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YY/T 1667-2020: Chlamydia pneumonia IgG antibody detection kit(ELISA)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1667-2020 | English | 119 |
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Chlamydia pneumonia IgG antibody detection kit(ELISA)
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YY/T 1667-2020
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Basic data | Standard ID | YY/T 1667-2020 (YY/T1667-2020) | | Description (Translated English) | Chlamydia pneumonia IgG antibody detection kit(ELISA) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 6,651 | | Date of Issue | 2020 | | Date of Implementation | 2021-04-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements, test methods, labels and instructions for use, as well as packaging, transportation and storage of Chlamydia pneumoniae IgG antibody detection kits (enzyme-linked immunosorbent assay). This standard applies to the detection kit for the qualitative detection of Chlamydia pneumoniae IgG antibodies in human serum or plasma by enzyme-linked immunosorbent assay. | YY/T 1667-2020: Chlamydia pneumonia IgG antibody detection kit(ELISA)---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.
Chlamydia pneumonia IgG antibody detection kit(ELISA)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Chlamydia pneumoniae IgG antibody detection kit
(Enzyme-linked immunosorbent assay)
2020-03-31 released
Implementation on 2021-04-01
Issued by the State Drug Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that certain contents of this document may involve patents. Publication of this document
The agency is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
Drafting organization of this standard. China Food and Drug Control Research Institute.
The main drafters of this standard. Liu Yan, Zhou Haiwei, Shen Shu, Zhang Chuntao.
Chlamydia pneumoniae IgG antibody detection kit
(Enzyme-linked immunosorbent assay)
1 Scope
This standard specifies the requirements, test methods, labeling and use of the Chlamydia pneumoniae IgG antibody detection kit (enzyme-linked immunosorbent assay)
Instructions and packaging, transportation and storage.
This standard applies to the qualitative detection of Chlamydia pneumoniae IgG antibodies in human serum or plasma using enzyme-linked immunosorbent assay.
Kit.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 191 Packaging, Storage and Transportation Graphic Mark
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents
3 requirements
3.1 Appearance
Manufacturers should specify appropriate appearance requirements based on the packaging characteristics of their products. Generally, there should be completeness and completeness of each component of the kit
Sex, trait requirements, etc.
3.2 Compliance rate of positive reference products
Use the Chlamydia pneumoniae IgG antibody test kit to test the national positive reference product or the standardized positive reference product, and the results should match
Meet the requirements of the corresponding reference products.
3.3 Compliance rate of negative reference products
Use the Chlamydia pneumoniae IgG antibody test kit to test the national negative reference product or the standardized negative reference product, and the results should match
Meet the requirements of the corresponding reference products.
3.4 The lowest detection limit
Use the Chlamydia pneumoniae IgG antibody detection kit to test the national minimum detection limit reference product or the standardized minimum detection limit reference product
The test results should meet the requirements of the corresponding reference products.
3.5 Repeatability
Use the Chlamydia pneumoniae IgG antibody test kit to test the national repetitive reference product or the standardized repetitive reference product, the result
All should be positive, and the coefficient of variation of the signal value or the calculated value should not be higher than 10.0%.
3.6 Inter-assay precision
Use the Chlamydia pneumoniae IgG antibody test kit to test the national repetitive reference product or the standardized repetitive reference product, the result
All should be positive, and the coefficient of variation of the signal value or calculated value should not be higher than 15.0%.
3.7 Stability
The validity period stability and thermal stability can be verified.
3.7.1 Stability of validity period
The manufacturer shall stipulate the validity period of the product. Take the test kit within a certain period of time after the validity
The test product compliance rate, minimum detection limit, repeatability, and the test results should meet the requirements of 3.2, 3.3, 3.4, and 3.5.
3.7.2 Thermal stability
Place the kit at 37°C for a certain period of time to detect the compliance rate of positive reference products, the compliance rate of negative reference products, the lowest detection limit,
Repeatability, the test results should meet the requirements of 3.2, 3.3, 3.4, 3.5.
Note 1.Thermal stability cannot be used to derive the expiry date of the product, unless it is a derivation formula based on a large amount of stability research data.
Note 2.Generally, when the validity period is 1 year, choose products that do not exceed 1 month, when the validity period is half a year, choose products that do not exceed half a month, and so on. But Ruchao
After the specified time, the product is acceptable if it meets the requirements.
Note 3.According to the product characteristics, the validity period stability or thermal stability can be selected for verification, but the selected method should be able to verify the stability of the product to ensure the validity period
Product performance meets standard requirements.
4 Test method
4.1 Appearance
Visual inspection with normal vision or corrected vision under natural light should meet the requirements of 3.1.
4.2 Compliance rate of positive reference products
Use national positive reference materials or standardized positive reference materials for testing, and operate according to the product manual. The result should meet 3.2
Claim.
4.3 Compliance rate of negative reference products
Use the national negative reference product or the standardized negative reference product for testing, and operate according to the product manual. The result should meet 3.3
Claim.
4.4 Lowest detection limit
Use the national minimum detection limit reference product or the standardized minimum detection limit reference product for testing, operate according to the product manual, and the result should be
Meet the requirements of 3.4.
4.5 Repeatability
Use the same batch number kit to test the national repetitive reference product or the standardized repetitive reference product, repeat the measurement 10 times, and calculate 10 measurements
Determine the result signal value or result calculation value average (X) and standard deviation (s), calculate the coefficient of variation (CV) according to formula (1), and the result should meet 3.5
Claim.
4.6 Precision between batches
Use three batch numbers of kits to test national repetitive reference products or standardized repetitive reference products, and repeat the measurement 10 times for each batch number.
Calculate the average (X) and standard deviation (s) of the signal value or the calculated value of the result of 30 determinations, and calculate the coefficient of variation (CV) according to formula (1), and the result
Should meet the requirements of 3.6.
4.7 Stability
The following methods can be used for verification.
4.7.1 Stability of validity period
Take the kit for a certain period of time after the expiration date, operate according to the instructions, and test according to 3.2, 3.3, 3.4, 3.5, and the test results should meet
3.7.1 requirements.
4.7.2 Thermal stability
Place the kit at 37°C for a certain period of time, operate according to the instructions, and test according to 3.2, 3.3, 3.4, 3.5, and test results
Should meet the requirements of 3.7.2.
5 Labels and instructions for use
Should meet the requirements of GB/T 29791.2.
6 Packaging, transportation and storage
6.1 Packaging
The packaging, storage and transportation pictorial signs should meet the requirements of GB/T 191.The packaging container should ensure good airtightness, integrity, no leakage and no damage.
6.2 Transportation
The kit should be transported as required by the manufacturer. During transportation, it should be moisture-proof, heavy objects should be prevented from being piled up, and direct sunlight, rain and snow should be avoided
Dip to prevent contact with acid and alkali substances and prevent damage to the inner and outer packaging.
6.3 Storage
The kit should be stored under the conditions specified by the manufacturer.
references
[1] Medical device instructions and label management regulations, State Food and Drug Administration Order (No. 6),.2014.7.30
[2] Announcement on the issuance of guidelines for the preparation of instructions for in vitro diagnostic reagents, the State Food and Drug Administration (2014)
Year 17)
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