Laboratory Evaluation of the DPP Syphilis Screen & Confirm Assay

Calvo, G.; Reyes-Diaz, M.; Klausner, J. D.; Qquellon Palacios, Luz Jazmín; Konda, K. A.; Vargas Rivera, Silver Keith; Caceres Palacios, Carlos Fernando; Vasquez, F.

dc.contributor.author	Vargas Rivera, Silver Keith
dc.contributor.author	Qquellon Palacios, Luz Jazmín
dc.contributor.author	Vasquez, F.
dc.contributor.author	Konda, K. A.
dc.contributor.author	Calvo, G.
dc.contributor.author	Reyes-Diaz, M.
dc.contributor.author	Caceres Palacios, Carlos Fernando
dc.contributor.author	Klausner, J. D.
dc.date.accessioned	2022-06-25T20:36:44Z
dc.date.available	2022-06-25T20:36:44Z
dc.date.issued	2022
dc.identifier.uri	https://hdl.handle.net/20.500.12866/11906
dc.description.abstract	Because syphilis is a public health concern, new strategies and tools for detecting active syphilis cases should be evaluated for future implementation. We assessed the laboratory performance of the DPP Syphilis Screen & Confirm rapid immunodiagnostic test (Chembio Diagnostics, Medford, NY, USA), using visual reading and the manufacturer’s electronic test microreader, for detection of treponemal and nontreponemal antibodies in 383 fully characterized stored serum specimens. We used the Treponema pallidum particle agglutination (TPPA) test and rapid plasma reagin (RPR) test as reference tests for the DPP Syphilis Screen & Confirm assay treponemal and nontreponemal components, respectively. The sensitivity values for treponemal antibody detection by electronic reader and visual interpretation were 83.2% and 85.9%, respectively, with 100% specificity. For nontreponemal antibody detection, the sensitivity values were 65.7% and 69.0% and the specificity values were 88.7% and 89.4% for electronic reader and visual interpretation, respectively. There was excellent correlation between visual interpretation and the microreader for either component (kappa coefficient, 0.953). When restricting the analysis to RPR titers of ≥1:8, the sensitivity was 96.9% for either reading method; numerical microreader values showed good correlation with RPR titers (Spearman rho of 0.77). The DPP Syphilis Screen & Confirm assay showed good performance, compared to reference syphilis tests, using serum. Field evaluation studies should be done to validate its use for detection of active cases and for monitoring of treated syphilis patients.	en_US
dc.language.iso	eng
dc.publisher	American Society for Microbiology
dc.relation.ispartofseries	Microbiology Spectrum
dc.rights	info:eu-repo/semantics/restrictedAccess
dc.rights.uri	https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject	dual testing	en_US
dc.subject	point of care	en_US
dc.subject	immunoserology	en_US
dc.subject	syphilis	en_US
dc.title	Laboratory Evaluation of the DPP Syphilis Screen & Confirm Assay	en_US
dc.type	info:eu-repo/semantics/article
dc.identifier.doi	https://doi.org/10.1128/spectrum.02642-21
dc.relation.issn	2165-0497