Field application of Lepto lateral flow for rapid diagnosis of leptospirosis

Field application of Lepto lateral flow for rapid diagnosis of leptospirosis
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DOI:
10.1099/jmm.0.05064-0
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发表时间:
2003-10-01
影响因子:
3
通讯作者:
Umapathi, T
Umapathi, T
中科院分区:
医学3区
文献类型:
--
作者:
Sehgal, SC;Vijayachari, P;Umapathi, T

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在流行钩端螺旋体病的安达曼群岛的一个初级卫生中心,对钩端螺旋体病的Lepto横向流动测定法进行了评估。117名疑似患者被纳入研究;收集全部患者急性期血清和恢复期血清104例。诊断钩端螺旋体病的标准标准是:(i)从血液中分离钩端螺旋体,(ii)显微镜凝集试验(MAT)血清转化,最低滴度为100,(iii)显微镜凝集试验(MAT)滴度提高4倍,或(iv)如果只有单一样本,MAT滴度为400或更高。横向流动试验结果与这些准则进行了比较。Lepto侧流在发病第1周敏感性为52.9%(37/70),第2-4周敏感性为86%(49/57)。特异性分别为93.6%(44/47)和89.4%(42/47)。发病第2-3天敏感性为34.3%(12/35),第4-5天敏感性为63.3%(14/22),第1周末敏感性为84.6%(11/13)。第一周的阳性预测值为92.5%(37/40),随后的阳性预测值为90.7%(49/54)。相应的阴性预测值分别为57.1%(44/77)和84%(42/50)。结果与标准标准的一致性在第1周较低,但在第2-4周较高,kappa值为0.7491。检测阳性率与样品的MAT滴度呈对数关系(r(2) = 0.9271)。横向流动的有效性和效用指标与IgM ELISA和Lepto试纸相似。该测试可以在患者床边进行,因为也可以使用全血进行测试。
The Lepto lateral flow assay for leptospirosis was evaluated at a primary health centre in the Andaman Islands, where leptospirosis is endemic. One hundred and seventeen suspected patients were included in the study; acute serum samples were collected from all of them and convalescent samples from 104. The standard criteria for diagnosis of leptospirosis were: (i) isolation of leptospires from blood, (ii) seroconversion in microscopic agglutination test (MAT) with a minimum titre of 100, (iii) a fourfold rise in titre in MAT or (iv) a MAT titre of 400 or more if only a single sample was available. The results of the lateral flow test were compared with these criteria. Lepto lateral flow had sensitivity of 52.9 % (37/70) in the first week of illness and 86 % (49/57) during weeks 2-4. The corresponding specificities were respectively 93.6 % (44/47) and 89.4 % (42/47). The sensitivity was 34.3 % (12/35) on days 2-3 of the illness, 63.3 % (14/22) on days 4-5 and 84.6 % (11/13) at the end of the first week. The test had a positive predictive value of 92.5 % (37/40) during the first week and 90.7 % (49/54) subsequently. Corresponding negative predictive values were respectively 57.1 % (44/77) and 84 % (42/50). Agreement of the results with the standard criteria was low during the first week, but high during weeks 2-4, with a kappa value of 0.7491. The positivity rates of the tests showed a logarithmic relationship with the MAT titres of samples (r(2) = 0.9271). All indices of validity and utility of lateral flow were similar to those of IgM ELISA and Lepto dipstick. The test can be performed at the bedside of the patient, as whole blood can also be used for testing.