Clinical trials: Point of Care Testing
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
Chlamydia Trachomatis Genital Infection, Gonorrhea
Point of Care Rapid STI Test Optimization and Validation Extension
The purpose of this sub-study (PROVE) is to support and facilitate the validation of commercially available point of care (POC) sexually transmitted infection (STI) diagnostic test kits/devices for potential on-site laboratory…
- Conditions
- Chlamydia Trachomatis Genital Infection, Gonorrhea, Trichomoniasis
- Trial name
- PROVE (NCT06566677)
- Where
- South Africa
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Wits RHI Research Centre Clinical Research Site
Jaundice, Serum Bilirubin
A Study to Evaluate a New Jaundice Stick Test
This is an observational prospective study. The main purpose is to evaluate the stability of the Bilistick system in a humid and hot climate compared to the quantitative test for serum bilirubin (SBR) measurement currently used…
- Trial name
- Bilistick (NCT02926131)
- Testing
- Blood sampling
- Where
- Thailand
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Screening for Syphilis Infections
Syph-Check Syphilis Antibody Point of Care (POC) Test
The study is designed to evaluate the performance of a rapid membrane test in a clinic or doctor's office setting to identify potential patients infected with syphilis and compare the results to currently licensed laboratory…
- Trial name
- SyphPoc (NCT00732355)
- Testing
- Syph-Check POC
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Healthcare Providers Direct, Inc.
Chronic Kidney Diseases, Kidney Injury, Acute
Clinical Performance of a Point-of-Care Creatinine Testing System in Individuals With Kidney Disease
The goal of this clinical performance study is to evaluate the accuracy and usability of the Eaglenos Creatinine Test System（referred to as EG）, a point-of-care testing (POCT) system that consists of a handheld device and its…
- Trial name
- NCT07251075
- Testing
- Reference Creatinine Test System（Cobas c 111）, Investigational Creatinine Test System （EG）
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Tingting Xu
Heart Failure
Uppsala Self-SCREENing of Heart Failure Study
The goal of this clinical trial is to investigate whether a stepwise multimodal home-based screening strategy with rapid point-of-care testing can detect undiagnosed heart failure (HF) in high-risk patients compared to usual…
- Trial name
- U-SCREEN-HF (NCT06940544)
- Testing
- Stepwise Multimodal Home-Based HF Screening
- Where
- Sweden
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Uppsala University
Hepatitis C
The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset
The goal of this observational study is to learn if offering a point-of-care screening test for exposure to the Hepatitis C virus, before providing a diagnostic test for Hepatitis C infection can increase testing, diagnosis and…
- Trial name
- NCT05713136
- Testing
- Diagnostic Test: Point-of-Care Testing
- Where
- 13 sites in Australia
- Volunteers
- 40,000 people, healthy volunteers welcome
- Sponsor
- Kirby Institute
Combined Point of Care Diagnostic of HIV, HBV and HCV
Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C
Prospective, cross-sectional, adaptative study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA IBC (a Multiplex Point-of-Care Test for the detection of HIV, HBV and HCV) in detecting anti-HIV…
- Trial name
- MAGICIEN (NCT06082336)
- Testing
- MagIA IBC test in capillary blood, MagIA IBC test in other blood matrices
- Where
- 2 sites in France
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- MagIA Diagnostics
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
Outcomes From Point-of-Care Sexually Transmitted Infection (STI) Testing in an Urban Sexual Health Clinic: A Randomized Trial
The goal of this clinical trial is to learn about the impact of a point-of-care test for gonorrhea and chlamydia in people without symptoms who are seeking sexually transmitted infection testing.
- Trial name
- NCT07399873
- Testing
- Point-of-care assay for chlamydia and gonorrhea, Laboratory-based chlamydia and gonorrhea NAAT, CRISPR-based assay
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Acute Myocardial Infarction
SpinChip Hs-cTnI Determination of the 99th Percentile URL
During a heart attack, the protein troponin I is released from the heart muscle into the bloodstream. Measurements of cardiac troponin in blood are used as an aid in the diagnosis of heart attack.
- Trial name
- HEAT-3 (NCT06463275)
- Testing
- SpinChip hs-cTnI
- Where
- 4 sites in Sweden
- Volunteers
- 1,355 people, healthy volunteers welcome
- Sponsor
- SpinChip Diagnostics ASA
Vitamin D Deficiency, Iodine Deficiency
Vitamin D, Iodine, and Lead Levels in Haitian Infants and Children.
Vitamin D deficiency is common worldwide, including in infants and children, and rickets remains a public health concern in many developing countries.
- Conditions
- Vitamin D Deficiency, Iodine Deficiency, Hypothyroidism, Rickets
- Trial name
- Haiti (NCT02301520)
- Where
- 2 sites in Haiti
- Volunteers
- 299 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
COVID-19
Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag ULTRA Test
Performance of the LumiraDx SARS-CoV-2 Ag ULTRA assay will be assessed by comparison to a reference method
- Trial name
- ASPIRE-2 (NCT05506618)
- Testing
- Nasal Swab, Nasopharyngeal swab
- Where
- 6 sites in United States
- Volunteers
- 758 people, healthy volunteers welcome
- Sponsor
- LumiraDx UK Limited
HIV Infections, Syphilis
Ending the HIV Epidemic Through Point-of-Care Technologies (EHPOC)
This study proposes to investigate the performance of existing and new technologies for HIV diagnosis, one of the key strategies for Ending the HIV Epidemic in the U.S.
- Trial name
- EHPOC (NCT04793750)
- Testing
- Cepheid GeneXpert HIV-1 Qual POC HIV VL test, DPP HIV-Syphilis test system, OraQuick
- Where
- 3 sites in United States
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Syphilis Infection, Syphilis
Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites
This study is a prospective cross-sectional study in which surgically non-invasive sample- taking is done only for the purpose of the study.
- Trial name
- NCT06365606
- Testing
- iStatis Syphilis Ab Test
- Where
- South Africa
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Syphilis Infection
Feasibility and Acceptability of Point of Care Rapid Syphilis Testing Among Patients Seeking Family Planning Services in Hawai'i
The purpose of the study is to see if rapid syphilis testing at the time of a family planning (contraception or abortion) visit is acceptable and practical for patients.
- Trial name
- NCT07358949
- Testing
- Rapid Syphilis Test
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Queen's Medical Center
HIV Testing, HIV Infections
Near Patient Study of the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in Oral Fluid and Fingerstick Whole Blood
Point-of-care (POC) tests for HIV are easy to use, rapid and provide accurate results while the patient is still in-front of a healthcare provider (HCP).
- Trial name
- NCT04810559
- Testing
- OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test
- Where
- 4 sites in Canada
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto
Dry Eye Syndrome
Point of Care Testing of Inflammatory Markers in Tears
To evaluate the use of a point of care device to measure markers of inflammation in various eye conditions. In particular, matrix metalloproteinase-9 (MMP-9) will be measured. MMP-9 is an enzyme that plays a role in inflammation.
- Trial name
- NCT02315079
- Testing
- Eye inflammation, Without eye inflammation
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- University of Florida
COVID-19 Infection
COVID-19 in Baselland: Investigation and Validation of Serological Diagnostic Assays and Epidemiological Study of Sars-CoV-2 Specific Antibody Responses
The study is to investigate the antibody response in the blood and saliva of people with a known COVID-19 infection in the canton of Baselland.
- Trial name
- SEROBL-COVID19 (NCT04483908)
- Testing
- blood draw, fingertip tests for POC assays, saliva collection
- Where
- Switzerland
- Volunteers
- 477 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
HIV Infections
Testing of INSTI™ HIV-1 Antibody Test Kit in Volunteer Subjects at Risk for HIV Infection
Each year up to 22 million persons in the US are tested for HIV. Currently available "rapid" tests do not provide test results for at least 30 minutes from the collection of serum and plasma from the subject.
- Trial name
- NCT00514605
- Testing
- Behavioral counseling, HIV-1 Antibody Test Kit
- Where
- 14 sites in United States
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Wheezing
PREcision Medicine Directed Corticosteroids In Children With preSchool Wheeze
Young children frequently attend the emergency department (ED) with wheeze which is usually triggered by a virus infection, such as the common cold.
- Trial name
- PRECISE (NCT06580600)
- Testing
- Point of care respiratory virus testing
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Queen's University, Belfast