GB/T 41699-2022 in English

VALID

Detection of mycoplasma contamination in veterinary biological product

Issued on:2022-10-12
Implemented on:2023-05-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $220.00
$214.00

Standard No:	GB/T 41699-2022
Document status:	VALID
Title in English:	Detection of mycoplasma contamination in veterinary biological product
Title in Chinese:	兽用生物制品外源支原体检验方法
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2022-10-12
Implemented on:	2023-05-01
ICS Classification:	11.220-Veterinary medicine
Chinese Classification:	B41-Animal quarantine, veterinary and epidemic prevention
Professional Classification:	GB-National Standard
Related Topics:	preparation method Cytoplasma Mycoplasma beast universal primer Mycoplasma Exogenous universal primer Primarch in vitro release method Veterinary biological products How to use mycoplasma detection Mycoplasma detection method wild-type mycoplasma Mycoplasma culture How to detect mycoplasma Mycoplasma culture Mycoplasma Mycoplasma detection in vitro biotinylation Test method for detection of mycoplasma Mycoplasma method In vitro material GBT41699 GB/T 41699-2022 Detect protoplast viability Mycoplasma PCR primers Biological product stock solution retest period Prokaryotic microorganism Mycoplasma What are the methods for preparing microbial protoplasts? Principle of protoplast fusion method Methods to detect the activity of protoplasts Principles of biophysical detection methods Pharmacopoeia Mycoplasma Detection Methods Specimen source Blood test method Biochemical method Protoplast fusion methods and principles Laboratory conditions for pharmacopoeial methods for mycoplasma testing Pharmacopoeia Mycoplasma Detection Methods Protoplast fusion method Mycoplasma culture methods Mycoplasma Pharmacopoeia Detection Methods Update on veterinary drug testing methods Pharmacopeial Methods Mycoplasma Mycoplasma canis testing Mycoplasma Detection Methods Pharmacopoeia Methods for isolating protozoa Infrared liquid cell sample preparation method Protoplast purification method Methods and principles of protoplast fusion Mycoplasma testing industry Mycoplasma Rapid Test Methodology Validation Pharmacopoeia Methods for isolating leaf protoplasts Mycoplasma drug resistance detection method Protoplast isolation method Principle of protoplast fusion method Mycoplasma cell detection test method Protoplast activity detection method Protoplast mutagenesis method Pharmacopoeial methods for mycoplasma detection Pyrogen detection methods for biological products Methods to test protoplast activity Protoplast fusion method Plant exosome verification method How to isolate protoplasts Methods and principles of protoplast fusion Protoplast preparation method using bacteria Schematic diagram of microbiological testing method Biological methods for mediating protoplast fusion Disadvantages of the Microbial Protoplast Fusion Method

《GB/T 41699-2022兽用生物制品外源支原体检验方法》由TC374（全国质量监管重点产品检验方法标准化技术委员会）归口，主管部门为国家标准化管理委员会。

Introduction

Interpretation of the core content of the standard

Main instruments: Biological safety cabinet, PCR amplification instrument, CO2 incubator

Comparative analysis of test methods

Comparison dimensions	PCR detection method	Culture method
Detection cycle	24-48 hours	14-21 days
Sensitivity	10-100 copies/μL	10^3-10^4 CFU/mL
Scope of application	All types of samples	Special requirements for live vaccines
False positive rate	<2%	1-5%

Technology evolution analysis

This standard combines the progress of molecular biology to make three major innovations:

New Multiple PCR primer system, covering 99% of known mycoplasma species
Improved culture medium components, shortening the culture cycle by 40%
Establish a double verification mechanism and stipulate for the first time the joint judgment rules of PCR/culture method

Key operation points

DNA extraction stage

Phenol-chloroform extraction should be strictly controlled under 2-8℃ environment
For nucleic acid precipitation, -20℃ pre-cooled isopropanol should be used
After DNA is dissolved, 260/280nm purity test is required

Implementation suggestion module

Quality control system construction suggestion

Demonstration case: After a company transformed its testing process, the false negative rate dropped from 6.8% to 0.5%

Introducing an automated nucleic acid extractor to reduce human errors
Establishing a double-blind review mechanism to prevent and control cross contamination
Quarterly SPIKE sample verification system reliability

Verification index reference value

Quality control items	Acceptance criteria	Monitoring frequency
Internal standard gene amplification	Ct≤32	Every experiment
Culture medium color stability	ΔpH≤0.2/24h	Culture medium batch verification

More samples: NB/T 47013.2-2015 GB 50021-2001(2009) GB 18306-2015

Sample only — not a preview of GB/T 41699-2022

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