GB/T 38792-2020 in English

VALID

Technical specification for cytological evaluation of protein allergenicity

Issued on:2020-04-28
Implemented on:2020-11-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $120.00
$117.00

Standard No:	GB/T 38792-2020
Document status:	VALID
Title in English:	Technical specification for cytological evaluation of protein allergenicity
Title in Chinese:	蛋白质致敏性细胞学评价技术规范
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2020-04-28
Implemented on:	2020-11-01
ICS Classification:	07.080-Biology. Botany. Zoology
Chinese Classification:	A21-Environmental Condition and General Test Method
Professional Classification:	GB-National Standard
Related Keywords:	protein allergenicity evaluation system protein allergenicity introduction analysis cytological evaluation key technical indicators technical specification
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《GB/T 38792-2020蛋白质致敏性细胞学评价技术规范》由424-cnis（中国标准化研究院）归口，主管部门为国家市场监督管理总局。

Introduction

Analysis of the core content of the standard

This standard establishes a protein allergenicity evaluation system based on the RBL-2H3 cell model, and quantifies the degree of allergenicity by measuring the β-hexosaminidase release rate. The key technical indicators include:

Evaluation dimensions	Requirements of this standard	International general method
Cell model	RBL-2H3 cell line(ATCC CRL-2256)	Human basophil KU812
Key indicators	β-hexosaminidase release rate	Histamine release
Experimental conditions	37℃/5%CO₂ incubator	37℃/5%CO₂ incubator
Results	Maximum release rate percentage	Half effective concentration (EC50)

Key technical points

1. Cell culture specifications

It is required to use MEM medium (containing 10% calf serum), the cell seeding density is 1×10⁵ cells/mL, and after 24 hours of culture and adhesion, 50μg/mL IgE needs to be activated for 24 hours.

2. Sample processing requirements

Solid samples: Plant samples need to be filtered through 450μm and then extracted with water, and animal samples need to be defatted with petroleum ether and treated with trichloroacetic acid
Liquid samples: Degrease with petroleum ether and then freeze-dry

Implementation suggestions

Laboratory configuration requirements

According to Article 4.2 of the standard, the experimental area should include:

Buffer room (≥3m², 1.5W/m² UV lamp)
Class 10,000 sterile room
Special refrigerator for cell storage (2-8℃)

Key points for quality control

The experiment needs to be set up:

Sample group (3 replicate wells)
Full release group (cell lysate control)
Blank control group (Tyrode's solution)

Technology evolution analysis

Compared with traditional animal experiments, this standard has the following advantages:

Higher sensitivity: can detect ng-level allergenic proteins
Better repeatability: CV value is controlled within 15%
Faster speed: evaluation completed within 72 hours

Application case

A dairy company used this standard to evaluate the allergenicity of whey protein and measured the release rate of β-hexosaminidase to be 62.35%, which was significantly higher than the international warning value (30%). The production process parameters were adjusted accordingly.

More samples: DL/T 368-2010 NB/T 47013.2-2015 DL/T 5154-2012

Sample only — not a preview of GB/T 38792-2020

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