Clinical trials: Point of Care Testing
Respiratory Tract Infections (RTI), Influenza-like Illness
Clinical Assessment of Respiratory Events for Kids: Integrating Diagnostics and Stewardship
This study, called Care4Kids, aims to improve the management of respiratory infections in children visiting emergency departments.
- Conditions
- Respiratory Tract Infections (RTI), Influenza-like Illness, Children
- Trial name
- CARE4KIDS (NCT07453914)
- Testing
- SPOTFIRE R
- Where
- 3 sites in France, Greece and 1 more
- Volunteers
- 720 people
- Sponsor
- BioMérieux
Covid19
Research & Evaluation of LumiraDx SARS-CoV-2 (COVID-19) Point of Care Ab Test
Evaluation of the agreement between fingerstick samples, venous blood, serum and plasma samples when using the LumiraDx SARS-CoV-2 Ab Test against the reference method, using standard qualitative comparison techniques.
- Trial name
- CAPTURE-2 (NCT04597047)
- Testing
- Capillary Collection & Testing, Venous Draw & Testing
- Where
- 4 sites in United States
- Volunteers
- 42 people
- Sponsor
- LumiraDx UK Limited
SARS-CoV-2, Influenza A
Clinical Validation of the LumiraDx SARS-CoV-2 & Flu A/B Combo Test
This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 \& Flu A/B tests at point of care sites.
- Conditions
- SARS-CoV-2, Influenza A, Influenza B, Asymptomatic COVID-19
- Trial name
- ITAP1489 (NCT05787444)
- Testing
- LumiraDx SARS-CoV-2 & Flu A/B
- Where
- United States
- Volunteers
- 1,081 people
- Sponsor
- LumiraDx UK Limited
Acute Myocardial Infarction
SpinChip Hs-cTnI Clinical Diagnostic Performance
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-4 (NCT06499519)
- Testing
- SpinChip hs-cTnI
- Where
- 9 sites in Denmark, Germany and 4 more
- Volunteers
- 1,551 people
- Sponsor
- SpinChip Diagnostics ASA
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
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
Acute Respiratory Infections (ARIs)
FebriDx® Method Comparison Study Protocol
The goal of this observational study is to learn about the performance and ease of use of FebriDx when operated by persons without laboratory experience or training in patients with acute respiratory symptoms.
- Trial name
- NCT06746259
- Testing
- Rapid point of care test to detect host immune response in ARI
- Where
- 8 sites in United States
- Volunteers
- 800 people
- Sponsor
- Lumos Diagnostics
Viral Conjunctivitis
ADenoVirus Initiative Study in Epidemiology in Spain
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
- NCT02254330
- Where
- 25 sites in Spain
- Volunteers
- 386 people
- Sponsor
- NicOx
Pressure Ulcers
A Test of the Investigational SEM Scanner
The objective of this study is to establish required data for SEM Scanner analysis of the readings given by the SEM Scanner in the target patient population..
- Trial name
- NCT01965444
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Bruin Biometrics, LLC
Anticoagulant Therapy
Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects
DOACs are increasingly used since 8 years. Standard coagulation tests (Prothrombin time [PT] and activated partial thromboplastin time [aPTT]) from plasma samples show a high variation.
- Trial name
- PHAPOCU (NCT05491460)
- Testing
- Apixaban 5 MG Tab, Dabigatran 150 MG Tab, Edoxaban 60Mg Tab
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Doasense GmbH
COVID-19
COVID-19: A POC Test Under Research & Evaluation
Collection of nasal/nasopharyngeal/throat swabs and blood samples from patients presenting at their designated care facility displaying symptoms of COVID-19 and undergoing a SOC SARS-CoV-2 test or those who have tested positive…
- Trial name
- CAPTURE (NCT04408066)
- Testing
- Sample Collection/Performance Evaluation (A), Sample Collection/Performance Evaluation (B)
- Where
- 3 sites in United Kingdom
- Volunteers
- 523 people
- Sponsor
- LumiraDx UK Limited
COVID-19, Influenza A
Performance Evaluation of LumiraDx SARS-CoV-2, Flu A/B, and RSV Tests for COVID-19 Assessment
A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 \& FLU A/B Test, and LumiraDx SARS-CoV-2 \& RSV Test at Point of Care Testing Sites.
- Conditions
- COVID-19, Influenza A, Influenza Type B, RSV Infection
- Trial name
- INSPIRE-2 (NCT05268939)
- Testing
- LumiraDx SARS-CoV-2 & Flu A/B test, LumiraDx SARS-CoV-2 & RSV test
- Where
- 8 sites in United States
- Volunteers
- 589 people
- Sponsor
- LumiraDx UK Limited
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
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.
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
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
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.
Diabetes Mellitus, Type 2, Liver Diseases
Validate Smart Breath Analyzer as Screening Tool for Diabetic, Hepatic, Renal, Lung, and Other Metabolic Disorders
This is a prospective, multicentric, non-treatment study to build and validate a portable, non-invasive smart breath analyzer that can screen underlying health issues using exhaled breath.
- Conditions
- Diabetes Mellitus, Type 2, Liver Diseases, Kidney Diseases, Lung Diseases
- Trial name
- RESPYR-SBA (NCT07646015)
- Where
- India
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Respyr