Detection of GFAP and D‐Dimer in a Point‐of‐Care Test for Large Vessel Occlusion Ischemic Stroke
Background The blood biomarkers GFAP (glial fibrillary acidic protein) and D‐dimer have been shown to accurately diagnose large vessel occlusion ischemic stroke. The Upfront DX LVOne is a novel lateral flow‐based point‐of‐care test used for the detection of GFAP and D‐dimer. This study sought to (1...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2025-03-01
|
| Series: | Stroke: Vascular and Interventional Neurology |
| Subjects: | |
| Online Access: | https://www.ahajournals.org/doi/10.1161/SVIN.124.001559 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850233407214190592 |
|---|---|
| author | Edoardo Gaude Danielle Murphy Jakob V.E. Gerstl Ari D. Kappel Adam A. Dmytriw Noah L.A. Nawabi Saef Izzy Rodolfo E. Alcedo Guardia Juan C. Vicenty‐Padilla Toby Gropen Nirav J. Patel David S. Liebeskind Adnan H. Siddiqui Alfred Pokmeng See Mohammed A. Aziz‐Sultan Joshua D. Bernstock |
| author_facet | Edoardo Gaude Danielle Murphy Jakob V.E. Gerstl Ari D. Kappel Adam A. Dmytriw Noah L.A. Nawabi Saef Izzy Rodolfo E. Alcedo Guardia Juan C. Vicenty‐Padilla Toby Gropen Nirav J. Patel David S. Liebeskind Adnan H. Siddiqui Alfred Pokmeng See Mohammed A. Aziz‐Sultan Joshua D. Bernstock |
| author_sort | Edoardo Gaude |
| collection | DOAJ |
| description | Background The blood biomarkers GFAP (glial fibrillary acidic protein) and D‐dimer have been shown to accurately diagnose large vessel occlusion ischemic stroke. The Upfront DX LVOne is a novel lateral flow‐based point‐of‐care test used for the detection of GFAP and D‐dimer. This study sought to (1) assess the performance of LVOne against commercially available point‐of‐care test platforms, which independently detect GFAP and D‐dimer (Abbott iSTAT TBI Plasma and LumiraDx D‐dimer), and to (2) assess the diagnostic performance of LVOne in large vessel occlusion detection. Methods Manufacturer‐reported detection thresholds of the LVOne test for GFAP and D‐dimer (213 pg/mL and 600 ng/mL, respectively) were compared against commercial hospital‐based point‐of‐care test platforms using 20 randomly selected plasma samples for each biomarker. D‐dimer correlation between LVOne and LumiraDx was assessed using Spearman's Rank correlation coefficient; GFAP correlation between LVOne and the Abbott iSTAT TBI results were assessed using point biserial correlation. Diagnostic performance of the LVOne point‐of‐care test in conjunction with clinical assessment for detection of large vessel occlusion in plasma samples from 210 patients with suspected stroke was validated. Results There was a strong positive correlation (Rho = 0.86, P<0.001) between the qualitative scoring of the lateral flow test and serum GFAP concentrations. Similarly, there was a significant positive correlation between the D‐dimer quantification and LVOne semiquantitative measurements (Rho = 0.90; P<0.0001). In our cohort of 210 patients with suspected stroke, the LVOne test in conjunction with clinical assessment had a sensitivity of 75% (95% CI, 51%–91%), a specificity of 92% (95% CI, 87%–95%), a positive predictive value of 48% (95% CI, 30%–67%), and a negative predictive value of 97% (95% CI, 94%–99%) for detection of large vessel occlusion. Conclusion Our results validate detection thresholds for the LVOne test in a representative cohort of plasma samples of patients with suspected stroke. Further studies are required to demonstrate the efficacy, safety, and diagnostic performance of LVOne in capillary blood during emergency care/clinical triage. |
| format | Article |
| id | doaj-art-613cbb2dfb6a470ea83127a0ff809be9 |
| institution | OA Journals |
| issn | 2694-5746 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | Stroke: Vascular and Interventional Neurology |
| spelling | doaj-art-613cbb2dfb6a470ea83127a0ff809be92025-08-20T02:02:57ZengWileyStroke: Vascular and Interventional Neurology2694-57462025-03-015210.1161/SVIN.124.001559Detection of GFAP and D‐Dimer in a Point‐of‐Care Test for Large Vessel Occlusion Ischemic StrokeEdoardo Gaude0Danielle Murphy1Jakob V.E. Gerstl2Ari D. Kappel3Adam A. Dmytriw4Noah L.A. Nawabi5Saef Izzy6Rodolfo E. Alcedo Guardia7Juan C. Vicenty‐Padilla8Toby Gropen9Nirav J. Patel10David S. Liebeskind11Adnan H. Siddiqui12Alfred Pokmeng See13Mohammed A. Aziz‐Sultan14Joshua D. Bernstock15CRUK Cambridge Institute, University of Cambridge Cambridge UKCRUK Cambridge Institute, University of Cambridge Cambridge UKDepartment of Neurosurgery Brigham and Women's Hospital, Harvard Medical School Boston MADepartment of Neurosurgery Brigham and Women's Hospital, Harvard Medical School Boston MANeuroendovascular Program Massachusetts General Hospital, Harvard Medical School Boston MADepartment of Neurosurgery Brigham and Women's Hospital, Harvard Medical School Boston MADepartment of Neurology Brigham and Women's Hospital, Harvard Medical School Boston MADepartment of Neurosurgery School of Medicine, University of Puerto Rico San Juan Puerto RicoDepartment of Neurosurgery School of Medicine, University of Puerto Rico San Juan Puerto RicoDepartment of Neurology University of Alabama at Birmingham Birmingham ALDepartment of Neurosurgery Brigham and Women's Hospital, Harvard Medical School Boston MAUCLA Stroke Center Department of Neurology UCLA Los Angeles CADepartment of Neurosurgery State University of New York at Buffalo's Jacobs School of Medicine and Biomedical Sciences Buffalo NYDepartment of Neurosurgery Boston Children's Hospital Harvard Medical School Boston MADepartment of Neurosurgery Brigham and Women's Hospital, Harvard Medical School Boston MADepartment of Neurosurgery Brigham and Women's Hospital, Harvard Medical School Boston MABackground The blood biomarkers GFAP (glial fibrillary acidic protein) and D‐dimer have been shown to accurately diagnose large vessel occlusion ischemic stroke. The Upfront DX LVOne is a novel lateral flow‐based point‐of‐care test used for the detection of GFAP and D‐dimer. This study sought to (1) assess the performance of LVOne against commercially available point‐of‐care test platforms, which independently detect GFAP and D‐dimer (Abbott iSTAT TBI Plasma and LumiraDx D‐dimer), and to (2) assess the diagnostic performance of LVOne in large vessel occlusion detection. Methods Manufacturer‐reported detection thresholds of the LVOne test for GFAP and D‐dimer (213 pg/mL and 600 ng/mL, respectively) were compared against commercial hospital‐based point‐of‐care test platforms using 20 randomly selected plasma samples for each biomarker. D‐dimer correlation between LVOne and LumiraDx was assessed using Spearman's Rank correlation coefficient; GFAP correlation between LVOne and the Abbott iSTAT TBI results were assessed using point biserial correlation. Diagnostic performance of the LVOne point‐of‐care test in conjunction with clinical assessment for detection of large vessel occlusion in plasma samples from 210 patients with suspected stroke was validated. Results There was a strong positive correlation (Rho = 0.86, P<0.001) between the qualitative scoring of the lateral flow test and serum GFAP concentrations. Similarly, there was a significant positive correlation between the D‐dimer quantification and LVOne semiquantitative measurements (Rho = 0.90; P<0.0001). In our cohort of 210 patients with suspected stroke, the LVOne test in conjunction with clinical assessment had a sensitivity of 75% (95% CI, 51%–91%), a specificity of 92% (95% CI, 87%–95%), a positive predictive value of 48% (95% CI, 30%–67%), and a negative predictive value of 97% (95% CI, 94%–99%) for detection of large vessel occlusion. Conclusion Our results validate detection thresholds for the LVOne test in a representative cohort of plasma samples of patients with suspected stroke. Further studies are required to demonstrate the efficacy, safety, and diagnostic performance of LVOne in capillary blood during emergency care/clinical triage.https://www.ahajournals.org/doi/10.1161/SVIN.124.001559biomarkersD‐dimerglial fibrillary acidic proteinlarge vessel occlusionpoint of care diagnosticsprehospital triage |
| spellingShingle | Edoardo Gaude Danielle Murphy Jakob V.E. Gerstl Ari D. Kappel Adam A. Dmytriw Noah L.A. Nawabi Saef Izzy Rodolfo E. Alcedo Guardia Juan C. Vicenty‐Padilla Toby Gropen Nirav J. Patel David S. Liebeskind Adnan H. Siddiqui Alfred Pokmeng See Mohammed A. Aziz‐Sultan Joshua D. Bernstock Detection of GFAP and D‐Dimer in a Point‐of‐Care Test for Large Vessel Occlusion Ischemic Stroke Stroke: Vascular and Interventional Neurology biomarkers D‐dimer glial fibrillary acidic protein large vessel occlusion point of care diagnostics prehospital triage |
| title | Detection of GFAP and D‐Dimer in a Point‐of‐Care Test for Large Vessel Occlusion Ischemic Stroke |
| title_full | Detection of GFAP and D‐Dimer in a Point‐of‐Care Test for Large Vessel Occlusion Ischemic Stroke |
| title_fullStr | Detection of GFAP and D‐Dimer in a Point‐of‐Care Test for Large Vessel Occlusion Ischemic Stroke |
| title_full_unstemmed | Detection of GFAP and D‐Dimer in a Point‐of‐Care Test for Large Vessel Occlusion Ischemic Stroke |
| title_short | Detection of GFAP and D‐Dimer in a Point‐of‐Care Test for Large Vessel Occlusion Ischemic Stroke |
| title_sort | detection of gfap and d dimer in a point of care test for large vessel occlusion ischemic stroke |
| topic | biomarkers D‐dimer glial fibrillary acidic protein large vessel occlusion point of care diagnostics prehospital triage |
| url | https://www.ahajournals.org/doi/10.1161/SVIN.124.001559 |
| work_keys_str_mv | AT edoardogaude detectionofgfapandddimerinapointofcaretestforlargevesselocclusionischemicstroke AT daniellemurphy detectionofgfapandddimerinapointofcaretestforlargevesselocclusionischemicstroke AT jakobvegerstl detectionofgfapandddimerinapointofcaretestforlargevesselocclusionischemicstroke AT aridkappel detectionofgfapandddimerinapointofcaretestforlargevesselocclusionischemicstroke AT adamadmytriw detectionofgfapandddimerinapointofcaretestforlargevesselocclusionischemicstroke AT noahlanawabi detectionofgfapandddimerinapointofcaretestforlargevesselocclusionischemicstroke AT saefizzy detectionofgfapandddimerinapointofcaretestforlargevesselocclusionischemicstroke AT rodolfoealcedoguardia detectionofgfapandddimerinapointofcaretestforlargevesselocclusionischemicstroke AT juancvicentypadilla detectionofgfapandddimerinapointofcaretestforlargevesselocclusionischemicstroke AT tobygropen detectionofgfapandddimerinapointofcaretestforlargevesselocclusionischemicstroke AT niravjpatel detectionofgfapandddimerinapointofcaretestforlargevesselocclusionischemicstroke AT davidsliebeskind detectionofgfapandddimerinapointofcaretestforlargevesselocclusionischemicstroke AT adnanhsiddiqui detectionofgfapandddimerinapointofcaretestforlargevesselocclusionischemicstroke AT alfredpokmengsee detectionofgfapandddimerinapointofcaretestforlargevesselocclusionischemicstroke AT mohammedaazizsultan detectionofgfapandddimerinapointofcaretestforlargevesselocclusionischemicstroke AT joshuadbernstock detectionofgfapandddimerinapointofcaretestforlargevesselocclusionischemicstroke |