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Assessing the commu...
Assessing the commutability of reference material formats for the harmonization of amyloid beta measurements.
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- Bjerke, Maria, 1977 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
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- Andreasson, Ulf, 1968 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
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Kuhlmann, Julia (author)
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- Portelius, Erik, 1977 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
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- Pannee, Josef, 1979 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
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Lewczuk, Piotr (author)
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Umek, Robert M (author)
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Vanmechelen, Eugeen (author)
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Vanderstichele, Hugo (author)
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Stoops, Erik (author)
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Lewis, Jennifer (author)
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Vandijck, Manu (author)
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Kostanjevecki, Vesna (author)
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Jeromin, Andreas (author)
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Salamone, Salvatore J (author)
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Schmidt, Oliver (author)
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Matzen, Anja (author)
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Madin, Kairat (author)
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Eichenlaub, Udo (author)
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Bittner, Tobias (author)
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Shaw, Leslie M (author)
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Zegers, Ingrid (author)
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- Zetterberg, Henrik, 1973 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
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- Blennow, Kaj, 1958 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
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(creator_code:org_t)
- 2015-10-23
- 2016
- English.
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In: Clinical chemistry and laboratory medicine : CCLM / FESCC. - : Walter de Gruyter GmbH. - 1437-4331 .- 1434-6621. ; 54:7, s. 1177-91
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Abstract
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- BACKGROUND: The cerebrospinal fluid (CSF) amyloid-β (Aβ42) peptide is an important biomarker for Alzheimer's disease (AD). Variability in measured Aβ42 concentrations at different laboratories may be overcome by standardization and establishing traceability to a reference system. Candidate certified reference materials (CRMs) are validated herein for this purpose. METHODS: Commutability of 16 candidate CRM formats was assessed across five CSF Aβ42 immunoassays and one mass spectrometry (MS) method in a set of 48 individual clinical CSF samples. Promising candidate CRM formats (neat CSF and CSF spiked with Aβ42) were identified and subjected to validation across eight (Elecsys, EUROIMMUN, IBL, INNO-BIA AlzBio3, INNOTEST, MSD, Simoa, and Saladax) immunoassays and the MS method in 32 individual CSF samples. Commutability was evaluated by Passing-Bablok regression and the candidate CRM termed commutable when found within the prediction interval (PI). The relative distance to the regression line was assessed. RESULTS: The neat CSF candidate CRM format was commutable for almost all method comparisons, except for the Simoa/MSD, Simoa/MS and MS/IBL where it was found just outside the 95% PI. However, the neat CSF was found within 5% relative distance to the regression line for MS/IBL, between 5% and 10% for Simoa/MS and between 10% and 15% for Simoa/MSD comparisons. CONCLUSIONS: The neat CSF candidate CRM format was commutable for 33 of 36 method comparisons, only one comparison more than expected given the 95% PI acceptance limit. We conclude that the neat CSF candidate CRM can be used for value assignment of the kit calibrators for the different Aβ42 methods.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Neurovetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Neurosciences (hsv//eng)
Keyword
- Alzheimer’s disease; amyloid; biomarker; cerebrospinal fluid; commutability; reference material
Publication and Content Type
- ref (subject category)
- art (subject category)
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Bjerke, Maria, 1 ...
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Andreasson, Ulf, ...
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Kuhlmann, Julia
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Portelius, Erik, ...
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Pannee, Josef, 1 ...
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Lewczuk, Piotr
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show more...
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Umek, Robert M
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Vanmechelen, Eug ...
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Vanderstichele, ...
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Stoops, Erik
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Lewis, Jennifer
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Vandijck, Manu
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Kostanjevecki, V ...
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Jeromin, Andreas
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Salamone, Salvat ...
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Schmidt, Oliver
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Matzen, Anja
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Madin, Kairat
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Eichenlaub, Udo
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Bittner, Tobias
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Shaw, Leslie M
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Zegers, Ingrid
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Zetterberg, Henr ...
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Blennow, Kaj, 19 ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Neurosciences
- Articles in the publication
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Clinical chemist ...
- By the university
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University of Gothenburg