[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"treponema-pallidum\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:treponema-pallidum":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100599849","this-study-evaluates-the-alpco-syphilis-t-and-syphilis-nt-clia-kits-for-detecting-syphilis-antibodies-in-serum-and-plasma-samples-from-at-risk-hiv-positive-pregnant-and-healthy-individuals-will-assess-assay-performance-versus-established-comparator-tests-100599849",false,"NCT07089836","This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests.","ALPCO Syphilis-T and Syphilis-NT CLIA Kits: Detection of Antibodies to Treponema Pallidum and Against Lipoidal Antigens in Human Serum and Plasma","Inclusion Criteria:\n\n* Male, Female, or Other(s)\n* Patients undergoing routine syphilis testing (asymptomatic at risk, suspected with symptoms, prior history of syphilis, high risk for syphilis) or previously diagnosed with syphilis through a test performed in an accredited laboratory.\n* Participants must be willing to provide the required blood samples for the clinical study, in addition to any samples requested by their physician.\n* Pregnant individuals and children (under 22): 1 clinical study tube of blood.\n* All other participants (excluding pregnant individuals and children): 2 clinical study tubes of blood.\n* Participants must be able and willing to sign the informed consent form (ICF).\n* Participants aged 13 to 17 will be asked to sign an assent form. Written parental or guardian consent will also be required prior to enrollment. The assent form will use age-appropriate language and be reviewed with the participant before any procedures.\n\nExclusion Criteria:\n\n* Patients currently being treated with antibiotics or completed a course of antibiotics within the past 30 days\n* Patients with pre-existing conditions that would make blood collection difficult or harmful\n* If the samples are not collected in strict accordance with the established sampling protocol, as determined by the study team.\n* Any medical, psychological, or social condition that, in the judgment of the investigator, could interfere with the participant's ability to comply with study requirements, or pose a risk to their safety, or compromise the integrity of the study.",true,"ALL","13 Years",{"count":20,"type":21},1000,"ESTIMATED","OBSERVATIONAL","This study will evaluate the clinical performance of two investigational diagnostic kits developed by ALPCO: the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit. These kits are designed to detect antibodies to Treponema pallidum and non-treponemal lipoidal antigens, respectively, in human serum and plasma using the automated KleeYa platform. The study will collect and analyze blood samples from individuals suspected of having syphilis, those at high risk, HIV-positive patients, pregnant individuals, and healthy controls. The aim is to determine the kits' Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to established reference assays.",[25,26,27,28,29,30,31],"Treponema Pallidum","Treponema Pallidum Infection","Syphilis Infection","Serum","Plasma","Blooddraw","Sexually Transmitted Infection (STI)",[33,34,35,36,37,38,39,40,41,42],"Non Treponema","Treponema","Syphilis","Sample Collection","Treponema pallidum","Non-treponemal test","Chemiluminescent immunoassay","HIV-positive","Pregnant women","Blood sample collection","RECRUITING","2026-02-09",{"date":46,"type":47},"2026-02-11","ACTUAL",{"date":49,"type":47},"2025-12-10",{"date":51,"type":21},"2026-07",{"name":53,"class":54},"American Laboratory Products Company","INDUSTRY",6,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":16,"sex":17,"minAge":63,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":71,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100561188","a-cross-sectional-investigational-study-to-evaluate-the-sensitivity-specificity-and-utility-of-the-medmira-inc-multiplo-complete-syphilis-tpntp-antibody-test-poct-to-diagnose-infectious-syphilis-in-participants-attending-the-sexual-health-clinic-in-ottawa-ontario-100561188","NCT06586905","A Cross-sectional Investigational Study to Evaluate the Sensitivity, Specificity, and Utility of the MedMira Inc. Multiplo® Complete Syphilis (TP\u002FnTP) Antibody Test (POCT) to Diagnose Infectious Syphilis in Participants Attending the Sexual Health Clinic in Ottawa, Ontario.","A Cross-sectional Investigational Study to Evaluate the Sensitivity, Specificity, and Utility of the MedMira Inc. Multiplo® Complete Syphilis (TP\u002FnTP) Antibody Test (POCT) to Diagnose Infectious Syphilis in Participants Attending the Sexual Health Clinic in Ottawa, Ontario. The MedMira Inc. Multiplo® Complete Syphilis (TP\u002FnTP) Antibody Test is Authorized for Investigational Use.","Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Those who, at the discretion of the HCPs\u002Fresearch co-ordinator, appear intoxicated and\u002For with extreme distress, or confused, will be excluded from this research because they would not be able to provide informed consent to participate, as well as those below the age of 16 years.","16 Years",{"count":65,"type":21},1300,"INTERVENTIONAL",[68],"NA","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\u002FnTP) 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).",[35,25],[35,72,73,74,37,75,76],"TP\u002FnTP","Multiplo Complete Syphilis (TP\u002FnTP) Antibody Test","MedMira","rapid test","point of care","2025-11-17",{"date":79,"type":47},"2025-11-18",{"date":81,"type":47},"2024-08-26",{"date":83,"type":21},"2026-07-31",{"name":85,"class":54},"MedMira Laboratories Inc.",1]