Absence of Interference on in vitro Clinical Diagnostic Assays Often Performed on Hospitalized Patients by Relmapirazin, a Fluorescent Tracer Agent for Point-of-Care Assessment of Glomerular Filtration Rate.
Aug 2026· International journal of toxicology· pp.
10915818261477667
· 0 citations· 11 references
Medicine
TL;DR
Investigation of possible interference this agent may induce with typical clinical diagnostic assays given to incoming and hospitalized patients found no interference from relmapirazin was detected in the suite of metabolic and cardiac assays evaluated.
Abstract
The FDA has recently approved a medical device which determines a glomerular filtration rate assessment at the point-of-care by transdermal detection of the fluorescent tracer agent relmapirazin. Previous in vitro and in vivo studies on this agent yielded negligible safety/toxicology concern resulting in advancement to phase I, II, and III human clinical studies. Now that clinical use is occurring, herein we investigated possible interference this agent may induce with typical clinical diagnostic assays given to incoming and hospitalized patients. The testing methodology followed the CLSI EP07-A3 Interference Testing in Clinical Chemistry guideline for determination of interference. No interference from relmapirazin was detected in the suite of metabolic and cardiac assays evaluated.
Hematic enzyme elevations during avacopan therapy were infrequent in this US cohort, yet severe DILI occurred, and findings support vigilant early monitoring and informed discussions of potential risks during ongoing regulatory reassessment.
Eric T. Roberts, Dina Dadabhoy, Ryan Antolini et al.· Arthritis & Rheumatology· 0 citations
Cefepime (CFPM)-associated neurotoxicity is linked to elevated plasma concentrations, particularly in patients with impaired renal function. Although cystatin C-based estimated glomerular filtration rate (eGFRcys) has been proposed as a potentially superior marker of renal function for dose optimization, its clin...
Kyohei Sugiyama, Tomoki Kimura, Nanaho Fukumoto et al.· Journal of Pharmaceutical He...· 0 citations
AIM
Lipoprotein(a) [Lp(a)] is an independent risk factor for cardiovascular disease (CVD); however, the goal of resolving its measurement issues remains unachieved. Expanding on the "first step" by Miida et al., this study evaluated the feasibility of harmonizing Lp(a) measurements using an IFCC endorsed mass spectrome...
Keita Yamashita, Mitsuru Wakita, Noriyasu Niizeki et al.· Journal of atherosclerosis a...· 0 citations
Real-world outpatient DOAC concentrations demonstrated substantial variability and frequent off-label underdosing; these findings may nonetheless support individualized interpretation of outpatient spot sample DOAC concentrations in selected clinical settings.
Yoonjung Kim, Sojin Lee, Yongjung Park et al.· Diagnostics· 0 citations
Evidence on culprit antibiotics and their characteristic phenotypes, the mechanistic basis of susceptibility markers including HLA-B*57:01 and slow NAT2 acetylator status, the methods and limits of disproportionality analysis, and the pharmacist's role in medication review and monitoring are brought together.
Chao Liu, Dan Luo, Rui-Feng Lin· Frontiers in Pharmacology· 0 citations
Abstract Objectives We validated the analytical performance and clinical diagnostic efficacy of the eCL8000i point-of-care testing (POCT) system for high-sensitivity cardiac troponin T (hs-cTnT), following the standardized verification protocol for hs-cTnT POCT assays. Methods A two-phase evaluation was conducted: Phas...
Fei Ding, Yu-Yao Li, Jia Li et al.· Journal of Laboratory Medici...· 0 citations
We use cookies to run the site and, with your consent, for analytics and to show ads.
See our Cookie Policy.
