Anti-drug Antibody Sample Testing and Reporting Harmonization.

A clear scientific and operational need exists for harmonized bioanalytical immunogenicity study reporting to facilitate communication of immunogenicity findings and expedient review by industry and health authorities. To address these key bioanalytical reporting gaps and provide a report structure for documenting immunogenicity results, this cross-industry group was formed to establish harmonized recommendations and a develop a submission template to facilitate agency filings. Provided here are recommendations for reporting clinical anti-drug antibody (ADA) assay results using ligand-binding assay technologies.

Simple method to determine the concentration and incorporation ratio of ruthenium-labeled antibodies.

Ruthenium-labeled antibodies are commonly used detection reagents in bioanalysis assays and must be characterized to ensure quality. The aim of this work was to develop a method to determine the concentration and incorporation ratio (the degree of labeling [DOL]) of ruthenium-labeled antibodies by UV/VIS spectroscopy. Free SULFO-TAG compound was scanned using UV/VIS and showed an absorbance peak at 292 nm.

Systolic dysfunction and complete heart block as complications of fulminant myocarditis in a recovered COVID-19 patient.

We describe the first case report of fulminant myocarditis and complete heart block which was initially presented by severe systolic dysfunction and tachyarrhythmia, in a patient who recently recovered from covid-19. Continuous close follow-up should be considered for patients infected with COVID-19 after discharge, especially for those with any metabolic and pharmacologic risk factors for the conductive block to recognize these rare complications and reverse CHB early by administering a high dose of corticosteroid or other anti-inflammatory medications. < To illustrate the presentation of COVID-19 fulminant myocarditis by severe systolic dysfunction, tachyarrhythmia, and different degrees of atrioventricular block.

Association of polymorphisms at LDLR locus with coronary artery disease independently from lipid profile.

Coronary artery disease (CAD) is the leading cause of mortality in many parts of the world. Genome-wide association studies (GWAS) have identified several genetic variants associated with CAD in Low-density lipoprotein receptor (LDLR) locus. This study was evaluated the possible association of genetic markers at LDLR locus with CAD irrespective to lipid profile and as well as the association of these SNPs with severity of CAD in Iranian population.