Evaluation of a New, Rapid, Fully Automated Assay for the Measurement of ADAMTS13 Activity
| العنوان: | Evaluation of a New, Rapid, Fully Automated Assay for the Measurement of ADAMTS13 Activity |
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| المؤلفون: | Susanna Faraudo, Ilaria Mancini, Erminia Rinaldi, Marina Biganzoli, Carla Valsecchi, Josep Serra-Domenech, David Giles, Maribel Mirabet, Luca Facchini, Daniel Mane-Padros, Lucia Schiavone, Flora Peyvandi, Silvia Maria Trisolini, Silvia Blanch |
| المصدر: | Thrombosis and Haemostasis. 119:1767-1772 |
| بيانات النشر: | Georg Thieme Verlag KG, 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | 0301 basic medicine, Time Factors, Thrombotic microangiopathy, Thrombotic thrombocytopenic purpura, ADAMTS13 Protein, Enzyme-Linked Immunosorbent Assay, 030204 cardiovascular system & hematology, Adamts13 activity, Workflow, 03 medical and health sciences, 0302 clinical medicine, Predictive Value of Tests, hemic and lymphatic diseases, Disintegrin, medicine, Humans, Atypical Hemolytic Uremic Syndrome, Automation, Laboratory, Immunoassay, Metalloproteinase, Thrombospondin, Purpura, Thrombotic Thrombocytopenic, biology, business.industry, Reproducibility of Results, Hematology, medicine.disease, ADAMTS13, 030104 developmental biology, Fully automated, Case-Control Studies, Luminescent Measurements, biology.protein, Cancer research, business, Biomarkers |
| الوصف: | 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. |
| تدمد: | 2567-689X 0340-6245 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b6e23b6df0728dbc607e7a9d16bf9a74 https://doi.org/10.1055/s-0039-1696718 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....b6e23b6df0728dbc607e7a9d16bf9a74 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 2567689X 03406245 |
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