Wadsworth Center, New York State Department of Health, Albany, New York, USA.
J Clin Microbiol. 2022 Apr 20;60(4):e0013920. doi: 10.1128/JCM.00139-20. Epub 2021 Sep 29.
Detection of botulinum neurotoxin or isolation of the toxin-producing organism is required for the laboratory confirmation of botulism in clinical specimens. In an effort to reduce animal testing required by the gold standard method of botulinum neurotoxin detection, the mouse bioassay, many technologies have been developed to detect and characterize the causative agent of botulism. Recent advancements in these technologies have led to improvements in technical performance of diagnostic assays; however, many emerging assays have not been validated for the detection of all serotypes in complex clinical and environmental matrices. Improvements to culture protocols, endopeptidase-based assays, and a variety of immunological and molecular methods have provided laboratories with a variety of testing options to evaluate and incorporate into their testing algorithms. While significant advances have been made to improve these assays, additional work is necessary to evaluate these methods in various clinical matrices and to establish standardized criteria for data analysis and interpretation.
为了在临床标本中对肉毒中毒进行实验室确认，需要检测肉毒神经毒素或分离产生毒素的生物体。为了减少肉毒神经毒素检测的金标准方法——小鼠生物测定所需的动物试验，已经开发了许多技术来检测和表征肉毒中毒的病原体。这些技术的最新进展提高了诊断检测的技术性能；然而，许多新兴检测方法尚未针对复杂临床和环境基质中所有血清型的检测进行验证。培养方案、内切蛋白酶检测以及各种免疫学和分子方法的改进为实验室提供了各种检测选择，以评估并纳入其检测算法中。虽然已经取得了重大进展来改进这些检测方法，但仍需要开展更多工作，以在各种临床基质中评估这些方法，并为数据分析和解释建立标准化标准。
