基于磁微粒化学发光法的sST2检测性能验证

Performance verification of sST2 detection based on magnetic microparticle chemiluminescence

目的对磁微粒化学发光法检测可溶性生长刺激表达基因2蛋白(sST2)进行性能验证,评价该方法的稳定性与可靠性。方法采用基于磁微粒化学发光法的试剂盒,对患者及健康人群的血清及厂家提供的质控物质进行检测并对该方法进行性能评价。结果经试验检测,该方法的精密度(血清:低值及高值CV分别为2.2%及2.3%、质控品:低值及高值CV分别为1.7%及1.5%)、重复性(血清:低值及高值CV分别为1.07%及1.41%、质控品:低值及高值CV分别为0.98%及1.23%)、线性范围(血清:1.00~300.00 ng/mL范围内方法一r为0.9999、方法二r为0.9998,质控品:6.40~200.00 ng/mL范围内方法一r为0.9999、方法二r为0.9999)、最低检测限(0.028 ng/mL)、临床可报告范围(40倍稀释)、参考区间验证(健康人样本靶值均在参考区间内)、临床样本对比测试(与参照方法对比阳性及阴性符合率分别为96.88%及96.55%)、样本稳定性测试(高、低值样本室温静置3 d相对偏差为-15.3%及-14.6%,而2~8℃静置7 d相对偏差为-0.44%及0.39%,-20℃静置7 d相对偏差为-2.08%及-0.72%),具有较好稳定性、干扰实验(胆红素≤1 mmol/L、血红蛋白≤10 g/L、脂肪乳≤20 g/L时,对样本检测无明显干扰作用)结果均符合临床应用需求。结论基于磁微粒化学发光法检测试剂盒符合临床应用要求,适于临床应用推广。

Objective To verify the performance of soluble growth stimulating express gene 2(sST2)protein detection based on the magnetic microparticle chemiluminescence method,and evaluate its stability and reliability.Methods The serum samples from patients and healthy persons and quality control materials provided by the manufacturer were detected by the kit based on the magnetic microparticle chemiluminescence method,and its performance was evaluated.Results When the samples were detected one day at a time for 5 days,the coefficients of variation(CVs)of serum samples with low and high sST2 levels were 2.2%and 2.3%,respectively,and those of quality control materials were 1.7%and 1.5%,respectively.When the samples were detected 20 times repeatedly,the CVs of serum samples with low and high sST2 levels were 1.07%and 1.41%,respectively,and those of quality control materials were 0.98%and 1.23%,respectively.When serum sST2 levels were in the range of 1.00-300.00 ng/mL,the correlation coefficient(r)was 0.9999 and 0.9998.When the sST2 levels in quality control materials were in the range of 6.40-200.00 ng/mL,the r was beyond 0.9999.The lowest detection limit of the kit was 0.028 ng/mL.When serum samples were diluted to 40 folds,the detection results of the kit were still accepted.The levels of serum sST2 from 40 healthy persons were in the reference interval.The positive and negative coincidence rates were 96.88%and 96.55%,respectively,between the kit and reference method.The relative deviations of serum samples with low and high sST2 levels were-15.3%and-14.6%for storing 3 days at room temperature,-0.44%and 0.39%for storing 7 days at 2-8℃,and-2.08%and-0.72%for storing 7 days at-20℃,respectively.There was no obvious interference effect on the detection of serum sST2 levels when the concentrations of serum bilirubin,hemoglobin and fat emulsion were less than 1 mmol/L,10 g/L and 20 g/L,respectively.Conclusion All of the precision,repeatability,linear range,lowest detection limit,clinical reportable range,reference interval validation,and the results of clinical sample comparison test,sample stability test and interference test of the detection kit based on the magnetic microparticle chemiluminescence method meet the requirements of clinical application,which can be applied in the clinical laboratory.