Syphilis, Treponema Pallidum
Conditions
Keywords
Syphilis, TP/nTP, Multiplo Complete Syphilis (TP/nTP) Antibody Test, MedMira, Treponema pallidum, rapid test, point of care
Brief summary
Due to the recent resurgence of infectious syphilis in Canada and the changing epidemiology of the disease to involve heterosexuals and females of child bearing age leading to a record number of congenital syphilis cases and stillbirths, the demand of a rapid test such as POCT that can be used at the place and time that front-line public health workers meet the at risk population is getting louder. Indeed during a number of federal, provincial and territorial meetings on the control of syphilis outbreaks in Canada, requests for POCT to detect syphilis infections have repeatedly come up. However, before a POCT can be widely used, research to find out if it is accurate and reliable is necessary. This study is designed to test the performance of the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) (MedMira Inc., Halifax, Nova Scotia) in an urban clinic (Sexual Health Clinic) in Ottawa, Ontario, Canada and compare its performance in parallel with the usual testing method (the gold standard, i.e. conventional syphilis serology testing).
Interventions
DEVICEMedical Device
Multiplo Complete Syphilis (TP/nTP) Antibody Test
Sponsors
Public Health Agency of Canada (PHAC)
MedMira Laboratories Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Individuals attending the Clinic for routine sexual health care and requiring syphilis testing as part of this care, who are able to provide informed consent and are a minimum 16 years of age are eligible for this study. This includes patients attending the Clinic for follow-up appointments following diagnosis with syphilis infection. Those who have had other STIs in the past, or being suspected of having other STIs, are not excluded as long as testing for syphilis is part of the care provided to them. Once it has been determined that the
Exclusion criteria
does not apply to a patient, the recruitment of participants will be offered without other pre-selection criteria unless there may be other unforeseeable circumstances arising, such as shortage of Clinic staff or large numbers of patients in attendance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the accuracy of Multiplo Complete Syphilis (TP/nTP) Antibody Test | 1 patient visit of appoximately 30 minutes | For each enrolled subject, Multiplo Complete Syphilis (TP/nTP) Antibody Test will be used to test fingerstick whole blood from the patient. A venipuncture whole blood sample will also be drawn from the patient and will be tested using conventional serological testing methods to determine patient status. |
Countries
Canada
Contacts
Primary ContactJennifer MacLellan
Backup ContactKayla Turner
Outcome results
None listed