Clinical trials: Point-of-Care Testing
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.
HCV Infection
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
A multicenter prospective study to evaluate the clinical performance, usability, and contrived result interpretation of the INSTI® HCV Antibody Test (INSTI HCV) with fingerstick (FS) whole blood specimens from participants with…
- Trial name
- NCT07904403
- Testing
- INSTI HCV Antibody Test
- Volunteers
- 1,660 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Plague, Plague, Bubonic
Yersinia Pestis Lateral Flow Immunoassay for Blood Samples
Plague is a deadly but highly treatable disease caused by the bacterium Y. pestis. Due to the historical development of Y. pestis as a bioweapon by several nation states, it is listed by the US as a potential bioweapon that could…
- Conditions
- Plague, Plague, Bubonic, Plague, Pneumonic, Yersinia Pestis Plague
- Trial name
- SMARTPRT (NCT04688996)
- Testing
- Lateral Flow Assay for Pathogens of the Plague
- Where
- 2 sites in United States, Madagascar
- Volunteers
- 500 people
- Sponsor
- Brimrose Technology Corporation
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
SARS-CoV
Validation of a Rapid, Non-invasive Point-of-care IVD Test for Diagnosis of SARS-COV-2 (COVID-19) Infection
A prospective non-interventional study to evaluate the performance of EASYCOV IVD as point-of-care (POC) test by comparing SARS-CoV-2 positive patients with SARS-CoV-2 negative controls on paired specimens (nasopharyngeal swabs…
- Trial name
- EasyCov (NCT04583319)
- Testing
- EasyCov POC
- Where
- Turkey (Türkiye)
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Firalis SA
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
Fracture Arm, Fracture Leg
Accuro XV Ultrasound Imaging System for BoneEnhance and Fracture Detection Algorithms
The Accuro XV is a cart-based, bedside ultrasound instrument that incorporates new signal processing-based technologies for enhanced bone and soft-tissue imaging.
- Conditions
- Fracture Arm, Fracture Leg, Wrist Injury, Ankle Injury
- Trial name
- NCT07853768
- Testing
- Accuro XV Ultrasound Imaging System
- Where
- 10 sites in United States
- Volunteers
- 25,000 people
- Sponsor
- Rivanna Medical, Inc.
Influenza
Rapid Diagnostic Test for Influenza
The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).
- Trial name
- NCT01089816
- Testing
- Local/Regional Public Health Notification
- Where
- 4 sites in Vietnam
- Volunteers
- 569 people
- Sponsor
- Meso Scale Diagnostics, LLC.
Ventricular Dysfunction, Left, Ventricular Function, Left
Federated Learning for Point-of-Care Cardiac Ultrasound
This prospective, multicenter study will evaluate a federated machine-learning system designed to analyze focused cardiac point-of-care ultrasound examinations.
- Conditions
- Ventricular Dysfunction, Left, Ventricular Function, Left, Echocardiography, Ultrasonography
- Trial name
- FL-POCUS (NCT07800962)
- Testing
- Focused Cardiac Point-of-Care Ultrasonography, FL-POCUS Federated Machine-Learning Analysis System
- Where
- United States
- Volunteers
- 3,000 people
- Sponsor
- Truway Health, Inc.
Covid19
Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag Test
Performance of the LumiraDx SARS-CoV-2 Ag assay will be assessed by comparison to a reference method.
- Trial name
- ASPIRE (NCT04557046)
- Testing
- Nasal Swab, Nasopharyngeal swab, Throat swab
- Where
- 7 sites in United States
- Volunteers
- 1,134 people
- Sponsor
- LumiraDx UK Limited
Venus Leg Ulcers
WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test
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
- NCT01537003
- Testing
- Promogran, Coban 2 layer
- Where
- 7 sites in United States, Germany and 2 more
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Systagenix Wound Management
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
Liver Diseases, Healthy
Blood Collection for Development and Validation of Point-of-Care Diagnostic Liver Function Tests
This is an observational study exploring the performance of a novel point-of-care diagnostic testing platform designed to quantitate the presence of liver function biomarkers such as bilirubin.
- Conditions
- Liver Diseases, Healthy, Liver Cirrhosis, Liver Fibrosis
- Trial name
- NCT05457543
- Testing
- Adult
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Group K Diagnostics Inc.
Hepatitis B, Hepatitis B Infection
A Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites
A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and EDTA venipuncture whole blood are collected by a healthcare…
- Trial name
- NCT06368466
- Testing
- iStatis HBsAg Test
- Where
- Australia
- Volunteers
- 175 people
- Sponsor
- bioLytical Laboratories
Embolism and Thrombosis, Infection
Evaluation of the LumiraDx Point of Care D-Dimer and CRP Tests
A Multicenter Study Conducted to Evaluate the Agreement between Fingerstick Whole Blood, Venous Whole Blood and Plasma Determined on the LumiraDx Point of Care D-Dimer and Point of Care CRP Tests to Results on the Reference…
- Conditions
- Embolism and Thrombosis, Infection, Inflammation
- Trial name
- NOVEL-3 (NCT04375982)
- Testing
- Venepuncture, Fingerstick
- Where
- 4 sites in United States
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- LumiraDx UK Limited
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
Congestive Heart Failure
Evaluation of the Samsung LABGEO IVD-A20 CHF Test in a Point-of-Care Setting
To establish the performance characteristics of the Samsung LABGEO IVD-A20 CHF Test in intended use settings, by comparing test results of the A20 CHF Test with results obtained from an FDA-cleared comparator assay.
- Trial name
- NCT02107495
- Testing
- Samsung LABGEO IVD-A20 CHF Test
- Where
- 3 sites in United States
- Volunteers
- 191 people, healthy volunteers welcome
- Sponsor
- Samsung Electronics
Atopic Asthma
Determination of Accuracy in Measurement of Total Immunoglobulin E Using a Test Device in Atopic Subjects
The purpose of this study is to determine the accuracy of the Novel point of care test (POCT) total IgE assay in atopic patients. 120 patients with atopic conditions and approximately 40 healthy subjects will be enrolled.
- Trial name
- NCT02758548
- Testing
- Blood sample, POCT device
- Where
- 12 sites in Germany, Italy and 3 more
- Volunteers
- 193 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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
Viral Conjunctivitis
ADenoVirus Initiative Study in Epidemiology in UK
The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.
- Trial name
- NCT02112773
- Where
- United Kingdom
- Volunteers
- 31 people
- Sponsor
- NicOx