利用优化的发色性灰质卵母细胞裂解物测定法检测磁共振成像对比剂中的内毒素

IF 1.1 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Malaysian Journal of Medical Sciences Pub Date : 2024-10-01 Epub Date: 2024-10-08 DOI:10.21315/mjms2024.31.5.20

Atiqah Ab Aziz, Sahrinanah Mappiare, Hui Yin Nam, Durga Devi, Mohd Rafie Johan, Tunku Kamarul

{"title":"利用优化的发色性灰质卵母细胞裂解物测定法检测磁共振成像对比剂中的内毒素","authors":"Atiqah Ab Aziz, Sahrinanah Mappiare, Hui Yin Nam, Durga Devi, Mohd Rafie Johan, Tunku Kamarul","doi":"10.21315/mjms2024.31.5.20","DOIUrl":null,"url":null,"abstract":"Endotoxin contamination in magnetic resonance imaging (MRI) contrast agents can pose a risk to patient safety causing immune reactions. Strict endotoxin limits are enforced for implants and catheters inserted into the body, but there are not clear rules for MRI contrast agents. Here, we investigated the efficacy of chromogenic LAL assay test for screening endotoxin activity in MRI contrast media manufactured in Malaysia. The powdered agent was dissolved in water for injection and endotoxin levels were measured. The coefficient of efficiency value for the standard curve, exhibiting r 2 ≥ 0.98, along with the absence of interfering substances and endotoxin activity below the regulatory threshold of 0.5 EU/mL, support the conclusion that the agent is unlikely to be pyrogenic or induce pyrogenic effect.","PeriodicalId":47388,"journal":{"name":"Malaysian Journal of Medical Sciences","volume":"31 5","pages":"284-291"},"PeriodicalIF":1.1000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11477474/pdf/","citationCount":"0","resultStr":"{\"title\":\"Endotoxin Detection in Magnetic Resonance Imaging Contrast Agent Using Optimising Chromogenic Limulus Amebocyte Lysate Assay.\",\"authors\":\"Atiqah Ab Aziz, Sahrinanah Mappiare, Hui Yin Nam, Durga Devi, Mohd Rafie Johan, Tunku Kamarul\",\"doi\":\"10.21315/mjms2024.31.5.20\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Endotoxin contamination in magnetic resonance imaging (MRI) contrast agents can pose a risk to patient safety causing immune reactions. Strict endotoxin limits are enforced for implants and catheters inserted into the body, but there are not clear rules for MRI contrast agents. Here, we investigated the efficacy of chromogenic LAL assay test for screening endotoxin activity in MRI contrast media manufactured in Malaysia. The powdered agent was dissolved in water for injection and endotoxin levels were measured. The coefficient of efficiency value for the standard curve, exhibiting r 2 ≥ 0.98, along with the absence of interfering substances and endotoxin activity below the regulatory threshold of 0.5 EU/mL, support the conclusion that the agent is unlikely to be pyrogenic or induce pyrogenic effect.\",\"PeriodicalId\":47388,\"journal\":{\"name\":\"Malaysian Journal of Medical Sciences\",\"volume\":\"31 5\",\"pages\":\"284-291\"},\"PeriodicalIF\":1.1000,\"publicationDate\":\"2024-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11477474/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Malaysian Journal of Medical Sciences\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.21315/mjms2024.31.5.20\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/10/8 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q4\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Malaysian Journal of Medical Sciences","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.21315/mjms2024.31.5.20","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/8 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

摘要

磁共振成像（MRI）造影剂中的内毒素污染会对患者的安全构成风险，引起免疫反应。对植入人体的植入物和导管有严格的内毒素限制，但对磁共振成像造影剂却没有明确的规定。在此，我们研究了在马来西亚生产的核磁共振成像造影剂中使用发色性 LAL 检测试验筛查内毒素活性的有效性。将粉末状造影剂溶解在水中进行注射，然后测量内毒素含量。标准曲线的效率系数 r 2 ≥ 0.98，且不含干扰物质，内毒素活性低于 0.5 EU/mL 的监管阈值，因此可得出该制剂不太可能具有热原或诱发热原效应的结论。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

Endotoxin Detection in Magnetic Resonance Imaging Contrast Agent Using Optimising Chromogenic Limulus Amebocyte Lysate Assay.

Endotoxin contamination in magnetic resonance imaging (MRI) contrast agents can pose a risk to patient safety causing immune reactions. Strict endotoxin limits are enforced for implants and catheters inserted into the body, but there are not clear rules for MRI contrast agents. Here, we investigated the efficacy of chromogenic LAL assay test for screening endotoxin activity in MRI contrast media manufactured in Malaysia. The powdered agent was dissolved in water for injection and endotoxin levels were measured. The coefficient of efficiency value for the standard curve, exhibiting r ² ≥ 0.98, along with the absence of interfering substances and endotoxin activity below the regulatory threshold of 0.5 EU/mL, support the conclusion that the agent is unlikely to be pyrogenic or induce pyrogenic effect.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Malaysian Journal of Medical Sciences MEDICINE, RESEARCH & EXPERIMENTAL-

CiteScore

2.70

自引率

0.00%

发文量

审稿时长

9 weeks

期刊介绍： The Malaysian Journal of Medical Sciences (MJMS) is a peer-reviewed, open-access, fully online journal that is published at least six times a year. The journal’s scope encompasses all aspects of medical sciences including biomedical, allied health, clinical and social sciences. We accept high quality papers from basic to translational research especially from low & middle income countries, as classified by the United Nations & World Bank (https://datahelpdesk.worldbank.org/knowledgebase/ articles/906519), with the aim that published research will benefit back the bottom billion population from these countries. Manuscripts submitted from developed or high income countries to MJMS must contain data and information that will benefit the socio-health and bio-medical sciences of these low and middle income countries. The MJMS editorial board consists of internationally regarded clinicians and scientists from low and middle income countries.