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Evaluation of a novel immunoassay to detect p-tau Thr217 in the CSF to distinguish Alzheimer disease from other dementias

Hanes, Jozef
Autor Hanes, Jozef From the AXON Neuroscience R&D Services SE (J. Hanes, A.K., E.K., L.F., B.K., E.S., N.Z.), Bratislava, Slovakia Department of Psychiatry and Neurochemistry (H.K., H.Z., K.B.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal Clinical Neurochemistry Laboratory (H.K., H.Z., K.B.), Sahlgrenska University Hospital, Mölndal, Sweden AXON Neuroscience CRM Services SE (S.K.), Bratislava, Slovakia International Clinical Research Centre (J. Hort, M.V.), St. Anne's University Hospital Brno Memory Clinic, Department of Neurology (J. Hort, M.V.), Charles University, 2nd Faculty of Medicine and Motol University Hospital, Czech Republic Department of Clinical Chemistry, Neurochemistry Laboratory (L.B., C.E.T.), Amsterdam Neuroscience, VU University Medical Center Amsterdam, the Netherlands Axon Neuroscience SE (M.N.), Larnaca, Cyprus Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology, Queen Square, London UK Dementia Research Institute at UCL (H.Z.), London Clinical Memory Research Unit (O.H.), Department of Clinical Sciences Malmö, Lund University Memory Clinic (O.H.), Skåne University Hospital, Malmö, Sweden and Department of Neurology, Alzheimer Center (P.S.), Amsterdam Neuroscience, the Netherlands
Kovac, Andrej
Autor Kovac, Andrej From the AXON Neuroscience R&D Services SE (J. Hanes, A.K., E.K., L.F., B.K., E.S., N.Z.), Bratislava, Slovakia Department of Psychiatry and Neurochemistry (H.K., H.Z., K.B.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal Clinical Neurochemistry Laboratory (H.K., H.Z., K.B.), Sahlgrenska University Hospital, Mölndal, Sweden AXON Neuroscience CRM Services SE (S.K.), Bratislava, Slovakia International Clinical Research Centre (J. Hort, M.V.), St. Anne's University Hospital Brno Memory Clinic, Department of Neurology (J. Hort, M.V.), Charles University, 2nd Faculty of Medicine and Motol University Hospital, Czech Republic Department of Clinical Chemistry, Neurochemistry Laboratory (L.B., C.E.T.), Amsterdam Neuroscience, VU University Medical Center Amsterdam, the Netherlands Axon Neuroscience SE (M.N.), Larnaca, Cyprus Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology, Queen Square, London UK Dementia Research Institute at UCL (H.Z.), London Clinical Memory Research Unit (O.H.), Department of Clinical Sciences Malmö, Lund University Memory Clinic (O.H.), Skåne University Hospital, Malmö, Sweden and Department of Neurology, Alzheimer Center (P.S.), Amsterdam Neuroscience, the Netherlands
Kvartsberg, Hlin
Autor Kvartsberg, Hlin From the AXON Neuroscience R&D Services SE (J. Hanes, A.K., E.K., L.F., B.K., E.S., N.Z.), Bratislava, Slovakia Department of Psychiatry and Neurochemistry (H.K., H.Z., K.B.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal Clinical Neurochemistry Laboratory (H.K., H.Z., K.B.), Sahlgrenska University Hospital, Mölndal, Sweden AXON Neuroscience CRM Services SE (S.K.), Bratislava, Slovakia International Clinical Research Centre (J. Hort, M.V.), St. Anne's University Hospital Brno Memory Clinic, Department of Neurology (J. Hort, M.V.), Charles University, 2nd Faculty of Medicine and Motol University Hospital, Czech Republic Department of Clinical Chemistry, Neurochemistry Laboratory (L.B., C.E.T.), Amsterdam Neuroscience, VU University Medical Center Amsterdam, the Netherlands Axon Neuroscience SE (M.N.), Larnaca, Cyprus Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology, Queen Square, London UK Dementia Research Institute at UCL (H.Z.), London Clinical Memory Research Unit (O.H.), Department of Clinical Sciences Malmö, Lund University Memory Clinic (O.H.), Skåne University Hospital, Malmö, Sweden and Department of Neurology, Alzheimer Center (P.S.), Amsterdam Neuroscience, the Netherlands
Kontsekova, Eva
Autor Kontsekova, Eva From the AXON Neuroscience R&D Services SE (J. Hanes, A.K., E.K., L.F., B.K., E.S., N.Z.), Bratislava, Slovakia Department of Psychiatry and Neurochemistry (H.K., H.Z., K.B.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal Clinical Neurochemistry Laboratory (H.K., H.Z., K.B.), Sahlgrenska University Hospital, Mölndal, Sweden AXON Neuroscience CRM Services SE (S.K.), Bratislava, Slovakia International Clinical Research Centre (J. Hort, M.V.), St. Anne's University Hospital Brno Memory Clinic, Department of Neurology (J. Hort, M.V.), Charles University, 2nd Faculty of Medicine and Motol University Hospital, Czech Republic Department of Clinical Chemistry, Neurochemistry Laboratory (L.B., C.E.T.), Amsterdam Neuroscience, VU University Medical Center Amsterdam, the Netherlands Axon Neuroscience SE (M.N.), Larnaca, Cyprus Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology, Queen Square, London UK Dementia Research Institute at UCL (H.Z.), London Clinical Memory Research Unit (O.H.), Department of Clinical Sciences Malmö, Lund University Memory Clinic (O.H.), Skåne University Hospital, Malmö, Sweden and Department of Neurology, Alzheimer Center (P.S.), Amsterdam Neuroscience, the Netherlands
Fialova, Lubica
Autor Fialova, Lubica From the AXON Neuroscience R&D Services SE (J. Hanes, A.K., E.K., L.F., B.K., E.S., N.Z.), Bratislava, Slovakia Department of Psychiatry and Neurochemistry (H.K., H.Z., K.B.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal Clinical Neurochemistry Laboratory (H.K., H.Z., K.B.), Sahlgrenska University Hospital, Mölndal, Sweden AXON Neuroscience CRM Services SE (S.K.), Bratislava, Slovakia International Clinical Research Centre (J. Hort, M.V.), St. Anne's University Hospital Brno Memory Clinic, Department of Neurology (J. Hort, M.V.), Charles University, 2nd Faculty of Medicine and Motol University Hospital, Czech Republic Department of Clinical Chemistry, Neurochemistry Laboratory (L.B., C.E.T.), Amsterdam Neuroscience, VU University Medical Center Amsterdam, the Netherlands Axon Neuroscience SE (M.N.), Larnaca, Cyprus Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology, Queen Square, London UK Dementia Research Institute at UCL (H.Z.), London Clinical Memory Research Unit (O.H.), Department of Clinical Sciences Malmö, Lund University Memory Clinic (O.H.), Skåne University Hospital, Malmö, Sweden and Department of Neurology, Alzheimer Center (P.S.), Amsterdam Neuroscience, the Netherlands
Katina, Stanislav
Autor Katina, Stanislav From the AXON Neuroscience R&D Services SE (J. Hanes, A.K., E.K., L.F., B.K., E.S., N.Z.), Bratislava, Slovakia Department of Psychiatry and Neurochemistry (H.K., H.Z., K.B.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal Clinical Neurochemistry Laboratory (H.K., H.Z., K.B.), Sahlgrenska University Hospital, Mölndal, Sweden AXON Neuroscience CRM Services SE (S.K.), Bratislava, Slovakia International Clinical Research Centre (J. Hort, M.V.), St. Anne's University Hospital Brno Memory Clinic, Department of Neurology (J. Hort, M.V.), Charles University, 2nd Faculty of Medicine and Motol University Hospital, Czech Republic Department of Clinical Chemistry, Neurochemistry Laboratory (L.B., C.E.T.), Amsterdam Neuroscience, VU University Medical Center Amsterdam, the Netherlands Axon Neuroscience SE (M.N.), Larnaca, Cyprus Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology, Queen Square, London UK Dementia Research Institute at UCL (H.Z.), London Clinical Memory Research Unit (O.H.), Department of Clinical Sciences Malmö, Lund University Memory Clinic (O.H.), Skåne University Hospital, Malmö, Sweden and Department of Neurology, Alzheimer Center (P.S.), Amsterdam Neuroscience, the Netherlands
Kovacech, Branislav
Autor Kovacech, Branislav From the AXON Neuroscience R&D Services SE (J. Hanes, A.K., E.K., L.F., B.K., E.S., N.Z.), Bratislava, Slovakia Department of Psychiatry and Neurochemistry (H.K., H.Z., K.B.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal Clinical Neurochemistry Laboratory (H.K., H.Z., K.B.), Sahlgrenska University Hospital, Mölndal, Sweden AXON Neuroscience CRM Services SE (S.K.), Bratislava, Slovakia International Clinical Research Centre (J. Hort, M.V.), St. Anne's University Hospital Brno Memory Clinic, Department of Neurology (J. Hort, M.V.), Charles University, 2nd Faculty of Medicine and Motol University Hospital, Czech Republic Department of Clinical Chemistry, Neurochemistry Laboratory (L.B., C.E.T.), Amsterdam Neuroscience, VU University Medical Center Amsterdam, the Netherlands Axon Neuroscience SE (M.N.), Larnaca, Cyprus Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology, Queen Square, London UK Dementia Research Institute at UCL (H.Z.), London Clinical Memory Research Unit (O.H.), Department of Clinical Sciences Malmö, Lund University Memory Clinic (O.H.), Skåne University Hospital, Malmö, Sweden and Department of Neurology, Alzheimer Center (P.S.), Amsterdam Neuroscience, the Netherlands
Stevens, Eva
Autor Stevens, Eva From the AXON Neuroscience R&D Services SE (J. Hanes, A.K., E.K., L.F., B.K., E.S., N.Z.), Bratislava, Slovakia Department of Psychiatry and Neurochemistry (H.K., H.Z., K.B.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal Clinical Neurochemistry Laboratory (H.K., H.Z., K.B.), Sahlgrenska University Hospital, Mölndal, Sweden AXON Neuroscience CRM Services SE (S.K.), Bratislava, Slovakia International Clinical Research Centre (J. Hort, M.V.), St. Anne's University Hospital Brno Memory Clinic, Department of Neurology (J. Hort, M.V.), Charles University, 2nd Faculty of Medicine and Motol University Hospital, Czech Republic Department of Clinical Chemistry, Neurochemistry Laboratory (L.B., C.E.T.), Amsterdam Neuroscience, VU University Medical Center Amsterdam, the Netherlands Axon Neuroscience SE (M.N.), Larnaca, Cyprus Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology, Queen Square, London UK Dementia Research Institute at UCL (H.Z.), London Clinical Memory Research Unit (O.H.), Department of Clinical Sciences Malmö, Lund University Memory Clinic (O.H.), Skåne University Hospital, Malmö, Sweden and Department of Neurology, Alzheimer Center (P.S.), Amsterdam Neuroscience, the Netherlands
Hort, Jakub
Autor Hort, Jakub From the AXON Neuroscience R&D Services SE (J. Hanes, A.K., E.K., L.F., B.K., E.S., N.Z.), Bratislava, Slovakia Department of Psychiatry and Neurochemistry (H.K., H.Z., K.B.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal Clinical Neurochemistry Laboratory (H.K., H.Z., K.B.), Sahlgrenska University Hospital, Mölndal, Sweden AXON Neuroscience CRM Services SE (S.K.), Bratislava, Slovakia International Clinical Research Centre (J. Hort, M.V.), St. Anne's University Hospital Brno Memory Clinic, Department of Neurology (J. Hort, M.V.), Charles University, 2nd Faculty of Medicine and Motol University Hospital, Czech Republic Department of Clinical Chemistry, Neurochemistry Laboratory (L.B., C.E.T.), Amsterdam Neuroscience, VU University Medical Center Amsterdam, the Netherlands Axon Neuroscience SE (M.N.), Larnaca, Cyprus Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology, Queen Square, London UK Dementia Research Institute at UCL (H.Z.), London Clinical Memory Research Unit (O.H.), Department of Clinical Sciences Malmö, Lund University Memory Clinic (O.H.), Skåne University Hospital, Malmö, Sweden and Department of Neurology, Alzheimer Center (P.S.), Amsterdam Neuroscience, the Netherlands
Vyhnalek, Martin
Autor Vyhnalek, Martin From the AXON Neuroscience R&D Services SE (J. Hanes, A.K., E.K., L.F., B.K., E.S., N.Z.), Bratislava, Slovakia Department of Psychiatry and Neurochemistry (H.K., H.Z., K.B.), Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal Clinical Neurochemistry Laboratory (H.K., H.Z., K.B.), Sahlgrenska University Hospital, Mölndal, Sweden AXON Neuroscience CRM Services SE (S.K.), Bratislava, Slovakia International Clinical Research Centre (J. Hort, M.V.), St. Anne's University Hospital Brno Memory Clinic, Department of Neurology (J. Hort, M.V.), Charles University, 2nd Faculty of Medicine and Motol University Hospital, Czech Republic Department of Clinical Chemistry, Neurochemistry Laboratory (L.B., C.E.T.), Amsterdam Neuroscience, VU University Medical Center Amsterdam, the Netherlands Axon Neuroscience SE (M.N.), Larnaca, Cyprus Department of Neurodegenerative Disease (H.Z.), UCL Institute of Neurology, Queen Square, London UK Dementia Research Institute at UCL (H.Z.), London Clinical Memory Research Unit (O.H.), Department of Clinical Sciences Malmö, Lund University Memory Clinic (O.H.), Skåne University Hospital, Malmö, Sweden and Department of Neurology, Alzheimer Center (P.S.), Amsterdam Neuroscience, the Netherlands

Neurology. 2020 ; 95 (22) : e3026-e3035. [pub] 20200924

ISSN 1526-632X
Medvik
Zdroj

OBJECTIVE: To investigate whether tau phosphorylated at Thr217 (p-tau T217) assay in CSF can distinguish patients with Alzheimer disease (AD) from patients with other dementias and healthy controls. METHODS: We developed and validated a novel Simoa immunoassay to detect p-tau T217 in CSF. There was a total of 190 participants from 3 cohorts with AD (n = 77) and other neurodegenerative diseases (n = 69) as well as healthy participants (n = 44). RESULTS: The p-tau T217 assay (cutoff 242 pg/mL) identified patients with AD with accuracy of 90%, with 78% positive predictive value (PPV), 97% negative predictive value (NPV), 93% sensitivity, and 88% specificity, compared favorably with p-tau T181 ELISA (52 pg/mL), showing 78% accuracy, 58% PPV, 98% NPV, 71% specificity, and 97% sensitivity. The assay distinguished patients with AD from age-matched healthy controls (cutoff 163 pg/mL, 98% sensitivity, 93% specificity), similarly to p-tau T181 ELISA (cutoff 60 pg/mL, 96% sensitivity, 86% specificity). In patients with AD, we found a strong correlation between p-tau T217 and p-tau T181, total tau and β-amyloid 40, but not β-amyloid 42. CONCLUSIONS: This study demonstrates that p-tau T217 displayed better diagnostic accuracy than p-tau T181. The data suggest that the new p-tau T217 assay has potential as an AD diagnostic test in clinical evaluation. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that a CSF immunoassay for p-tau T217 distinguishes patients with AD from patients with other dementias and healthy controls.

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