Derivation of cutoffs for the Elecsys® amyloid β (1–42) assay in Alzheimer's disease
Abstract Introduction An Elecsys® Amyloid β (Aβ [1–42]) immunoassay cutoff for classification of patients with Alzheimer's disease was investigated. Methods Cerebrospinal fluid samples collected from patients with mild‐to‐moderate Alzheimer's disease were analyzed by Elecsys® immunoassays:...
| Main Authors: | , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2018-01-01
|
| Series: | Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring |
| Subjects: | |
| Online Access: | https://doi.org/10.1016/j.dadm.2018.07.002 |
| _version_ | 1819031415522590720 |
|---|---|
| author | Leslie M. Shaw Teresa Waligorska Leona Fields Magdalena Korecka Michal Figurski John Q. Trojanowski Udo Eichenlaub Simone Wahl Marian Quan Michael J. Pontecorvo D. Richard Lachno Jayne A. Talbot Scott W. Andersen Eric R. Siemers Robert A. Dean |
| author_facet | Leslie M. Shaw Teresa Waligorska Leona Fields Magdalena Korecka Michal Figurski John Q. Trojanowski Udo Eichenlaub Simone Wahl Marian Quan Michael J. Pontecorvo D. Richard Lachno Jayne A. Talbot Scott W. Andersen Eric R. Siemers Robert A. Dean |
| author_sort | Leslie M. Shaw |
| collection | DOAJ |
| description | Abstract Introduction An Elecsys® Amyloid β (Aβ [1–42]) immunoassay cutoff for classification of patients with Alzheimer's disease was investigated. Methods Cerebrospinal fluid samples collected from patients with mild‐to‐moderate Alzheimer's disease were analyzed by Elecsys® immunoassays: (1) Aβ (1–42), (2) total tau, and (3) phosphorylated tau. Cutoffs (Aβ [1–42] and ratios with tau) were estimated by method comparison between AlzBio3 (n = 206), mixture modeling (n = 216), and concordance with florbetapir F 18 imaging‐based classification (n = 75). Results A 1065‐pg/mL (95% confidence interval: 985–1153) Elecsys® Aβ (1–42) cutoff provided 94% overall percentage agreement with AlzBio3. Comparable cutoff estimates (95% confidence interval) were derived from mixture modeling (equally weighted: 1017 [949–1205] pg/mL; prevalence weighted: 1172 [1081–1344] pg/mL) and concordance with florbetapir F 18 imaging (visual read: 1198 [998–1591] pg/mL; automated: 1198 [1051–1638] pg/mL). Discussion Based on three approaches, a 1100‐pg/mL Elecsys® Aβ (1–42) cutoff is suitable for clinical trials with similar populations and preanalytical handling. |
| first_indexed | 2024-12-21T06:45:41Z |
| format | Article |
| id | doaj.art-bc35f0e3552b41acbe1dcbd426ecd5fb |
| institution | Directory Open Access Journal |
| issn | 2352-8729 |
| language | English |
| last_indexed | 2024-12-21T06:45:41Z |
| publishDate | 2018-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring |
| spelling | doaj.art-bc35f0e3552b41acbe1dcbd426ecd5fb2022-12-21T19:12:37ZengWileyAlzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring2352-87292018-01-0110169870510.1016/j.dadm.2018.07.002Derivation of cutoffs for the Elecsys® amyloid β (1–42) assay in Alzheimer's diseaseLeslie M. Shaw0Teresa Waligorska1Leona Fields2Magdalena Korecka3Michal Figurski4John Q. Trojanowski5Udo Eichenlaub6Simone Wahl7Marian Quan8Michael J. Pontecorvo9D. Richard Lachno10Jayne A. Talbot11Scott W. Andersen12Eric R. Siemers13Robert A. Dean14Department of Pathology and Laboratory MedicinePerelman School of Medicine, University of PennsylvaniaPhiladelphiaPAUSADepartment of Pathology and Laboratory MedicinePerelman School of Medicine, University of PennsylvaniaPhiladelphiaPAUSADepartment of Pathology and Laboratory MedicinePerelman School of Medicine, University of PennsylvaniaPhiladelphiaPAUSADepartment of Pathology and Laboratory MedicinePerelman School of Medicine, University of PennsylvaniaPhiladelphiaPAUSADepartment of Pathology and Laboratory MedicinePerelman School of Medicine, University of PennsylvaniaPhiladelphiaPAUSADepartment of Pathology and Laboratory MedicinePerelman School of Medicine, University of PennsylvaniaPhiladelphiaPAUSARoche Diagnostics GmbHBavariaGermanyRoche Diagnostics GmbHBavariaGermanyRoche DiagnosticsIndianapolisINUSAClinical DevelopmentAvid RadiopharmaceuticalsPhiladelphiaPAUSAEli Lilly and CompanyWindleshamSurreyUKEli Lilly and CompanyIndianapolisINUSAEli Lilly and CompanyIndianapolisINUSAEli Lilly and CompanyIndianapolisINUSAIndiana University School of MedicineIndianapolisINUSAAbstract Introduction An Elecsys® Amyloid β (Aβ [1–42]) immunoassay cutoff for classification of patients with Alzheimer's disease was investigated. Methods Cerebrospinal fluid samples collected from patients with mild‐to‐moderate Alzheimer's disease were analyzed by Elecsys® immunoassays: (1) Aβ (1–42), (2) total tau, and (3) phosphorylated tau. Cutoffs (Aβ [1–42] and ratios with tau) were estimated by method comparison between AlzBio3 (n = 206), mixture modeling (n = 216), and concordance with florbetapir F 18 imaging‐based classification (n = 75). Results A 1065‐pg/mL (95% confidence interval: 985–1153) Elecsys® Aβ (1–42) cutoff provided 94% overall percentage agreement with AlzBio3. Comparable cutoff estimates (95% confidence interval) were derived from mixture modeling (equally weighted: 1017 [949–1205] pg/mL; prevalence weighted: 1172 [1081–1344] pg/mL) and concordance with florbetapir F 18 imaging (visual read: 1198 [998–1591] pg/mL; automated: 1198 [1051–1638] pg/mL). Discussion Based on three approaches, a 1100‐pg/mL Elecsys® Aβ (1–42) cutoff is suitable for clinical trials with similar populations and preanalytical handling.https://doi.org/10.1016/j.dadm.2018.07.002Alzheimer's diseaseBiomarkersImmunoassayAmyloid βCerebrospinal fluidMethod comparison |
| spellingShingle | Leslie M. Shaw Teresa Waligorska Leona Fields Magdalena Korecka Michal Figurski John Q. Trojanowski Udo Eichenlaub Simone Wahl Marian Quan Michael J. Pontecorvo D. Richard Lachno Jayne A. Talbot Scott W. Andersen Eric R. Siemers Robert A. Dean Derivation of cutoffs for the Elecsys® amyloid β (1–42) assay in Alzheimer's disease Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring Alzheimer's disease Biomarkers Immunoassay Amyloid β Cerebrospinal fluid Method comparison |
| title | Derivation of cutoffs for the Elecsys® amyloid β (1–42) assay in Alzheimer's disease |
| title_full | Derivation of cutoffs for the Elecsys® amyloid β (1–42) assay in Alzheimer's disease |
| title_fullStr | Derivation of cutoffs for the Elecsys® amyloid β (1–42) assay in Alzheimer's disease |
| title_full_unstemmed | Derivation of cutoffs for the Elecsys® amyloid β (1–42) assay in Alzheimer's disease |
| title_short | Derivation of cutoffs for the Elecsys® amyloid β (1–42) assay in Alzheimer's disease |
| title_sort | derivation of cutoffs for the elecsys r amyloid β 1 42 assay in alzheimer s disease |
| topic | Alzheimer's disease Biomarkers Immunoassay Amyloid β Cerebrospinal fluid Method comparison |
| url | https://doi.org/10.1016/j.dadm.2018.07.002 |
| work_keys_str_mv | AT lesliemshaw derivationofcutoffsfortheelecsysamyloidb142assayinalzheimersdisease AT teresawaligorska derivationofcutoffsfortheelecsysamyloidb142assayinalzheimersdisease AT leonafields derivationofcutoffsfortheelecsysamyloidb142assayinalzheimersdisease AT magdalenakorecka derivationofcutoffsfortheelecsysamyloidb142assayinalzheimersdisease AT michalfigurski derivationofcutoffsfortheelecsysamyloidb142assayinalzheimersdisease AT johnqtrojanowski derivationofcutoffsfortheelecsysamyloidb142assayinalzheimersdisease AT udoeichenlaub derivationofcutoffsfortheelecsysamyloidb142assayinalzheimersdisease AT simonewahl derivationofcutoffsfortheelecsysamyloidb142assayinalzheimersdisease AT marianquan derivationofcutoffsfortheelecsysamyloidb142assayinalzheimersdisease AT michaeljpontecorvo derivationofcutoffsfortheelecsysamyloidb142assayinalzheimersdisease AT drichardlachno derivationofcutoffsfortheelecsysamyloidb142assayinalzheimersdisease AT jayneatalbot derivationofcutoffsfortheelecsysamyloidb142assayinalzheimersdisease AT scottwandersen derivationofcutoffsfortheelecsysamyloidb142assayinalzheimersdisease AT ericrsiemers derivationofcutoffsfortheelecsysamyloidb142assayinalzheimersdisease AT robertadean derivationofcutoffsfortheelecsysamyloidb142assayinalzheimersdisease |