Evaluation of INSTAND e.V.’s external proficiency testing program for tetanus and diphtheria antitoxin detection: Lessons for assessing levels of immunoprotection

Abstract Objectives The aim of this study was to evaluate the development and status quo quality high throughput in vitro diagnostic testing for tetanus diphtheria antitoxin antibody (ATX) concentrations based on external assessment (EQA) data. Methods We analyzed manufacturer-specific data 22 EQA surveys—each detection ATX—to check strength corresponding systems. Results While results were mostly well aligned, individual surveys showed widely dispersed ATX concentrations. medians manufacturer collectives deviated from overall median by up 8.9-fold case 3.5-fold ATX. Such a distribution is particularly critical cut-off range immunity may lead an incorrect vaccination status. Conclusion These surprising as there are International Standards both ATX; however, be linked concentration reference material, which deviates considerably clinically significant To increase accuracy assays, we recommend recalibration test systems verification their traceability Standards.