机构地区:[1]南方医科大学南方医院检验科,广州510515 [2]南方医科大学南方医院放疗科,广州510515
出 处:《中华检验医学杂志》2024年第11期1271-1276,共6页Chinese Journal of Laboratory Medicine
基 金:南方医科大学南方医院临床研究项目(2020CR025)。
摘 要:目的探讨提高EB病毒(EBV)核酸检测灵敏度对于鼻咽癌的诊断和疗效评估的价值。方法观察性研究。按照性能验证实验的要求,验证本研究所用的EBV DNA检测系统在100拷贝/ml水平的检测精密度,并通过与数字PCR法的比较评估检测系统的准确性。收集2021年12月至2022年5月就诊于南方医科大学南方医院的52份病理确诊为鼻咽部未分化非角化性癌的初诊患者血浆样本,以及156份在我院放疗科接受治疗的鼻咽癌患者血浆样本,回顾分析2021年12月至2022年5月南方医院送检EBV DNA定量检测样本5488份,比较将检测阈值限从500拷贝/ml提升至100拷贝/ml对鼻咽癌检出率和疗效评估的影响。结果在100拷贝/ml水平上,对样本进行30次重复检测,检测值与靶值的对数值偏倚均低于0.4(CV=6.94%)。用本研究使用的检测系统和数字PCR法分别测定156例鼻咽癌患者外周血中的EBV DNA,2种方法的测定结果一致性良好(r=0.95,P<0.001)。将EBV DNA检测阈值限从500拷贝/ml提升至100拷贝/ml,可使初诊未治疗的鼻咽癌患者检出率从67.31%(35/52)提高至82.69%(43/52)。对于治疗中的鼻咽癌患者,以500拷贝/ml和100拷贝/ml为检测阈值限,外周血EBV DNA检出率分别为12.82%(20/156)和23.72%(37/156)。结论提升EBV核酸检测灵敏度可提高EBV检出率,对于鼻咽癌患者的辅助诊断及疗效评估具有一定价值。Objectives To explore the value of improving the sensitivity of Epstein-Barr virus(EBV)DNA detection for the diagnosis and efficacy assessment of nasopharyngeal carcinoma.Methods This was an observational study.The precision of the EBV DNA detection system used in this study was verified at the level of 100 copies/ml in accordance with the requirements of verification experiments,and the accuracy of the detection system was evaluated by comparing with digital PCR method.Totally 52 plasma samples were collected from patients who were newly diagnosed with undifferentiated non-keratinizing carcinoma of the nasopharynx at Nanfang Hospital of Southern Medical University from December 2021 to May 2022 in addition to156 plasma samples from nasopharyngeal carcinoma patients treated at the Radiotherapy Department of the hospital,and a retrospective analysis was also performed on 5488 plasma samples that had been submitted for quantitative EBV DNA detection over the same period at the hospital.The effetcs of raising the EBV DNA detection threshold from 500 copies/ml to 100 copies/ml on the detection rate of nasopharyngeal carcinoma and the therapeutic efficacy assessment were compared.Results The bias between the logarithmic values of the detected quantities and the target quantities was below±0.4(CV=6.94%)for the testings of 30 repetitions of the sample at the level of 100 copies/ml.The circulating EBV DNA of 156 patients with nasopharyngeal carcinoma was measured by the detection system and by digital PCR,and the results of the two methods showed good consistency(r=0.95,P<0.001).By raising the EBV DNA detection threshold from 500 copies/ml to 100 copies/ml,the detection rate of nasopharyngeal carcinoma in untreated patients increased from 67.31%(35/52)to 82.69%(43/52).For nasopharyngeal carcinoma patients under treatment,the peripheral blood EBV DNA detection rates were 12.82%(20/156)and 23.72%(37/156)with detection thresholds of 500 copies/ml and 100 copies/ml,respectively.Conclusion This research improved the EBV dete
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