Clinical trials: Point-of-Care Testing
Point-of-Care Testing, HIV
Ayaangwaamiziwin Initiative: Carefulness and Preparedness
The goal of this clinical trial is to implement a test, treat, and connect intervention approach using HIV and syphilis rapid point-of-care (POC) testing in 3 Canadian Prairie provinces (Alberta, Manitoba, and Saskatchewan)…
- Conditions
- Point-of-Care Testing, HIV, Syphilis
- Trial name
- AI (NCT06893159)
- Testing
- INSTI HIV-1/2 Antibody Test, INSTI Multiplex HIV-1/2 Syphilis Antibody Test, Multiplo Complete Syphilis (TP/nTP) Antibody Test
- Where
- 8 sites in Canada
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto
Syphilis, Treponema Pallidum
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.
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…
- Trial name
- NCT06586905
- Testing
- Medical Device
- Where
- Canada
- Volunteers
- 1,300 people, healthy volunteers welcome
- Sponsor
- MedMira Laboratories Inc.
Treponema Pallidum Infection, Chlamydia Trachomatis Infection
Improving Maternal and Child Health Through Point-of-care STI Testing
The goal of this clinical trial is to learn if point-of-care tests (POCTs) for sexually transmitted infections (STIs) improve the timely treatment of syphilis, chlamydia, gonorrhea, and trichomonas in pregnant women.
- Conditions
- Treponema Pallidum Infection, Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection, Trichomonas Vaginalis Vaginitis
- Trial name
- MATCH-POINT (NCT07290439)
- Testing
- Point-of-care STI tests, Standard of care STI testing
- Where
- United States
- Volunteers
- 756 people, healthy volunteers welcome
- Sponsor
- Emory University
Colorectal Cancer
Evaluation of a Point-of-care Testing Instrument for Fecal Immunochemical Test
Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer.Use of the fecal immunochemical test (FIT) for colorectal cancer (CRC) prevention is supported by previous studies.However…
- Trial name
- NCT05232721
- Testing
- The new instrument and colonoscopy with pathological examination
- Where
- China
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Shandong University
HIV - Human Immunodeficiency Virus, HBV (Hepatitis B Virus)
MAGIA H3S Point of Care Test Performance for HIV, HBV, HCV, and Syphilis Screening in Pregnant Women in DR Congo
Performance study to evaluate the clinical performance of the In-Vitro Diagnostic Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and…
- Conditions
- HIV - Human Immunodeficiency Virus, HBV (Hepatitis B Virus), Hepatitis C Virus (HCV), Syphilis
- Trial name
- MAGICS MAM (NCT07388979)
- Testing
- MAGIA H3S
- Volunteers
- 7,500 people, healthy volunteers welcome
- Sponsor
- Gardiens de Vies
HIV
Operational Assessment of Point-of-Care Diagnostics in Primary Healthcare Clinics
Diagnostic point-of-care (POC) tests are being rapidly developed and implemented in resource-limited settings. There has been a rapid rise of HIV and TB POC tests in South Africa during the last 10-15 years.
- Trial name
- NCT02692274
- Where
- South Africa
- Volunteers
- 309 people, healthy volunteers welcome
- Sponsor
- University of KwaZulu
Diagnoses Disease
Evaluation of HemoTypeSC as a Novel Rapid Test for Point-of-Care Screening for Sickle-Cell Disease, Hemoglobin C Disease, and Carrier Status in Low-Resource Settings
Sickle cell disease is a life-threatening genetic disorder that can be effectively treated following early diagnosis via newborn screening.
- Trial name
- NCT03619798
- Testing
- HemoTypeSC
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Silver Lake Research Corporation
Tetanus
TETANUS Antibody Detection in Saliva Study
This study aims to design, develop and optimise a non-invasive, saliva sample-based point-of-care lateral flow test for use in low and middle income settings that can return a qualitative result on whether an individual has or…
- Trial name
- TETANUS (NCT07446166)
- Testing
- Point of care, saliva-based lateral flow test, Blood based immunoassay
- Where
- Rwanda
- Volunteers
- 390 people, healthy volunteers welcome
- Sponsor
- University of Birmingham
HIV
HIV Point-of-Care Test Evaluation in Infants
HIV Point-of-Care tests in Babies Study (BABY) - Operational evaluation of HIV Point-of-Care tests for very early infant HIV diagnostics in infants born to HIV infected mothers in Mbeya, Tanzania.
- Trial name
- BABY (NCT02545296)
- Testing
- In-vitro Diagnostics
- Where
- Tanzania
- Volunteers
- 604 people, healthy volunteers welcome
- Sponsor
- Michael Hoelscher
HIV, Syphilis
Evaluation of the MBio Combined Syphilis/HIV Point-of-Care Diagnostic Test
This is a diagnostic validation study for a combined Syphilis/HIV test made by MBio Diagnostics, Inc (MBio, Boulder, CO, USA). Although the MBio Syphilis/HIV diagnostic platform is designed for use at point of care (POC), it is…
- Trial name
- MBIO (NCT01530672)
- Testing
- MBIO POC combined HIV syphilis test ( SnapEsi)
- Where
- 2 sites in Kenya
- Volunteers
- 2,900 people, healthy volunteers welcome
- Sponsor
- PATH
Dehydration, Seizure
Point of Care Device Use in the Pediatric Emergency Department
To compare the effect of "point-of-care" (POC) analysis of blood work with traditional laboratory methods on length of stay in a pediatric emergency department (PED).
- Conditions
- Dehydration, Seizure, Gastroenteritis, Hyperglycemia
- Trial name
- NCT00285285
- Testing
- Point of Care Device; i-Stat Analyzer
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Yale University
Syphilis, Syphilis Infection
Retrospective Study of iStatis Syphilis Ab Test (POC)
The purpose of this retrospective clinical trial is to establish the clinical performance of the iStatis Syphilis AbTest. The data will be used to demonstrate the product is safe and effective for its intended use.
- Trial name
- NCT06367621
- Testing
- iStatis Syphilis Antibody Test
- Where
- South Africa
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Warfarin
Patient Self Testing of Warfarin Therapy
To test the hypothesis that home international normalised ratio (INR) monitoring with supervised patient self-testing (PST)can provide comparable or superior time in therapeutic range (TTR) to that provided by traditional…
- Trial name
- NCT00594828
- Testing
- CoaguChek (Patient self testing), Anticoagulation Management Service (AMS)
- Where
- Ireland
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- University College Cork
COVID-19 Infection
Novel Point-of-Care Diagnostic Test for SARS-CoV-2 (COVID-19)
This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus that causes the disease COVID-19. This may help to improve testing for COVID-19.
- Trial name
- END CoV-2 (NCT04513990)
- Testing
- Biospecimen Collection, Questionnaire Administration
- Where
- 2 sites in United States
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
Type 2 Diabetes
Point of Care HbA1c as a Screening Test for Type 2 Diabetes in First Nations
1. Purpose to estimate the prevalence of undiagnosed diabetes mellitus and pre-diabetes in a BC First Nation community to determine the utility of community based screening by examining how many positively screened people follow…
- Trial name
- NCT01333176
- Testing
- Point-of-care "finger-poke" HbA1c determination., HbA1c blood test, HbA1c finger poke test
- Where
- Canada
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Aged ≥2 Years in Schistosomiasis Affected Areas
Validation of POC-CCA Rapid Urine Test for Qualitative Detection of Schistosoma Japonicum
This is a longitudinal cohort study that will be coordinated with the 2019 schistosomiasis stool survey in Napu. The study will use the stool survey results as entry criteria to identify subjects to become the index cases.
- Trial name
- SchisCCA (NCT03870204)
- Testing
- POC-CCA rapid urine test
- Where
- Indonesia
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- Ina-Respond
HIV
Point-of-care Viral Load Testing Among HIV-infected Adolescents in Haiti
This study is designed as an individual randomized trial among 150 HIV-infected adolescents aged 10-24 years who have been on ART for >6 months and will be randomized in a 1:1 fashion to one of two arms: 1) the intervention arm…
- Trial name
- NCT03288246
- Testing
- point-of-care viral load test
- Where
- Haiti
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
HIV
Early Infant Diagnosis Point of Care Pilot
In Mozambique, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories in Maputo, Nampula, Beira and Quelimane.
- Trial name
- NCT02634450
- Testing
- Alere q
- Where
- 8 sites in Mozambique
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Instituto Nacional de Saúde, Mozambique
Allergy, Allergic Asthma
abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies
This is a multicenter, prospective, observational study designed to determine the clinical sensitivity and specificity of the Abionic IVD CAPSULE Allergic Asthma panel performed on Abionic's abioSCOPE device using K3-EDTA…
- Conditions
- Allergy, Allergic Asthma, Allergy to Cats, Allergy to House Dust
- Trial name
- NCT04442932
- Testing
- Blood Collection
- Where
- 5 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Abionic SA
COVID-19, COVID
Clinical Validation of the Aptitude Medical Systems Metrix COVID-19 Test
The Metrix COVID Test will be evaluated for use in Point-of-Care and Non-Laboratory settings in a home testing environment utilizing the clinical study design described herein.
- Trial name
- NCT06744660
- Testing
- Aptitude Medical Systems Metrix COVID Test
- Where
- United States
- Volunteers
- 697 people, healthy volunteers welcome
- Sponsor
- Aptitude Medical Systems