Abstract
ABSTRACT.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 microscopy+ cases and was negative in 11/27 (40.7%, 95% CI: 22.39–61.20) of the microscopy− cases. Compared with the rK39 serology, LAMP detected 113/120 (94.2%, 95% CI: 88.35–97.62) of the rK39+ cases and was negative in 149/154 (96.8%, 95% CI: 92.59–98.94) of the rK39− cases. However, when compared with microscopy only, rK39 detected 83/87 (95.4%, 95% CI: 88.64–98.73) of the microscopy+ 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 = 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.
Highlights
Leishmaniasis remains one of the world’s most neglected infectious diseases (NIDs)
The findings concur with ours where we demonstrated a sensitivity of 100% among 23 visceral leishmaniasis (VL) patients coinfected with HIV suggesting that loop-mediated isothermal amplification assay (LAMP) assay is optimum for the diagnosis of VL in coinfected patients
The Loopamp Leishmania Detection Kit has shown a very good diagnostic performance in this study, and the possibility of using a simple sample preparation method (Boil and Spin) and a portable and robust real-time fluorimeter opens an avenue for the diagnosis of VL at the PoC, enabling treatment when confirmatory diagnosis is required
Summary
Leishmaniasis remains one of the world’s most neglected infectious diseases (NIDs). The WHO estimates that 350 million people in 98 countries are at risk of contracting leishmaniasis and approximately 1.5 million new cases occur yearly.[1] Around 400,000 of these are the most severe clinical manifestation, termed as visceral leishmaniasis (VL). VL, known as Kala azar, is a devastating parasitic disease that is transmitted by the sand fly vector and kills some 95% of untreated patients. Diagnosis, and prevention of leishmaniasis in the last 10 years, worldwide, the disease shows a trend of geographical spread appearing in countries and areas previously free from leishmaniasis. The emergence and spread of drug-resistant Leishmania, poor response to the existing drugs and relapses, and coinfection with HIV present major challenges to the control of leishmaniasis globally
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