Development and testing of a rapid diagnostic test for bubonic and pneumonic plague
Development and testing of a rapid diagnostic test for bubonic and pneumonic plague
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DOI：
10.1016/s0140-6736(03)12270-2
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发表时间：
2003-01-18
期刊：
影响因子：
168.9
通讯作者：
Nato, A
中科院分区：
文献类型：
--
作者：
Chanteau, S;Rahalison, L;Nato, A
背景鼠疫如果得不到及时和适当的治疗往往是致命的。它主要影响贫困和偏远人口。诊断迟缓是造成人类死亡和疾病蔓延的主要原因之一，因为它限制了控制措施的有效性。目的：建立鼠疫快速诊断试验（RDT），并对其进行评价。用一系列细菌培养物和临床样本评估了灵敏度和特异性，并与现有的鼠疫ELISA和细菌学检测结果进行了比较。被认为有鼠疫患者的样本进行了测试与RDT在实验室和卫生工作者在26个试点网站在Madagasca.Findings的RDT检测浓度低至0. 5 ng/mL的F1抗原在长达15分钟，并有一个保质期为21天，在60 degreesC。其敏感性和特异性均为100%。RDT检测阳性临床标本分别比细菌学方法和ELISA方法高41.6%和31%。在远程中心和实验室进行的测试之间的一致率为89.8%。结合细菌学方法和F1 ELISA作为参考标准，ROT的阳性和阴性预测值分别为90.6%和86.7%，respectively.Interpretation我们的RDT是一种特异性，敏感性和可靠的测试，可以很容易地由卫生工作者在病人的床边，肺鼠疫和腺鼠疫的快速诊断。这一试验对于控制流行国家的鼠疫具有关键重要性。
Background Plague is often fatal without prompt and appropriate treatment. It affects mainly poor and remote populations. Late diagnosis is one of the major causes of human death and spread of the disease, since it limits the effectiveness of control measures. We aimed to develop and assess a rapid diagnostic test (RDT) for plague.Methods We developed a test that used monoclonal antibodies to the F1 antigen of Yersinia pestis. Sensitivity and specificity were assessed with a range of bacterial cultures and clinical samples, and compared with findings from available ELISA and bacteriological tests for plague. Samples from patients thought to have plague were tested with the RDT in the laboratory and by health workers in 26 pilot sites in Madagascar.Findings The RDT detected concentrations of F1 antigen as low as 0.5 ng/mL in up to 15 min, and had a shelf life of 21 days at 60degreesC. Its sensitivity and specificity were both 100%. RDT detected 41.6% and 31% more positive clinical specimens than did bacteriological methods and ELISA, respectively. The agreement rate between tests done at remote centres and in the laboratory was 89.8%. With the combination of bacteriological methods and F1 ELISA as reference standard, the positive and negative predictive values of the ROT were 90.6% and 86.7%, respectively.Interpretation Our RDT is a specific, sensitive, and reliable test that can easily be done by health workers at the patient's bedside, for the rapid diagnosis of pneumonic and bubonic plague. This test will be of key importance for the control of plague in endemic countries.