Validation of a new serology-based dipstick test for rapid diagnosis of typhoid fever.

Currently, no reliable diagnostic test is available for typhoid fever. One serology-based dipstick test, developed indigenously, was validated in this study. Preserved sera from 336 fever patients with known culture results for Salmonella Typhi were blindly tested by the Widal test and the new assay. Analytical sensitivities, specificities, and efficiencies for the new assay versus the Widal test were 68.8% versus 62.5%, 71.1% versus 37.1%, and 70.5% versus 43.2%, respectively (p < 0.001), considering S. Typhi-positive samples as gold standards. Thereafter, fresh sera from 102 hospital-attending children with clinical typhoid fever (including 20 confirmed nontyphoidal cases as control) were tested by both methods and analyzed statistically. The diagnostic sensitivity, specificity, and efficiency were 51.2%, 85%, and 57.8% for the new assay, and 43.9%, 65%, and 48% for the Widal test, respectively. Overall performance ability of the new assay was not better than the Widal test (p > 0.5). Further improvement of the new point-of-care typhoid assay is recommended before implementation in the field setup.