Objective:To evaluate the performance of a novel luminescence assay for the detection of central nervous system specific protein S100β,Pylon S100β assay.Methods:The precision,linear range,anti-interference ability and normal reference range of Pylon S100β assay were evaluated according to the relevant Clinical and Laboratory Standards Committee guidelines,and the method comparison study was conducted between Pylon S100β assay and Elecsys S100 assay based on a electroluminescence method.S100β levels of patients of different disease groups and healthy controls were compared to evaluate the clinical performance of Pylon S100β assay.Results:The reproducibility and within laboratory imprecision CVs of Pylon S100β was both 6.30％at the low concentration(mean 0.250 μg/L),and those were 6.48％and 6.53％respectively at the high concentration(mean 2.96 μg/L).The method showed linearity between 0.05 and 36.9μg/L.Interfering substances(triglyceride ≤15 mg/ml,hemoglobin ≤10 mg/ml,biotin ≤50 ng/ml,bilirubin ≤0.4 mg/ml)did not affect the detection by Pylon S100β.The reference range(＜0.105 μg/L)provided by the manufacturer is compatible with the test population of our laboratory.Pylon S100β assays and Roche Elecsys S100 assays were used to detect 40 samples,and the results of the two methods showed good consistency.S100β was significantly increased in patients with cardiopulmonary bypass surgery,coma,stroke,mild and severe traumatic brain injury(P＜0.001).Conclusion:Pylon S100β assay showed good detection precision,linearity and anti-interference ability,and the results of Pylon S100β assays are consistent with those of Elecsys S100 assays.Thus,Pylon S100β assay meets the requirements of clinical analysis.Moreover,S100β assay has potential clinical application value in a variety of diseases with brain injury.
维普
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