Leishmaniasis Research and Treatment Centre, University of Gondar, Gondar, Ethiopia.
Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
PLoS Negl Trop Dis. 2020 Dec 31;14(12):e0008963. doi: 10.1371/journal.pntd.0008963. eCollection 2020 Dec.
Diagnosis of a first-time visceral leishmaniasis (VL) infection in Ethiopia is established by use of a rapid diagnostic test (RDT) detecting antibodies against rK39, direct agglutination test (DAT) and microscopy according to the national algorithm. The performance of individual tests and algorithm is variable and depends on several factors, one being HIV status. Limited data are available on the performance of tests in VL-HIV coinfected patients. Assessment of the performance of DAT (ITM-A), rK39 ELISA (Serion) and six RDT (Onsite Leishmania Ab CTK, Antigen ICT Xinjier, IT Leish Biorad, Kalazar Detect Inbios, rK39 IgG1 Coris, rk28 IgG1 Coris) for the diagnosis of VL was done on a panel of 91 stored serum and plasma samples of 'first-episode' suspected VL patients, with HIV coinfection (n = 51) and without (n = 40). A combined reference standard was used: either positive microscopy on tissue aspirates, or in case of negative microscopy, positive PCR results on the aspirate slide. Additionally, endemic healthy controls (n = 20), non-endemic controls (n = 10) and patients with confirmed malaria infection (n = 10) were tested for specificity evaluation. Sensitivities ranged from 69.2% for DAT (applied cut-off ≥ 1/3200) to 92.2% for the Onsite RDT, whereas specificities ranged from 20.0% for Kalazar Antigen ICT to 100% for IT Leish and rK39 IgG1. Sensitivities from all assays decreased upon stratification according to HIV status but was only significantly different for rK39 Serion ELISA (p-value 0.0084) and the Onsite RDT (p-value 0.0159). In conclusion, performance of commercially available assays for VL on samples from Northern-Ethiopian patients varied widely with a substantial decrease in sensitivity in the VL-HIV coinfected group. Clear guidelines on minimal performance criteria of individual tests and algorithms are needed, as well as which reference standard should be used to determine the performance.
在埃塞俄比亚，首次诊断内脏利什曼病（VL）感染是通过使用快速诊断检测（RDT）检测针对 rK39 的抗体、直接凝集检测（DAT）和显微镜检查根据国家算法进行的。单个检测和算法的性能各不相同，取决于几个因素，其中一个是 HIV 状态。关于 VL-HIV 合并感染患者检测性能的有限数据。评估 DAT（ITM-A）、rK39 ELISA（Serion）和六种 RDT（Onsite Leishmania Ab CTK、Antigen ICT Xinjier、IT Leish Biorad、Kalazar Detect Inbios、rK39 IgG1 Coris、rk28 IgG1 Coris）对 VL 诊断的性能是在一组 91 份存储的血清和血浆样本上进行的，这些样本来自“首次发作”疑似 VL 患者，其中 HIV 合并感染（n=51）和未合并感染（n=40）。使用联合参考标准：组织抽吸物显微镜检查阳性，或者在显微镜检查阴性的情况下，抽吸物载玻片上的 PCR 结果阳性。此外，还对地方性健康对照（n=20）、非地方性对照（n=10）和确诊疟疾感染患者（n=10）进行了特异性评估。灵敏度范围从 DAT（应用截止值≥1/3200）的 69.2%到 Onsite RDT 的 92.2%，而特异性范围从 Kalazar Antigen ICT 的 20.0%到 IT Leish 和 rK39 IgG1 的 100%。根据 HIV 状态分层后，所有检测的灵敏度均下降，但 rK39 Serion ELISA（p 值 0.0084）和 Onsite RDT（p 值 0.0159）的差异有统计学意义。总之，在来自埃塞俄比亚北部患者的样本上，商业上可获得的 VL 检测的性能差异很大，在 VL-HIV 合并感染组中，灵敏度显著下降。需要明确关于单个检测和算法的最低性能标准的指南，以及应使用哪种参考标准来确定性能。
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