Clinical trials: Point of Care Testing
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
Viral Conjunctivitis
ADenoVirus Initiative Study in Epidemiology in Germany
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
- NCT02054273
- Where
- 13 sites in Germany
- Volunteers
- 240 people
- Sponsor
- NicOx
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
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
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
Acute Respiratory Tract Infections
FebriDx DISRUPT Acute Respiratory Infection Trial in Acute Respiratory Infection: An Evaluation of FebriDx® POC Test
The aim of this study is to determine performance characteristics of the FebriDx test in predicting viral or bacterial infection etiology among febrile (observed or reported) patients presenting the emergency department, urgent…
- Trial name
- NCT02018198
- Testing
- FebriDx
- Where
- 20 sites in United States
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- Rapid Pathogen Screening
Acute Myocardial Infarction
SpinChip Hs-cTnI Sample Type Validation
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-2 (NCT06453707)
- Testing
- SpinChip hs-cTnI
- Where
- Norway
- Volunteers
- 180 people
- Sponsor
- SpinChip Diagnostics ASA
Hepatitis B, Hepatitis B Infection
Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings
A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of testing the samples on iStatis HBsAg Test at the point of care.
- Trial name
- NCT06368479
- Testing
- iStatis HBsAg Test
- Where
- South Africa
- Volunteers
- 1,400 people
- Sponsor
- bioLytical Laboratories
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
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
Sepsis, Sepsis Bacterial
Analytical Validation of the abioSCOPE Device With the IVD CAPSULE PSP Test: Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood.
Abionic has developed a targeted, rapid test for pancreatic stone protein (PSP) in human K2-EDTA venous whole blood using the abioSCOPE instrument.
- Trial name
- NCT05627076
- Testing
- Blood Sampling
- Where
- France
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Abionic SA
Acute Coronary Syndrome
Clinical Study to Validate the Use of a New Point of Care Troponin I Test
This trial is designed as a prospective, multi-center, observational study of "all-comers" eligible adult subjects presenting to participating emergency departments with symptoms suggestive of acute coronary syndrome (ACS)
- Trial name
- NCT02620397
- Where
- 14 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Trinity Biotech
Viral Conjunctivitis
ADenoVirus Initiative Study in Epidemiology in Italy
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
- NCT03055065
- Where
- Italy
- Volunteers
- 241 people
- Sponsor
- NicOx
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
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
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
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
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