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

• Published in: The American journal of tropical medicine and hygiene 2018-01, Vol.98 (1), p.274-277
• Main Authors: Muñoz, Mónica, Beltrán-Alzate, Juan Camilo, Duthie, Malcolm S, Serrano-Coll, Héctor, Cardona-Castro, Nora
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Antigens; Antigens, Bacterial - immunology; Child; Child, Preschool; Colombia; Disaccharides - immunology; Enzyme-Linked Immunosorbent Assay - methods; Enzymes; Female; Humans; Immunoglobulin M - immunology; Immunoglobulins; Leprosy; Leprosy - diagnosis; Male; Middle Aged; Proteins; Sensitivity and Specificity; Young Adult
• ISSN: 0002-9637; 1476-1645
• DOI: 10.4269/ajtmh.17-0500

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 ( = 338) and paucibacillary patients ( = 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.