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.
This study is to test the Multiplo Complete Syphilis (TP/nTP) Antibody Test for its performance in an urban STI clinic using finger-prick obtained whole blood to perform the POCT at the clinic.
Evaluation of the Sensitivity, Specificity, and Utility of the Reveal® TP (Syphilis) Antibody POCT to Diagnose Infectious Syphilis in Participants Attending the BCCDC's STI Clinic in Vancouver, BC
This study is to test the Reveal® TP (Syphilis) antibody POCT (MedMira, Inc., Halifax, Nova Scotia) for its performance in an urban STI clinic in Vancouver, British Columbia and compare its performance in parallel with the usual testing method (the gold standard).
Clinical Performance of Reveal G4 Rapid HIV-1 Antibody Test for the Detection of HIV-1 Antibodies in Fingerstick and Venous Whole Blood Samples
To determine the efficacy of an improved rapid diagnostic test using venous whole blood and fingerstick whole blood. The clinical performance of Reveal G4 Rapid HIV-1 Antibody Test will be determined by comparing the results with patient infected status for HIV-1 (human immunodeficiency virus type 1).
The study will consist of a single one-hour visit, at which time blood samples will be collected and tested with the investigational device (Reveal G4) and FDA approved comparator assays for detection of HIV-1 antibodies.
100 项与 MedMira Laboratories, Inc. 相关的临床结果
0 项与 MedMira Laboratories, Inc. 相关的专利(医药)
100 项与 MedMira Laboratories, Inc. 相关的药物交易
100 项与 MedMira Laboratories, Inc. 相关的转化医学