02408nas a2200241   4500000000100000008004100001653002300042653001200065653001700077653003100094653001100125100001400136700001100150700001400161700001400175700001700189700001600206700001300222700001300235700000900248245005600257520185300313       2013                            d10aSerologic Response10aleprosy10alateral flow10aimmunochromatographic test10aBrazil1 aCardoso L1 aDias R1 aFreitas A1 aHungria E1 aOliveira R M1 aCollovati M1 aReed S G1 aDuthie M1 aMA S00aDevelopment of a new point-of-care test for leprosy3 aLeprosy is a dermato-neurological disease that remains an important public health problem in many endemic countries. Leprosy presents as a spectrum and no laboratory test is commercially available for its diagnosis/prognosis. Here we report the development of a new point-of-care (POC) test for leprosy using LID-1 fusion-protein and phenolic glycolipid-I (PGL-I) (NDO-LID,Orangelife®/Brazil). A new rapid-test reader platform integrated in a cell phone was also used (Smart Reader application-SR®). NDO-LID® tests were evaluated among newly diagnosed untreated multibacillary (MB=108) and paucibacillary (PB=104) leprosy patients, (Ridley & Jopling classification); leprosy household contacts (HHC=75); pulmonary tuberculosis patients (sputum positive/HIV negative;TB=53) and healthy endemic controls (EC=101) recruited in central-western Brazil. NDO-LID® anti IgM/IgG reactivity (SR®:cut-off=10) was compared to anti PGL-I IgM ELISA (cut-off:optical density=0.250). Across the spectrum of leprosy forms (from lepromatous/LL to tuberculoid/TT pole) a gradual decrease in the seropositivity to NDO-LID® test was observed: 97.4% for LL, 83.7% for borderline lepromatous/BL, 76.9% for borderline borderline/BB patients; 26.2% for borderline tuberculoid/BT and 14% for TT patients. Seropositivity among HHC was 5.3%, 5.7% for TB and 3% among EC. The estimated sensitivity of NDO-LID® test was 87% and the specificity was 96.1%. The new NDO-LID® POC test represents a useful tool for MB leprosy detection/diagnosis and treatment and can also contribute to monitor treatment by leprosy controls programs. MB patient are important Mycobacterium leprae disseminators and are at increased risk of complications such as reactional episodes. The digital and automated rapid test SR®-app also represents an improvement towards more accurate results.