Clinical trials: Point-of-Care Testing
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.
SARS-CoV-2, Covid19
Clinical Evaluation of a Point-of-Care (POC), COVID-19 Rapid Antigen Test (CoviDx™)
Prospective study that will evaluate the clinical agreement of the CoviDx™ Rapid Antigen test compared to SARS-CoV-2 RT-PCR.
- Trial name
- CoviDx (NCT04750629)
- Testing
- POC CoviDx™ Rapid Antigen Test
- Where
- 2 sites in United States
- Volunteers
- 140 people
- Sponsor
- Lumos Diagnostics
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
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
Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections
This study is designed to assess the comparative clinical utility of the point of care cobas® liat CT/NG/MG to current standard practices in the diagnosis and treatment of urogenital infections with Chlamydia trachomatis (CT)…
- Conditions
- Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection, Mycoplasma Genitalium Infection
- Trial name
- NCT06369220
- Testing
- cobas® liat CT/NG/MG nucleic acid test, Standard of Care (SOC): Clinician's Standard Practice
- Where
- 4 sites in United States
- Volunteers
- 331 people
- Sponsor
- Hoffmann-La Roche
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
Anticoagulant Therapy
In Vitro Diagnostic Test for DOAC in Urine
This trial is conducted to assess the performance and handling of the in vitro diagnostic (IVD) device for oral direct factor Xa and thrombin inhibitors from urine samples of patients on treatment with direct oral anticoagulants…
- Trial name
- PADOASU (NCT03182829)
- Testing
- DOAC Dipstick
- Where
- 18 sites in Germany
- Volunteers
- 880 people
- Sponsor
- Doasense GmbH
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.
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
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
- 3 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Aptitude Medical Systems
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
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
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 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
Diabetic Foot Ulcer, Venous Leg Ulcer
DETEC® pH Point of Care Wound Diagnostic Test
The purpose of this study is to determine the relationship between wound alkalinity and the non-healing status of chronic ulcer wounds.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Wound, Non-Healed
- Trial name
- NCT04614038
- Testing
- DETEC® pH
- Where
- 2 sites in United States
- Volunteers
- 450 people
- Sponsor
- Progenitec 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
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
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