Clinical trials: Point of Care Testing
- Condition Point of Care Testing
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Allergy, Immunoglobulin E-Mediated Allergic Disorder
Kenota 1 CWS Method Comparison Validation Study
The goal of this Method Comparison Study is to compare total IgE results obtained from at least 360 subjects aged less than 80 years old using four different testing arms comprising three types of samples and two testing methods.
- Trial name
- NCT05702671
- Testing
- Total Immunoglobulin E, Obtained From Fingerstick Sample
- Where
- 3 sites in United States
- Volunteers
- 411 people, healthy volunteers welcome
- Sponsor
- Kenota Inc.
Pregnancy Related
Feasibility Study of an Automated Point-of-Care Urine Diagnostic Device for Pregnancy
The primary purpose of this observational study is to demonstrate the feasibility of an automated point-of-care urine diagnostic device in determining the pregnancy status of patients through urine samples collected from patients…
- Trial name
- NCT03575286
- Testing
- Pregnancy test
- Where
- United States
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Voyant Diagnostics, Inc.
Multiplex Testing of HIV, HBV, HCV and Syphilis, HIV
Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV/HBV/HCV/Syphilis)
Performance study to evaluate the clinical performance of the In-Vitro Diagnostics 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
- Multiplex Testing of HIV, HBV, HCV and Syphilis, HIV, HBV, HCV
- Trial name
- MAGICS IBCS (NCT07170748)
- Where
- 2 sites in Côte d’Ivoire, Kenya
- Volunteers
- 2,950 people, healthy volunteers welcome
- Sponsor
- MagIA Diagnostics
SARS-CoV-2, Influenza A
POC Performance Evaluation of LumiraDx SARS-CoV-2 Ag Ultra and SARS-CoV-2 & Flu A/B Tests.
This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 Ag Ultra test in detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and LumiraDx SARS-CoV-2 \& Flu A/B…
- Conditions
- SARS-CoV-2, Influenza A, Influenza B, COVID-19
- Trial name
- PURSUE (NCT05728970)
- Testing
- LumiraDx SARS-CoV-2 Ag Ultra, LumiraDx SARS-CoV-2 & Flu A/B
- Where
- 10 sites in United States
- Volunteers
- 716 people, healthy volunteers welcome
- Sponsor
- LumiraDx UK Limited
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.
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
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
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
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
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
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
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
Gonorrhea Infection
A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test
The objective of this study is to evaluate the performance, usability, and contrived result interpretation of iStatis Gonorrhea Antigen Test (iStatis Gonorrhea Test) in the intended near-patient or point-of-care setting by…
- Trial name
- NCT07569900
- Testing
- iStatis Gonorrhea Antigen Test
- Where
- 3 sites in South Africa
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
HIV 1 Infection, HIV 2 Infection
A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test
The objectives of this study are as follows: To evaluate the clinical performance of the TruPlex test using capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care…
- Conditions
- HIV 1 Infection, HIV 2 Infection, Syphilis Infection, Hepatitis B Infection
- Trial name
- NCT07563309
- Testing
- TruPlex HIV/HepB/Syphilis Rapid Test
- Where
- 3 sites in South Africa
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Diabetic Foot Ulcers
WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test on DFU
The purpose of this trial is to determine if wounds with elevated protease activity (EPA) treated with targeted interventions such as protease modulating therapies can improve clinical and economic outcomes.
- Trial name
- NCT01537016
- Testing
- PROMOGRAN, Tielle
- Where
- 5 sites in United States, Germany and 3 more
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Systagenix Wound Management
Communicable Disease, COVID-19
COVID-19 Diagnostic Self-testing Using Virtual Point-of-care
The goal of the research is to assess candidate COVID-19 rapid diagnostic tests (e.g. immunodiagnostic antibody tests, like Cellex qSARS-CoV-2 IgG/IgM Rapid Test, or antigen tests, like Turklab Test-It COVID-19 Home Test, AllBio…
- Conditions
- Communicable Disease, COVID-19, Sars-CoV2, Infectious Disease
- Trial name
- NCT04348864
- Testing
- COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support, Telemedicine
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Neuroganics LLC
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
Allergy, Allergic Asthma
Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation
This is a multicenter, prospective, observational study to evaluate the analytical performance of the Abionic IgE Multi-Allergen Test Panel on the abioSCOPE® device in a U.S.
- Conditions
- Allergy, Allergic Asthma, Allergy to Cats, Allergy to House Dust
- Trial name
- NCT04401631
- Testing
- Blood Collection
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Abionic SA
Hemolysis, Blood Specimen Collection
Clinical Study of a Novel Hemolysis Point of Care Test at an Emergency Department.
This study aims to investigate the outcome of hemolysis frequency when a hemolysis point of care test is introduced in an emergency department.
- Trial name
- NCT02976610
- Testing
- Hemolysis Point-of-Care test
- Where
- Sweden
- Volunteers
- 1,671 people, healthy volunteers welcome
- Sponsor
- Hemcheck Sweden AB