Current situation and reflection on limulus amebocyte lysate and recombinant reagents for testing

doi:10.19803/j.1672-8629.20240267

Abstract

Abstract: Objective To provide support for the scientific and orderly development of endotoxin detection and the use of limulus amebocyte lysate by studying the current status of the use and management of limulus amebocyte lysate and recombinant reagents for testing. Methods The relevant historical evolution and domestic and international regulatory status of limulus amebocyte lysate for testing were sorted out, and the basic situation of the main alternative methods for endotoxin testing and the recombinant reagents used in the context of horseshoe crab resource shortage was analyzed, combined with daily medical product testing and management practices. Results and Conclusion Summarize and sort out the main problems that may be faced in the field of endotoxin testing for sterile medical products, such as raw material shortages and outdated regulatory methods. Propose suggestions for clarifying the management of limulus amebocyte lysate, conducting research on improving the quality standards and production quality management of limulus amebocyte lysate used in medical product testing, and strengthening the supervision of reagents related to alternative methods for limulus amebocyte lysate testing.

Key words: limulus amebocyte lysate, Chinese horseshoe crab, testing reagent, bacterial endotoxin test method, alternative methods, recombinant reagents, supervision, management

CLC Number:

R972.1

YANG Yuxi, PEI Yusheng, LIU Tao, GAO Hua, CAI Tong. Current situation and reflection on limulus amebocyte lysate and recombinant reagents for testing[J]. Chinese Journal of Pharmacovigilance, 2024, 21(8): 847-851.

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https://zgywjj.magtechjournal.com/EN/Y2024/V21/I8/847

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