Analytical and clinical evaluations of Snibe Maglumi® S100B assay.

Abstract

Objectives: To assess the analytical performances of Snibe Maglumi^® S100 assay and compare it with the Roche Elecsys^® S100B assay in adults with mild traumatic brain injury (mTBI) focusing on reducing unnecessary cranial computed tomography (CT) scans per Scandinavian and French guidelines.

Methods: Analytical performance of the Maglumi^® S100 kit was assessed using quality controls from both Snibe and Roche, as well as pooled serums. Clinical performances were assessed using serum from 89 adult mTBI patients presenting to the adult emergency department of Clermont-Ferrand University Hospital with a Glasgow Coma Scale score of 14-15. CT scans were performed according to the Elecsys^® S100 measurement, with a decision threshold of 0.10 μg/L.

Results: Repeatability and reproducibility coefficients of variation determined using Elecsys^® S100B, Maglumi^® S100 controls and pooled serums were below 8 %. Six (7 %) mTBI patients included had clinically relevant intracranial lesions observed on CT scan (CT+), and eighty-three (93 %) patients had no lesions (CT-). S100B medians in CT- and CT+ patients were significantly different: 0.125 (0.085-0.219) vs. 0.368 (0.231-0.489) (p=0.006) for Elecsys^®, and 0.073 (0.046-0.140) vs. 0.327 (0.230-0.353) for Maglumi^® (p=0.004). The areas under the ROC curves for intracranial lesion detection were similar: 0.82 (0.73-0.91; p=0.0084) and 0.83 (0.75-0.92; p=0.0063) for Elecsys^® and Maglumi^®, respectively.

Conclusions: The Maglumi^® S100B assay can be used in the management of mTBI patients to exclude unnecessary CT scans. Further studies are needed to validate a clinical decision threshold for CT scan decisions.