ArticleResearch square2026
Analytical validation of an ultrasensitive multiplexed immunoassay for blood-based biomarkers GFAP, NF-L and tau.
Article in Research square, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
Abstract
Background: Blood based biomarkers are increasingly used for non-invasive diagnostics, prognostics, stratification, and therapeutic monitoring, however clinical validation of new biomarkers is often limited by inconsistent assay methods. Assay developers can enable more reliable clinical studies by conducting analytical evaluation to characterize assay performance. In the context of brain injury and neurodegeneration, GFAP, NF-L and tau have emerged as potentially useful biomarkers for stratifying injury severity. Here we demonstrate analytical validation of the MSD Methods: Analytical validation testing consisted of multi-site, multi-lot precision, accuracy, stability, dynamic range, and interference. All testing was conducted with plasma, serum, and diluent-based control samples. The precision study was conducted at three sites: Meso Scale Diagnostics, LLC. (Rockville, MD), Johns Hopkins University (Baltimore, MD) and All Children's Hospital (Tampa, FL). Three kit lots were tested at all three sites for a fully crossed study design. All runs contained an 8-point duplicate calibrator curve, duplicate sample measurements, and control samples. Data were analyzed at each site and then transmitted to MSD for combined analysis. Results: There were no significant differences between reagent-lot measurements. Intra-plate %CV averaged less than 10%. Between-site comparison of GFAP, NF-L and tau measurements revealed a small but significant difference in measurements across study sites. Accuracy reported that native samples recover within ± 20% of expected concentration through 20-fold dilution, and spiked samples recover within ± 20% through 256-fold dilution. No substances in a panel of potential interferents affected quantitation by more than ± 20% except for erythropoietin. Kits are shelf stable through 24 months, and GFAP, NF-L and tau in samples can withstand at least five freeze/thaw cycles, storage for 24 hours at 4°C, and storage for four hours at ambient temperature. Conclusions: The MSD S-PLEX
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.