Clinical trials: Point of Care Testing
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 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
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.
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.
Covid19, COVID-19 Pneumonia
imPulse™ Una Infrasound-to-ultrasound E-stethoscope
This study generates robust, uniform clinical data across emerging COVID-19 strains to train ML/AI algorithms of the Sponsor's imPulse™ Una infrasound-to-ultrasound e-stethoscope for digital diagnostic feature synthesis of…
- Conditions
- Covid19, COVID-19 Pneumonia, COVID-19 Respiratory Infection, COVID-19 Acute Respiratory Distress Syndrome
- Trial name
- NCT04941209
- Testing
- imPulse™ Una infrasound-to-ultrasound e-stethoscope, (PPA >95%) FDA EUA RT-PCR, HR-CT-scan
- Where
- 3 sites in Democratic Republic of the Congo, India and 1 more
- Volunteers
- 702 people
- Sponsor
- Level 42 AI, Inc.
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
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
SARS-CoV-2, Influenza A
POC Performance Evaluation of LumiraDx SARS-CoV-2 Ag Ultra and SARS-CoV-2 & Flu A/B Tests.
This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 Ag Ultra test in detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and LumiraDx SARS-CoV-2 \& Flu A/B…
- Conditions
- SARS-CoV-2, Influenza A, Influenza B, COVID-19
- Trial name
- PURSUE (NCT05728970)
- Testing
- LumiraDx SARS-CoV-2 Ag Ultra, LumiraDx SARS-CoV-2 & Flu A/B
- Where
- 10 sites in United States
- Volunteers
- 716 people, healthy volunteers welcome
- Sponsor
- LumiraDx UK Limited
SARS-CoV-2 Infection, Influenza A
SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings
The Metrix COVID/Flu 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.
- Conditions
- SARS-CoV-2 Infection, Influenza A, Influenza B
- Trial name
- NCT06191393
- Testing
- Aptitude Medical Systems Metrix COVID/Flu Test
- Where
- 3 sites in United States
- Volunteers
- 614 people
- Sponsor
- Aptitude Medical Systems
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.
SARS-Cov-2, Covid19
Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 (COVID-19) IgG Antibody Test in Fingerstick Whole Blood
Prospective, multi-center, observational, blinded clinical trial to compare a new point of care (POC) SARS-CoV-2 IgG antibody test to a reference SARS-CoV-2 PCR test using fingerstick whole blood.
- Trial name
- NCT04699903
- Testing
- POC SARS-Cov-2 IgG Antibody test
- Where
- 3 sites in United States
- Volunteers
- 201 people
- Sponsor
- Lumos Diagnostics
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
- United States
- Volunteers
- 697 people, healthy volunteers welcome
- Sponsor
- Aptitude Medical Systems
SARS (Severe Acute Respiratory Syndrome), Covid19
A Clinical Evaluation of Pine Trees Health Test System Including the Pine Trees Health Reader and COVID-19 Test for Point-of-Care
The scope of this study is to validate the Pine Trees Health COVID-19 Molecular Test with unique clinical specimens from across two (2) geographically diverse point-of-care testing sites in the United States.
- Trial name
- NCT05107258
- Testing
- The Pine Trees Health Test System
- Where
- 3 sites in United States
- Volunteers
- 195 people
- Sponsor
- Pine Trees, Inc.
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.
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
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
Combined Point of Care Diagnostic of HIV, HBV and HCV
Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C
Prospective, cross-sectional, adaptative study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA IBC (a Multiplex Point-of-Care Test for the detection of HIV, HBV and HCV) in detecting anti-HIV…
- Trial name
- MAGICIEN (NCT06082336)
- Testing
- MagIA IBC test in capillary blood, MagIA IBC test in other blood matrices
- Where
- 2 sites in France
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- MagIA Diagnostics
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.
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
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