NfL reliability across laboratories, stage-dependent diagnostic performance and matrix comparability in genetic FTD: a large GENFI study.
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Linnemann Christoph, Wilke Carlo, Mengel David, Zetterberg Henrik, Heller Carolin, Kuhle Jens, Bouzigues Arabella, Russell Lucy L, Foster Phoebe H, Ferry-Bolder Eve, Van Swieten John Cornelis, Jiskoot Lize C, Seelaar Harro, Moreno Fermin, Borroni Barbara, Sánchez-Valle Raquel, Galimberti Daniela, Laforce Robert, Graff Caroline, Masellis Mario, Tartaglia Maria Carmela, Rowe James Benedict, Finger Elizabeth, Vandenberghe Rik, de Mendonca Alexandre, Butler Chris R, Gerhard Alexander, Ducharme Simon, Ber Isabelle L E, Tiraboschi Pietro, Santana Isabel, Pasquier Florence, Levin Johannes, Otto Markus, Sorbi Sandro, Rohrer Jonathan Daniel, Synofzik Matthis, GENFI
Аннотация
METHODS: Comparative analysis of blood NfL levels in a large gFTD cohort (GENFI) for (1)-(4), with n=344 samples (n=148 presymptomatic, n=11 converter, n=46 symptomatic subjects, with mutations in C9orf72, GRN or MAPT; and n=139 within-family controls), each measured in three different international labs by Simoa HD-1 analyzer.
RESULTS: NfL revealed an excellent consistency (intraclass correlation coefficient (ICC) 0.964) and high reliability across the three labs (maximal bias (pg/mL) in Bland-Altman analysis: 1.12±1.20). High concordance of NfL across laboratories was moreover reflected by high areas under the curve for discriminating conversion stage against the (non-converting) presymptomatic stage across all three labs. Serum and plasma NfL were largely comparable (ICC 0.967). The robustness of NfL across 13 recruiting sites was demonstrated by a linear mixed effect model.
CONCLUSIONS: Our results underline the suitability of blood NfL in gFTD multicentre trials, including cross-lab reliable stratification of the highly trial-relevant conversion stage, matrix comparability and cross-site robustness.