Comparison of Enzyme-Linked Immunosorbent Assay Using Either Natural Octyl Disaccharide-Leprosy IDRI Diagnostic or Phenolic Glycolipid-I Antigens for the Detection of Leprosy Patients in Colombia

Mónica Muñoz Instituto Colombiano de Medicina Tropical–Universidad CES, Sabaneta, Antioquia, Colombia;

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Juan Camilo Beltrán-Alzate Instituto Colombiano de Medicina Tropical–Universidad CES, Sabaneta, Antioquia, Colombia;

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Malcolm S. Duthie IDRI, Seattle, Washington;

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Héctor Serrano-Coll Escuela de Graduados, Universidad CES, Medellín, Antioquia, Colombia;

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Nora Cardona-Castro Instituto Colombiano de Medicina Tropical–Universidad CES, Sabaneta, Antioquia, Colombia;
Facultad de Medicina Universidad CES, Medellín, Antioquia, Colombia

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Leprosy is a chronic infectious disease with a broad spectrum of manifestations. Delays in attaining correct diagnosis permit progressive peripheral nerve damage that can produce irreversible disabilities. Tests detecting antigen-specific antibodies can aid the diagnostic process and potentially detect patients earlier. Reported tests have lacked optimal sensitivity and specificity; however, the need to develop new tests to aid early diagnosis still remains. In this study, we determined the sensitivity, specificity, positive predictive value, and negative predictive value of enzyme-linked immunosorbent assay (ELISA) using natural octyl disaccharide-leprosy IDRI diagnostic (NDO-LID). Serum samples from confirmed multibacillary patients (N = 338) and paucibacillary patients (N = 58) were evaluated and contrasted against samples from individuals without leprosy (100 healthy persons, 36 leishmaniasis or tuberculosis patients). ELISA detecting either antigen-specific IgM, IgG, or the combination of IgG and IgM (with protein A) were conducted. At a sensitivity of 78% among all patients, serum IgM antibodies against the NDO-LID conjugate were detected at a greater level than those recognizing phenolic glycolipid-I antigen (64% overall sensitivity), while providing similar specificity (97% versus 100%, respectively). Given the inclusion of the LID-1 protein within NDO-LID, we also detected conjugate-specific IgG within patient sera at a sensitivity of 81.6%. The use of protein A to simultaneously detect both antigen-specific IgG and IgM isotypes yielded the highest overall sensitivity of 86.3%. Taken together, our data indicate that the detection of both IgG and IgM antibodies against NDO-LID with protein A provided the best overall ability to detect Colombian leprosy patients.

Author Notes

Address correspondence to Nora Cardona-Castro, Instituto Colombiano de Medicina Tropical ICMT - Facultad de Medicina Universidad CES, Carrera 43 A # 52 Sur 99, Sabaneta, Antioquia, Colombia. E-mail: ncardona@ces.edu.co

Authors’ addresses: Mónica Muñoz, Juan Camilo Beltrán-Alzate, and Nora Cardona-Castro, Department of Microbiology, Instituto Colombiano de Medicina tropical–Facultad de Medicina Univerisidad CES, Sabaneta, Antioquia, Colombia, E-mails: monicax15@hotmail.com, jbeltran@ces.edu.co, and ncardona@ces.edu.co. Héctor Serrano-Coll, Escuela de Graduados, Universidad CES, Medellín, Antioquia, Colombia, E-mail: hectorserranocoll@gmail.com. Malcolm S. Duthie, Infectious Disease Research Institute, Diagnostics/Surveillance Tools, Seattle, WA, E-mail: malcolm.duthie@idri.org.

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