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无甲基酸 (GAF) 组织学固定剂是甲素的合适替代品:来自开放性比较非劣势性研究的结果

Ales Ryska¹, Anna Sapino^2,3, Stefania Landolfi⁴

¹The Fingerland Department of Pathology, Charles University and Faculty Hospital, Hradec Kralove, Czech Republic.

Virchows Archiv : an international journal of pathology

|November 23, 2023

概括

无甘酸 (GAF) 固定剂提供与传统甲 (酸缓冲甲) 相比的组织保存和诊断价值. 这种创新的,无毒的替代品在医学诊断的组织样本固定方面显示出非劣势性.

科学领域:

组织病理学组织病理学
毒理学毒理学毒理学
医学诊断医学诊断医学诊断

背景情况:

甲溶液的形式素是组织学固定的长期标准,但存在毒性风险,包括致癌性.
欧盟等监管机构已经考虑禁止甲素,因为它具有危险的特性.
需要更安全,更有效的替代品用于用于诊断目的的组织固定.

研究的目的:

为了评估一种创新的无谷氨酸酸 (GAF) 固定剂的疗效.
在形态保存和诊断价值方面,将GAF固定剂与标准酸盐缓冲甲 (PBF) 进行比较.
为了确定GAF是否在组织学样本固定方面不低于PBF.

主要方法:

进行了一项开放的,非劣势的多中心试验.
用GAF或PBF固定组织样本.
形态保存和诊断价值由中央和地方病理学审查员使用二进制分数问题进行评估.

主要成果:

对于GAF和PBF的平均分数是可比的,中央和地方审查者之间略有差异.
两个固定剂的中位数得分始终高 (4.0),表明保存良好.
在所有测试的器官中,GAF表现为不低于PBF.

结论:

与酸缓冲甲素 (PBF) 相比,无酸甲素 (GAF) 固定剂提供相当的结构保存和诊断价值.
GAF是甲素的安全有效替代品,无毒性和致癌性问题.
该研究根据体外诊断医疗器械的国际标准验证了GAF的性能.

关键词:

固定方式固定方式在形式上,在形式上没有谷氨酸酸 (GAF),试验.

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