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YY/T 1225-2014: Diagnostic kit for detection of anti-mycoplasma pneumoniae
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1225-2014 | English | 259 |
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Diagnostic kit for detection of anti-mycoplasma pneumoniae
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YY/T 1225-2014
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Basic data | Standard ID | YY/T 1225-2014 (YY/T1225-2014) | | Description (Translated English) | Diagnostic kit for detection of anti-mycoplasma pneumoniae | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 11,129 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Quoted Standard | GB/T 191 | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to colloidal gold, enzyme-linked immunosorbent assay statutory human serum, plasma and whole blood in Mycoplasma pneumoniae IgG, IgM antibody detection kit. This Standard specifies the Mycoplasma pneumoniae antibody detection kit pro | YY/T 1225-2014: Diagnostic kit for detection of anti-mycoplasma pneumoniae---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Diagnostic kit for detection of anti-mycoplasma pneumoniae
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Mycoplasma pneumoniae antibody detection kit
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this document may involve patents. Distribution of this document
Institutions do not assume the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Chinese Academy of Food and Drug test.
The main drafters of this standard. Wang Yumei, Liu Yan, Zhangchun Tao, noble first.
Mycoplasma pneumoniae antibody detection kit
1 Scope
This standard specifies the Mycoplasma pneumoniae antibody detection kit product classifications, requirements, test methods, inspection rules, marking, labeling, package
Loading, transport and storage.
This standard applies to colloidal gold, enzyme-linked immunosorbent assay statutory human serum, plasma and whole blood Mycoplasma pneumoniae IgG, IgM antibody
The test kit.
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.
GB/T 191 Packaging - Pictorial signs
Category 3
According to the principle of the method can be divided into different colloidal gold, enzyme-linked immunosorbent assay and the like.
4 Requirements
4.1 Physical examination
4.1.1 Appearance
Shall comply with the requirements specified by the manufacturer.
4.1.2 liquid migration speed (only colloidal gold chromatography)
Shall comply with the requirements specified by the manufacturer.
4.1.3 film strip width (only colloidal gold chromatography)
Shall comply with the requirements specified by the manufacturer.
4.2 specificity (negative reference product compliance rate)
Negative reference materials for detecting Mycoplasma pneumoniae antibody test result should be negative.
4.3 accuracy (positive reference product compliance rate)
Mycoplasma pneumoniae (including strong, medium and weak positive) reference materials, and the results should be all positive.
4.4 The minimum detection limit
In certain minimum detectable concentration limit of reference materials for testing, the result should be positive for the reference product concentration should not exceed 1.64 (complement knot
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