降钙素原检测在感染性疾病诊断中的干扰研究  

Analysis of interference in PCT detection for infectious diseases

作　　者：王伟佳[1] 张秀明[1] 阚丽娟[1] 徐全中[1] 欧阳能良[1] 

机构地区：[1]中山大学附属中山医院检验医学中心,广东中山528403

出　　处：《中华医院感染学杂志》2013年第13期3048-3050,3053,共4页Chinese Journal of Nosocomiology

基　　金：广东省医学科研基金资助(A2009763)

摘　　要：目的探讨降钙素原(PCT)检测在感染性疾病诊断中潜在的干扰因素,为临床医师合理分析检验结果及正确使用抗菌药物提供依据。方法采用美国临床实验室标准化研究所(CLSI)颁布的EP15-A2文件验证PCT常用检测仪器"电化学发光免疫检测系统Roche Cobas E601"对PCT检测的精密度和准确度,评价由于仪器本身原因造成的检测结果偏离;然后对患者标本在不同标本采集管和不同放置时间的检测结果进行对比分析,并采用EP7-A2文件探讨内源性干扰物对标本PCT检测的干扰,评价由于标本不合格造成的检测结果偏离;最后,在保证仪器运行及标本采集均符合要求情况下,对214例正常体检人群、血培养阳性早期脓毒症患者及血培养阴性、白细胞、C反应蛋白无明显升高的慢性心衰患者样本中PCT进行检测,探讨由于患者自身因素造成的检测结果干扰。结果 Cobas E601对PCT检测具有良好的重复性,总不精密度<3.59%,与定值校准品的偏差<3.38%,符合临床检测10.00%的要求;EDTA抗凝管检测PCT结果最为稳定(CV总=6.37%),可室温稳定保存至少24h;血红蛋白(2g/L)、直接胆红素(428μmol/L)、血乳糜(2000FIU)不会对PCT的检测造成影响;脓毒症患者、慢性心力衰竭患者及正常人群3组样本间PCT水平差异有统计学意义(P<0.05),早期脓毒症患者PCT水平最高(77.37±59.83)ng/ml,再者为慢性心力衰竭患者(14.56±10.26)ng/ml,正常对照组无明显升高(0.04±0.01)ng/ml。结论 PCT的检测仪器性能应符合临床要求,虽然检测仪器具有较强的抗干扰能力,但在评价合并有慢性心力衰竭的感染性疾病时,应客观分析PCT的诊断价值。OBJECTIVE To find the potential interference factors in the detection of PCT so as to provide basis for the reasonable analysis of the detection result and for the correct use of antibiotics.METHODS EP15-A2issued by Clinical and Laboratory Standards Institute（CLSI）was employed to evaluate the precision and accuracy of common PCT analyzer electrochemiluminescence immunoassay system Cobas E601,by which we could find out the deviation caused by analyzer itself.Moreover,PCT was detected in different times with different sample types,as well as in different interfered samples（haematolysis,choloplania,lipemia）which EP7-A2documents could be used in the evaluation.Then the deviation caused by unacceptable samples could be screened out.At last,PCT of 214samples which were from normal persons,early sepsis patients with positive cultures of blood,and chronic heart failure patients with negative cultures of blood were wed to find the deviation caused by patients endogenous factors.RESULTS The precision and accuracy were good for the PCT detection by using Cobas e601.The totalCV was below 3.59%and the deviation from definite value was below 3.38%,which were consistent with clinical requests（10%）.PCT could be stably analyzed in EDTA-anticoagulant plasma（CV=6.37%）,that the results of PCT could be stable in at least 24hwhen these suitable sample types were used in the detection.Interference could not be observed when the level of interference objectives up to Hb（2g/L）,DB（428μmol/L）,chyle（2000FIU）.There was a significant difference between the three groups（P〈0.05）.PCT level in sepsis patients was the highest up to（77.37±59.83）ng/ml,next to which was chronic heart failure patients up to（14.56±10.26）ng/ml.CONCLUSIONThe ability of Cobas e601is consistent with the clinical request.Although the analyzer has strong anti-interference PCT in normal control was not elevated significantly,the level was only（0.04±0.01ng / ml）.ability in the detection of PCT,in the diagnosis of infectious dis

关 键 词：降钙素原 感染性疾病 诊断 干扰 

分 类 号：R446[医药卫生—诊断学]