Economic impact of a rapid, on‐demand ADAMTS‐13 activity assay for the diagnosis of thrombotic thrombocytopenic purpura

Abstract

Background: Thrombotic thrombocytopenic purpura (TTP) is a rare, life-threatening thrombotic microangiopathy (TMA), characterized by ADAMTS-13 activity <10%.ADAMTS-13 activity assays are typically performed in reference laboratories with a turnaround time of several days. First-line treatment for TTP, therapeutic plasma exchange (TPE), typically starts while results are pending. The automated, on-demand HemosIL AcuStar ADAMTS-13 Activity assay provides results in under an hour, which could reduce unnecessary TPE use and associated costs.Objectives: To estimate the hospital budget impact in the United States, United Kingdom, and France of using a rapid ADAMTS-13 activity assay. Methods:We compared routine use of a rapid assay in adults with TMA with a scenario in which results take 3 days. Model structure and variables were based on published literature, plus survey and interviews of five clinicians from the three countries.Costs for the ADAMTS-13 activity assays and TPE were included.Results: Model results suggest that if an on-demand, rapid ADAMTS-13 activity

Measuring ADAMTS-13 activity to diagnose thrombotic thrombocytopenic purpura: a novel, fast fiber-optic surface plasmon resonance immunoassay

“…For optimal prognosis of patients with TTP, correct diagnosis and subsequent treatment initiation within 4 to 8 hours after admission is crucial [ [5] , [6] , [7] ]. To date, ADAMTS-13 enzyme assays, typically including FRETS- and enzyme-linked immunosorbent assay-based assays, are only available in highly expert laboratories as diagnostic testing remains time-consuming, laborious, and require well-trained staff.…”

“…These clinical signs and symptoms overlap with other thrombotic microangiopathies (TMAs), like hemolytic uremic syndrome (HUS) [ [2] , [3] , [4] ]. To prevent misdiagnosis and initiate appropriate treatment in time, distinction between TTP and alternative TMAs within 4 to 8 hours of patient presentation is crucial [ [5] , [6] , [7] ]. To date, TTP diagnosis is only confirmed by an ADAMTS-13 activity below 10% (equal to 10 International Units (IU)/dL) of normal ADAMTS-13 activity [ 1 , 2 , 8 , 9 ].…”