become the provisions of this Standard through reference in this Standard. For dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this Standard. YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1.General requirements

3 Requirements

3.1 Technical requirements for rubella IgG antibody detection kit 3.1.1 Appearance Appearance shall meet the following conditions. 3.1.3 Specificity (negative coincidence rate) USE rubella IgG antibody detection reagents to test national negative reference materials or standardized negative reference materials. The results shall meet the requirements. 3.1.4 Repeatability (precision) 3.1.4.1 USE rubella IgG antibody detection reagents to test repeatability reference materials. The coefficient of variation (CV) of within-batch precision shall not exceed 15.0%. 3.2 Technical requirements for rubella IgM antibody detection kit 3.2.1 Appearance Appearance shall meet the following conditions. 3.2.4 Repeatability (precision) 3.2.4.1 USE rubella IgM antibody detection reagents to test repeatability reference materials, the coefficient of variation (CV) of within-batch precision shall not exceed 15.0%. 3.2.5 Detection limit USE rubella IgM antibody detection reagents to test national reference materials of minimum detection limit OR standardized reference materials of minimum detection limit. The results shall meet the requirements.

4 Test methods

4.1 Test method of rubella IgG antibody detection kit 4.1.1 Appearance INSPECT the appearance visually in natural light. The results shall meet the requirements of 3.1.1. 4.1.5 Detection limit USE national reference materials of minimum detection limit OR standardized reference materials of minimum detection limit to detect once respectively. OPERATE according to instructions. The results shall meet requirements of 3.1.5. 4.2 Test method of rubella IgM antibody detection kit 4.2.1 Appearance INSPECT the appearance visually in natural light. The results shall meet the requirements of 3.2.1. 4.2.4 Repeatability (precision) USE repeatability reference materials to detect for 10 times. OPERATE according to instructions. The results shall meet requirements of 3.2.4. 4.2.5 Detection limit USE national reference materials of minimum detection limit OR standardized reference materials of minimum detection limit to detect once respectively. OPERATE according to instructions. The results shall meet requirements of 3.2.5.

5 Marking, labeling, and instructions

5.1 Marking and labeling of reagents’ (kit) outer packing It shall include at least the following contents. 5.2 Marking and labeling of reagents’ (kit) each component’s packing It shall include at least the following contents. 5.3 Instructions manual of reagents (kit) It shall include at least the following contents.

6 Packaging, transportation, and storage

6.1 Packaging Pictorial markings for packaging, transportation, and storage shall comply with the specifications of YY/T 0466.1.Reagents (kit) shall be packaged according to the requirements of manufacturer. 6.2 Transportation Reagents (kit) shall be transported according to the requirements of manufacturer. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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