Clinical trials: Performance, Detection
- Condition Performance, Detection
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Breast Cancer Detection, Dense Breast Parenchyma
Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)
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 RRS3 (NCT04260620)
- Testing
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Delphinus Medical Technologies, Inc.
SARS-CoV-2, Covid-19
Performance Evaluation of SARS-COV-2 (Covid-19) Antigen Rapid Test
The SARS-CoV-2 Antigen Rapid Test is a bioassay intended for rapid point-of-care detection of the SARS-CoV-2 virus. Performance of the SARS-CoV-2 Antigen Rapid Test assay will be assessed by comparison to a reference method.
- Conditions
- SARS-CoV-2, Covid-19, Coronavirus
- Trial name
- NCT04808921
- Testing
- Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid Test
- Where
- United States
- Sponsor
- Sky Medical Supplies & Equipments, LLC
Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinical Trial
This clinical trial aims to systematically evaluate the clinical performance and accuracy of the HepaAiQ test kit, a multi-gene methylation assay based on PCR with fluorescent probe detection.
- Trial name
- NCT06842563
- Where
- China
- Volunteers
- 900 people
- Sponsor
- Singlera Genomics Inc.
Skin Cancer
Multi-Center Study to Evaluate the Performance of DermDx for Primary Care Physicians in the Detection of Skin Cancers
The proposed study is a pivotal, multi-center retrospective reader study designed to determine whether the use of DermDx as a concurrent reading aid improves the performance of primary care physicians (PCPs) in diagnosing skin…
- Trial name
- NCT06463860
- Testing
- DermDx
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- MetaOptima Technology Inc.
Hepatitis C
A Registration Study to Evaluate the Performance of CHIRON® RIBA® HCV 3.0 SIA in HCV Antibody Detection
To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 (RIBA, Investigational Product) test using known anti-HCV seropositive and seronegative specimens. Registration for license application
- Trial name
- NCT01582594
- Where
- 4 sites in China
- Volunteers
- 795 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Medical, China
Covid19, RSV Infection
Sample Collection Study to Aid Evaluation of an Influenza A/B, Respiratory Syncytial Virus & COVID-19 Virus POC Test
Collection of Nasal Swabs, Throat Swabs and Saliva Samples from patients presenting at their designated care or testing facility displaying symptoms of either Influenza, Respiratory Syncytial Virus (RSV), SARS-CoV-2 or those who…
- Conditions
- Covid19, RSV Infection, Influenza Type A, Influenza Type B
- Trial name
- INFORM (NCT04782336)
- Testing
- Sample Collection
- Where
- 6 sites in United Kingdom
- Volunteers
- 79 people
- Sponsor
- LumiraDx UK Limited
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.
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
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.
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
Bloodstream Infection, Sepsis
Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples
The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care…
- Conditions
- Bloodstream Infection, Sepsis, Septic Shock
- Trial name
- IID-BSIqPCR (NCT06531031)
- Testing
- InfectID-BSI (Bloodstream Infection) qPCR Assay
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 1,500 people
- Sponsor
- Microbio Co Ltd
Influenza A, Influenza B
Validation of the Respirio 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 in detecting Influenza A, when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase…
- Trial name
- NCT02487173
- Testing
- Respirio Flu Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Sofia® Influenza A+B Fluorescent Immunoassay (FIA)
- Where
- 4 sites in Australia
- Volunteers
- 83 people
- Sponsor
- Ellume Pty Ltd
Cerebral Malaria, Malarial Retinopathy
Automated Detection of Malarial Retinopathy in Patients Diagnosed With Cerebral Malaria
The focus of the study is performance validation of ASPIRE software device in processing mydriatic retinal images of a patient with clinically diagnosed Cerebral Malaria (CM), to detect malarial retinopathy (MR).
- Trial name
- ASPIRE (NCT06915285)
- Testing
- Automated software for malarial retinopathy detection
- Where
- Malawi
- Volunteers
- 834 people
- Sponsor
- VisionQuest Biomedical LLC
HIV Infections
Clinical Performance of Reveal G4 Rapid HIV-1 Antibody Test
To determine the efficacy of an improved rapid diagnostic test using venous whole blood and fingerstick whole blood. The clinical performance of Reveal G4 Rapid HIV-1 Antibody Test will be determined by comparing the results with…
- Trial name
- NCT02190578
- Testing
- Reveal G4
- Where
- 4 sites in United States
- Volunteers
- 1,649 people, healthy volunteers welcome
- Sponsor
- MedMira Laboratories Inc.
Immunodeficiency and Suspected Infection
Evaluation of High Throughput Sequencing for Screening of Pathogens in Immunocompromised Patients With Suspected Infectious Disease.
The study patients are patients suffering from primary or secondary immunodeficiencies investigated in the Hospital Necker for a suspected infectious disease.
- Trial name
- PATHOQUEST1 (NCT02007642)
- Testing
- Blood sampling / Body fluid sampling
- Where
- 2 sites in France
- Volunteers
- 250 people
- Sponsor
- Pathoquest