BACKGROUND: @entity2926 is an important but largely under-recognized public health problem in the tropics. Establishment of highly sensitive and specific laboratory diagnosis is essential to reveal the magnitude of problem and to improve treatment. This study aimed to evaluate the diagnostic accuracy of a recombinant LigA protein based IgM ELISA during outbreaks in the clinical-setting of a highly endemic country. METHODOLOGY/PRINCIPAL FINDINGS: A prospective study was conducted from October 2011 to September 2013 at a national referral hospital for @entity166 in Manila, Philippines. @entity1 who were hospitalized with clinically suspected @entity2926 were enrolled. Plasma and urine were collected on admission and/or at discharge and tested using the LigA-IgM ELISA and a whole cell-based IgM ELISA. Sensitivity and specificity of these tests were evaluated with cases diagnosed by microscopic agglutination test (MAT), culture and @entity5687 as the composite reference standard and blood bank donors as healthy controls: the mean+3 standard deviation optical density value of healthy controls was used as the cut-off limit (0.062 for the LigA-IgM ELISA and 0.691 for the whole cell-based IgM ELISA). Of 304 @entity1 enrolled in the study, 270 (89.1%) were male and the median age was 30.5 years; 167 (54.9%) were laboratory confirmed. The sensitivity and ROC curve AUC for the LigA-IgM ELISA was significantly greater than the whole cell-based IgM ELISA (69.5% vs. 54.3%, p<0.01; 0.90 vs. 0.82, p<0.01) on admission, but not at discharge. The specificity of LigA-IgM ELISA and whole cell-based IgM ELISA were not significantly different (98% vs. 97%). Among 158 MAT negative @entity1 , 53 and 28 were positive by LigA- and whole cell-based IgM ELISA, respectively; if the laboratory confirmation was re-defined by LigA-IgM ELISA and @entity5687 , the clinical findings were more characteristic of @entity2926 than the diagnosis based on MAT/culture/ @entity5687 . CONCLUSIONS/SIGNIFICANCE: The newly developed LigA-IgM ELISA is more sensitive than the whole cell-based IgM based ELISA. Although the final diagnosis must be validated by more specific tests, LigA-IgM ELISA could be a useful diagnostic test in a real clinical-setting, where diagnosis is needed in the early phase of infection.

Diagnostic Accuracy of Recombinant Immunoglobulin-like Protein A-Based IgM ELISA for the Early Diagnosis of XXXX in the Philippines.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity5687 :: ('27074', 'Gene') :: ['LAMP'] @entity166 :: ('MESH:D003141', 'Disease') :: ['infectious diseases'] @entity2926 :: ('MESH:D007922', 'Disease') :: ['leptospirosis', 'Leptospirosis']
@entity2926 :: (MESH:D007922,Disease) :: ['Leptospirosis']
