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Diagnostic accuracy of rK28-based immunochromatographic rapid diagnostic tests for visceral leishmaniasis: a prospective clinical cohort study in Sudan
- Source :
- Transactions of the Royal Society of Tropical Medicine and Hygiene. 109(9)
- Publication Year :
- 2015
-
Abstract
- Background Rapid diagnostic tests (RDTs) for visceral leishmaniasis (VL) based on rK39 antigen showed suboptimal sensitivity in East Africa. A prospective clinical cohort study in Sudan was designed to validate a novel rK28-based RDT for Leishmania donovani VL. Methods Patients (n=285) suspected of VL by residency, fever for ≥2 weeks, splenomegaly with no prior reported VL, and negative for malaria were consecutively enrolled at three Sudanese sites in 2012-2013 and informed consent obtained. Two human readers, who were blinded to the clinical status and other RDT results, evaluated patient whole blood (WB) and serum on the rK28 RDT. Based on Leishmania parasite detection in lymph node or bone marrow aspirates (Giemsa-stained smears or culture in Novy-MacNeal-Nicolle medium), patients were categorized as VL cases (n=200) or VL controls (n=85). Results The rK28 RDT had high specificity using either WB (100% [85/85]) or serum (97.6% [83/85]) and exhibited greater sensitivity (WB, 92.5% [185/200]; serum, 94.5% [189/200]) than a direct agglutination test performed with the same sera (92.9% [79/85] and 83.5% [167/200] for specificity and sensitivity, respectively). Two blinded readers scored a given WB or serum sample the same on the rK28 RDT 99.6% and 100% of the time, respectively. A reader scored each individual donor's paired WB and serum rK28 RDT results the same 97.2% of the time. Conclusions An inexpensive rK28 RDT that performs robustly with WB or serum will be valuable for diagnosing cases of VL in East Africa.
- Subjects :
- Adult
Male
medicine.medical_specialty
Point-of-Care Systems
Leishmania donovani
Protozoan Proteins
Sensitivity and Specificity
Giemsa stain
Chromatography, Affinity
Sudan
Coombs test
Direct agglutination test
Internal medicine
parasitic diseases
Medicine
Humans
Prospective Studies
Prospective cohort study
biology
medicine.diagnostic_test
business.industry
Public Health, Environmental and Occupational Health
Leishmaniasis
General Medicine
Reference Standards
medicine.disease
biology.organism_classification
Surgery
Coombs Test
Infectious Diseases
Visceral leishmaniasis
Case-Control Studies
Leishmaniasis, Visceral
Parasitology
Female
business
Malaria
Subjects
Details
- ISSN :
- 18783503
- Volume :
- 109
- Issue :
- 9
- Database :
- OpenAIRE
- Journal :
- Transactions of the Royal Society of Tropical Medicine and Hygiene
- Accession number :
- edsair.doi.dedup.....99637d599e4474ec77daa483cca494df