Evidence map›Paper›PMID 41361278›Full record

Trial reportBMC infectious diseases2025

Evaluating the MedMira Multiplo® Complete Syphilis (TP/nTP) antibody test in a sexually transmitted infection clinic in Ottawa, Canada: increased rapid diagnosis and improved antibiotic stewardship.

Patrick O'Byrne, Riley Dillabough, Kathleen Whyte, Lauren Orser, Vanessa Tran, Venkata R Duvvuri, Raymond Tsang

Registry-linked trialAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06586905 (A Cross-sectional Investigational Study to Evaluate the Sensitivity, Specificity, and Utility of the MedMira Inc. Multiplo® Complete Syphilis), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06586905 narecruitingnot on this map

A Cross-sectional Investigational Study to Evaluate the Sensitivity, Specificity, and Utility of the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) to Diagnose Infectious Syphilis in Participants Attending the Sexual Health Clinic in Ottawa, Ontario. The MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test is Authorized for Investigational Use.

TypeinterventionalSponsorMedMira Laboratories Inc.Ran2024 to 2026Enrolled1,300ConditionsSyphilis, Treponema PallidumArmsMedical Device
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Patrick O'ByrneSchool of Nursing, University of Ottawa, 125 University Private, Ottawa, Ontario, K1N 1A2, Canada. pjobyrne@uOttawa.ca.
Riley DillaboughOttawa Public Health, Sexual Health Clinic, 179 Clarence Street, Ottawa, Ontario, K1N 5P7, Canada.
Kathleen WhyteLaboratory for Syphilis Diagnostics, National Microbiology Laboratory Branch, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.
Lauren OrserSchool of Nursing, University of Ottawa, 125 University Private, Ottawa, Ontario, K1N 1A2, Canada.
Vanessa TranPublic Health Ontario, 661 University Avenue, Suite 1701, Toronto, ON, M5G 1M1, Canada.
Venkata R DuvvuriPublic Health Ontario, 661 University Avenue, Suite 1701, Toronto, ON, M5G 1M1, Canada.
Raymond TsangLaboratory for Syphilis Diagnostics, National Microbiology Laboratory Branch, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSyphilis now affects every population and serology is the mainstay of diagnosis. The issue is that serology has a turnaround time of several days. One solution is point-of-care tests (POCTs), which can provide results in minutes. We consequently evaluated the MedMira Multiplo® Complete Syphilis Test in an STI clinic in Ottawa, Canada.

methodsAnyone 16 + years old who consented and was undergoing syphilis testing at our clinic was eligible. Those who enrolled completed the POCT and saw a clinician to review their result. We calculated sensitivities and specificities for the POCT, compared to serology and diagnosis.

resultsFrom August 2024 to May 2025, we performed 622 syphilis POCTs on 600 participants. Compared to serology when chemiluminescent microparticle immunoassay (CMIA) and Treponema pallidum particle agglutination (TP.PA) tests were reactive, the POCT treponemal (TP) test had a sensitivity of 90.1% and specificity of 97.9%. Compared to any dilution of rapid plasma reagin (RPR), the POCT non-treponemal (nTP) test had a sensitivity of 82.5% and specificity of 99.1%. When we stratified POCT nTP results based on RPR titers, the POCT nTP had a sensitivity of 94.1% for RPR dilutions ≥ 1:8. Compared to serology, the POCT identified 91.4% of new syphilis infections and 97% of infectious syphilis.

conclusionsPOCTs informed clinical syphilis management. While most research has focused on how POCTs can facilitate treatment, in our study, there was a second major utility: to withhold antibiotics when recommended as empiric treatment but when the patient does not have active syphilis. Future research on syphilis POCTs should focus on their abilities to rule in and rule out infections.

trial registrationNCT06586905 (Registered Sept 4, 2024).

Indexed as

Antibodies, BacterialPoint-of-Care TestingSyphilisSyphilis SerodiagnosisAdolescentAdultAnti-Bacterial AgentsCanadaFemaleHumansMaleMiddle AgedPoint-of-Care SystemsSensitivity and SpecificityTreponema pallidumYoung AdultAnti-Bacterial AgentsAntibodies, BacterialAntimicrobial stewardshipPoint-of-care testingSyphilis diagnosisSyphilis treatment

Identifiers

PMID41361278
PMCPMC12797785

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.