Clinical trials: Performance, Detection
Measles
Clinical Diagnostic Performance Evaluation of a Measles Rapid Test in Senegal
The goal of this study is to measure the accuracy of a new measles rapid test when used in clinical health centres in several regions of Senegal.
- Trial name
- NCT05860920
- Testing
- Measles rapid diagnostic test
- Where
- 6 sites in Senegal
- Volunteers
- 254 people
- Sponsor
- Institut Pasteur de Dakar
Focus: Immunocompromised Individuals at High Risk of Aqcuiring Invasive Aspergillosis
Diagnostic Performance of an Aspergillus-specific Nested PCR Assay in Cerebrospinal Fluid Samples
Multicentre, diagnostic study evaluating the performance of an aspergillus-specific PCR in cerebrospinal fluid samples of immunocompromised patients for identification of central nervous system aspergillosis.
- Trial name
- NCT01614145
- Where
- 3 sites in Germany
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Heidelberg University
Congenital Heart Disease (CHD)
Can Smartphones Listen to Your Heart? A Performance Study on Detecting Inborn Heart Diseases in Your Heart Sounds
This observational study aims to assess the performance of the software called ausculto™. ausculto™ is a collection of computer algorithms that intend to analyse heart sounds recorded from the built-in microphone of a smartphone…
- Trial name
- AUSC-CHD (NCT07376785)
- Testing
- Computer algorithms
- Where
- 2 sites in Hong Kong
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- The University of Hong Kong
Group A Streptococcal Infection
Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis
Participants who meet the eligibility criteria and who consent to participation or whose parents/legal guardian consent to their participation, will be enrolled in the study for a period of up to 14 days.
- Trial name
- NCT03693495
- Testing
- ellume·lab Group A Streptococcus Test, Bacterial Culture, Polymerase Chain Reaction (PCR)
- Where
- 4 sites in New Zealand
- Sponsor
- Ellume Pty Ltd
COVID-19, Sars-CoV-2 Infection
This Trial is a Clinical Performance Validation Study That Will Evaluate the Clinical Agreement of the Sky Medical™ Rapid Antigen Test Comparing the Antigen Rapid Test to RT-PCR
Prospective study that will evaluate the clinical agreement of the Sky Medical™ Rapid Antigen Test compared to SARS-CoV-2 RT-PCR.
- Trial name
- NCT05491993
- Testing
- Sky Medical™ Rapid Antigen Test
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Sky Medical Supplies & Equipments, LLC
Blood Stream Infection, Blood Stream Infections
Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test
This study is designed to evaluate the clinical performance of the UllCORE Bloodstream Infection (BSI) Test, an investigational molecular diagnostic test intended to detect microorganisms and selected antimicrobial resistance…
- Conditions
- Blood Stream Infection, Blood Stream Infections, Sepsis, Fungemia
- Trial name
- B-RAPID (NCT07859852)
- Testing
- UllCORE BSI Test
- Where
- 20 sites in United States, France and 3 more
- Volunteers
- 1,500 people
- Sponsor
- Deepull Diagnostics S.L.
Testing, Performance
Validation of INSPiRED Innovative Smart Diagnostic Devices for the Detection of Parasites Infections.
Malaria, schistosomiasis and ancylostomiasis are three parasitic diseases which affect hundreds of millions of people and are an important cause of global mortality and morbidity.
- Conditions
- Testing, Performance, Specificity, Sensitivity
- Trial name
- INSPiRED-WP3 (NCT04505046)
- Where
- Gabon
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche Médicale de Lambaréné
Influenza A, Influenza B
Validation of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test for the Rapid Identification of Influenza A/B
The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza A as compared to the gold standard for detection, Reverse Transcriptase…
- Trial name
- NCT02767414
- Testing
- Respirio Flu Test, eLab Flu Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
- Where
- 7 sites in Australia
- Volunteers
- 1,500 people
- Sponsor
- Ellume Pty Ltd
Group A Streptococcal Infection
Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Patients With Acute Pharyngitis.
Participants who meet the eligibility criteria and who consent to participation or whose parents/legal guardian consent to their participation, will be enrolled in the study for a period of up to 14 days.
- Trial name
- NCT03171350
- Testing
- ellume.lab Group A Streptococcus Test
- Where
- 8 sites in Australia
- Volunteers
- 132 people
- Sponsor
- Ellume Pty Ltd
Malaria
Performance Evaluation of Malaria Plus Rapid Diagnostic Tests (RDTs) for the Detection of Plasmodium Infections in Patients With Symptoms Suggestive of Malaria
This trial is part of a portfolio of studies designed to assess the clinical and operational performance of Abbott's NxTekTM Malaria Pf Plus and NxTekTM Malaria Pf/Pv Plus Rapid Test Devices.
- Trial name
- NCT05286359
- Testing
- NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device
- Where
- Ethiopia
- Volunteers
- 1,023 people
- Sponsor
- Abbott Rapid Dx
Malaria, Diagnoses Disease
RapiGEN BIOCREDIT Malaria Ag RDTs WHO Prequalification Study
Since their introduction in the late 90's, rapid diagnostic tests (RDTs) have markedly improved our ability to control malaria; yet they have inherent limitations which include low sensitivity in Plasmodium vivax detection and…
- Conditions
- Malaria, Diagnoses Disease, RDT
- Trial name
- NCT05085301
- Testing
- Rapid diagnostic test
- Where
- 2 sites in Indonesia, Sudan
- Volunteers
- 674 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Influenza, Human
Assessment of the Clinical Performance of the ARROW-FLU System
The ARROW-FLU Influenza A\&B Test is an in vitro diagnostic immuno-chromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal or nasopharyngeal swab…
- Trial name
- NCT02996136
- Testing
- Flu Symptoms
- Where
- 14 sites in United States
- Volunteers
- 3,000 people
- Sponsor
- Sekisui Diagnostics, LLC
Breast Cancer Detection, Dense Breast Parenchyma
Delphinus SoftVue™ ROC Reader Study
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in…
- Conditions
- Breast Cancer Detection, Dense Breast Parenchyma, Benign Breast Findings, Normal Breast Screening
- Trial name
- DMT SV RRS2 (NCT03972605)
- Testing
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Delphinus Medical Technologies, Inc.
Covid19
Study to Evaluate the Performance of the Therma COVID-19 Rapid Antigen Test for Detection of SARS-CoV-2
The Therma COVID-19 Rapid Antigen Test is an in vitro rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in human saliva specimens.
- Trial name
- NCT04878068
- Testing
- Theram COVID-19 Rapid Antigen Test
- Volunteers
- 300 people
- Sponsor
- Cannabis Research Associates
Schistosomiasis Hematobium, Diagnostic
Schistosomiasis Diagnosis Using a CAA Antigen Test
Schistosomiasis is one of most important human parasitic diseases worldwide. Pregnant women and their infants are two vulnerable population groups, particularly in sub-Saharan Africa, where - amongst other infectious agents …
- Conditions
- Schistosomiasis Hematobium, Diagnostic, Drug Reaction, Pregnancy
- Trial name
- FreebiLyGAB (NCT03779347)
- Testing
- Praziquantel, UCP-LF CAA, composite diagnostic
- Where
- 2 sites in Gabon
- Volunteers
- 100 people
- Sponsor
- Centre de Recherche Médicale de Lambaréné
Covid-19, SARS-CoV-2
Performance of 3 Sampling Methods for the Detection of SARS-CoV-2 (COVID-19) With Real-time Reverse Transcriptase PCR
The performance of 3 different sampling methods (2 nasopharyngeal swabs, 1 oropharyngeal swab) for the detection of SARS-CoV-2 with real-time reverse transcriptase polymerase chain reaction will be compared.
- Conditions
- Covid-19, SARS-CoV-2, Diagnosis, Polymerase Chain Reaction
- Trial name
- NCT04361448
- Testing
- samling of oropharynx and nasopharynx
- Where
- Belgium
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Jessa Hospital
Tuberculosis, HIV
Evaluation Of The Performance Of The Nitrate Reductase And Resazurin Titre Assay For The Detection of Mycobacterium Tuberculosis Complex From Sputum In A High Tb and Hiv Setting
The Principle objective of this study is To evaluate the performance of NRA, NRA-p and REMA-p for the detection of M. tuberculosis complex from sputum samples from adult pulmonary TB suspects in a high TB and HIV prevalence…
- Conditions
- Tuberculosis, HIV, AIDS, HIV Infections
- Trial name
- NRA RETA (NCT01053598)
- Where
- Uganda
- Volunteers
- 600 people
- Sponsor
- Epicentre
Invasive Pulmonary Aspergillosis, Invasive Fungal Disease
LFD of Aspergillus Antigen in Paediatrics
Many children and young people are at risk of invasive fungal disease (IFD), such as those who have had a haematopoietic stem cell transplants, those with an immune deficiency or those who are prescribed immunosuppressive drugs…
- Trial name
- LFD-AsPaeds (NCT05569824)
- Testing
- Lateral-flow Device
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- St George's University Hospitals NHS Foundation Trust
Hearing Impaired Children
EarGenie MVP Performance Evaluation
This is a single-group clinical trial to evaluate the performance of the EarGenie minimum viable product (MVP) in normal hearing infants.
- Trial name
- NCT06406088
- Testing
- EarGenie MVP test
- Where
- Australia
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- The Bionics Institute of Australia
Malaria Diagnosis, Malaria,Falciparum
Evaluation of the Performance of a hsRDT Versus cRDT in Reactive Case Detection of Malaria Infections
A systematic review assessing the role, appropriateness and benefits of the active case detection strategy, both proactive and reactive, in low malaria transmission settings.
- Trial name
- NCT03511443
- Testing
- hsRDT
- Where
- Burma
- Volunteers
- 1,980 people, healthy volunteers welcome
- Sponsor
- University Research Co, LLC