Clinical trials: Point-of-Care Testing
Blood Loss Massive, Post Operative Hemorrhage
Evaluation of the Quantra QStat System in Obstetric Patients
This pilot study will assess the performance of the Quantra System with the QStat Cartridge versus standard of care coagulation testing in bleeding pregnant women at delivery.
- Trial name
- NCT05875987
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- HemoSonics LLC
Influenza, Human, Respiratory Syncytial Virus Infections
Evaluation of Performance of the LumiraDx Influenza A/B + RSV Test at POC Testing Sites
A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx Influenza A/B + RSV Test at Point of Care Testing Sites
- Trial name
- INSPIRE (NCT04288921)
- Testing
- Swab
- Where
- 20 sites in United States
- Volunteers
- 525 people
- Sponsor
- LumiraDx UK Limited
Ebola Virus Disease
Evaluation of the FilmArray BioThreat-E Test
The aim of our study is to assess the analytical and clinical performance of the FilmArray (FA) BioThreat-E test (BioFire®) for the diagnosis of Ebola virus disease in the field in Guinea versus conventional molecular techniques.
- Trial name
- NCT02658331
- Volunteers
- 156 people
- Sponsor
- BioMérieux
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
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
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
HIV1 Infection, HIV 2 Infection
A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test
To evaluate the clinical performance of each analyte (HIV, HBsAg, and Syphilis) on the TruPlex HIV/HepB/Syphilis Rapid Test (TruPlex Test) using capillary blood (fingerstick), EDTA whole blood, EDTA-plasma, and SST-serum samples…
- Conditions
- HIV1 Infection, HIV 2 Infection, Syphilis Infection, Hepatitis B Infection
- Trial name
- NCT07569913
- Testing
- TruPlex HIV/HepB/Syphilis Rapid Test
- Where
- Australia
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Viral Conjunctivitis
ADenoVirus Initiative Study in Epidemiology in France
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
- NCT02054234
- Where
- 19 sites in France
- Volunteers
- 357 people
- Sponsor
- NicOx
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
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
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
Acute Myocardial Infarction (AMI)
SpinChip Hs-cTnI Multisite Precision
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-1 (NCT06851013)
- Testing
- SpinChip hs-cTnI
- Where
- 3 sites in Norway
- Volunteers
- 37 people
- Sponsor
- SpinChip Diagnostics ASA
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
SARS-CoV-2, Covid19
Clinical Evaluation of a COVID-19 Antigen Self-Test (CoviDx™)
Prospective study that will evaluate the clinical agreement of the CoviDx™ Self test compared to SARS-CoV-2 RT-PCR.
- Trial name
- CoviDx™ (NCT05403346)
- Testing
- CoviDx™ Covid-19 Antigen Self-Test
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Lumos Diagnostics
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
Hypothyroidism
Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit
This is a Phase 4, single-center, open-label, interventional study, wherein all enrolled subjects will be tested for Thyroid Stimulating Hormone (TSH) by using the quantitative and the qualitative Point-of-Care (POC) TSH test…
- Trial name
- NCT01921452
- Testing
- Quantitative POC TSH Kit, Qualitative POC TSH Kit, Third generation TSH Kit
- Where
- China
- Volunteers
- 283 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
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
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.