Laboratory Based Comparative Evaluation of the Performance of Rk28 and Rk39 Tests And Dat in the Diagnosis of Visceral Leishmaniasis.

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Addis Ababa University


Visceral Leishmaniasis (VL) caused by L.donovani is endemic and a major health problem in Ethiopia with 4000-7000 cases annually. The reference standard for VL diagnosis is parasitological which is highly specific but with varying sensitivity. The procedure is invasive, risky and not suitable for field use. Serological techniques like the DAT and rk39 rapid diagnostic tests (RDTs) have been developed and are in use in different VL diagnostic. The DAT has good sensitivity and specificity, but is not ideal for field work while the performance of the rk39 RDTs tend to show homogeneity in endemic regions and heterogeneity between regions. This study evaluated the performance of three rk28 based rapid diagnostic test prototypes (Inbioss+, DPP and EMT), two market available rk39 rapid diagnostic tests (Inbioss and Diamed) and FD-DAT and compared the results. The evaluation was carried out using stored sera from VL patients (n=95), healthy controls (n=35) endemic control (n=41), other disease (n=35), cutaneous leishmaniasis (n=35). The results show that the three prototypes rk28 rapid tests provided sensitivities of 97.9%, 95.8% and 98.9% compared to two rk39 rapid tests and DAT with sensitivity of 96.8%, 92.6% and 91.6% respectively. Specificity results were 82.9% (Inbioss+), 94.6% (DPP), 80.2% (EMT), 98.2% (DiaMed & Inbioss), and 97.3% (DAT), control panel comprising of healthy non endemic control, healthy endemic controls, and other diseases. The DPP test has optimal combination of sensitivity and specificity, 95.8% and 94.6%, than the other tests. Also the DPP is easy to perform and interpret, with lesser steps and convenient format to use in a field setting. The findings in this study indicate that the DPP test has a great potential as a VL serodiagnostic test simplifying VL disease confirmation mainly at the tertiary health care setting. Key words: Visceral Leishmaniasis;RDT, rk28; rk39; DAT; Ethiopia



Visceral Leishmaniasis; RDT, rk28; rk39; DAT; Ethiopia