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YY/T 1785-2021: (Amino acid and carnitine detection kit (tandem mass spectrometry))
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1785-2021 | English | 259 |
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(Amino acid and carnitine detection kit (tandem mass spectrometry))
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YY/T 1785-2021
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Basic data | Standard ID | YY/T 1785-2021 (YY/T1785-2021) | | Description (Translated English) | (Amino acid and carnitine detection kit (tandem mass spectrometry)) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 12,190 | | Issuing agency(ies) | State Drug Administration | YY/T 1785-2021: (Amino acid and carnitine detection kit (tandem mass spectrometry))---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.
(Amino acid and carnitine detection kit (tandem mass spectrometry))
ICS 11.100.10
C44
People's Republic of China Pharmaceutical Industry Standard
Amino acid and carnitine detection kit (tandem mass spectrometry)
Published on 2021-09-06
2023-03-01 Implementation
Released 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 some content of this document may be patented. Publication of this document
Institutions do not assume responsibility for identifying these patents.
This standard is proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Standardization Technical Committee of Medical Clinical Laboratory and In Vitro Diagnostic System (SAC/TC136).
This standard was drafted by. China National Institute for Food and Drug Control, Shenzhen Huada Gene Co., Ltd., Guangzhou Darui Biotechnology Co., Ltd.
Co., Ltd., Beijing Huada Jibei Biotechnology Co., Ltd., Chinese People's Liberation Army General Hospital, PerkinElmer Medical Diagnostic Products (Part 1)
Hai) Co., Ltd., Guangzhou Fenghua Biological Engineering Co., Ltd., Beijing Bohui Innovation Biotechnology Co., Ltd.
The main drafters of this standard. Qu Shoufang, Yan Miaoli, Wu Yingsong, Zhang Shenyan, Tian Yaping, Jiang Kuan, Wang Qin, Lu Xiangdong, Huang Jie, Yu Ting.
Amino acid and carnitine detection kit (tandem mass spectrometry)
1 Scope
This standard specifies the requirements, test methods, labels and instructions for use, packaging,
transportation and storage, etc.
This standard applies to kits for quantitative detection of amino acids and carnitine in dried blood film samples of neonatal filter paper by tandem mass spectrometry, including
Non-derivatized and derivatized methods.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191-2008 Graphical signs of packaging, storage and transportation
GB/T 29791.2-2013 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) - Part 2.In vitro diagnostics for professional use
break reagent
3 Requirements
3.1 Appearance
The components of the kit should be complete and complete without liquid leakage.
3.2 Accuracy
The accuracy should meet one of the following requirements.
a) Using the reference material as a sample for testing, the relative deviation of the measurement results should be within the range of ±20.0%;
b) The recovery of each analyte should be between 80.0% and 120.0% or meet the requirements claimed by the manufacturer.
Note 1.For the description of the national standard products involved in this standard, please refer to Appendix A.
Note 2.See Appendix B for analytes whose recoveries should be between 80.0% and 120.0%, and Appendix A and Appendix B for analytes that meet the requirements claimed by the manufacturer.
Not listed.
3.3 Linear
Within the linear interval of each analyte claimed by the manufacturer, the linear correlation coefficient (r) of the corresponding analyte should not be less than 0.9900.
3.4 Precision
3.4.1 Intra-assay precision
The CV (%) of each analyte test result should not be greater than 20.0%.
3.4.2 Between-assay precision
The CV (%) of each analyte test result should not be greater than 25.0%.
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