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Göteborgs universitets publikationer

Assessing the commutability of reference material formats for the harmonization of amyloid beta measurements.

Författare och institution:
Maria Bjerke (Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi); Ulf Andreasson (Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi); Julia Kuhlmann (-); Erik Portelius (Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi); Josef Pannee (Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi); Piotr Lewczuk (-); Robert M Umek (-); Eugeen Vanmechelen (-); Hugo Vanderstichele (-); Erik Stoops (-); Jennifer Lewis (-); Manu Vandijck (-); Vesna Kostanjevecki (-); Andreas Jeromin (-); Salvatore J Salamone (-); Oliver Schmidt (-); Anja Matzen (-); Kairat Madin (-); Udo Eichenlaub (-); Tobias Bittner (-); Leslie M Shaw (-); Ingrid Zegers (-); Henrik Zetterberg (Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi); Kaj Blennow (Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi)
Publicerad i:
Clinical chemistry and laboratory medicine : CCLM / FESCC, 54 ( 7 ) s. 1177-91
ISSN:
1437-4331
Publikationstyp:
Artikel, refereegranskad vetenskaplig
Publiceringsår:
2016
Språk:
engelska
Fulltextlänk:
Sammanfattning (abstract):
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.
Ämne (baseras på Högskoleverkets indelning av forskningsämnen):
MEDICIN OCH HÄLSOVETENSKAP ->
Medicinska grundvetenskaper ->
Neurovetenskaper
Nyckelord:
Alzheimer’s disease; amyloid; biomarker; cerebrospinal fluid; commutability; reference material
Postens nummer:
224917
Posten skapad:
2015-10-27 15:47
Posten ändrad:
2016-07-04 10:34

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