Multicenter Pivotal Clinical Trial of Urine Malaria Test for Rapid Diagnosis of Plasmodium falciparum Malaria.
Multicenter Pivotal Clinical Trial of Urine Malaria Test for Rapid Diagnosis of Plasmodium falciparum Malaria.
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DOI：
10.1128/jcm.01431-16
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发表时间：
2017-01
影响因子：
9.4
通讯作者：
Brieger W
中科院分区：
文献类型：
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作者：
Oyibo WA;Ezeigwe N;Ntadom G;Oladosu OO;Rainwater-Loveth K;O'Meara W;Okpokoro E;Brieger W
扩大疟疾诊断能力的必要性以及治疗前强制检测的政策要求促使人们探索非侵入性快速诊断检测。我们报告的结果，第一个横断面，单盲临床性能评估尿疟疾试验（UMT）诊断恶性疟原虫疟疾发热患者。采用UMT和显微镜检查（作为金标准）对≥2岁发热（腋温≥37.5°C）或前48小时内有发热史的参与者的匹配尿液和手指采血样本进行检测。进行BinaxNOW（Pf和Pan版本）血液RDT以评估相对性能。进行尿分析和类风湿因子（RF）检测，以评价可能的干扰。以95%置信区间（CI）计算诊断性能特征。在筛选的1，800名参与者中，1，691人入组;其中566人（34%）发热，1，125人（66%）无发热。在入组的参与者中，341例（20%）经显微镜检测呈阳性，419例（25%）经UMT检测呈阳性，676例（40%）经BinaxNOW Pf检测呈阳性，368例（22%）经BinaxNow Pan检测呈阳性。UMT在发热患者中的敏感性为85%，特异性为84%。在≤5岁的发热儿童中，UMT的敏感性为93%，特异性为83%。UMT（0.84）的受试者-操作者特征曲线下面积（AUC）与BinaxNOW Pf（0.86）或BinaxNOW Pan（0.87）无显著差异，表明检测的总体性能无差异。性别，季节和RF没有影响城市轨道交通的性能。尿中白细胞、血尿和尿胆素原浓度与较低的UMT特异性相关。UMT的性能与BinaxNOW Pf/Pan测试相当，使UMT成为一种有前途的工具，可以在公共和私人医疗保健环境中扩大疟疾测试，这些环境中存在血液疟疾诊断测试的挑战。
The need to expand malaria diagnosis capabilities alongside policy requirements for mandatory testing before treatment motivates exploration of noninvasive rapid diagnostic tests (RDTs). We report the outcome of the first cross-sectional, single-blind clinical performance evaluation of a urine malaria test (UMT) for diagnosis of Plasmodium falciparum malaria in febrile patients. Matched urine and finger-prick blood samples from participants ≥2 years of age with fever (axillary temperature of ≥37.5°C) or with a history of fever in the preceding 48 h were tested with UMT and microscopy (as the gold standard). BinaxNOW (Pf and Pan versions) blood RDTs were done to assess relative performance. Urinalysis and rheumatoid factor (RF) tests were conducted to evaluate possible interference. Diagnostic performance characteristics were computed at 95% confidence intervals (CIs). Of 1,800 participants screened, 1,691 were enrolled; of these 566 (34%) were febrile, and 1,125 (66%) were afebrile. Among enrolled participants, 341 (20%) tested positive by microscopy, 419 (25%) were positive by UMT, 676 (40%) were positive by BinaxNOW Pf, and 368 (22%) were positive by BinaxNow Pan. UMT sensitivity among febrile patients (for whom the test was indicated) was 85%, and specificity was 84%. Among febrile children ≤5 years of age, UMT sensitivity was 93%, and specificity was 83%. The area under the receiver-operator characteristic curve (AUC) of UMT (0.84) was not significantly different from that of BinaxNOW Pf (0.86) or of BinaxNOW Pan (0.87), indicating that the tests do not differ in overall performance. Gender, seasons, and RF did not impact UMT performance. Leukocytes, hematuria, and urobilinogen concentrations in urine were associated with lower UMT specificities. UMT performance was comparable to that of the BinaxNOW Pf/Pan tests, making UMT a promising tool to expand malaria testing in public and private health care settings where there are challenges to blood-based malaria diagnosis testing.