Atiqah Ab Aziz, Sahrinanah Mappiare, Hui Yin Nam, Durga Devi, Mohd Rafie Johan, Tunku Kamarul
{"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":"<p><p>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 <i>r</i> <sup>2</sup> ≥ 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.</p>","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}
引用次数: 0
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 r2 ≥ 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.
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.