Post-Graduation Program in Science and Biotechnology, Fluminense Federal University, Niteroi 24220-900, Brazil.
Carlos Chagas Filho Biophysics Institute, Federal University of Rio de Janeiro, Rio de Janeiro 21941-170, Brazil.
Int J Mol Sci. 2024 Jul 18;25(14):7844. doi: 10.3390/ijms25147844.
Pyrogens are fever-inducing substances routinely investigated in health products through tests such as the Rabbit Pyrogen Test (RPT), the Limulus Amebocyte Lysate (LAL), and the Monocyte Activation Test (MAT). However, the applications of the MAT for medical devices and biomaterials remain limited. This work aimed to overview the studies evaluating the pyrogenicity of medical devices and biomaterials using the MAT, highlighting its successes and potential challenges. An electronic search was performed by December 2023 in PubMed, Scopus, and Web of Science, identifying 321 records which resulted in ten selected studies. Data were extracted detailing the tested materials, MAT variants, interferences, and comparisons between methods. Methodological quality was assessed using the ToxRTool, and the results were synthesized descriptively. The selected studies investigated various materials, including polymers, metals, and natural compounds, employing the different biological matrices of the MAT. Results showed the MAT's versatility, with successful detection of pyrogens in most materials tested, though variability in sensitivity was noted based on the material and testing conditions. Challenges remain in optimizing protocols for different material properties, such as determining the best methods for direct contact versus eluate testing and addressing the incubation conditions. In conclusion, the MAT demonstrates significant potential as a pyrogen detection method for medical devices and biomaterials. However, continued research is essential to address existing gaps, optimize protocols, and validate the test across a broader range of materials.
热原是在健康产品中通过兔热原试验（RPT）、鲎试剂（LAL）和单核细胞激活试验（MAT）等测试常规研究的发热物质。然而，MAT 在医疗器械和生物材料中的应用仍然有限。本工作旨在综述使用 MAT 评估医疗器械和生物材料热原性的研究，强调其成功和潜在挑战。2023 年 12 月在 PubMed、Scopus 和 Web of Science 上进行了电子检索，共确定了 321 条记录，最终选择了 10 项研究。提取了详细说明测试材料、MAT 变体、干扰以及方法之间比较的数据。使用 ToxRTool 评估方法学质量，并进行描述性综合。所选研究调查了各种材料，包括聚合物、金属和天然化合物，采用了 MAT 的不同生物基质。结果表明 MAT 具有多功能性，能够成功检测大多数测试材料中的热原，但根据材料和测试条件，敏感性存在差异。在优化针对不同材料特性的方案方面仍存在挑战，例如确定直接接触与浸提液测试的最佳方法以及解决孵育条件。总之，MAT 作为医疗器械和生物材料的热原检测方法具有重要潜力。然而，为了弥补现有差距、优化方案并在更广泛的材料范围内验证该测试，仍需要进一步研究。
