Clinical trials: Point-of-Care Testing
- Condition Point-of-Care Testing
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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.
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.
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
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, 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, 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
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
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
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
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
Acute Respiratory Infections (ARIs)
FebriDx® Method Comparison Study Protocol
The goal of this observational study is to learn about the performance and ease of use of FebriDx when operated by persons without laboratory experience or training in patients with acute respiratory symptoms.
- Trial name
- NCT06746259
- Testing
- Rapid point of care test to detect host immune response in ARI
- Where
- 8 sites in United States
- Volunteers
- 800 people
- Sponsor
- Lumos Diagnostics
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.
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
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
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.
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
Allergy, Allergic Asthma
abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies
This is a multicenter, prospective, observational study designed to determine the clinical sensitivity and specificity of the Abionic IVD CAPSULE Allergic Asthma panel performed on Abionic's abioSCOPE device using K3-EDTA…
- Conditions
- Allergy, Allergic Asthma, Allergy to Cats, Allergy to House Dust
- Trial name
- NCT04442932
- Testing
- Blood Collection
- Where
- 5 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Abionic SA
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
Plague, Plague, Bubonic
Yersinia Pestis Lateral Flow Immunoassay for Blood Samples
Plague is a deadly but highly treatable disease caused by the bacterium Y. pestis. Due to the historical development of Y. pestis as a bioweapon by several nation states, it is listed by the US as a potential bioweapon that could…
- Conditions
- Plague, Plague, Bubonic, Plague, Pneumonic, Yersinia Pestis Plague
- Trial name
- SMARTPRT (NCT04688996)
- Testing
- Lateral Flow Assay for Pathogens of the Plague
- Where
- 2 sites in United States, Madagascar
- Volunteers
- 500 people
- Sponsor
- Brimrose Technology Corporation