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YY/T 1451-2016: B-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide test reagent (quantitative labelling immunoassay)
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B-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide test reagent (quantitative labelling immunoassay)
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YY/T 1451-2016
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Basic data | Standard ID | YY/T 1451-2016 (YY/T1451-2016) | | Description (Translated English) | B-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide test reagent (quantitative labelling immunoassay) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 10,120 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Quoted Standard | GB/T 191; GB/T 21415-2008; YY/T 0466.1 | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the requirements, test methods, labeling, labeling, instructions, packaging, transport and storage of brain natriuretic peptide and amino-terminal brain natriuretic peptide test reagents (cartridges) (quantitative labeling immunoassay). This standard is applicable to reagents (cassettes) for quantitatively detecting amino-terminal brain natriuretic peptides (hereinafter referred to as "BNP reagent (box)") for quantitative detection of brain natriuretic peptides [hereinafter Referred to as "NT-proBNP detection reagent (box)" "]. This standard does not apply to: a) various types of colloidal gold marking test paper; b) with 1251 and other radioisotopes labeled various types of radioimmunoassay or immunoassay kit. | YY/T 1451-2016: B-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide test reagent (quantitative labelling immunoassay)
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B-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide test reagent (quantitative labeling experiment immunoassay)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Brain natriuretic peptide and amino - terminal brain natriuretic peptide
Reagent (box) (quantitative labeling immunoassay)
testreagent (quantitativelabelingimmunoassay)
2016-01-26 release
2017-01-01 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, China Food and Drug Administration Research Institute of Medical Devices, Johnson & Johnson (Shanghai)
Medical Equipment Co., Ltd., Hangzhou Zhongsheng Shengtai Biotechnology Co., Ltd., Roche Diagnostic Products (Shanghai) Co., Ltd.
The main drafters of this standard. Wang Ruixia, Wang Yumei, Zhuo Xiaofang, Zhou Xuyi, Mu Shiyu.
Introduction
Natriuretic peptide (natriureticpeptide, NP) is nearly 20 years to find a class of sodium, diuretic endogenous peptide, to the head
So far, humans have found five kinds of natriuretic peptides, namely atrial natriuretic peptide (ANP), B-type natriuretic peptide (B-type
natriuretic peptide, BNP), C-typenatriuretic peptide (CNP), V-type natriuretic peptide (ventriclelnatri-
ureticpeptide, VNP) and D-type natriuretic peptide (VNP). Japanese scholar TetsujiSudoh
And so on in 1988 from the brain brain isolated BNP, which also known as brain natriuretic peptide (brainnatriureticpeptide, BNP), in fact
Mainly from the heart.
BNP is a good indicator of cardiac function, it is the diagnosis of chronic congestive heart failure (heart failure) with a high degree of sensitivity,
Specificity, in.2001 has been included in the European Heart Association's latest guidelines for heart failure. BNP is mainly synthesized by the ventricles, initially
Was synthesized into a prepro-BNP containing 134 amino acids, and then the N-terminal 26-amino acid signal peptide was cleaved to contain 108 amino acids
proBNP, which was further cleaved by endopeptidase to form NT-proBNP containing 76 amino acids at the N-terminus and 32 amino acids with C-terminal
BNP, released into the blood. As NT-proBNP and BNP are equimolar release, so the two in the diagnosis of cardiovascular disease, treatment
Measurement and prognosis has a similar clinical application.
BNP translation of the current on the lot, the literature is not the same. In 1989, there are scholars in China will be translated as "brain sodium
And "B-type natriuretic peptide", "B-type natriuretic peptide", "B-type natriuretic peptide", "B-type natriuretic peptide", "B-type natriuretic peptide"
Natriuretic peptide "," type B urinary sodium excretion peptide "and" B sodium natriuretic peptide. "The same substance using a large number of translation to the clinical application of a lot of confusion
And inconvenience, the urgent need for the early translation of its Chinese standard uniform. In this standard, BNP (B-typenatriureticpeptide or
Brainnatriureticpeptide) B-type natriuretic peptide or brain natriuretic peptide, NT-proBNP (N-terminalpro-B-typenatriuretic
peptide or Amino-terminalpro-B-typenatriuretic peptide/Brainnatriureticpeptide)
Natriuretic peptide precursor or N-terminal brain natriuretic peptide precursor.
Brain natriuretic peptide and amino - terminal brain natriuretic peptide
Reagent (box) (quantitative labeling immunoassay)
1 Scope
This standard specifies the requirements for brain natriuretic peptide and amino-terminal brain natriuretic peptide precursor test kit (quantitative labeling immunoassay)
Inspection method, identification, labeling, instruction manual, packaging, transportation and storage.
This standard is applicable to reagents (cassettes) for the quantitative detection of brain natriuretic peptide (hereinafter referred to as "BNP reagent (box)"),
(Hereinafter referred to as "NT-proBNP detection reagent (cassette)") for quantitative detection of sodium peptidoglysin.
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, inner and outer packaging, labels
And so on.
a) kit components should be complete, 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
Should be based on GB/T 21415-2008 and the relevant provisions of the use of BNP, NT-proBNP calibrator source, the assignment process and
Measurement uncertainty and so on.
3.3 Accuracy
Accuracy should meet one of the following requirements.
a) Relative deviation.
A test reference substance (CRM) or other recognized reference substance that can be used to evaluate a conventional method is used as a sample for its measurement
The relative deviation of the results should not exceed ± 10%.
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