1. Evaluation of a New, Rapid, Fully Automated Assay for the Measurement of ADAMTS13 Activity.
- Author
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Valsecchi C, Mirabet M, Mancini I, Biganzoli M, Schiavone L, Faraudo S, Mane-Padros D, Giles D, Serra-Domenech J, Blanch S, Trisolini SM, Facchini L, Rinaldi E, and Peyvandi F
- Subjects
- ADAMTS13 Protein deficiency, Atypical Hemolytic Uremic Syndrome blood, Atypical Hemolytic Uremic Syndrome enzymology, Automation, Laboratory, Biomarkers blood, Case-Control Studies, Enzyme-Linked Immunosorbent Assay, Humans, Luminescent Measurements, Predictive Value of Tests, Purpura, Thrombotic Thrombocytopenic blood, Purpura, Thrombotic Thrombocytopenic enzymology, Reproducibility of Results, Time Factors, Workflow, ADAMTS13 Protein blood, Atypical Hemolytic Uremic Syndrome diagnosis, Immunoassay methods, Purpura, Thrombotic Thrombocytopenic diagnosis
- Abstract
Thrombotic thrombocytopenic purpura (TTP) is a rare thrombotic microangiopathy (TMA) characterized by the severe deficiency of a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS13) activity (< 10%). Rapid ADAMTS13 testing is crucial for an early diagnosis and optimal management of acute TTP. We evaluated the performance of the HemosIL AcuStar ADAMTS13 activity assay (Instrumentation Laboratory, Bedford, Massachusetts, United States), a fully automated chemiluminescent immunoassay with an analytical time of 33 minutes. A method comparison study was performed on 176 samples from 49 healthy donors and 127 TMA patients (109 TTP, 7 atypical hemolytic uremic syndrome, 11 other TMAs), comparing this new assay with an in-house FRETS-VWF73 assay and a commercial enzyme-linked immunosorbent assay (ELISA) (TECHNOZYM ADAMTS-13 Activity, Technoclone GmbH, Vienna, Austria). Agreement between methods was assessed with focus on ADAMTS13 activity less than 10%, the medical decision level relevant for TTP diagnosis. The HemosIL AcuStar ADAMTS13 Activity showed good correlation with both the FRETS-VWF73 ( r = 0.96) and ELISA ( r = 0.96) methods. Slope of the Passing-Bablok regression was 1.05 for FRETS-VWF73 and 1.02 for ELISA, and absolute bias at the medical decision level was +0.1 and +0.3%, respectively. The study also revealed high agreement with FRETS-VWF73 (kappa 0.97) and ELISA (kappa 0.98) methods in classifying TTP patients with a severe deficiency of ADAMTS13 activity. Because of its short turnaround time and full automation, the HemosIL AcuStar ADAMTS13 activity assay might become the assay of choice to rapidly test ADAMTS13 activity in plasma and thus establish the diagnosis of acute TTP in emergency settings., Competing Interests: F.P. has received honoraria for participating as a speaker at satellite symposia and educational meetings organized by Ablynx, Grifols, Novo Nordisk, Roche, Shire, and Sobi. She has received consulting fees from Kedrion and she is recipient of a research grant funding from Biokit paid to Fondazione Luigi Villa. She is member of the scientific advisory board of Ablynx. I.M. received personal fees by Sanofi for participating in a Sanofi Advisory Board meeting. C.V., M.B., and L.S. are affiliated with Fondazione Luigi Villa, that received financial support from Biokit for the present work. M.M., S.F., D.M.-P., D.G., J.S.-D., and S.B. are employed at Biokit that is the developer of the assay in evaluation. The other authors do not have any conflict of interests to disclose., (Georg Thieme Verlag KG Stuttgart · New York.)
- Published
- 2019
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