Diagnostic Accuracy of PCR in gambiense Sleeping Sickness Diagnosis, Staging and Post-Treatment Follow-Up: A 2-year Longitudinal Study
Diagnostic Accuracy of PCR in gambiense Sleeping Sickness Diagnosis, Staging and Post-Treatment Follow-Up: A 2-year Longitudinal Study
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DOI：
10.1371/journal.pntd.0000972
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发表时间：
2011-02-01
影响因子：
3.8
通讯作者：
Buscher, Philippe
中科院分区：
文献类型：
--
作者：
Deborggraeve, Stijn;Lejon, Veerle;Buscher, Philippe
工作背景：聚合酶链反应（PCR）已被提出用于昏睡病的诊断，分期和治疗后随访，但没有大规模的临床评价其诊断准确性已经发生you.Methodology/主要发现：18 S核糖体RNA基因靶向PCR进行血液和脑脊液（CSF）的360 T。布氏冈比亚昏睡病患者和12名血液（来自刚果民主共和国的地方病控制。PCR诊断的敏感性和特异性（95%的置信区间），疾病分期和治疗失败超过2年的治疗后随访进行了测定。参考标准试验为用于诊断的锥虫检测和用于分期和检测治疗失败的锥虫检测和/或CSF中白色血细胞浓度升高。血液PCR诊断的敏感性为88.4%（84.4-92.5%），特异性为99.2%（97.7 ~ 100%）;脑脊液PCR诊断的敏感性为88.4%（84.8-91.9%），特异性为82.9%（71.2-94.6%）。在治疗后随访期间，血液PCR检测治疗失败的敏感性较低。在脑脊液中，PCR阳性慢慢消失，并观察到，直到2年的随访结束时，在大约20%的成功治疗的患者。虽然PCR技术在冈比亚昏睡病诊断和分期方面优于或类似于目前的寄生虫检测技术，但它不能用于治疗后随访。五分之一治愈患者的持续PCR阳性表明成功治疗后活的或死的寄生虫或其DNA的持续存在，并且可能需要修改关于昏睡病病理生理学的一些范例。
Background: The polymerase chain reaction (PCR) has been proposed for diagnosis, staging and post-treatment follow-up of sleeping sickness but no large-scale clinical evaluations of its diagnostic accuracy have taken place yet.Methodology/Principal Findings: An 18S ribosomal RNA gene targeting PCR was performed on blood and cerebrospinal fluid (CSF) of 360 T. brucei gambiense sleeping sickness patients and on blood of 12(endemic controls from the Democratic Republic of Congo. Sensitivity and specificity (with 95% confidence intervals) of PCR for diagnosis, disease staging and treatment failure over 2 years follow-up post-treatment were determined. Reference standard tests were trypanosome detection for diagnosis and trypanosome detection and/or increased white blood cell concentration in CSF for staging and detection of treatment failure. PCR on blood showed a sensitivity of 88.4% (84.4-92.5%) and a specificity of 99.2% (97.7-100%) for diagnosis, while for disease staging the sensitivity and specificity of PCR on cerebrospinal fluid were 88.4% (84.8-91.9%) and 82.9% (71.2-94.6%), respectively. During follow-up after treatment, PCR on blood had low sensitivity to detect treatment failure. In cerebrospinal fluid, PCR positivity vanished slowly and was observed until the end of the 2 year follow-up in around 20% of successfully treated patients.Conclusions/Significance: For T.b. gambiense sleeping sickness diagnosis and staging, PCR performed better than, or similar to, the current parasite detection techniques but it cannot be used for post-treatment follow-up. Continued PCR positivity in one out of five cured patients points to persistence of living or dead parasites or their DNA after successful treatment and may necessitate the revision of some paradigms about the pathophysiology of sleeping sickness.