Vijayachari P, Sugunan A P, Sehgal S C
National Leptospirosis Reference Centre, Regional Medical Research Centre (Indian Council of Medical Research), Port Blair, Andaman & Nicobar Islands, India.
Epidemiol Infect. 2002 Dec;129(3):617-21. doi: 10.1017/s0950268802007537.
Lepto Dri Dot is a new card agglutination test developed by the Dutch Royal Tropical Institute for the rapid diagnosis of leptospirosis. We evaluated the test in field conditions in The Andaman Islands. Patients suspected of leptospirosis who attended three primary health centres were included in the study. The test results were compared with blood culture or microscopic agglutination tests on paired serum samples; 74 of 124 patients were diagnosed as having leptospirosis based on these criteria. Lepto Dri Dot had a sensitivity of 67.6% (50/74) and a specificity of 66.0% (33/50) during week 1. During weeks 2-4 the values increased to 85.5% (47/55) and 80% (40/50) respectively. An IgM ELISA was also performed on the serum samples for comparison and this was marginally less sensitive, but more specific, during the first week of illness. The positivity rates for the Dri Dot test during days 2-3, 4-5 and 6-7 were 53.1% (17/32), 75.0% (18/24) and 83.3% (15/18), respectively. The corresponding values for ELISA were 28.1% (9/32), 54% (13/24) and 77.8% (14/18). Both Dri Dot and ELISA showed good agreement with the standard diagnostic criteria after the first week of illness (kappa= 0.65 and 0.74, respectively). The overall concordance of the two tests was 89.5 % (kappa = 0.79). The test does not require special storage or sophisticated equipment and can be performed by relatively low skilled personnel.
钩端螺旋体病快速诊断试剂盒(Lepto Dri Dot)是荷兰皇家热带病研究所研发的一种新型卡片凝集试验,用于钩端螺旋体病的快速诊断。我们在安达曼群岛的实地条件下对该试验进行了评估。本研究纳入了在三个初级卫生中心就诊的疑似钩端螺旋体病患者。将试验结果与配对血清样本的血培养或显微镜凝集试验结果进行比较;根据这些标准,124例患者中有74例被诊断为钩端螺旋体病。在第1周,钩端螺旋体病快速诊断试剂盒的敏感性为67.6%(50/74),特异性为66.0%(33/50)。在第2 - 4周,这些值分别增至85.5%(47/55)和80%(40/50)。还对血清样本进行了IgM酶联免疫吸附测定(ELISA)以作比较,在疾病的第一周,该方法敏感性略低,但特异性更高。在发病后第2 - 3天、4 - 5天和6 - 7天,快速诊断试剂盒试验的阳性率分别为53.1%(17/32)、75.0%(18/24)和83.3%(15/18)。ELISA的相应值分别为28.1%(9/32)、54%(13/24)和77.8%(14/18)。在发病第一周后,快速诊断试剂盒试验和ELISA与标准诊断标准均显示出良好的一致性(kappa值分别为0.65和0.74)。两种试验的总体一致性为89.5%(kappa值 = 0.79)。该试验不需要特殊储存或精密设备,且可由技术相对不熟练的人员进行操作。