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Validation of Immune-Complex Enzyme Immunoassays for Diagnosis of Pneumococcal Pneumonia among Adults in Kenya

机译:免疫复合酶免疫法在肯尼亚成年人肺炎球菌肺炎诊断中的验证

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The efficacy of pneumococcal vaccines in protecting against pneumococcal pneumonia can feasibly be measured only with a diagnostic technique that has a high specificity (0.98 to 1.00) and a sensitivity greatly exceeding that of blood cultures (>0.2 to 0.3). In this context immune-complex enzyme immunoassays (EIAs) offer a novel, convenient diagnostic method, and we have investigated three such assays with appropriate study populations in Kenya. Sera from 129 Kenyan adults with pneumococcal pneumonia and 97 ill controls from the same clinics, but without pneumococcal disease syndromes, were assayed with immune-complex EIAs for pneumolysin, C-polysaccharide, and mixed capsular polysaccharides (Pneumovax II). At an optical density (OD) threshold yielding a specificity of 0.95, the sensitivities (95% confidence intervals) of the assays were 0.22 (0.15 to 0.30), 0.26 (0.19 to 0.34), and 0.22 (0.15 to 0.29), respectively. For pneumolysin immune complexes, human immunodeficiency virus (HIV)-positive patients had a higher mean OD than HIV-negative patients (639 versus 321;P < 0.0001), but stratification by HIV infection status did not alter the performance of this test. Combining the results of all three EIAs did not enhance the diagnostic performances of the individual assays. In Kenyan adults the sensitivities of the immune-complex EIAs could exceed that of blood cultures only at levels of specificity that were insufficient for the performance of vaccine efficacy studies.
机译:肺炎球菌疫苗预防肺炎球菌性肺炎的功效仅可通过具有高特异性(0.98至1.00)且灵敏度大大超过血液培养物(> 0.2至0.3)的诊断技术来测量。在这种情况下,免疫复合酶免疫测定法(EIA)提供了一种新颖,便捷的诊断方法,并且我们在肯尼亚采用适当的研究人群研究了三种此类测定法。使用免疫复合物EIA对肺炎球菌溶血素,C多糖和混合荚膜多糖(Pneumovax II)进行免疫复合EIA分析,分析了来自同一诊所的129名肯尼亚肺炎球菌肺炎和97名患病对照的肯尼亚成年人的血清。在产生0.95特异性的光密度(OD)阈值下,测定的灵敏度(95%置信区间)分别为0.22(0.15至0.30),0.26(0.19至0.34)和0.22(0.15至0.29)。对于肺炎球菌溶血素免疫复合物,人类免疫缺陷病毒(HIV)阳性患者的平均OD值高于HIV阴性患者(639 vs 321; P <0.0001),但HIV感染状况的分层并未改变此测试的性能。将所有三个EIA的结果相结合并不能提高单个测定的诊断性能。在肯尼亚成年人中,免疫复合物EIA的敏感性仅在其特异性水平不足以进行疫苗功效研究的情况下才能超过血液培养物。

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