10 completed, 4 not yet recruiting, 2 recruiting. 13 Not applicable, 1 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 13 | Completed 7, Not yet recruiting 4, Recruiting 2 |
| Phase 2 | 1 | Completed 1 |
| Phase 3 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use INSTI HCV Antibody Test - HCV Infection | Not applicable | Not yet recruiting | bioLytical Laboratories | 388 | 2026-11-01 | 2026-10-29 |
| Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection INSTI HCV Antibody Test - HCV Infection | Not applicable | Not yet recruiting | bioLytical Laboratories | 1660 | 2026-11-01 | 2026-10-29 |
| A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test TruPlex HIV/HepB/Syphilis Rapid Test - HIV1 Infection, HIV 2 Infection | Not applicable | Not yet recruiting | bioLytical Laboratories | 500 | 2026-09-01 | 2026-05-06 |
| Performance Study of the INSTI® and TruPlex Rapid Blood Typing Platforms INSTI® Rapid Blood Type Test, TruPlex Rapid Blood Type Test - ABO Blood Type, RhD Blood Type | Not applicable | Not yet recruiting | bioLytical Laboratories | 2500 | 2026-08-31 | 2026-08-18 |
| A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test TruPlex HIV/HepB/Syphilis Rapid Test - HIV 1 Infection, HIV 2 Infection | Not applicable | Recruiting | bioLytical Laboratories | 1000 | 2025-12-18 | 2026-10-02 |
| A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test iStatis Gonorrhea Antigen Test - Gonorrhea Infection | Not applicable | Recruiting | bioLytical Laboratories | 650 | 2025-11-26 | 2026-09-30 |
| A Study to Evaluate the Performance of INSTI® HIV Self Test When Performed by Unobserved Intended Users in the US NSTI® HIV Self-Test - Human Immunodeficiency Virus I Infection, Human Immunodeficiency Virus II Infection | Not applicable | Completed | bioLytical Laboratories | 122 | 2025-07-24 | 2025-08-20 |
| A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test INSTI® HIV Self-Test - Human Immunodeficiency Virus I Infection, Human Immunodeficiency Virus II Infection | Not applicable | Completed | bioLytical Laboratories | 1728 | 2024-05-02 | 2025-07-11 |
| A Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites iStatis HBsAg Test - Hepatitis B, Hepatitis B Infection | Not applicable | Completed | bioLytical Laboratories | 175 | 2024-04-30 | 2025-02-21 |
| Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings iStatis HBsAg Test - Hepatitis B, Hepatitis B Infection | Not applicable | Completed | bioLytical Laboratories | 1400 | 2024-03-19 | 2025-02-21 |
| Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites iStatis Syphilis Ab Test - Syphilis Infection, Syphilis | Not applicable | Completed | bioLytical Laboratories | 1500 | 2024-03-14 | 2024-08-12 |
| Retrospective Study of iStatis Syphilis Ab Test (POC) iStatis Syphilis Antibody Test - Syphilis, Syphilis Infection | Completed | bioLytical Laboratories | 1500 | 2023-11-15 | 2024-08-12 | |
| Trial of Hepatitis C Self-Testing in the Hands of Untrained Lay Users INSTI HCV Self Test - Hepatitis C | Not applicable | Completed | bioLytical Laboratories | 1415 | 2023-10-12 | 2025-02-21 |
| INSTI® HCV (Hepatitis C Virus) Antibody Self-Test Contrived Result Interpretation INSTI HCV Self Test - Hepatitis C | Completed | bioLytical Laboratories | 405 | 2023-10-12 | 2024-04-10 | |
| Evaluation of Clinical Performance and Usability of iStatis COVID-19 Ag Rapid Test at POC iStatis COVID-19 Ag Rapid Test, "COVID-19 RT-PCR Test EUA Number: EUA200011, Company: Laboratory Corporation of America ("Labcorp") - COVID-19 Virus Infection, COVID-19 | Not applicable | Completed | bioLytical Laboratories | 129 | 2022-01-13 | 2022-08-24 |
| Testing of INSTI™ HIV-1 Antibody Test Kit in Volunteer Subjects at Risk for HIV Infection Behavioral counseling, HIV-1 Antibody Test Kit - HIV Infections | Phase 2 / Phase 3 | Completed | bioLytical Laboratories | 2500 | 2007-07-01 | 2021-01-27 |
Hepatitis B (4) · Hepatitis C (4) · Syphilis (2) · Acquired Immunodeficiency Syndrome (1) · COVID-19 (1) · HIV Infections (1)
Behavior Therapy (1)
South Africa (6) · United States (3) · Australia (2) · Canada (2)
Anthony LaMarca (1) · Mohammed Majam (1) · Steven A Geller (1)