TY - JOUR
T1 - Utility of the loop-mediated isothermal amplification assay for the diagnosis of visceral leishmaniasis from blood samples in Ethiopia
AU - Hagos, Dawit Gebreegzabher
AU - Kiros, Yazezew Kebede
AU - Abdulkader, Mahmud
AU - Arefaine, Zekarias Gessessew
AU - Nigus, Etsay
AU - Schallig, Henk H. D. F.
AU - Wolday, Dawit
N1 - Funding Information: Financial support: The project was supported by the European and Developing Countries Clinical Trial Partnership (EDCTP)—European Commission (Grant ID#: TMA2016SF-1437), The Hague, The Netherlands. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Publisher Copyright: © 2021 by The American Society of Tropical Medicine and Hygiene
PY - 2021/10/1
Y1 - 2021/10/1
N2 - Rapid and accurate diagnosis of visceral leishmaniasis (VL) is needed to initiate prompt treatment to reduce morbidity and mortality. Here, we evaluated the performance of loop-mediated isothermal amplification (LAMP) assay for the diagnosis of VL from blood in an endemic area in Ethiopia. LAMP was positive in 117/122 confirmed VL cases and negative in 149/152 controls, resulting in a sensitivity of 95.9% (95% CI: 90.69-98.66) and a specificity of 98.0% (95% CI: 94.34-99.59), respectively. The sensitivity of the LAMP assay was 95.0% (95% CI: 88.61-98.34) in HIV-negatives and 100% (95% CI: 85.18-100.0) in HIV-positives. Compared with microscopy, LAMP detected 82/87 (94.3%, 95% CI: 87.10-98.11) of the microscopy1 cases and was negative in 11/27 (40.7%, 95% CI: 22.39-61.20) of the microscopy2 cases. Compared with the rK39 serology, LAMP detected 113/120 (94.2%, 95% CI: 88.35-97.62) of the rK391 cases and was negative in 149/154 (96.8%, 95% CI: 92.59-98.94) of the rK392 cases. However, when compared with microscopy only, rK39 detected 83/87 (95.4%, 95% CI: 88.64-98.73) of the microscopy1 cases and negative in only 12/27 (44.4%, 95% CI: 25.48-64.67) of the microscopy- cases. There was an excellent agreement between rK39 and LAMP (Kappa 5 0.91, 95% CI: 0.86-0.96). Furthermore, an algorithm using rK39 followed by LAMP would yield a sensitivity of 99.2% (95%CI: 95.52-99.89) and a specificity of 98.0% (95% CI: 94.34-99.59). The findings demonstrate that LAMP assay is an accurate and rapid molecular assay for VL diagnosis, including in HIV-1 coinfected patients, in an endemic setting.
AB - Rapid and accurate diagnosis of visceral leishmaniasis (VL) is needed to initiate prompt treatment to reduce morbidity and mortality. Here, we evaluated the performance of loop-mediated isothermal amplification (LAMP) assay for the diagnosis of VL from blood in an endemic area in Ethiopia. LAMP was positive in 117/122 confirmed VL cases and negative in 149/152 controls, resulting in a sensitivity of 95.9% (95% CI: 90.69-98.66) and a specificity of 98.0% (95% CI: 94.34-99.59), respectively. The sensitivity of the LAMP assay was 95.0% (95% CI: 88.61-98.34) in HIV-negatives and 100% (95% CI: 85.18-100.0) in HIV-positives. Compared with microscopy, LAMP detected 82/87 (94.3%, 95% CI: 87.10-98.11) of the microscopy1 cases and was negative in 11/27 (40.7%, 95% CI: 22.39-61.20) of the microscopy2 cases. Compared with the rK39 serology, LAMP detected 113/120 (94.2%, 95% CI: 88.35-97.62) of the rK391 cases and was negative in 149/154 (96.8%, 95% CI: 92.59-98.94) of the rK392 cases. However, when compared with microscopy only, rK39 detected 83/87 (95.4%, 95% CI: 88.64-98.73) of the microscopy1 cases and negative in only 12/27 (44.4%, 95% CI: 25.48-64.67) of the microscopy- cases. There was an excellent agreement between rK39 and LAMP (Kappa 5 0.91, 95% CI: 0.86-0.96). Furthermore, an algorithm using rK39 followed by LAMP would yield a sensitivity of 99.2% (95%CI: 95.52-99.89) and a specificity of 98.0% (95% CI: 94.34-99.59). The findings demonstrate that LAMP assay is an accurate and rapid molecular assay for VL diagnosis, including in HIV-1 coinfected patients, in an endemic setting.
UR - http://www.scopus.com/inward/record.url?scp=85116991958&partnerID=8YFLogxK
U2 - https://doi.org/10.4269/ajtmh.21-0334
DO - https://doi.org/10.4269/ajtmh.21-0334
M3 - Article
C2 - 34310340
SN - 0002-9637
VL - 105
SP - 1050
EP - 1055
JO - American journal of tropical medicine and hygiene
JF - American journal of tropical medicine and hygiene
IS - 4
ER -