两种不同检测系统测定血清降钙素原的比较实验研究(1)
摘要：目的 探讨三联生物微阵列化学发光检测系统测定血清降钙素原(PCT)结果的可靠性。方法 以罗氏Cobas e 601电化学发光检测系统为参照系统，三联生物微阵列化学发光检测系统为待评估系统，对血清PCT浓度进行测定并进行统计分析。结果罗氏电化学发光检测系统血清 PCT日内精密度的变异系数(CV)为5.33%～7.88%，日间CV为5.62%～8.56%。三联生物微阵列化学发光检测系统的日内CV为4.93%～7.28%，日间CV为5.47%～8.90%。两种检测系统有较好的相关性(回归方程y=1.174x+0.213，P<0.05)，相关系数r2为0.997。在医学决定水平(PCT为0.50 ng/ml和2.0 ng/ml)处的Kappa值分别为0.878(P=4.60×10-7)和0.933(P=7.72×10-8)，阳性符合率分别为94.44%和100.00%，阴性符合率分别为93.33%和95.45%。结论 三联生物微阵列化学发光免疫分析法与罗氏电化学发光法测定血清PCT结果相关性和一致性好，可用于临床血清PCT的快速检测。
, 百拇医药
关键词：降钙素原;血清;罗氏电化学发光法;三联生物微阵列化学发光免疫分析法
中图分类号：R346 文献标识码：A DOI：10.3969/j.issn.1006-1959.2019.06.055
文章编号：1006-1959(2019)06-0169-03
Abstract：Objective To investigate the reliability of the triple biomicroarray chemiluminescence detection system for the determination of serum procalcitonin (PCT) results. Methods The Roche Cobas e 601 electrochemiluminescence detection system was used as the reference system. The triple biomicroarray chemiluminescence detection system was used as the system to be evaluated. The serum PCT concentration was measured and statistically analyzed. Results The coefficient of variation (CV) of intra-day precision of PCT in the Roche electrochemiluminescence detection system was 5.33%～7.88%， and the daytime CV was 5.62%～8.56%. The intra-day CV of the triple biomicroarray chemiluminescence detection system was 4.93%～7.28%， and the daytime CV was 5.47%～8.90%. The two detection systems have a good correlation (regression equation y=1.174x+0.213， P<0.05) and the correlation coefficient r2 is 0.997. The Kappa values at the medical decision level (PCT 0.50 ng/ml and 2.0 ng/ml) were 0.878 (P=4.60×10-7) and 0.933 (P=7.72×10-8)， respectively. The positive coincidence rates were 94.44% and 100.00%， the negative coincidence rate was 93.33% and 95.45%.Conclusion The triple biomicroarray chemiluminescence immunoassay and Roche electrochemiluminescence method have good correlation and consistency in the determination of serum PCT results， which can be used for rapid detection of clinical serum PCT.
, 百拇医药
Key words：Procalcitonin;Serum;Roche electrochemiluminescence;Triple biomicroarray chemiluminescence immunoassay
降鈣素原(procalcitonin，PCT)是目前公认的细菌感染的标志物[1]。临床上，PCT常用于脓毒血症、感染性休克的辅助诊断，在小儿颅内感染[2]，血流感革兰氏阴、阳性菌[3]，凝固酶阴性葡萄球菌血流感染和污染血标本[4]等的鉴别诊断中发挥着重要作用。早期及时、准确测定血清PCT水平对及时发现潜在的细菌感染、积极指导临床用药和术后感染监测等均有重要意义。目前，由于仪器、试剂盒测定方法和实验室检测能力的差异，导致血清PCT测定结果仍有较大差异。为积极响应国家对国产仪器的研发、转化与应用，本研究以我院常用的罗氏电化学发光检测系统为参考检测系统，首次对江苏三联生物工程有限公司生产的微阵列化学发光免疫分析系统测定血清PCT结果的准确性和一致性进行评估，为该仪器及配套试剂的临床应用提供依据。, 百拇医药(田刚 丁俊杰 宋敏)
, 百拇医药
关键词：降钙素原;血清;罗氏电化学发光法;三联生物微阵列化学发光免疫分析法
中图分类号：R346 文献标识码：A DOI：10.3969/j.issn.1006-1959.2019.06.055
文章编号：1006-1959(2019)06-0169-03
Abstract：Objective To investigate the reliability of the triple biomicroarray chemiluminescence detection system for the determination of serum procalcitonin (PCT) results. Methods The Roche Cobas e 601 electrochemiluminescence detection system was used as the reference system. The triple biomicroarray chemiluminescence detection system was used as the system to be evaluated. The serum PCT concentration was measured and statistically analyzed. Results The coefficient of variation (CV) of intra-day precision of PCT in the Roche electrochemiluminescence detection system was 5.33%～7.88%， and the daytime CV was 5.62%～8.56%. The intra-day CV of the triple biomicroarray chemiluminescence detection system was 4.93%～7.28%， and the daytime CV was 5.47%～8.90%. The two detection systems have a good correlation (regression equation y=1.174x+0.213， P<0.05) and the correlation coefficient r2 is 0.997. The Kappa values at the medical decision level (PCT 0.50 ng/ml and 2.0 ng/ml) were 0.878 (P=4.60×10-7) and 0.933 (P=7.72×10-8)， respectively. The positive coincidence rates were 94.44% and 100.00%， the negative coincidence rate was 93.33% and 95.45%.Conclusion The triple biomicroarray chemiluminescence immunoassay and Roche electrochemiluminescence method have good correlation and consistency in the determination of serum PCT results， which can be used for rapid detection of clinical serum PCT.
, 百拇医药
Key words：Procalcitonin;Serum;Roche electrochemiluminescence;Triple biomicroarray chemiluminescence immunoassay
降鈣素原(procalcitonin，PCT)是目前公认的细菌感染的标志物[1]。临床上，PCT常用于脓毒血症、感染性休克的辅助诊断，在小儿颅内感染[2]，血流感革兰氏阴、阳性菌[3]，凝固酶阴性葡萄球菌血流感染和污染血标本[4]等的鉴别诊断中发挥着重要作用。早期及时、准确测定血清PCT水平对及时发现潜在的细菌感染、积极指导临床用药和术后感染监测等均有重要意义。目前，由于仪器、试剂盒测定方法和实验室检测能力的差异，导致血清PCT测定结果仍有较大差异。为积极响应国家对国产仪器的研发、转化与应用，本研究以我院常用的罗氏电化学发光检测系统为参考检测系统，首次对江苏三联生物工程有限公司生产的微阵列化学发光免疫分析系统测定血清PCT结果的准确性和一致性进行评估，为该仪器及配套试剂的临床应用提供依据。, 百拇医药(田刚 丁俊杰 宋敏)