Multicentre comparison of a diagnostic assay: aquaporin-4 antibodies in neuromyelitis optica.
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Waters Patrick, Reindl Markus, Saiz Albert, Schanda Kathrin, Tuller Friederike, Kral Vlastimil, Nytrova Petra, Sobek Ondrej, Nielsen Helle Hvilsted, Barington Torben, Lillevang Søren T, Illes Zsolt, Rentzsch Kristin, Berthele Achim, Berki Tímea, Granieri Letizia, Bertolotto Antonio, Giometto Bruno, Zuliani Luigi, Hamann Dörte, van Pelt E Daniëlle, Hintzen Rogier, Höftberger Romana, Costa Carme, Comabella Manuel, Montalban Xavier, Tintoré Mar, Siva Aksel, Altintas Ayse, Deniz Günnur, Woodhall Mark, Palace Jacqueline, Paul Friedemann, Hartung Hans-Peter, Aktas Orhan, Jarius Sven, Wildemann Brigitte, Vedeler Christian, Ruiz Anne, Leite M Isabel, Trillenberg Peter, Probst Monika, Saschenbrecker Sandra, Vincent Angela, Marignier Romain
Аннотация
METHODS: Coded samples from patients with neuromyelitis optica (NMO) or NMOSD (101) and controls (92) were tested at 15 European diagnostic centres using 21 assays including live (n=3) or fixed cell-based assays (n=10), flow cytometry (n=4), immunohistochemistry (n=3) and ELISA (n=1).
RESULTS: Results of tests on 92 controls identified 12assays as highly specific (0-1 false-positive results). 32 samples from 50 (64%) NMO sera and 34 from 51 (67%) NMOSD sera were positive on at least two of the 12 highly specific assays, leaving 35 patients with seronegative NMO/spectrum disorder (SD). On the basis of a combination of clinical phenotype and the highly specific assays, 66 AQP4-Ab seropositive samples were used to establish the sensitivities (51.5-100%) of all 21 assays. The specificities (85.8-100%) were based on 92 control samples and 35 seronegative NMO/SD patient samples.
CONCLUSIONS: The cell-based assays were most sensitive and specific overall, but immunohistochemistry or flow cytometry could be equally accurate in specialist centres. Since patients with AQP4-Ab negative NMO/SD require different management, the use of both appropriate control samples and defined seronegative NMOSD samples is essential to evaluate these assays in a clinically meaningful way. The process described here can be applied to the evaluation of other antibody assays in the newly evolving field of autoimmune neurology.