免疫比浊法检测肌红蛋白的性能验证及临床应用评估

摘要

Objective To evaluate the performance of serum myoglobin detection kit using immune turbidime‐try and investigate the clinical diagnosis value of myoglobin .Methods 150 healthy adults were enrolled in this case control study to establish serum myoglobin (Mb) reference value .The analytical performance (accuracy ,precision , linearity) of serum Mb detection kit using immune turbidimetry was assessed .Eighty patients were classified into dif‐ferent acute coronary syndrome groups according to their electrocardiographic examination .Serum Mb level of ACS group was compared with that of normal control group .In ACS group with statistical difference ,benign disease groups were further collected .Receiver operating characteristic (ROC) curve and area under curve (AUC) were used to evaluate the diagnostic value of Mb compared with other cardiac markers .Results The reference interval of Mb was < 70 .22 mg/L (males) and < 52 .22 mg/L (females) respectively ,which had statistically significant difference (t= 4 .39 ,P< 0 .05) .The detection result of 2 level controls was 100 .31 and 295 .50 mg/L respectively ,which were both within the acceptable limits .The within‐lot and between‐lot variations of four level samples were both below 5% .There was a good linear correlation between theoretical value and actual detection result in range of 0 - 800 mg/L .The serum level of Mb was (285 .28 ± 314 .63) ,(76 .24 ± 40 .77) and (44 .96 ± 12 .62) mg/L in ACS group ,non‐ACS group and normal control group respectively ,which had statistically significant difference(P< 0 .05) .The AUC of Mb was 0 .878 in ACS group .In ACS group ,the sensitivity of Mb was higher than that of cTnI and CK‐MB (80 .0% ,43 .7% and 57 .5% ) .Conclusion Experimental results show that serum myoglobin detection kit using im‐mune turbidimetry has good performance in the precision and linearity .%目的：对免疫比浊法检测肌红蛋白（Mb）的检测性能进行评价，并对 Mb 的临床应用进行评估。方法检测150例健康人（健康对照组）血清 Mb 水平，建立参考值范围，评估免疫比浊法检测 Mb 的准确度、精密度、线性。对80例急性冠脉综合征（ACS）患者按心电图结果分组后，比较 ACS 组血清 Mb 浓度与健康对照组是否存在差异。对于存在差异的 ACS 患者，进一步收集疾病对照组，通过绘制 ROC 曲线，评价 Mb 与其他心肌标志物的诊断性能。结果健康人血清 Mb 参考范围为＜70．22 mg／L（男）、＜52．22 mg／L （女），差异有统计学意义（t＝4．39， P＜ 0．05）。2个水平质控检测结果为100．31、295．50 mg／L ，均在厂商允许偏差范围内，批内、批间变异系数（CV）均在5％以内，0～800 mg／L 范围内线性良好。 ACS 组、非 ACS 组、健康对照组的 Mb 水平分别为（285．28±314．63）、（76．24±40．77）、（44．96±12．62）mg／L ，差异有统计学意义（P ＜ 0．05）。 Mb 在 ACS 组中的 ROC 曲线下面积（AUC）为 0．878。在 ACS 组中，Mb 的诊断敏感度为80．0％，优于肌钙蛋白 I（cTnI）的43．7％和肌酸激酶同工酶（CK‐MB）的57．5％。结论免疫比浊法检测 Mb 的检测性能符合要求。