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W., W. smears, individuals showing bad smears with samples from all sites are grouped as having paucibacillary (PB) leprosy, while those showing positive smears with samples from any site are grouped as having multibacillary (MB) leprosy. In practice, however, because skin-smear solutions are absent or unreliable, most programs use clinical criteria to classify individual individuals and select their treatment regimens. The medical system uses the number of skin lesions and the number of nerves involved to group leprosy individuals into one of two simplified groups: MB leprosy (five or NCT-503 more lesions) and PB leprosy (less than five lesions). Therefore, TT individuals and most BT individuals are classified as having PB leprosy, while LL, BL, BB, and some BT individuals are classified as having MB leprosy. Leprosy treatment entails a prolonged regimen of antibiotics in the form of multidrug therapy (MDT). For MB leprosy, a combination therapy utilizing rifampin, dapsone, and clofazimine is recommended for 12 months, while for PB leprosy a routine with only rifampin and dapsone given over 6 months is definitely recommended. It is particularly important to ensure that individuals with MB disease are not undertreated with the regimen for the PB form of the disease. Therefore, dedication of an appropriate treatment routine requires the accurate and differential analysis of the MB and PB forms. A rapid, easy-to-use test that would simplify leprosy analysis could greatly assist with the quick CD93 initiation of treatment. Tests NCT-503 based on IgM acknowledgement of phenolic glycolipid I (PGL-I) have been used in a confirmatory part in the medical center (3, 4, 6, 14, 19, 20, 26). Screening for the presence of PGL-I-specific IgM gives a fairly high false-positive rate ( 10%) in areas where leprosy is definitely endemic, and while positive reactions are indicated to be risk factors in the development of disease, the fact that many people with antibodies against PGL-I do not develop NCT-503 leprosy has hindered the common adoption of these tests in screening programs (4, 5, 14). For these reasons, additional antigens have been produced by our group as well as others with the goal of providing a obvious, accurate, and quick means of diagnosis of leprosy (8, 9, 15, 23). In the study explained here, we have extended our previous observations by creating a new polyepitope chimeric fusion protein with the potential to bind to serum antibodies of leprosy patients to provide a leprosy diagnosis. We processed our previous observations by determining antibody-reactive regions within select antigens in order to produce a synthetic protein that combines these reactive portions within a single product. Our results indicate that all portions contained within the synthetic protein retain their antibody binding activity and that this protein has power for leprosy diagnosis. MATERIALS AND METHODS Subject and samples. Sera were obtained from patients with leprosy (10 patients with MB leprosy and 9 patients with PB leprosy in Sao Paulo, Brazil, and 20 patients with MB leprosy and 15 patients with PB leprosy in Cebu City, Philippines); from 10 controls in Cebu City, an area where leprosy is usually endemic (ECs); and from 8 U.S.-based control individuals, that is, individuals from an area where leprosy is not endemic (NECs). The sera from patients with MB and PB leprosy used in this study were derived from newly diagnosed, previously untreated individuals who did not have indicators of reversal reactions. Sera were collected from 9 female and 10 male leprosy patients (age range, 22 to 63 years; average age, 55.0 years) recruited in Sao Paulo during 2008 and 2009. Sera were also collected from 10 female and 25 male leprosy patients (age range, 17 to 67 years; average age, 30.9 years) recruited in Cebu City between 2007 and 2009. Leprosy was classified in each case by clinical and histological observations carried out by qualified staff. The ECs in Cebu City comprised five females and five males (age range, 21 to 56 years; average.