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鲎试剂的比较及其与美国药典热原检查法的相关性

Comparison of limulus amebocyte lysates and correlation with the United States Pharmacopeial pyrogen test.

作者信息

Wachtel R E, Tsuji K

出版信息

Appl Environ Microbiol. 1977 Jun;33(6):1265-9. doi: 10.1128/aem.33.6.1265-1269.1977.

DOI:10.1128/aem.33.6.1265-1269.1977
PMID:327936
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC170868/
Abstract

Six limulus amebocyte lysate (LAL) preparations obtained from five different suppliers were evaluated for sensitivity, dependability, cost, convenience of use, and correlation with the United States Pharmacopeial (USP) rabbit pyrogen test method. Endotoxins from various gram-negative microorganisms were used for the evaluation. Major differences among the LAL preparations lie in the area of sensitivity. Differences, up to 100-fold, exist in the sensitivity of the various LAL preparations to the same endotoxin. The LAL tests in general were 3 to 300 times more sensitive than was the USP rabbit pyrogen test method. The LAL and the USP rabbit pyrogen test data correlated well when the endotoxin in a relatively pure and undegraded form was examined. However, large discrepancies in correlation were found when partially degraded endotoxins were compared. One LAL preparation responded to both intact and degraded endotoxin, whereas others responded only to intact endotoxin; the latter closely correlated with the febrile response of the rabbit. Therefore, proper selection of an LAL preparation is important for its application in clinical, pharmaceutical, public health, and environmental areas.

摘要

对从五个不同供应商处获得的六种鲎试剂(LAL)制剂进行了评估,评估内容包括灵敏度、可靠性、成本、使用便利性以及与美国药典(USP)家兔热原试验方法的相关性。使用来自各种革兰氏阴性微生物的内毒素进行评估。LAL制剂之间的主要差异在于灵敏度方面。不同的LAL制剂对同一种内毒素的灵敏度差异高达100倍。一般来说,LAL试验的灵敏度比USP家兔热原试验方法高3至300倍。当检测相对纯净且未降解形式的内毒素时,LAL和USP家兔热原试验数据相关性良好。然而,当比较部分降解的内毒素时,发现相关性存在很大差异。一种LAL制剂对完整和降解的内毒素均有反应,而其他制剂仅对完整内毒素有反应;后者与家兔的发热反应密切相关。因此,正确选择LAL制剂对于其在临床、制药、公共卫生和环境领域的应用很重要。

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本文引用的文献

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Quantitative comparison of in vitro and in vivo methods for the detection of endotoxin.检测内毒素的体外和体内方法的定量比较。
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