一种基于新型发光法的中枢神经特异性蛋白S100β检测试剂盒的性能评估

Performance evaluation of a central nervous system specific protein S100βdetection kit based on a novel luminescence method

目的:对基于新型发光法的Pylon中枢神经特异性蛋白S100β检测试剂的性能进行评估。方法:依据美国临床和实验室标准委员会相关文件方案对S100β检测试剂盒的分析性能,包括精密度、线性范围、抗干扰能力、正常人群参考区间等性能进行评估,并与电化学发光法ElecsysS100β检测进行方法学比对。比较不同疾病与健康人群的S100β水平,以评估该方法的临床应用价值。结果:PylonS100β检测在低浓度(平均值0.250μg/L)重复性精密度和实验室内总不精密度均为6.30%,在高浓度(平均值2.96μg/L)重复性精密度和实验室内总不精密度分别为6.48%、6.53%。该方法在0.05~36.9μg/L之间呈线性。干扰物质(甘油三酯≤15mg/mL、血红蛋白≤10mg/mL、生物素≤50ng/mL、胆红素≤0.4mg/mL)对PylonS100β检测结果无影响。PylonS100β检测厂家说明书申明的参考区间(<0.105μg/L)适合本实验室检测人群。40例样本同时进行PylonS100β检测与罗氏电化学发光法检测,结果表明两种检测方法结果一致性良好。在体外循环心脏手术后、ICU昏迷、脑卒中、轻度和重度创伤性脑损伤患者的S100β显著升高(P<0.001)。结论:PylonS100β检测具有良好的精密度、线性范围、抗干扰能力,其与罗氏电化学发光法S100检测结果一致性好,符合于临床分析的要求,并且S100β在多种脑损伤相关疾病中显示出潜在的临床应用价值。

Objective:To evaluate the performance of a novel luminescence assay for the detection of central nervous system specific protein S100β,Pylon S100βassay.Methods:The precision,linear range,anti-interference ability and normal reference range of Pylon S100βassay were evaluated according to the relevant Clinical and Laboratory Standards Committee guidelines,and the method comparison study was conducted between Pylon S100βassay and Elecsys S100 assay based on a electroluminescence method.S100βlevels of patients of different disease groups and healthy controls were compared to evaluate the clinical performance of Pylon S100βassay.Results:The reproducibility and within laboratory imprecision CVs of Pylon S100βwas both 6.30%at the low concentration(mean 0.250μg/L),and those were 6.48%and 6.53%respectively at the high concentration(mean 2.96μg/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(<0.105μg/L)provided by the manufacturer is compatible with the test population of our laboratory.Pylon S100βassays and Roche Elecsys S100 assays were used to detect 40 samples,and the results of the two methods showed good consistency.S100βwas significantly increased in patients with cardiopulmonary bypass surgery,coma,stroke,mild and severe traumatic brain injury(P<0.001).Conclusion:Pylon S100βassay showed good detection precision,linearity and anti-interference ability,and the results of Pylon S100βassays are consistent with those of Elecsys S100 assays.Thus,Pylon S100βassay meets the requirements of clinical analysis.Moreover,S100βassay has potential clinical application value in a variety of diseases with brain injury.