@article{02dd030509964c5fa4afacd9ce862a38,
title = "Comparative Analysis of Commercially Available Typhoid Point-of-Care Tests: Results of a Prospective and Hybrid Retrospective Multicenter Diagnostic Accuracy Study in Kenya and Pakistan",
abstract = "Blood and bone marrow cultures are considered the gold standard for the diagnosis of typhoid, but these methods require infrastructure and skilled staff that are not always available in low- and middle-income countries where typhoid is endemic. The objective of the study is to evaluate the sensitivity and specificity of nine commercially available Salmonella Typhi rapid diagnostic tests (RDTs) using blood culture as a reference standard in a multicenter study. This was a prospective and retrospective multicenter diagnostic accuracy study conducted in two geographically distant areas where typhoid is endemic (Pakistan and Kenya; NCT04801602). Nine RDTs were evaluated, including the Widal test. Point estimates for sensitivity and specificity were calculated using the Wilson method. Latent class analyses were performed using R to address the imperfect gold standard. A total of 531 serum samples were evaluated (264 blood culture positive; 267 blood culture negative). The sensitivity of RDTs varied widely (range, 0 to 78.8%), with the best overall performance shown by Enterocheck WB (72.7% sensitivity, 86.5% specificity). In latent class modeling, CTK IgG was found to have the highest sensitivity (79.1%), while the highest overall accuracy was observed with Enterocheck (73.8% sensitivity, 94.5% specificity). All commercially available Salmonella Typhi RDTs evaluated in the study had sensitivity and specificity values that fell below the required levels to be recommended for an accurate diagnosis. There were minimal differences in RDT performances between regions of endemicity. These findings highlight the clear need for new and more-accurate Salmonella Typhi tests.",
keywords = "Salmonella Typhi, blood culture, blood culture, point-of-care tests, rapid diagnostic tests, typhoid",
author = "Jyotshna Sapkota and Rumina Hasan and Robert Onsare and Sonia Arafah and Sam Kariuki and Sadia Shakoor and Farah Qamar and Sheillah Mundalo and Frida Njeru and Rael Too and Elizabeth Ndegwa and Andrews, {Jason R.} and Sabine Dittrich",
note = "Funding Information: Editorial assistance was provided by Stuart Wakelin, supported by FIND—the Global Alliance for Diagnostics. We acknowledge the Director General, KEMRI, where the samples from the sites in Kenya were analyzed. We thank all field officers, laboratory staffs, all patients, and all other participants of the study. Funding Information: Editor Nathan A. Ledeboer, Medical College of Wisconsin Copyright {\textcopyright} 2022 Sapkota et al. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license. Address correspondence to Jyotshna Sapkota, Jyotshna.Sapkota@finddx.org. The authors declare a conflict of interest. J.S., S.A., and S.D. were employees of FIND at the time of the study. J.R.A. has received funding from the US National Institutes of Health and Bill and Melinda Gates Foundation. J.S., R.O., R.H., S.K., S.S., F.Q., S.M., F.N., R.T., and E.N. declare that they have no competing interests relevant to this work. Received 13 July 2022 Returned for modification 11 August 2022 Accepted 1 November 2022 Published 30 November 2022 Funding Information: This study was funded by the UK government via a grant to FIND—the Global Alliance for Diagnostics. Funding Information: Editorial assistance was provided by Stuart Wakelin, supported by FIND-the Global Alliance for Diagnostics. We acknowledge the Director General, KEMRI, where the samples from the sites in Kenya were analyzed. We thank all field officers, laboratory staffs, all patients, and all other participants of the study. This study was funded by the UK government via a grant to FIND-the Global Alliance for Diagnostics. Publisher Copyright: Copyright {\textcopyright} 2022 Sapkota et al. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license.",
year = "2022",
month = dec,
doi = "10.1128/jcm.01000-22",
language = "English",
volume = "60",
journal = "Journal of Clinical Microbiology",
issn = "0095-1137",
publisher = "American Society for Microbiology",
number = "12",
}