Title : Diagnostic effectiveness of urine and saliva samples for detection of visceral leishmaniasis using rK39-based immunochromatographic test in Ethiopia

Abstract:

Background:
A whole blood /serum by rK39immunochromatographic test are the most widely used biological samples for diagnosis/screening of visceral leishmaniasis (VL). However, sample collection is relatively invasive and more difficult to apply in children and during field surveillance. Finding of alternative, non-invasive and easy surveillance samples like urine and saliva for VL diagnosis is vital. Thus, study was amid to evaluate the effectiveness of urine and saliva samples for the diagnosis of VL using rK-39 based rapid test.

Methods:
Institutional based cross-sectional study was conducted from April 2022 to July 2022 in Northwest Ethiopia. Blood, saliva, and midstream urine samples were collected among VL confirmed patients and non-endemic healthy controls. Data was entered in to Epi-data (4.2) and analyzed using STATA (version 21). The diagnostic performance of both samples were evaluated using sensitivity, specificity and area under the curve (AUC) using serum based rk-39 test results as a reference. Kappa statistics was used to evaluate the agreement of urine and saliva rk39-based rapid test with reference test.

Result: 
A total of 63 participants (32 confirmed VL patients and 31 healthy control individuals were enrolled in the study. The sensitivity, specificity and area under the curve (AUC) of urine by rK-39 based rapid test were found to be 87.5% (79.3-95.67%), 96.7% (92-100%) and 0.92 respectively. Similarly, sensitivity, specificity and area under the curve (AUC) of saliva by rK39 rapid test were found to be 90.6% (83.4-97.82%), 100%, and 0.95. The kappa agreement of urine and saliva with reference serum sample were strong (k= 0.84) and (k=0.904) respectively.

Conclusion:
In this study, both urine and saliva samples showed a promising finding to be a serum alternative specimen for the diagnosis of VL mainly in areas lacking advanced medical facilities and skilled personnel. Yet, clinical practice needs further multicentred study with large sample size inclusive of both symptomatic and asymptomatic participants

Biography:

Mr Mebratu Tamir Tegegne was born in 1996 and now he is now 28 years old working as researcher and lecturer at university of Gondar. He received BSc in medical laboratory science since June, 2019 and joined to University of Gondar as graduate assistant on July 2019. After one year he have been MSc fellow at university of Gondar for two year and received his MSc in medical parasitology since 2022. From December 2022 up to present, he is working as lecturer and researcher and get published more than 10 articles and over 20 articles are under review particularly neglected tropical infectious diseases.