Detection of urinary leishmanial antigen by latex agglutination test (KAtex) in kala-azar patients
Background: A new unique latex agglutination test (KAtex) that detects a stable, nonprotein, disease specific parasite antigen in the freshly voided urine of patients suffering from active kala-azar has been introduced by Kalon Biological Ltd. UK. This is absolutely non-invasive method of diagnosis...
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| Main Authors: | , , , |
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| Format: | Article |
| Language: | en |
| Published: |
Ibn Sina Medical College
2010
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| Subjects: | |
| Online Access: | http://irep.iium.edu.my/87308/1/KAtex%20BJMS.pdf http://irep.iium.edu.my/87308/ http://doi.org/10.3329/bjms.v9i4.6688 |
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| Summary: | Background: A new unique latex agglutination test (KAtex) that detects a stable, nonprotein, disease specific parasite antigen in the freshly voided urine of patients suffering from active kala-azar has been introduced by Kalon Biological Ltd. UK. This is absolutely non-invasive method of diagnosis for visceral leishmaniasis and suitable for implementation as a rapid diagnostic tool at the point of care. Objective: Diagnostic potential of KAtex was evaluated among clinically suspected kala-azar patients in an
endemic zone of Bangladesh. Methodology: KAtex was done using freshly voided urine according to the manufacturer’s instructions for sixty (60) clinically suspected patients of kala-azar admitted in Rajshahi Medical College Hospital (RMCH), Bangladesh and forty (40) healthy controls during December 2005 to June 2006. Leishmania nested Polymerase
Chain Reaction (Ln-PCR) using peripheral blood buffy coat was performed for all study population (100) and Ln-PCR positive cases were considered as confirmed cases of kalaazar. Results: Out of 60 clinically suspected kala-azar patients, 56 were Ln-PCR positive and 53 of 56 Ln-PCR positive cases were KAtex positive (sensitivity, 94.64%; Mantel-Haenszel Chi sq. 79.66, p= 0.0000, confidence interval [CI], >95 to 100%). None of the
healthy controls was found positive by Ln-PCR but 2 of 40 were KAtex positive (specificity, 95%; confidence interval [CI], >95 to 100%). The positive and negative predictive values of KAtex were noted as 98.10% and 92.85% respectively. Conclusion: This limited prospective study suggests that KAtex is an absolutely non-invasive urinebased antigen detection test with high sensitivity and specificity and may be useful for
screening active kala-azar patients, particularly suitable for field use. |
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