Background: Thrombotic thrombocytopenic purpura (TTP) is a fatal disease caused by severe deficiency in ADAMTS-13 (a disintegrin and metalloproteinase with thrombospondin type 1 motifs 13) activity. ADAMTS-13 activity measurement is essential for the diagnosis of TTP, but conventional standard assays are manual and time-consuming. Automated ADAMTS-13 activity assays have recently become available; however, their accuracy remains challenging.
Objectives: We here developed a novel chemiluminescent enzyme immunoassay (CLEIA) for ADAMTS-13 activity that is fully automated, highly sensitive, and has a short reaction time (17 minutes). We evaluated the utility of our fully automated CLEIA for measuring ADAMTS-13 activity and inhibitory antibodies and compared it with conventional manual assays.
Methods: We compared our CLEIA for ADAMTS-13 activity and inhibitory antibodies with an in-house FRETS-VWF73 assay and commercial enzyme-linked immunosorbent assay (ELISA) using samples from 100 patients and 50 healthy donors. Agreement between assays was evaluated using a cutoff value of 10 international units/dL for ADAMTS-13 activity and 0.5 Bethesda units/mL for inhibitory antibodies.
Results: The CLEIA and conventional assays for ADAMTS-13 activity correlated well. The CLEIA showed high agreement with the FRETS-VWF73 assay (kappa = 0.96) and ELISA (kappa = 1.0) in classifying patients with a cutoff value of 10 international units/dL for ADAMTS-13 activity. Furthermore, in classifying patients with the cutoff value of 0.5 Bethesda units/mL for inhibitory antibodies, the CLEIA agreed strongly with the FRETS-VWF73 assay (kappa = 0.95) and ELISA (kappa = 0.98). Its diagnostic performance for TTP was satisfactory.
Conclusion: The high-performance and fully automated CLEIA enables rapid in-hospital diagnosis and follow-up of TTP, as well as detection of inhibitory ADAMTS-13 autoantibodies.
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http://dx.doi.org/10.1016/j.jtha.2024.11.020 | DOI Listing |
Cureus
December 2024
Hematology and Oncology, University of Texas MD Anderson Cancer Center, Galveston, USA.
There are two main classifications for thrombotic thrombocytopenic purpura (TTP): immune and hereditary. The majority of TTP cases are immune in nature and are due to inhibitor autoantibodies against ADAMTS13. Hereditary TTP is caused by biallelic pathogenic variants in the ADAMTS13 gene.
View Article and Find Full Text PDFInt J Lab Hematol
December 2024
LabPLUS, Auckland City Hospital, Auckland, New Zealand.
Introduction: The TECHNOSCREEN ADAMTS-13 assay (ADSC) is a new lateral flow test which is simple and quick to perform, with a high negative predictive value (NPV); it may improve the diagnostic workflow for TTP. LabPlus in Auckland, New Zealand, performs all ADAMTS13 tests in the Auckland and Northland regions. The ADSC was used at LabPlus between 2022 and 2023 as part of a protocol where results of 0 IU/mL and 0.
View Article and Find Full Text PDFCureus
November 2024
Department of Medicine, Dr. Baba Saheb Ambedkar Medical College and Hospital, New Delhi, IND.
J Thromb Haemost
December 2024
Department of Hematology, Nara Medical University, Kashihara, Japan; Department of Blood Transfusion Medicine, Nara Medical University, Kashihara, Japan. Electronic address:
Res Pract Thromb Haemost
October 2024
Department of Pathology and Laboratory Medicine, University of Kansas Medical Center, Kansas City, Kansas, USA.
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