Rapid diagnostic testing for syphilis in Arctic communities (the STAR study): a multisite prospective field diagnostic accuracy study in an intended-use setting

We evaluated the field diagnostic accuracy of a syphilis rapid test (RDT), using serum and whole blood by non-laboratorians in two Canadian Arctic communities. We implemented a multisite prospective field evaluation wherein patients were screened by an RDT containing treponemal and non-treponemal co...

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Published in:Clinical microbiology and infection Vol. 29; no. 10; p. 1335.e1
Main Authors: Caya, Chelsea, Singh, Ameeta E, Serhir, Bouchra, Morin, Veronique, Libman, Michael D, Corsini, Rachel, Goldfarb, David M, Wong, Tom, Xia, Yiqing, Maheu-Giroux, Mathieu, Yansouni, Cedric P
Format: Journal Article
Language:English
Published: England 01.10.2023
Subjects:
Performance evaluation
Circumpolar health
Point of care
Diagnostic accuracy
Syphilis
Specimen type
Rapid diagnostic test
Sexually transmitted infection
ISSN:1469-0691, 1469-0691
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Summary:We evaluated the field diagnostic accuracy of a syphilis rapid test (RDT), using serum and whole blood by non-laboratorians in two Canadian Arctic communities. We implemented a multisite prospective field evaluation wherein patients were screened by an RDT containing treponemal and non-treponemal components (Chembio DPP® Syphilis Screen & Confirm) between January 2020 and December 2021. Venous whole blood and serum were collected for rapid testing and compared with laboratory-based serology reference testing using a reverse sequence algorithm of treponemal and rapid plasma reagin (RPR) testing. Overall, 135 whole blood and 139 serum specimens were collected from 161 participants during clinical encounters. Treponemal-RDT sensitivity against a treponemal-reference standard (38/161 confirmed cases) was similar for serum (78% [95% CI: 61-90%]) and whole blood (81% [95% CI: 63-93%]). In those with RPR titres ≥1:8 (i.e. suggestive of recent/active infection), sensitivity increased to 93% (95% CI: 77-99%) for serum and 92% (95% CI: 73-99%) for whole blood. Treponemal-RDT specificity was excellent (99% [95% CI: 95-100%]) for both specimen types. Non-treponemal-RDT sensitivity against RPR was 94% (95% CI: 80-99%) for serum and 79% (95% CI: 60-92%) for whole blood. Sensitivity increased to 100% (95% CI: 88-100%) for serum and 92% (95% CI: 73-99%) for whole blood when RPR titres ≥1:8. RDT performance with whole blood was similar to that with serum. Non-laboratorians using the RDT accurately identified individuals with infectious syphilis under real-world conditions in an intended-use setting at the point of care. Implementing the RDT can eliminate treatment delays and may enhance disease control.
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ISSN:1469-0691
1469-0691
DOI:10.1016/j.cmi.2023.06.013