Evaluation of urine sample for diagnosis of visceral leishmaniasis using rK-39 immunochromatographic test in Northwest Ethiopia

• Published in: PloS one Vol. 17; no. 2; p. e0263696
• Main Authors: Eyayu, Tahir, Yasin, Melashu, Workineh, Lemma, Tiruneh, Tegenaw, Andualem, Henok, Sema, Meslo, Damtie, Shewaneh, Abebaw, Aynework, Getie, Birhanu, Andargie, Desalegn, Achaw, Barnabas, Taklual, Wubet
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 07.02.2022; Public Library of Science (PLoS)
• Subjects: Accuracy; Adolescent; Adult; Analysis; Antigens, Protozoan - blood; Antigens, Protozoan - urine; Biology and Life Sciences; Child; Chromatography; Chromatography, Affinity - methods; Contingency; Cross-Sectional Studies; Developing countries; Diagnosis; Diagnostic systems; Ethiopia; Female; Health sciences; Hospitals; Humans; Immunologic Tests - methods; Kala-azar; LDCs; Leishmaniasis, Visceral - blood; Leishmaniasis, Visceral - diagnosis; Leishmaniasis, Visceral - urine; Likelihood ratio; Male; Medical diagnosis; Medical laboratories; Medicine and Health Sciences; Methods; Middle Aged; Morbidity; Mortality; Parameter sensitivity; Parasitic diseases; People and Places; Performance evaluation; Predictive Value of Tests; Reagent Strips; Sensitivity; Sensitivity analysis; Sensitivity and Specificity; Serology; Spleen; Statistical analysis; Statistical methods; Tropical diseases; Urinalysis - methods; Urine; Vector-borne diseases; Visceral leishmaniasis; Young Adult; Ethiopia; Bangladesh; Sudan; Africa
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0263696

Visceral leishmaniasis is the most severe form of leishmaniasis which ranks second in mortality and fourth in morbidity. Parasitological diagnostic techniques with splenic aspirate remain the gold standard. However, sample collection is risky, painful, and difficult. Alternatively, serological techniques provide good diagnostic accuracy using serum sample that is difficult for applying on small children and in the field. So, finding alternative non-invasive and self-collected samples like urine is very important. Thus, the study aimed to evaluate the diagnostic performance of the rK-39 strip test using urine for diagnosis of visceral leishmaniasis. A multicenter institutional-based cross-sectional study was conducted from November 2019 to March 2021 at Northwest Ethiopia. Sociodemographic information was collected using a structured questionnaire. Blood sample and midstream urine sample were collected for rK-39 test. Data were entered into Epi-data version 4.2 and analyzed using SPSS version 24.0. Diagnostic performance parameters of urine-based rK-39 rapid test, i.e. sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios (LR+/-), and diagnostic accuracy were determined on contingency table by using serum-based rK-39 test result as a reference. An agreement between urine and serum-based rK-39 test was statistically determined by kappa value. In total, 300 subjects, age ranged between 7 and 60 years, were included in the study. The overall sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of urine-based rK-39 test were found to be 98.0% (95% CI: 93.0% - 99.8%), 95.5% (95% CI: 91.6% - 97.9%), 91.6% (95% CI: 85.2%- 95.4%), 98.9 (95% CI: 96.0%- 99.7%), and 96.33% (95% CI: 93.53-98.16%), respectively. Additionally, there was a strong agreement between the results obtained on rK-39 ICT using urine and serum samples (kappa = 0.92; P < 0.001). Urine-based rK-39 ICT had an excellent high sensitivity, specificity and strong agreement with serum-based rK-39 ICT results. This indicates that urine sample would be a promising noninvasive and easy to collect sample for diagnosis of VL in field and rural settings.