Clinical trials: Point-of-Care Testing
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
Neisseria Gonorrhea, Trichomoniasis Vaginalis
Acceptability Research on Integrated Point of Care Sexually Transmitted Infection (STI) Testing and Expedited Partner Therapy (EPT)
This protocol builds on nearly a decade of collaborative HIV/STI prevention research to conduct a prospective cohort study of Adolescent Girls and Young Women (AGYW) eligible for PrEP in South Africa in which we will assess the…
- Conditions
- Neisseria Gonorrhea, Trichomoniasis Vaginalis, Chlamydia Trachomatis Infection
- Trial name
- ARISE (NCT06570733)
- Where
- South Africa
- Volunteers
- 305 people
- Sponsor
- Wits RHI Research Centre Clinical Research Site
Respiratory Tract Infections
Point-of-care Testing of Respiratory Pathogens at Pediatric Emergency Room
The main objective of the trial is to evaluate the effect of point-of-care testing of respiratory pathogens at a pediatric emergency room on the antibiotic consumption and hospital admissions in acutely ill children.
- Trial name
- Hevi-RCT (NCT03932942)
- Testing
- QIAstat at pediatric emergency room
- Where
- Finland
- Volunteers
- 1,350 people
- Sponsor
- University of Oulu
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
HIV Infections, HIV/AIDS
Evaluating the Feasibility of Point of Care Birth Testing in Eswatini
This study aims to assess the feasibility and utility of birth testing using point-of-care (POC) testing in maternity settings in Eswatini.
- Conditions
- HIV Infections, HIV/AIDS, Pediatric HIV Infection, Transmission, Perinatal Infection
- Trial name
- NCT04206878
- Testing
- Point-of-care birth test
- Where
- Eswatini
- Volunteers
- 3,316 people
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
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
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
Crohn Disease, Ulcerative Colitis
Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease
This is a comparative pragmatic trial in patients with UC and CD on maintenance treatment with IFX. All IBD patients from cohort A with maintenance IFX treatment at a referral IBD clinic are prospectively included between June…
- Trial name
- NCT04775732
- Testing
- infliximab therapeutic drug monitoring
- Where
- 2 sites in Belgium
- Volunteers
- 187 people
- Sponsor
- Imelda GI Clinical Research Center
Warfarin
Patient Self Testing of Warfarin Therapy
To test the hypothesis that home international normalised ratio (INR) monitoring with supervised patient self-testing (PST)can provide comparable or superior time in therapeutic range (TTR) to that provided by traditional…
- Trial name
- NCT00594828
- Testing
- CoaguChek (Patient self testing), Anticoagulation Management Service (AMS)
- Where
- Ireland
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- University College Cork
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.
COVID-19 Infection
Novel Point-of-Care Diagnostic Test for SARS-CoV-2 (COVID-19)
This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus that causes the disease COVID-19. This may help to improve testing for COVID-19.
- Trial name
- END CoV-2 (NCT04513990)
- Testing
- Biospecimen Collection, Questionnaire Administration
- Where
- 2 sites in United States
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
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
Type 2 Diabetes
Point of Care HbA1c as a Screening Test for Type 2 Diabetes in First Nations
1. Purpose to estimate the prevalence of undiagnosed diabetes mellitus and pre-diabetes in a BC First Nation community to determine the utility of community based screening by examining how many positively screened people follow…
- Trial name
- NCT01333176
- Testing
- Point-of-care "finger-poke" HbA1c determination., HbA1c blood test, HbA1c finger poke test
- Where
- Canada
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Aged ≥2 Years in Schistosomiasis Affected Areas
Validation of POC-CCA Rapid Urine Test for Qualitative Detection of Schistosoma Japonicum
This is a longitudinal cohort study that will be coordinated with the 2019 schistosomiasis stool survey in Napu. The study will use the stool survey results as entry criteria to identify subjects to become the index cases.
- Trial name
- SchisCCA (NCT03870204)
- Testing
- POC-CCA rapid urine test
- Where
- Indonesia
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- Ina-Respond
Sepsis
Use of Procalcitonin, a Blood Test to Guide Antibiotic Therapy for Sepsis in Adults
Trial design: Randomised controlled, two-arm, parallel, clinical trial to assess the efficacy and safety of sequential daily procalcitonin assessments to guide de-escalation of empirical antibiotic therapy in adult patients with…
- Trial name
- PROCALBAN (NCT05955612)
- Testing
- Procalcitonin measurement
- Where
- Bangladesh
- Volunteers
- 532 people
- Sponsor
- University of Oxford
HIV
Point-of-care Viral Load Testing Among HIV-infected Adolescents in Haiti
This study is designed as an individual randomized trial among 150 HIV-infected adolescents aged 10-24 years who have been on ART for >6 months and will be randomized in a 1:1 fashion to one of two arms: 1) the intervention arm…
- Trial name
- NCT03288246
- Testing
- point-of-care viral load test
- Where
- Haiti
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
HIV
Early Infant Diagnosis Point of Care Pilot
In Mozambique, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories in Maputo, Nampula, Beira and Quelimane.
- Trial name
- NCT02634450
- Testing
- Alere q
- Where
- 8 sites in Mozambique
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Instituto Nacional de Saúde, Mozambique
Infection
ERNIE4: Urine and CRP Point-of-care Test in Acutely Ill Children
This study aims to assess the accuracy of a novel urine test for diagnosing urinary tract infections in acutely ill children presenting to ambulatory care.
- Trial name
- ERNIE4 (NCT03835104)
- Testing
- CRP point-of-care testing
- Where
- Belgium
- Volunteers
- 868 people
- Sponsor
- KU Leuven
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