YY/T 1422-2016 English PDF

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YY/T 1422-2016: Pregnancy-associated plasma protein A(PAPP-A)in serum test reagent(quantitative labelling immunoassay)
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1422-2016	159	Add to Cart	3 days	Pregnancy-associated plasma protein A(PAPP-A)in serum test reagent(quantitative labelling immunoassay)	Valid

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Basic data

Standard ID: YY/T 1422-2016 (YY/T1422-2016)
Description (Translated English): Pregnancy-associated plasma protein A(PAPP-A)in serum test reagent(quantitative labelling immunoassay)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Word Count Estimation: 8,838
Date of Issue: 2016-07-29
Date of Implementation: 2017-06-01
Quoted Standard: GB/T 191; GB/T 21415-2008; YY/T 0466.1
Regulation (derived from): State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the requirements, test methods and labeling, labeling, instruction manual, packaging, transportation and storage of serum pregnancy-related plasma protein A test kit (quantitative labeling immunoassay). This standard applies to the serum pregnancy-related plasma protein A quantitative detection reagent (box) (quantitative labeling immunoassay) [hereinafter referred to as PAPP-A reagent (box)]. Quantitative labeling immunoassays include enzyme-linked immunosorbent assay (ELISA), time-resolved fluorescence immunoassay, (electro) chemiluminescence, and so on. This standard does not apply to: a) various types of colloidal gold marking test paper; b) radioactive isotopes such as ^ 125I labeled various types of radioimmunoassay or immunoassay kits.

YY/T 1422-2016: Pregnancy-associated plasma protein A(PAPP-A)in serum test reagent(quantitative labelling immunoassay)

---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.
Pregnancy-associated plasma protein A (PAPP-A) in serum test reagent (quantitative labeling experiment immunoassay) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Serum pregnancy-related plasma protein A detection reagent (box) (Quantitative labeling immunoassay) Pregnancy-associatedplasmaproteinA (PAPP-A) inserumtestreagent 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued

Foreword

This standard is 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. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized. The drafting of this standard. Beijing Medical Device Testing Institute, Zhengzhou Antu Biological Engineering Co., Ltd., Beijing Yuande Biomedical Cheng Co., Ltd., Suzhou Xinbo Biotechnology Co., Ltd. The main drafters of this standard. Wang Ruixia, Shi Xiaoqin, Tang Lei, Tu Xianju. Serum pregnancy-related plasma protein A detection reagent (box) (Quantitative labeling immunoassay)

1 Scope

This standard specifies the requirements for serum pregnancy-related plasma protein A detection reagents (cartridges) (quantitative labeling immunoassay), test methods and Identification, labeling, instruction manual, packaging, transportation and storage. This standard applies to the serum pregnancy-related plasma protein A quantitative detection reagent (box) (quantitative labeling immunoassay) [hereinafter referred to as PAPP-A reagent (box)]. Quantitative labeling immunoassays include enzyme-linked immunosorbent assay (ELISA), time-resolved fluoroimmunoassay, (Electric) chemiluminescence and so on. This standard does not apply to. a) various types of colloidal gold marking test paper; b) Various radioimmunoassay or immunoassay kits labeled with radioisotope such as 125I.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 191 packaging and storage icon GB/T 21415-2008 In Vitro Diagnostic Medical Devices Quantitative Measurement of Biological Samples Metering of Calibration and Control Substance The origin of traceability YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements

3 request

3.1 appearance Should be based on the characteristics of the product packaging to specify the appropriate appearance requirements. Generally should be the composition of the components of the kit, traits; inside and outside packaging, labels Clear and so on. a) kit should be complete components, both inside and outside the packaging should be complete, clear label; b) liquid reagents no leakage, freeze-dried components were loose body, after the liquid solution evenly (no visible particles, no precipitation). 3.2 traceability The source, assignment process and measurement of the PAPP-A calibrator used in accordance with GB/T 21415-2008 and the relevant regulations shall be provided And so on. 3.3 Accuracy Accuracy should meet one of the following requirements. a) test with a reference material (CRM) or other recognized reference material that can be used to evaluate the conventional method as a sample. The relative deviation of the results should not exceed ± 10%; ......

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