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YY/T 1588-2018 English PDF

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YY/T 1588-2018: Procalcitonin testing kit
Status: Valid
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Basic data

Standard ID YY/T 1588-2018 (YY/T1588-2018)
Description (Translated English) Procalcitonin testing kit
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 7,755
Date of Issue 2018-02-24
Date of Implementation 2019-03-01
Quoted Standard GB/T 191; GB/T 21415; GB/T 29791.2
Regulation (derived from) China Food and Drug Administration announced No. 27 of 2018
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the requirements for the procalcitonin assay kit, test methods and labeling, labeling and instruction manuals, packaging, transportation and storage. This standard applies to a kit for quantitative detection of procalcitonin in serum or plasma samples based on the principle of antigen-antibody reaction (hereinafter referred to as "kit"). This standard does not apply to immunochromatography.

YY/T 1588-2018: Procalcitonin testing kit

---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.
Procalcitonin testing kit ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Procalcitonin assay kit Published by.2018-02-24 2019-03-01 Implementation The State Food and Drug Administration issued

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. Publication of this document The agency does not assume responsibility for identifying these patents. This standard is proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the National Medical Laboratory Laboratory and the In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136). This standard was drafted by. Beijing Institute of Medical Device Testing, Thermo Fisher (Shanghai) Instrument Co., Ltd., and Ningbo Meikang Biotech Co., Ltd. Co., Ltd., Hangzhou Zhonghan Shengtai Biotechnology Co., Ltd., Zhengzhou Antu Biological Engineering Co., Ltd. The main drafters of this standard. Dai Leiying, Shen Ping, Zou Bingde, Hong Longbin, Zhang Lihong. Procalcitonin assay kit

1 Scope

This standard stipulates the requirements, test methods and labels, labels and instructions for use of the procalcitonin assay kit, packaging, transportation, and storage. Etc. This standard applies to a kit for the quantitative detection of serum or plasma samples of procalcitonin based on the principle of antigen-antibody reaction (follow- Called "kit"). This standard does not apply to immunochromatography.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB/T 191 packaging, storage and transportation logo GB/T 21415 In Vitro Diagnostic Medical Devices Biological Samples Measurements Calibrator and Controlled Material Assignment Measurements Source GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labels) Part 2. In vitro diagnostic reagents for professional use

3 requirements

3.1 Appearance The components of the kit should be complete and complete, with no liquid leakage. 3.2 Traceability According to GB/T 21415 and related regulations, the source, assignment process, and measurement uncertainty of the used Calcitonin Calibrator should be provided. content. 3.3 Detection limit Manufacturers should provide the detection limit of the kit. The detection limit is not more than 0.2ng/mL. 3.4 Accuracy Accuracy should meet one of the following requirements. a) Relative Deviation. Certified Reference Material (CRM) or other recognized reference material that can be used to evaluate conventional methods as a sample The relative deviation of the measurement results should not exceed ±15%. b) Recovery test. The known concentration of procalcitonin is added to the serum matrix or other body fluid components. The recovery rate should be [85%, 115%]. 3.5 Linear The manufacturer shall specify the linear range of the kit and meet the following requirements.

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