03284nas a2200445   4500000000100000008004100001260001600042653001500058653001000073653000900083653002200092653002600114653002400140653003100164653001500195653002900210653001100239653001100250653002800261653000900289653001600298653002500314653003200339653001600371100002400387700001200411700001400423700001500437700001600452700001600468700001100484700001300495700001600508245011300524856006600637300000800703490000700711520210600718022001402824       2013                            d  c2013 Oct 2310aAdolescent10aAdult10aAged10aAged, 80 and over10aAntibodies, Bacterial10aAntigens, Bacterial10aBacteriological Techniques10aCell Phone10aChromatography, Affinity10aFemale10aHumans10aLeprosy, Multibacillary10aMale10aMiddle Aged10aMycobacterium leprae10aSensitivity and Specificity10aYoung Adult1 aPaula Vaz Cardoso L1 aDias RF1 aFreitas A1 aHungria EM1 aOliveira RM1 aCollovati M1 aReed S1 aDuthie M1 aStefani MMA00aDevelopment of a quantitative rapid diagnostic test for multibacillary leprosy using smart phone technology.  uhttp://www.biomedcentral.com/content/pdf/1471-2334-13-497.pdf  a4970 v133 a<p><b>BACKGROUND: </b>Despite efforts to eliminate leprosy as public health problem, delayed diagnosis and disabilities still occur in many countries. Leprosy diagnosis remains based on clinical manifestations and the number of clinicians with expertise in leprosy diagnosis is in decline. We have developed a new immunochromatographic test with the goal of producing a simple and rapid system that can be used, with a minimal amount of training, to provide an objective and consistent diagnosis of multibacillary leprosy.</p><p><b>METHODS: </b>The test immobilizes two antigens that have been recognized as excellent candidates for serologic diagnosis (the PGL-I mimetic, ND-O, and LID-1), on a nitrocellulose membrane. This allows the detection of specific IgM and IgG antibodies within 20 minutes of the addition of patient sera. Furthermore, we coupled the NDO-LID® rapid tests with a new cell phone-based test reader platform (Smart Reader®) to provide objective interpretation that was both quantifiable and consistent.</p><p><b>RESULTS: </b>Direct comparison of serologic responses indicated that the rapid test detected a greater proportion of leprosy patients than a lab-based PGL-I ELISA. While positive responses were detected by PGL-I ELISA in 83.3% of multibacillary patients and 15.4% of paucibacillary patients, these numbers were increased to 87% and 21.2%, respectively, when a combination of the NDO-LID® test and Smart Reader® was used. Among multibacillary leprosy the sensitivity of NDO-LID® test assessed by Smart Reader® was 87% (95% CI, 79.2-92.7%) and the specificity was 96.1% (95% CI, 91.7- 98.6%). The positive predictive value and the negative predictive value of NDO-LID® tests were 94% (95% CI, 87.4-97.8%) and 91.4% (95% CI, 85.9-95.2%), respectively.</p><p><b>CONCLUSION: </b>The widespread provision of rapid diagnostic tests to facilitate the diagnosis or prognosis of multibacillary leprosy could impact on leprosy control programs by aiding early detection, directing appropriate treatment and potentially interrupting Mycobacterium leprae transmission.</p>  a1471-2334