Clinical trials: Point of Care Testing
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.
Blood Coagulation Tests
Evaluation of the Accuracy of the Hemochron Signature Elite Point of Care Device Compared With Laboratory Assay
Central Neuraxial Blockade (CNB) is commonly used in anaesthetics. It has several advantages over a general anaesthetic however contraindications include coagulopathy.
- Trial name
- NCT02255214
- Where
- United Kingdom
- Volunteers
- 24 people
- Sponsor
- NHS Lothian
HIV
Strategies to Increase HIV Testing, Linkages to Care, and Male Circumcision in Africa
The purpose of this study is to determine efficient, scalable, evidence-based strategies to link HIV positive individuals to care and HIV negative individuals to prevention measures, such as voluntary male circumcision.
- Trial name
- NCT02038582
- Testing
- POC CD4 Testing, CD4 Referral, Lay Counselor Follow-up
- Where
- 2 sites in South Africa, Uganda
- Volunteers
- 2,075 people, healthy volunteers welcome
- Sponsor
- University of Washington
Congenital Heart Defect, Blood Coagulation Disorder
Bedside Evaluation of Coagulation in Children With Congenital Heart Disease
The purpose of this study is to assess coagulation and platelet function in children with congenital heart disease, measured with a bedside device (thromboelastometry and impedance aggregometry).
- Trial name
- POCHEMO (NCT02387944)
- Where
- Switzerland
- Volunteers
- 200 people
- Sponsor
- Centre Hospitalier Universitaire Vaudois
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.
Pulmonary Artery Hypertension
Assessing the Repeatability of NT-proBNP Testing Using Laboratory and Point of Care Testing in PAH
The purpose of this study is to examine N-terminal pro brain natriuretic peptide (NT-proBNP) and brain natriuretic peptide (BNP) biomarkers in a number of different settings including assessing the repeatability of laboratory and…
- Trial name
- REPEAT-PAH (NCT05421949)
- Testing
- Exercise group
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
Sexually Transmitted Infection, Chlamydia
Investigating Point-of-care Diagnostics for Sexually Transmitted Infections and Antimicrobial Resistance in Primary Care in Zimbabwe
A prospective interventional study to evaluate a strategy of point-of-care testing for sexually transmitted infections including chlamydia, gonorrhoea, trichomoniasis, syphilis, and Hepatitis B with comprehensive case management…
- Conditions
- Sexually Transmitted Infection, Chlamydia, Gonorrhea, Trichomoniasis
- Trial name
- IPSAZ (NCT05541081)
- Testing
- Point-of-care STI testing
- Where
- Zimbabwe
- Volunteers
- 1,005 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Syphilis
The Feasibility of Implementing Syphilis Point-of-care Testing Into a Prenatal Clinic for People Facing Barriers to Care
The goal of this clinical trial is to learn if a finger-prick blood test for rapid diagnosis of syphilis infection can be implemented in a low-barrier prenatal clinic for people at risk of syphilis in pregnancy.
- Trial name
- PRESSING (NCT06829602)
- Testing
- Rapid Syphilis/HIV point-of-care test
- Where
- Canada
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- McMaster University
HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV)
Combating Related Epidemics in HCV
This is a two-arm cluster randomized control trial to evaluate the effectiveness of a single-visit point-of-care (POC) test and treat bundle (intervention arm) compared to the current standard-of-care (SOC, control arm).
- Conditions
- HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV), HEPATITIS C (HCV)
- Trial name
- CREST (NCT07560046)
- Testing
- Cepheid GeneXpert HCV Test, Abbott Determine HIV - 1/2 Ag/Ab, Abbott Determine HbsAg 2
- Volunteers
- 1,280 people
- Sponsor
- Duke University
Early Infant HIV Diagnosis
Point of Care Virologic Testing to Improve Outcomes of HIV-Infected Children
This is a two-arm, unmasked, randomized, controlled trial to test the effectiveness of the Alere Q point-of-care (POC) HIV diagnostic assay for use in resource-poor settings.
- Trial name
- NCT02682810
- Testing
- DNA PCR HIV diagnostic test, Alere Q
- Where
- 6 sites in Zambia
- Volunteers
- 4,000 people
- Sponsor
- University of North Carolina, Chapel Hill
Celiac Disease
ICT Tools for the Diagnosis of Autoimmune Diseases
The ITAMA project, which ended in 03/2022, came from the need to increase/anticipate the number of diagnosed cases of celiac disease (CD).
- Trial name
- ITAMA_CAP (NCT05715970)
- Testing
- PoCT+questionnaire administration
- Where
- 2 sites in Italy, Malta
- Volunteers
- 25,000 people, healthy volunteers welcome
- Sponsor
- University of Palermo
Neonatal Disorder
Gastric Lipase Enhanced Nasogastric Tube Study in Neonates
The newborn infants who are sick and those who are born prior to due date (preterm) are admitted to the neonatal unit. These babies are unable to feed through their mouth, so a special tube is passed through their nose to the…
- Trial name
- NCT04271995
- Where
- United Kingdom
- Volunteers
- 233 people
- Sponsor
- Imperial College London
Tetanus
TETANUS Antibody Detection in Saliva Study
This study aims to design, develop and optimise a non-invasive, saliva sample-based point-of-care lateral flow test for use in low and middle income settings that can return a qualitative result on whether an individual has or…
- Trial name
- TETANUS (NCT07446166)
- Testing
- Point of care, saliva-based lateral flow test, Blood based immunoassay
- Where
- Rwanda
- Volunteers
- 390 people, healthy volunteers welcome
- Sponsor
- University of Birmingham
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
Typhoid Fever
Commercial Typhoid Tests Validation Trial
Typhoid fever (typhoid) is an enteric bacterial infection caused by Salmonella enterica serovar Typhi (Salmonella Typhi; S. Typhi).
- Trial name
- NCT04801602
- Testing
- Rapid diagnostic tests
- Where
- 2 sites in Kenya, Pakistan
- Volunteers
- 3,091 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Micronutrient Levels
VITAmin and Micronutrient Testing: Acceptability and SCOPE of Point-of-care Device
Childhood obesity is a global health crisis with 1.2 million children in England severely obese, predisposing them to multiple health risks which decrease lifespan and compromise health.
- Trial name
- VITASCOPE (NCT06882421)
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
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
Respiratory Infections in Children
Improving Antibiotic Stewardship for Children With Respiratory Illness Presenting to Village Health Workers in Uganda
This is a stepped wedge, cluster randomized study of a clinical algorithm that includes point-of-care C-reactive protein testing to inform antibiotic treatment decisions by village health workers for children presenting with…
- Trial name
- STAR (NCT05294510)
- Testing
- STAR Sick Child Job Aid
- Where
- Uganda
- Volunteers
- 1,280 people
- Sponsor
- University of North Carolina, Chapel Hill
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
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