Immunochromatographic strip-test detection of anti-K39 antibody in Indian visceral leishmaniasis.
Stored sera from 429 Indian subjects were assayed to extend the analysis of the accuracy of immunochromatographic strip-test detection of anti-K39 antibody in the non-invasive diagnosis of visceral leishmaniasis (VL). All 225 samples from patients with proven Leishmania infection tested positive [estimated sensitivity = 100%; 95% confidence interval (CI)=98%-100%]. Sera from 99 of the 100 symptomatic patients with other diseases were non-reactive (estimated specificity = 99%; CI = 94%-100%). However, samples from 13 of the 104 apparently healthy controls showed positive strip-test results (estimated specificity = 88%; CI = 79%-93%), yielding an overall specificity of 93% (190/204; CI = 88%-96%). If applied in a practical clinical setting (on symptomatic patients in whom active VL is suspected and other common infections have been excluded), strip testing of serum for anti-K39 antibody should be both sensitive and specific for diagnosing VL in India.
Sundar
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Kala-Azar Medical Research Center, Banaras Hindu University, Institute of Medical Sciences, Varanasi, India. shyam_vns@satyam.net.in
Pai
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Sahu
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Kumar
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Murray
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HW
D000293:Adolescent; D000328:Adult; D000818:Animals; D000913:Antibodies, Protozoan / Q000097:blood*; D000953:Antigens, Protozoan / Q000276:immunology*; D005260:Female; D006801:Humans; D007891:Leishmania / Q000276:immunology*; D007898:Leishmaniasis, Visceral / Q000175:diagnosis*; D008297:Male; D010274:Parasitology / Q000379:methods; D015800:Protozoan Proteins / Q000276:immunology*; D011934:Reagent Strips; D012189:Retrospective Studies; D012680:Sensitivity and Specificity
D000913:Antibodies, Protozoan; D000953:Antigens, Protozoan; D015800:Protozoan Proteins; D011934:Reagent Strips; C079253:K39 antigen, Leishmania