Clinical trials: Point of Care Testing
- Condition Point of Care Testing
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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.
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.
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.
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
Influenza
Rapid Diagnostic Test for Influenza
The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).
- Trial name
- NCT01089816
- Testing
- Local/Regional Public Health Notification
- Where
- 4 sites in Vietnam
- Volunteers
- 569 people
- Sponsor
- Meso Scale Diagnostics, LLC.
Covid19, RSV Infection
Sample Collection Study to Aid Evaluation of an Influenza A/B, Respiratory Syncytial Virus & COVID-19 Virus POC Test
Collection of Nasal Swabs, Throat Swabs and Saliva Samples from patients presenting at their designated care or testing facility displaying symptoms of either Influenza, Respiratory Syncytial Virus (RSV), SARS-CoV-2 or those who…
- Conditions
- Covid19, RSV Infection, Influenza Type A, Influenza Type B
- Trial name
- INFORM (NCT04782336)
- Testing
- Sample Collection
- Where
- 6 sites in United Kingdom
- Volunteers
- 79 people
- Sponsor
- LumiraDx UK Limited
Streptococcal Pharyngitis, Group A Streptococcal Infection
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
The goal of this observational study is to learn how well the SalivIQ™ Strep A test detects Group A Streptococcus, the bacteria that cause strep throat.
- Trial name
- NCT07891728
- Testing
- qPCR
- Where
- 3 sites in United States
- Volunteers
- 668 people
- Sponsor
- SalivIQ Diagnostics, Inc.
Gonorrhea Infection
A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test
The objective of this study is to evaluate the performance, usability, and contrived result interpretation of iStatis Gonorrhea Antigen Test (iStatis Gonorrhea Test) in the intended near-patient or point-of-care setting by…
- Trial name
- NCT07569900
- Testing
- iStatis Gonorrhea Antigen Test
- Where
- 3 sites in South Africa
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Viral Conjunctivitis
ADenoVirus Initiative Study in Epidemiology in UK
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
- NCT02112773
- Where
- United Kingdom
- Volunteers
- 31 people
- Sponsor
- NicOx
Fracture Arm, Fracture Leg
Accuro XV Ultrasound Imaging System for BoneEnhance and Fracture Detection Algorithms
The Accuro XV is a cart-based, bedside ultrasound instrument that incorporates new signal processing-based technologies for enhanced bone and soft-tissue imaging.
- Conditions
- Fracture Arm, Fracture Leg, Wrist Injury, Ankle Injury
- Trial name
- NCT07853768
- Testing
- Accuro XV Ultrasound Imaging System
- Where
- 10 sites in United States
- Volunteers
- 25,000 people
- Sponsor
- Rivanna Medical, Inc.
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
Influenza Human
Clinical Validation of the Point-of-Care MSD Influenza Test
The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).
- Trial name
- NCT00863343
- Testing
- Public Health Notification
- Where
- 3 sites in United States
- Volunteers
- 391 people
- Sponsor
- Meso Scale Diagnostics, LLC.