title: A rapid ELISA for the diagnosis of MB leprosy based on complementary detection of antibodies against a novel protein-glycolipid conjugate.
abstract: Despite the widespread use of multidrug therapy for treatment, delays in clinical recognition and under-reporting of leprosy indicate that Mycobacterium leprae transmission is continuing. Thus, leprosy is likely to persist as a significant burden on health systems in many regions. In this study, we combined 2 previously characterized leprosy antigens, leprosy IDRI diagnostic-1 (LID-1) and ND-O, into the single fusion complex (ND-O-LID) and determined the serum antibody responses of leprosy patients from Colombia and the Philippines. Following confirmation that antibodies recognized each component within the conjugate, we assessed the performance of a rapid enzyme-linked immunosorbent assay (ELISA) system (Leprosy Detect(TM) fast ELISA; InBios International, Inc., Seattle, WA, USA) based on ND-O-LID capable of generating results within 1.5hours of sample addition. We found ELISA results correlated with the bacteriological index and Ridley-Jopling categorization, with lepromatous leprosy patients having the highest responses, while those of borderline tuberculoid patients were lower. Multibacillary (MB) leprosy patients were distinguished with a high degree of sensitivity (95.7%) and specificity (93.2%), suggesting that this ELISA could potentially replace invasive and insensitive skin slit smear procedures that require expert microscopic examinations. Due to the speed and robustness of this assay, we believe this is an excellent tool for detecting MB leprosy patients in a simple and highly-quantitative manner.
authors.affiliation: Infectious Disease Research Institute, Seattle, WA 98102, USA. Electronic address: mduthie@idri.org.
authors.forename: Malcolm S
authors.initials: MS
authors.lastname: Duthie
authors.affiliation: Infectious Disease Research Institute, Seattle, WA 98102, USA.
authors.forename: Ruben
authors.initials: R
authors.lastname: Raychaudhuri
authors.affiliation: Infectious Disease Research Institute, Seattle, WA 98102, USA.
authors.forename: Yeung L
authors.initials: YL
authors.lastname: Tutterrow
authors.affiliation: Infectious Disease Research Institute, Seattle, WA 98102, USA.
authors.forename: Ayesha
authors.initials: A
authors.lastname: Misquith
authors.affiliation: Infectious Disease Research Institute, Seattle, WA 98102, USA.
authors.forename: Julie
authors.initials: J
authors.lastname: Bowman
authors.affiliation: Infectious Disease Research Institute, Seattle, WA 98102, USA.
authors.forename: Allen
authors.initials: A
authors.lastname: Casey
authors.affiliation: Leonard Wood Memorial Center for Leprosy Research, Cebu City, Philippines.
authors.forename: Marivic F
authors.initials: MF
authors.lastname: Balagon
authors.affiliation: Leonard Wood Memorial Center for Leprosy Research, Cebu City, Philippines.
authors.forename: Armi
authors.initials: A
authors.lastname: Maghanoy
authors.affiliation: Instituto Colombiano de Medicina Tropical, Universidad CES, Medellín, Antioquia, Colombia.
authors.forename: Juan Camilo
authors.initials: JC
authors.lastname: Beltran-Alzate
authors.affiliation: Instituto Colombiano de Medicina Tropical, Universidad CES, Medellín, Antioquia, Colombia.
authors.forename: Marcela
authors.initials: M
authors.lastname: Romero-Alzate
authors.affiliation: Instituto Colombiano de Medicina Tropical, Universidad CES, Medellín, Antioquia, Colombia.
authors.forename: Nora
authors.initials: N
authors.lastname: Cardona-Castro
authors.affiliation: Infectious Disease Research Institute, Seattle, WA 98102, USA.
authors.forename: Steven G
authors.initials: SG
authors.lastname: Reed
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000907:Antibodies, Bacterial / Q000097:blood*; D001426:Bacterial Proteins; D002648:Child; D003105:Colombia; D003955:Diagnostic Tests, Routine / Q000379:methods*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D005260:Female; D006017:Glycolipids; D006801:Humans; D056006:Leprosy, Multibacillary / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D009166:Mycobacterium leprae / Q000276:immunology*; D010679:Philippines; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; D001426:Bacterial Proteins; D006017:Glycolipids
keywords: Diagnosis; Leprosy; Mycobacteria; Serology