A multicenter laboratory assessment of a new automated chemiluminescent assay for ADAMTS13 activity

BackgroundThrombotic thrombocytopenic purpura (TTP) is a rare but potentially fatal disorder caused by ADAMTS13 (a disintegrin and metalloproteinase with thrombospondin type 1 motif, member 13) deficiency. Prompt identification/exclusion of TTP can thus be facilitated rapid testing. The most commonly utilized (enzyme?linked immunosorbent assay [ELISA]–based) takes several hours to perform so does not generally permit testing.ObjectivesTo evaluate the utility new automated test for activity, HemosIL AcuStar Activity assay, based on chemiluminescence able performed an ACL instrument within 33 minutes.Patients/MethodsThis multicenter (n = 8) assessment included testing more than 700 samples, similar numbers prospective 348) retrospective 385) samples. main comparator was Technozym ELISA. We also assessed comparative performance detection inhibitors using Bethesda assay.ResultsOverall, chemiluminescent yielded results ELISA, albeit slight negative bias. inhibitor comparable, positive bias assay. Assay precision both assays, we verified normal reference ranges.ConclusionsThe provided rapidly, which were largely comparable ELISA lower average. Conversely, levels tended identified at higher level Thus, provides fast accurate means quantitate plasma TTP/ADAMTS13 identification/exclusion, other applications.