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GB/T 33411-2025 English PDF

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Upon your order, we will start to translate GB/T 33411-2025_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

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Q: Should I purchase the latest version GB/T 33411-2025?

Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 33411-2025 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.

US$219.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 33411-2025: Guidelines for enzyme immunoassays kit
Status: Valid

GB/T 33411: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 33411-2025	219	Add to Cart	3 days	Guidelines for enzyme immunoassays kit	Valid
GB/T 33411-2016	119	Add to Cart	2 days	Guidelines for enzyme immunoassays kit	Valid

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Basic data

Standard ID: GB/T 33411-2025 (GB/T33411-2025)
Description (Translated English): Guidelines for enzyme immunoassays kit
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: A40
Classification of International Standard: 07.080
Word Count Estimation: 10,183
Date of Issue: 2025-04-25
Date of Implementation: 2025-04-25
Older Standard (superseded by this standard): GB/T 33411-2016
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 33411-2025: Guidelines for enzyme immunoassays 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.
ICS 07.080 CCSA40 National Standard of the People's Republic of China Replaces GB/T 33411-2016 General Rules for Enzyme-Linked Immunoassay Kits Released on 2025-04-25 2025-04-25 implementation State Administration for Market Regulation The National Standardization Administration issued

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document replaces GB/T 33411-2016 "General Rules for Enzyme-Linked Immunoassay Kits". Compared with GB/T 33411-2016, except for the structure In addition to adjustments and editorial changes, the main technical changes are as follows. --- Changed the scope of application (see Chapter 1, Chapter 1 of the.2016 edition); --- Changed the requirements and test methods for detection limits (see 4.4.2 and 5.2, 2.4.1 and 3.3 of the.2016 edition); --- Deleted the requirements for limit of quantification (see 2.4.2 of the.2016 edition); --- Added specificity requirements and test methods (see 4.4.3 and 5.3); --- Added the requirements and test methods for the compliance rate of negative control products (see 4.4.5 and 5.5); --- Added the requirements and test methods for the compliance rate of positive control substances (see 4.4.6 and 5.6); --- Changed the requirements and test methods for accuracy (see 4.4.7 and 5.7, 2.6 and 3.5 of the.2016 edition); --- Changed the precision requirements and test methods (see 4.4.8 and 5.8, 2.5 and 3.4 of the.2016 edition); --- Added stability requirements and test methods (see 4.4.9 and 5.9); --- Added sample preparation (see 5.1); --- Changed the standard curve linearity test method (see 5.4, 3.2 of the.2016 edition); --- Changed the instruction manual requirements (see Chapter 6, Chapter 4 of the.2016 edition). Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document was proposed and coordinated by the National Technical Committee for Biochemical Testing Standardization (SAC/TC387). This document was drafted by. Wuxi Food Safety Inspection and Testing Center, Jiangsu Institute of Microbiology Co., Ltd., Yantai Zhigong Biotechnology Co., Ltd. Biopharmaceutical Technology Co., Ltd., Shenzhen Yirui Biotechnology Co., Ltd., and Nanjing GenScript Biotechnology Co., Ltd. The main drafters of this document are. Huang Lijun, Mi Xiaoli, Li Lidong, Dong Liumin, Hua Jiamiao, Fu Hui, Sun Zhen, Che Tuanjie, Feng Yongwei, Xue Qinghai, Wang Bingzhi, Zhou Xiaoyu, Yan Libo, Tan Xijian, and Huang Yongjian. The previous versions of this document and the documents it replaces are as follows. ---This document was first published in.2016; ---This is the first revision. General Rules for Enzyme-Linked Immunoassay Kits

1 Scope

This document specifies the general requirements, instruction manual requirements and labels for enzyme-linked immunosorbent assay kits and describes the corresponding test method. This document applies to the quality evaluation and inspection methods during the research, production and use of enzyme-linked immunosorbent assay kits.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB/T 4889-2008 Statistical processing and interpretation of data Estimation and testing of mean and variance of normal distribution GB/T 44830-2024 General rules for enzyme-linked immunosorbent assay kits

3 Terms and definitions

There are no terms or definitions that require definition in this document.

4 General requirements

4.1 Appearance The kit has a complete appearance and contains all the components; the solid phase carrier coated with antigen or antibody is transparent and dry, and is sealed; the liquid component is clear and Clear and transparent; the freeze-dried components are loose and after reconstitution, the solution is clear and free of foreign matter. 4.2 Main components of the kit The kit consists of a complete set of reagents and materials, preferably including. coated solid phase carrier, antibody, standard substance/standard sample/quality control product/control Products, enzyme conjugates, substrates, washing solutions and stop solutions, etc. 4.3 Reagents and materials 4.3.1 Solid phase carrier. adsorption performance, blank value, transparency, etc. should meet the performance requirements of the test kit. 4.3.2 Antibodies. They should have high affinity and specificity and meet the performance requirements of the kit. 4.3.3 Standard substances/standard samples. Standard substances/standard samples that have been certified by the state and granted with a standard substance/standard sample certificate, or that meet the Commercial standard solution for traceability requirements. 4.3.4 Enzyme conjugates. They should have the catalytic activity of the enzyme and the immunological activity of the antibody or antigen. Qualitative analysis should meet the performance requirements of the kit. 4.4 Performance 4.4.1 Performance indicators The performance indicators of the kit include detection limit, specificity, standard curve linearity, negative control conformity rate, positive control conformity rate, positive ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of GB/T 33411-2025_English be delivered?

Answer: Upon your order, we will start to translate GB/T 33411-2025_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of GB/T 33411-2025_English with my colleagues?

Answer: Yes. The purchased PDF of GB/T 33411-2025_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version GB/T 33411-2025?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 33411-2025 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.