Sensitivity and specificity of HAT Sero-K-SeT, a rapid diagnostic test for serodiagnosis of sleeping sickness caused by Trypanosoma brucei gambiense: a case-control study
Sensitivity and specificity of HAT Sero-K-SeT, a rapid diagnostic test for serodiagnosis of sleeping sickness caused by Trypanosoma brucei gambiense: a case-control study
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DOI：
10.1016/s2214-109x(14)70203-7
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发表时间：
2014-06-01
影响因子：
34.3
通讯作者：
Lejon, Veerle
中科院分区：
文献类型：
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作者：
Buscher, Philippe;Mertens, Pascal;Lejon, Veerle
背景 非洲人类锥虫病 (HAT) 是一种危及生命的感染，影响撒哈拉以南非洲的农村人口。使用卡凝集试验卡凝集试验对冈比亚锥虫病 (CATT)/布氏锥虫 (T b) 进行抗体检测进行大规模人群筛查，帮助将 2011 年报告的冈比亚 HAT 病例数量减少到不足 10 000 例。由于病例数低导致此类主动筛查的成本效益降低，我们旨在评估快速血清诊断测试 (HAT Sero-K-SeT) 的诊断准确性方法 在我们的病例对照研究中，我们评估了在刚果民主共和国班顿杜省初级保健中心或流动小组（以及在这些中心确诊疾病状况的现有患者）接受 HAT Sero-K-SeT 和 CATT/T b gambiense 治疗的 11 岁以上参与者。我们将病例定义为在淋巴结抽吸物、血液或脑脊液中发现锥虫的患者。在筛查过程中，我们招募了没有 HAT 病史或血液或淋巴液中未检测到锥虫且与病例居住在同一区域的对照组。我们评估了冈比亚 HAT 的三种抗体检测测试的诊断准确性：HAT Sero-K-SeT 和 CATT/T b 冈比亚（在初级保健中心使用静脉血进行）和免疫锥虫分析（在比利时安特卫普热带医学研究所使用血浆进行）。结果 2012 年 6 月 6 日至 2013 年 2 月 25 日期间，我们纳入了 134 例病例和 356 名对照者。 HAT Sero-K-SeT 的敏感性为 0.985（132 个真阳性，95% CI 0.947-0.996），特异性为 0.986（351 个真阴性，0.968-0.994），与 CATT/T b gambiense（敏感性 95% CI 0.955，95% CI）没有显着差异。 0.906-0.979 [128 个真阳性] 和特异城市 0.972、0.949-0.985 [346 个真阴性]）或免疫锥虫分析（灵敏度 0.985、0.947-0.996 [132 个真阳性] 和特异城市 0.980、0.960-0.990 [349真阴性]）。解释 HAT Sero-K-SeT 的诊断准确性足以在当地卫生中心检测 b 冈比亚抗体，并且可以在冷链和电力供应不可用且无法进行 CATT/T b 冈比亚抗体时用于主动筛查。为欧盟委员会 FP7（NIDIAG，拨款协议 260260）和世界卫生组织控制被忽视的热带病、创新和强化疾病管理提供资金。
Background Human African trypanosomiasis (HAT) is a life-threatening infection affecting rural populations in sub-Saharan Africa. Large-scale population screening by antibody detection with the Card Agglutination Test for Trypanosomiasis (CATT)/Trypanosoma brucei (T b) gambiense helped reduce the number of reported cases of gambiense HAT to fewer than 10 000 in 2011. Because low case numbers lead to decreased cost-effectiveness of such active screening, we aimed to assess diagnostic accuracy of a rapid serodiagnostic test (HAT Sero-K-SeT) applicable in primary health-care centres.Methods In our case-control study, we assessed participants older than 11 years who presented for HAT Sero-K-SeT and CATT/T b gambiense at primary care centres or to mobile teams (and existing patients with confirmed disease status at these centres) in Bandundu Province, DR Congo. We defined cases as patients with trypanosomes that had been identified in lymph node aspirate, blood, or cerebrospinal fluid. During screening, we recruited controls without previous history of HAT or detectable trypanosomes in blood or lymph who resided in the same area as the cases. We assessed diagnostic accuracy of three antibody detection tests for gambiense HAT: HAT Sero-K-SeT and CATT/T b gambiense (done with venous blood at the primary care centres) and immune trypanolysis (done with plasma at the Institute of Tropical Medicine, Antwerp, Belgium).Findings Between June 6, 2012, and Feb 25, 2013, we included 134 cases and 356 controls. HAT Sero-K-SeT had a sensitivity of 0.985 (132 true positives, 95% CI 0.947-0.996) and a specificity of 0.986 (351 true negatives, 0.968-0.994), which did not differ significantly from CATT/T b gambiense (sensitivity 95% CI 0.955, 95% CI 0.906-0.979 [128 true positives] and specifi city 0.972, 0.949-0.985 [346 true negatives]) or immune trypanolysis (sensitivity 0.985, 0.947-0.996 [132 true positives] and specifi city 0.980, 0.960-0.990 [349 true negatives]). Interpretation The diagnostic accuracy of HAT Sero-K-SeT is adequate for T b gambiense antibody detection in local health centres and could be used for active screening whenever a cold chain and electricity supply are unavailable and CATT/T b gambiense cannot be done.Funding European Commission FP7 (NIDIAG, Grant Agreement 260260) and WHO Control of Neglected Tropical Diseases, Innovative and Intensified Disease Management.