Clinical trials: Point-of-Care Testing
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.
Treponema Pallidum Infection, Chlamydia Trachomatis Infection
Improving Maternal and Child Health Through Point-of-care STI Testing
The goal of this clinical trial is to learn if point-of-care tests (POCTs) for sexually transmitted infections (STIs) improve the timely treatment of syphilis, chlamydia, gonorrhea, and trichomonas in pregnant women.
- Conditions
- Treponema Pallidum Infection, Chlamydia Trachomatis Infection, Neisseria Gonorrheae Infection, Trichomonas Vaginalis Vaginitis
- Trial name
- MATCH-POINT (NCT07290439)
- Testing
- Point-of-care STI tests, Standard of care STI testing
- Where
- United States
- Volunteers
- 756 people, healthy volunteers welcome
- Sponsor
- Emory University
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
Palliative Care
Feasibility Testing of the Quality-monitoring Tool, Qdact, for the Palliative Care Research Cooperative
Few formal mechanisms for collecting, analyzing, and reporting data on quality in palliative care exist. Such infrastructure is needed to understand current clinical practices, inform quality improvement projects, and research…
- Trial name
- QFT (NCT02411305)
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Duke University
Lower Respiratory Tract Infection (LRTI), Pneumonia
Optimising Antibiotic Use for Paediatric Lower Respiratory Tract Infections in Africa
Lower respiratory tract infections (LRTIs) remain a leading cause of hospitalisation and death among young children in Africa. Although viral infections account for a substantial proportion of LRTIs, antibiotics are frequently…
- Conditions
- Lower Respiratory Tract Infection (LRTI), Pneumonia, Bronchopneumonia, Bronchiolitis
- Trial name
- BEACON (NCT07841691)
- Testing
- CRP- and PREPARE-guided Antibiotic Prescription
- Where
- South Africa
- Volunteers
- 400 people
- Sponsor
- University of Witwatersrand, South Africa
Acute Febrile Illness
Electronic Algorithms Based on Host Biomarkers to Manage Febrile Children
Health professionals in developing countries have limited ability to identify children at risk of dying and those in need of antibiotics.
- Trial name
- e-POCT (NCT02225769)
- Testing
- Management of febrile children using e-POCT, Management of febrile children using ALMANACH
- Where
- Tanzania
- Volunteers
- 3,192 people
- Sponsor
- Swiss Tropical & Public Health Institute
Neonatal Screening, Kernicterus
Bilistick Point-of-care System 2.0 Bilirubin Validation
This is a validation study involving the Bilistick System 2.0 point-of-care bilirubin measuring device. The validation will be conducted by comparing bilirubin measurements utilizing the standard-of-care blood sample collected…
- Conditions
- Neonatal Screening, Kernicterus, Newborn Jaundice, Point-of-Care Testing
- Trial name
- NCT06058910
- Testing
- Bilistick System 2.0 point-of-care testing device
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Kettering Health Network
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
This is a Pilot Study Which Aims to Assess the Validity and Applicability of Lateral Flow Assays (LFAs) Which Can be Used as a Point of Care Test for COVID-19, Covid19
The LAVA (Lateral Flow Antigen Validation and Applicability) Study for COVID-19
This is a pilot study which aims to assess the validity and applicability of lateral flow assays (LFAs) which can be used as a point of care test for COVID-19.
- Trial name
- LAVA (NCT04629157)
- Testing
- Innova Lateral Flow Device
- Where
- 2 sites in United Kingdom
- Volunteers
- 400 people
- Sponsor
- Alder Hey Children's NHS Foundation Trust
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.
Malaria, Diagnoses Disease
Clinical Validation of Novel Malaria Diagnostic Tools for POC Point-of-Care Testing
The aim of this study is to perform a performance evaluation of novel diagnostic tools for detecting malaria in malaria-endemic countries.
- Conditions
- Malaria, Diagnoses Disease, RDT
- Trial name
- NCT06225700
- Where
- Rwanda
- Volunteers
- 509 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Mild Traumatic Brain Injury, Pediatric Traumatic Brain Injury
Kids Injury Detection Study Using the i-STAT
KIDS-STAT is a prospective study evaluating whether a rapid blood test measuring the brain injury biomarkers GFAP and UCH-L1 using the i-STAT Alinity system can help identify children with mild traumatic brain injury who do not…
- Conditions
- Mild Traumatic Brain Injury, Pediatric Traumatic Brain Injury, Head Trauma
- Trial name
- KIDS-STAT (NCT07835919)
- Testing
- i-STAT TBI Cartridge with the i-STAT Alinity System
- Volunteers
- 700 people
- Sponsor
- Children's Healthcare of Atlanta
Cutaneous Leishmaniases
Evaluation of Point-of-care Tests for the Diagnosis of Cutaneous Leishmaniasis in Afghanistan
New point-of-care (POC) tests are needed and assessing the performance of these tests for cutaneous leishmaniasis (CL) in Afghanistan may help increasing the number of CL patients with access to accurate diagnosis, and enable…
- Trial name
- CLeishPOCAFG (NCT03435419)
- Testing
- LoopampTM Leishmania Detection Kit, CL DetectTM Rapid Test
- Volunteers
- 274 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Ovarian Cancer, Endometrial Cancer
Predictors of Ovarian Cancer and Endometrial Cancer for Artificial-Intelligence-Based Screening Tools
The goal of this observational study is to explore the possible associated factors of ovarian cancer and endometrial cancer in Indonesia and develop screening tools that could predict the risk of both types of cancer The specific…
- Conditions
- Ovarian Cancer, Endometrial Cancer, Endometrial Hyperplasia
- Trial name
- NCT05697601
- Testing
- Artificial-Intelligence Based Screening Tools, Pathology analysis
- Where
- Indonesia
- Volunteers
- 2,905 people, healthy volunteers welcome
- Sponsor
- Hasanuddin University
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
Point-of-Care Testing, HIV
Ayaangwaamiziwin Initiative: Carefulness and Preparedness
The goal of this clinical trial is to implement a test, treat, and connect intervention approach using HIV and syphilis rapid point-of-care (POC) testing in 3 Canadian Prairie provinces (Alberta, Manitoba, and Saskatchewan)…
- Conditions
- Point-of-Care Testing, HIV, Syphilis
- Trial name
- AI (NCT06893159)
- Testing
- INSTI HIV-1/2 Antibody Test, INSTI Multiplex HIV-1/2 Syphilis Antibody Test, Multiplo Complete Syphilis (TP/nTP) Antibody Test
- Where
- 8 sites in Canada
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto
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
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.
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
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