YY/T 1236-2014Cytomegalovirus(CMV)IgG/IgM antibody detection kit (English PDF)
巨细胞病毒IgG/IgM抗体检测试剂（盒）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 1236-2014 is the English-translated version of 巨细胞病毒IgG/IgM抗体检测试剂（盒）.
YY/T 1236-2014 is the Chinese pharmaceutical industry standard for the kit that detects IgG and IgM antibody to cytomegalovirus.
It specifies the requirements, the test methods, the logos, the labels, the instruction manual and the rules for packaging, transport and storage, covering the appearance, the agreement with the reference materials for positive and negative sera, the detection limit, the specificity, the repeatability and the stability of the kit. Issued on 17 June 2014, it has applied since 1 July 2015.
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Document preview — YY/T 1236-2014
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Requirements
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
1 Scope
This standard specifies the CMV IgG/IgM antibody detection reagent (box) [hereinafter referred to as "reagent (kit)"] requirements, test methods, Logos, labels and brochures, packaging, transportation and storage.
This standard applies to the qualitative detection of human serum/plasma CMV IgG/IgM antibody detection reagent (box) (enzyme-linked immunosorbent assay), CMV IgG/IgM antibody detection reagent (box) (chemiluminescence), cytomegalovirus IgG/IgM antibody detection reagent (box) (immunity Fluorescence), cytomegalovirus IgG/IgM antibody detection reagent (box) (Western blot) and the like.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.
Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
3 Requirements
3.1 CMV IgG antibody detection reagent (box) Technical Requirements
3.1.1 Appearance
Appearance should meet the following conditions.
a) reagent (box) shall comply with the requirements specified by the manufacturer appearance;
b) reagent (box) should complete component packaging clean appearance, no leaks, no damage; signs, labels legible.
3.1.2 Accuracy (positive coincidence rate)
With cytomegalovirus IgG antibody test positive reference to national products or through standardized corporate positive reference material for testing, the results should be Meet the requirements.
3.1.3 Specificity (negative coincidence rate)
With cytomegalovirus IgG antibody test negative national standardized reference materials or by negative reference material for testing, the results should be consistent Claim.
3.1.4 Repeatability (precision)
3.1.4.1 With cytomegalovirus
IgG antibody detection reagent for detecting repetitive reference material, within run precision coefficient of variation (CV) should not At 15.0%.
NOTE: 3.1.4.1 does not apply to products immunoblotting.
3.1.4.2 With cytomegalovirus
IgG antibody test repeatability reference material for testing, the result should be a uniform color, and are positive.
3.1.5 Limit of detection
With cytomegalovirus IgG antibody detection reagent for the national minimum detection limit of the reference product or standardized by the minimum detection limit of the reference material were seized
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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.
Referenced standards
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Related Standards
YY/T 0466.1-2009 — Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY/T 0466.1-2016 — Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY/T 0466.1-2023 — Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
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