ArticlePloS one2022
Evaluation of urine sample for diagnosis of visceral leishmaniasis using rK-39 immunochromatographic test in Northwest Ethiopia.
Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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3 citing papers in PubMed, 15 citations in OpenAlex.
- Comparison of a recombinant endonuclease III protein and its synthetic peptides in ELISA for the diagnosis of tegumentary leishmaniasis using human serum and urine samples: A preliminary study.PLoS neglected tropical diseases · 2026Article
- Article
- Real Time PCR-based diagnosis of human visceral leishmaniasis using urine samples.PLOS global public health · 2022Article
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12 authors at 2 institutions in 1 country.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundVisceral 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.
methodsA 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.
resultIn 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).
conclusionUrine-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.
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