Prospective evaluation of three rapid diagnostic tests for diagnosis of human leptospirosis.
Prospective evaluation of three rapid diagnostic tests for diagnosis of human leptospirosis.
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DOI：
10.1371/journal.pntd.0002290
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发表时间：
2013
影响因子：
3.8
通讯作者：
Boer KR
中科院分区：
文献类型：
--
作者：
Goris MG;Leeflang MM;Loden M;Wagenaar JF;Klatser PR;Hartskeerl RA;Boer KR
通过显微镜凝集试验（MAT）或培养诊断钩端螺旋体病仅限于专业实验室。虽然ELISA技术更常见，但它们仍然需要实验室设施。快速诊断测试（RDTs）可用于简单的床旁诊断。本研究旨在前瞻性评价RDT LeptoTek Dri Dot、LeptoTek Lateral Flow和Leptocheck-WB的诊断性能。在2001年至2012年期间，在常规诊断（MAT、ELISA和培养）之前，对被送去诊断钩端螺旋体病的参与者的血清标本同时应用了一种或两种RDT。病例定义基于MAT、ELISA和培养结果。不符合病例定义的受试者被认为没有钩端螺旋体病。根据第一次提交的样本和配对样本，在总体分析中或根据发病后天数分层，确定诊断准确性。LeptoTek Dri Dot的总体灵敏度和特异性分别为75%和96%，LeptoTek Lateral Flow为78%和95%，Leptocheck-WB为78%和98%。根据第一份提交的样品，灵敏度较低（LeptoTek Dri Dot为51%，LeptoTek Lateral Flow为69%，Leptocheck-WB为55%），但当配对样本的结果合并时，尽管伴随着较低的特异性，（LeptoTek Dri Dot分别为82%和91%，LeptoTek Lateral Flow分别为86%和84%，Leptocheck-WB分别为80%和93%）。所有这三个测试目前抗体测试有助于钩端螺旋体病的诊断，从而支持临床怀疑，并有助于认识。由于被测RDT的总体灵敏度不超过80%，因此应谨慎仅依赖RDT结果，强烈建议通过参考试验进行确认。钩端螺旋体病是世界上传播最广的人畜共患病之一，可引起急性发热。这种疾病可以迅速发展成一种严重的，可能致命的，具有高死亡率的形式。需要进行实验室检查以确诊。从病人体内培养钩端螺旋体需要几个月的时间。因此，大多数使用的实验室检测是基于对钩端螺旋体抗体的检测。显微镜凝集试验被认为是参比标准品，但仅在专业实验室进行。在这项研究中，我们通过11年的前瞻性评估来测量三种快速诊断测试（RDTs）的诊断准确性。这些测试在15分钟内产生结果。RDT的总体敏感性（77%）和特异性（96%）相似。评价第一份提交的标本导致灵敏度较低（LeptoTek Dri Dot为51%，LeptoTek Lateral Flow为69%，Leptocheck-WB为55%）。当对配对标本进行评价时，灵敏度增加，但特异性降低（LeptoTek Dri Dot分别为82%和91%，LeptoTek Lateral Flow分别为86%和84%，Leptocheck-WB分别为80%和93%）。基于这些结果，仍然强烈建议通过参考检测进行确认，尽管RDT有助于钩端螺旋体病的诊断，从而支持临床怀疑并有助于提高认识。
Diagnosis of leptospirosis by the microscopic agglutination test (MAT) or by culture is confined to specialized laboratories. Although ELISA techniques are more common, they still require laboratory facilities. Rapid Diagnostic Tests (RDTs) can be used for easy point-of-care diagnosis. This study aims to evaluate the diagnostic performance of the RDTs LeptoTek Dri Dot, LeptoTek Lateral Flow, and Leptocheck-WB, prospectively. During 2001 to 2012, one or two of the RDTs at the same time have been applied prior to routine diagnostics (MAT, ELISA and culture) on serum specimens from participants sent in for leptospirosis diagnosis. The case definition was based on MAT, ELISA and culture results. Participants not fulfilling the case definition were considered not to have leptospirosis. The diagnostic accuracy was determined based on the 1st submitted sample and paired samples, either in an overall analysis or stratified according to days post onset of illness. The overall sensitivity and specificity for the LeptoTek Dri Dot was 75% respectively 96%, for the LeptoTek Lateral Flow 78% respectively 95%, and for the Leptocheck-WB 78% respectively 98%. Based on the 1st submitted sample the sensitivity was low (51% for LeptoTek Dri Dot, 69% for LeptoTek Lateral Flow, and 55% for Leptocheck-WB), but substantially increased when the results of paired samples were combined, although accompanied by a lower specificity (82% respectively 91% for LeptoTek Dri Dot, 86% respectively 84% for LeptoTek Lateral Flow, and 80% respectively 93% for Leptocheck-WB). All three tests present antibody tests contributing to the diagnosis of leptospirosis, thus supporting clinical suspicion and contributing to awareness. Since the overall sensitivity of the tested RDTs did not exceed 80%, one should be cautious to rely only on an RDT result, and confirmation by reference tests is strongly recommended. Leptospirosis is one of the world's most spread zoonoses causing acute fever. The illness can rapidly develop into a severe, potentially fatal, form with a high mortality rate. Laboratory tests are needed to confirm the diagnosis. Culturing leptospires from patient material can take months to grow. Therefore, most used laboratory tests are based on detection of antibodies against leptospires. The microscopic agglutination test is considered the reference standard but is only performed at specialized laboratories. In this study, we measured the diagnostic accuracy of three rapid diagnostic tests (RDTs) by doing a prospective evaluation during 11 years. These tests produce results within 15 minutes. The overall sensitivities (77%) and specificities (96%) were similar for the RDTs. Evaluating the first submitted specimen resulted in lower sensitivities (51% for LeptoTek Dri Dot, 69% for LeptoTek Lateral Flow, and 55% for Leptocheck-WB). When paired specimens were evaluated, the sensitivity increased although the specificity decreased (82% respectively 91% for LeptoTek Dri Dot, 86% respectively 84% for LeptoTek Lateral Flow, and 80% respectively 93% for Leptocheck-WB). Based on these results confirmation by reference tests is still strongly recommended, although the RDTs contribute to the diagnosis of leptospirosis, thus supporting clinical suspicion and contributing to awareness.
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实时PCR的开发和验证，用于检测临床材料中致病性钩端螺旋体。
影响因子：
3.7
作者：
Ahmed A;Engelberts MF;Boer KR;Ahmed N;Hartskeerl RA
通讯作者：
Hartskeerl RA
影响因子：
9.4
作者：
Smits, HL;van der Hoorn, MAWG;Hartskeerl, RA
通讯作者：
Hartskeerl, RA
影响因子：
9.3
作者：
Bossuyt, PM;Reitsma, JB;de Vet, HCW
通讯作者：
de Vet, HCW
DOI：
10.1016/s0172-5599(80)80045-9
发表时间：
1980-01-01
期刊：
ZENTRALBLATT FUR BAKTERIOLOGIE MIKROBIOLOGIE UND HYGIENE SERIES A-MEDICAL MICROBIOLOGY INFECTIOUS DISEASES VIROLOGY PARASITOLOGY
影响因子：
--
作者：
TERPSTRA, WJ;LIGTHART, GS;SCHOONE, GJ
通讯作者：
SCHOONE, GJ
影响因子：
4.9
作者：
Wuthiekanun, Vanaporn;Amornchai, Premjit;Peacock, Sharon J.
通讯作者：
Peacock, Sharon J.