Laboratory evaluation of two point-of-care test kits for the identification of infectious syphilis

Tsang, Raymond S. W.; Shuel, Michelle; Hayden, Kristy; Caeseele, Paul Van; Stein, Derek

doi:10.14745/ccdr.v48i23a05

Cited by 7 publications

(8 citation statements)

References 6 publications

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“…A further innovative practice would be to incorporate a syphilis point-of-care test in conjunction with outreach services, allowing persons to be diagnosed and treated at the same visit, while reducing barriers to accessing care. Recent trials of one such test have shown good sensitivity for cases with RPR ≥8 dilutions, which would have included all our cases 16,17 . One must also keep in mind the motto “Treatment is prevention.” Improved diagnosis and treatment of syphilis before pregnancy and of sexual partners will decrease the incidence of syphilis in pregnancy.…”

Section: Discussionmentioning

confidence: 99%

Case series of stillbirths due to syphilis in Edmonton, Alberta, Canada

et al. 2023

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Background Data on the incidence and characteristics of stillbirths attributed to congenital syphilis were collected. Methods We extracted data on stillbirths in the Edmonton Zone on January 1, 2015, through June 30, 2021, born to persons diagnosed with infectious syphilis (primary, secondary, early latent, or early neurosyphilis) during pregnancy or at the time of delivery. Results Of 314 infants documented to be exposed to infectious syphilis during gestation, 16 (5.1%) were stillborn. Three of the 16 females with stillbirths were diagnosed with syphilis during pregnancy but not treated, 12 were diagnosed only at the time of stillbirth (1 of whom was treated early in pregnancy and presumably reinfected), and 1 had a stillbirth in the week after one dose of benzathine penicillin G. Conclusions Stillbirths due to congenital syphilis were all due to failure to treat syphilis in pregnancy. Innovative strategies to prevent syphilis in the community and to reach those experiencing barriers to care are urgently required to not miss opportunities to diagnose and treat syphilis as early as possible during pregnancy.

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Section: Discussionmentioning

confidence: 99%

Case series of stillbirths due to syphilis in Edmonton, Alberta, Canada

et al. 2023

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“…The RVF Core Technology test has been reported before [ 36 , 37 , 38 , 39 ]. The ACT::SOE3 recombinant protein at a concentration of 1 mg/mL is formulated in PBS, pH 7.5, containing 0.1% Tweet 20, 0.6% SDS, 10 mM EDTA and 0.01% of sodium azide.…”

Section: Methodsmentioning

confidence: 99%

Point-of-Care Diagnostic for Trichomonas vaginalis, the Most Prevalent, Non-Viral Sexually Transmitted Infection

Alderete

Chan²

2023

Pathogens

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A point-of-care (POC) diagnostic is needed for both women and men to establish universal screening and surveillance for the number one, non-viral sexually transmitted infection (STI) caused by Trichomonas vaginalis. We developed a POC diagnostic for this STI using the MedMira Rapid Vertical Flow (RVF®) Technology test cartridge with a membrane that includes a Vertical procedural/reagent control line (referred to as CVL) and spotted with 1 µg of a 72.4-kDa truncated version of α-actinin called ACT::SOE3. This protein is a specific diagnostic target for antibody in sera of individuals with trichomoniasis. Serum antibody to ACT::SOE3 is a positive reaction with the test spot. Specificity of ACT::SOE3 was revealed with monoclonal antibodies (MAbs) generated to ACT::SOE3. Addition of negative control serum with MAb 67B reactive to ACT::SOE3 shows detection of both ACT::SOE3 and the CVL. Only positive sera of individuals had antibody reactive with ACT::SOE3 and detected the presence of the spot and the CVL. Negative control sera were unreactive with ACT::SOE3 and only showed the presence of the CVL. Importantly, to show proof-of-principle for POC application, ACT::SOE3 was detected with the positive patient sera spiked with whole blood. Finally, packaged cartridges stored with desiccant packs at 37 °C for one year gave identical results with the positive and negative human sera. Our results show the validity of this new POC serodiagnostic for this STI.

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“…The RDT that will be used in this study is the Chembio DPP 1 Syphilis Screen & Confirm Assay (Chembio Diagnostic Systems Inc., Medford, NY; Chembio RDT) [13]. Previously published evaluations of the diagnostic accuracy of the Chembio RDT indicate that when using serum, the RDT has acceptable sensitivity (�85%) and specificity (�94%) relative to traditional laboratory-based diagnostic approaches [14][15][16][17][18]. The majority of these studies however, have been conducted either in laboratory settings or by trained laboratory personnel which may bias the observed accuracy.…”

Section: Study Aimsmentioning

confidence: 99%

Stopping syphilis transmission in Arctic communities through rapid diagnostic testing: The STAR study protocol

et al. 2022

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Background Intense transmission of syphilis has emerged in some Canadian Arctic communities despite screening and prevention efforts. The remoteness of most communities and limited diagnostic infrastructure yield long delays (≥14 days) between screening and treatment of cases. These hamper syphilis control efforts and may contribute to sustained transmission. Syphilis rapid diagnostic tests (RDTs) have been developed to make screening more accessible and to inform clinical decision-making within the same clinical encounter. These RDTs have been successfully deployed in several countries, but not yet in Canada. Methods and design We describe the methodology of the “Stopping Syphilis Transmission in Arctic Communities Through Rapid Diagnostic Testing” (STAR) study, wherein the clinical and epidemiological impact of deploying a dual syphilis RDT in the context of ongoing transmission in Nunavut and Nunavik will be evaluated. In this prospective multisite field evaluation, sexually active individuals aged ≥14 years at risk for syphilis will be offered screening by an RDT at the point-of-care by non-laboratory trained registered nurses. Whole blood and serum specimens will be concurrently collected, when feasible, for rapid testing with an RDT containing both treponemal and non-treponemal components (Chembio DPP® Syphilis Screen & Confirm) and compared to laboratory-based reference testing according to a reverse sequence algorithm. The diagnostic accuracy of the RDT, using both whole blood and centrifuged serum specimens, will be validated under real-world conditions in remote Northern settings, outside of specialized laboratories. Additionally, screening-to-treatment time, case detection rates, and the number of infectious contacts averted by using the RDT relative to reference testing will be estimated. The impact of both diagnostic approaches on syphilis transmission dynamics will also be modeled. Discussion This study will provide much needed evidence for strengthening rapid responses to emerging syphilis outbreaks in remote Arctic regions, by supplementing traditional diagnostic strategies with an RDT to rapidly triage patients likely in need of treatment. These results will also inform the development and tailoring of future diagnostic strategies and public health responses to emerging outbreaks in the North.

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Laboratory evaluation of two point-of-care test kits for the identification of infectious syphilis

Cited by 7 publications

References 6 publications

Case series of stillbirths due to syphilis in Edmonton, Alberta, Canada

Case series of stillbirths due to syphilis in Edmonton, Alberta, Canada

Point-of-Care Diagnostic for Trichomonas vaginalis, the Most Prevalent, Non-Viral Sexually Transmitted Infection

Stopping syphilis transmission in Arctic communities through rapid diagnostic testing: The STAR study protocol

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