Validation of rK39 immunochromatographic test and direct agglutination test for the diagnosis of Mediterranean visceral leishmaniasis in Spain.
Validation of rK39 immunochromatographic test and direct agglutination test for the diagnosis of Mediterranean visceral leishmaniasis in Spain.
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DOI：
10.1371/journal.pntd.0006277
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发表时间：
2018-03
影响因子：
3.8
通讯作者：
Cruz I
中科院分区：
文献类型：
--
作者：
Bangert M;Flores-Chávez MD;Llanes-Acevedo IP;Arcones C;Chicharro C;García E;Ortega S;Nieto J;Cruz I
内脏利什曼病（VL）是利什曼病最严重的形式，在欧洲流行，地中海国家报告了地方病状态，同时令人担忧的向北传播。血清学诊断，包括基于重组抗原rK 39（rK 39-ICT）的免疫层析试验和基于全寄生虫抗原的直接凝集试验（DAT），已在VL高负荷地区（如东非和印度次大陆）得到验证。到目前为止，在欧洲还没有使用大量患者的研究对这两种方法进行评估。我们选择了一系列来自确诊的VL（包括HIV共感染）、恰加斯病、疟疾、其他寄生虫感染的患者的临床血清样品和阴性样品（n = 743; 2009-2015年），以测试rK 39-ICT快速测试（Kalazar Detect Rapid Test; InBios International，Inc.，美国）和DAT（ITM-DAT/VLG;比利时安特卫普热带医学研究所）。纳入内部免疫荧光抗体检测（IFAT）进行比较。HIV阴性VL患者中rK 39-ICT和DAT的估计灵敏度分别为83.1% [75.1-91.2]和84.2% [76.3-92.1]。在HIV/VL合并感染患者中，rK 39的灵敏度降至67.3% [52.7-82.0]，DAT的灵敏度增至91.3% [82.1-100.0]。在HIV阴性VL患者中，内部IFAT的敏感性（84.2% [76.3-92.1]）高于HIV/VL患者（79.4% [73.3-96.2]）。DAT在HIV阴性VL可疑者血清中得到32个假阳性，而rK 39和IFAT分别为0和2个，但正确检测到更多的HIV/VL患者（42/46），而不是rK 39（31/46）和IFAT（39/46）。虽然rK 39-ICT和DAT表现出可接受的灵敏度和特异性，但在西班牙需要与其他检测相结合以高度灵敏地诊断VL病例。在合并感染HIV或其他寄生虫感染的患者中观察到测试性能的重要变化。这项研究可以帮助告知选择血清学试验时，使用筛选或诊断VL在欧洲地中海设置。内脏利什曼病是利什曼病中最严重的一种，是一种通过被感染的白蛉叮咬而传播的疾病。虽然利什曼病的最大负担是在东非和印度次大陆，但这种疾病在欧洲部分地区也是地方病。以前的研究已经研究了诊断方法的性能，但没有详细研究来自欧洲环境的样本。我们使用了来自西班牙马德里国家参考实验室的大量样本，评估了欧洲内脏利什曼病血清学诊断的利什曼病快速试验和直接凝集试验。这两种检测方法在诊断VL方面都是有效的，但在检测合并感染HIV或其他寄生虫感染的患者时，发现了重要的差异。这项研究可以帮助了解哪些诊断测试适合在欧洲地中海环境中使用。
Visceral leishmaniasis (VL), the most severe form of leishmaniasis, is endemic in Europe with Mediterranean countries reporting endemic status alongside a worrying northward spread. Serological diagnosis, including immunochromatographic test based on the recombinant antigen rK39 (rK39-ICT) and a direct agglutination test (DAT) based on the whole parasite antigen, have been validated in regions with high VL burden, such as eastern Africa and the Indian subcontinent. To date, no studies using a large set of patients have performed an assessment of both methods within Europe. We selected a range of clinical serum samples from patients with confirmed VL (including HIV co-infection), Chagas disease, malaria, other parasitic infections and negative samples (n = 743; years 2009–2015) to test the performance of rK39-ICT rapid test (Kalazar Detect Rapid Test; InBios International, Inc., USA) and DAT (ITM-DAT/VLG; Institute of Tropical Medicine Antwerp, Belgium). An in-house immunofluorescence antibody test (IFAT), was included for comparison. Estimated sensitivities for rK39-ICT and DAT in HIV-negative VL patients were 83.1% [75.1–91.2] and 84.2% [76.3–92.1], respectively. Sensitivity was reduced to 67.3% [52.7–82.0] for rK39 and increased to 91.3% [82.1–100.0] for DAT in HIV/VL co-infected patients. The in-house IFAT was more sensitive in HIV-negative VL patients, 84.2% [76.3–92.1] than in HIV/VL patients, 79.4% [73.3–96.2]. DAT gave 32 false positives in sera from HIV-negative VL suspects, compared to 0 and 2 for rK39 and IFAT, respectively, but correctly detected more HIV/VL patients (42/46) than rK39 (31/46) and IFAT (39/46). Though rK39-ICT and DAT exhibited acceptable sensitivity and specificity a combination with other tests is required for highly sensitive diagnosis of VL cases in Spain. Important variation in the performance of the tests were seen in patients co-infected with HIV or with other parasitic infections. This study can help inform the choice of serological test to be used when screening or diagnosing VL in a European Mediterranean setting. Visceral leishmaniasis is the most severe form of leishmaniasis, a disease transmitted through the bite of an infected sandfly. Although the biggest burden of leishmaniasis is in eastern Africa and the Indian subcontinent, the disease is also endemic in parts of Europe. Previous studies have looked at performance of diagnostic methods, but not in great detail on samples derived from a European setting. Using a large set of samples from a national reference laboratory in Madrid, Spain, we assessed a leishmaniasis rapid test and a direct agglutination test for serological diagnosis of visceral leishmaniasis in Europe. Both tests were effective at diagnosing VL, but important differences were seen when testing patients co-infected with HIV or with other parasitic infections. This study can help inform which diagnostic tests are suitable for use in a European Mediterranean setting.
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