Kalluri Pavani, Naheed Aliya, Rahman Saifur, Ansaruzzaman Mohammad, Faruque Abu Syed Golam, Bird Michele, Khatun Fatema, Bhuiyan Nurul Amin, Nato Farida, Fournier Jean-Michel, Bopp Cheryl, Breiman Robert F, Nair Gopinath Balakrish, Mintz Eric D
Centers for Disease Control and Prevention, Atlanta, GA, USA.
Trop Med Int Health. 2006 Jan;11(1):49-55. doi: 10.1111/j.1365-3156.2005.01539.x.
To evaluate SMART, Medicos Dip Stick and an Institut Pasteur (IP) cholera dipstick tests for accuracy and ease of use.
Every 50th patient presenting with diarrhoea at ICDDR,B between 1 April 2003 and 30 November 2003 was enrolled. The rapid diagnostic tests were performed by field and laboratory technicians, and sensitivity (Se), specificity (Sp), positive (PPV) and negative (NPV) predictive values calculated.
We isolated Vibrio cholerae O1 from 116 (38%) of 304 patients. The Se, Sp, PPV and NPV of the SMART test were 58%, 95%, 84% and 84% for field technicians, and 83%, 88%, 83% and 88% for laboratory technicians. The Se, Sp, PPV and NPV of the IP dipstick test were 93%, 67%, 63% and 94% for field technicians, and 94%, 76%, 70% and 95% for laboratory technicians. The Se, Sp, PPV and NPV of the Medicos test were 84%, 79%, 71% and 90% for field technicians, and 88%, 80%, 72% and 92% for laboratory technicians. A high proportion of indeterminates (30%) hampered the performance of the SMART test. The IP dipstick had the highest Se, irrespective of technician skill level.
The IP dipstick is the most appropriate rapid diagnostic assay for the detection of V. cholerae O1 in locations where the skill level of personnel may be low, such as remote areas or refugee camp settings. High cost may limit the utility of any diagnostic test in the developing world.
评估SMART、Medicos Dip Stick以及巴斯德研究所(IP)霍乱快速检测试纸条检测的准确性和易用性。
纳入2003年4月1日至2003年11月30日期间在孟加拉腹泻病研究国际中心(ICDDR,B)每第50位出现腹泻症状的患者。由现场和实验室技术人员进行快速诊断检测,并计算敏感性(Se)、特异性(Sp)、阳性预测值(PPV)和阴性预测值(NPV)。
我们从304例患者中的116例(38%)分离出霍乱弧菌O1。对于现场技术人员,SMART检测的Se、Sp、PPV和NPV分别为58%、95%、84%和84%,对于实验室技术人员分别为83%、88%、83%和88%。对于现场技术人员,IP试纸条检测的Se、Sp、PPV和NPV分别为93%、67%、63%和94%,对于实验室技术人员分别为94%、76%、70%和95%。对于现场技术人员,Medicos检测的Se、Sp、PPV和NPV分别为84%、79%、71%和90%,对于实验室技术人员分别为88%、80%、72%和92%。高比例的不确定结果(30%)妨碍了SMART检测的性能。无论技术人员技能水平如何,IP试纸条具有最高的敏感性。
在人员技能水平可能较低的地区,如偏远地区或难民营环境中,IP试纸条是检测霍乱弧菌O1最合适的快速诊断检测方法。高成本可能会限制任何诊断检测在发展中国家的应用。