Clinical trials: Immunoassay
Oncology
COVID-19 Detection Test in Oncology
EVIDENCE is a non interventional, French, multicenter study. Patients will be screened by local severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoassay in their oncology department (rapid diagnostic test (RDT) or…
- Trial name
- EVIDENCE (NCT04367870)
- Where
- 7 sites in France
- Volunteers
- 441 people
- Sponsor
- UNICANCER
Melioidosis
Adapting LFI for Melioidosis
Towards the goal of reducing melioidosis, this study will help clinicians in Sarawak to diagnose and understand the causes and risk factors for melioidosis.
- Trial name
- NCT03528265
- Testing
- Lateral flow immunoassay
- Where
- Malaysia
- Volunteers
- 100 people
- Sponsor
- Duke University
Evidence of Ruptured Membranes in Women Greater Than 15 Weekd
A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes
Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart review after delivery.
- Trial name
- NCT02208011
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Louisiana State University, Baton Rouge
Allergy, Allergic Asthma
Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation
This is a multicenter, prospective, observational study to evaluate the analytical performance of the Abionic IgE Multi-Allergen Test Panel on the abioSCOPE® device in a U.S.
- Conditions
- Allergy, Allergic Asthma, Allergy to Cats, Allergy to House Dust
- Trial name
- NCT04401631
- Testing
- Blood Collection
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Abionic SA
Endometriosis, Endometriosis-related Pain
Microbiota and Immunoassay in Women With and Without Endometriosis: a Pilot Study
Endometriosis is an estrogen-dependent chronic inflammatory disease characterized by the presence of endometrial tissue outside the uterine cavity. This pathology has a prevalence of about 5-10% in reproductive-aged women.
- Trial name
- NCT05433909
- Testing
- Blood, fecal, vaginal and endometrial liquid samples
- Where
- Italy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Vitamin D Deficiency, Vitamin D Insufficiency
ALPCO 25(OH) Vitamin D CLIA Kit - Fresh Versus Frozen Serum and Plasma Stability Study
This study evaluates the stability of 25-hydroxyvitamin D [25(OH)D] measurements in human serum and plasma using the ALPCO 25(OH) Vitamin D CLIA Kit.
- Conditions
- Vitamin D Deficiency, Vitamin D Insufficiency, Healthy Volunteers
- Trial name
- NCT07565064
- Testing
- ALPCO 25(OH) Vitamin D CLIA Kit
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- American Laboratory Products Company
Nephropathy
Clinical Trial of Anti-PLA2R-IgG Detection Kit (Time-resolved Fluorescence Immunoassay)
Conduct comparative experimental studies on clinical serum samples using assessment reagents and approved products, and evaluate the equivalence between assessment reagents and comparison reagents.
- Trial name
- NCT06456801
- Where
- China
- Volunteers
- 219 people
- Sponsor
- Zhejiang University
Dengue, Chikungunya
Impact of Differential and Systematic Diagnosis of Dengue, Chikungunya and Malaria on Patient Management and Antibiotic Use in West Africa
The differential and systematic diagnosis of malaria, dengue and chikungunya in patients with fever (≥38.5°C) of undetermined etiology would allow the identification of infection by these pathogens and thus limit the…
- Conditions
- Dengue, Chikungunya, Malaria
- Trial name
- NCT06257810
- Testing
- VIDAS® Dengue Antigen NS1, VIDAS® Anti-Dengue IgM, VIDAS® Anti-Dengue IgG, VIDAS® Anti-Chikungunya IgM and VIDAS® Anti-Chikungunya IgG, Standard of care practices
- Where
- 3 sites in Burkina Faso, Côte d’Ivoire
- Volunteers
- 804 people
- Sponsor
- BioMérieux
Bacterial Sensitivity Tests, Antimicrobial Drug Resistance
AMR-DetecTool for the Diagnostic of MDR Bacterial Infections
The fight against bacteria is one of the greatest challenges faced by societies, especially with the spread of multi drug resistant (MDR) bacteria.
- Trial name
- AMR DetecTool (NCT05378217)
- Testing
- AMR LFIA Assay
- Where
- 3 sites in France, Hungary and 1 more
- Volunteers
- 167 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Hemophilia A
Activity and Content of Factor VIII (FVIII) in Human Plasma: The Assessment of a Novel Immunoassay
A novel immuno-assay is being evaluated for the measurement of Factor VIII. Current procedure measures a rate assay which is subject to much artefact.
- Trial name
- NCT00839202
- Testing
- FVIII immuno-assay
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Children's Hospital Los Angeles
Organ Transplantation
Re-evaluation of Donor-specific Anti-HLA Alloantibodies Immunoassay After Organ Transplantation, From Antigen Level to Epitope Level
Transplantation is the only treatment for end-stage organ dysfunction, with dialysis for the kidney. However, donor / recipient (D / R) tissue incompatibility accounts for the majority of long-term graft losses, through the…
- Trial name
- ACORG-HLA (NCT03861962)
- Testing
- DNA sequencing called "new generation" (or NGS)
- Volunteers
- 20,000 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Cervical Intraepithelial Neoplasia Grade I/ II/ III (CIN I/II/III), Human Papillomavirus (HPV) Infections
A Study to Assess the Reduction of Human Papillomavirus (HPV) Viral Infectivity and Transmission in HPV-Positive Women After Vaccination With 9vHPV (RIFT-HPV)
This is a non-randomized, open label study to assess the reduction of Human Papillomavirus (HPV) infectivity and transmission in women positive for HPV16 and/or 18 in a cervical, oral and anal sample and vaccinated with…
- Conditions
- Cervical Intraepithelial Neoplasia Grade I/ II/ III (CIN I/II/III), Human Papillomavirus (HPV) Infections, High-risk HPV, HPV-16/ 18
- Trial name
- RIFT-HPV (NCT05334706)
- Testing
- Nonavalent HPV vaccine (9vHPV/Gardasil-9™).
- Where
- Spain
- Volunteers
- 69 people
- Sponsor
- Miquel Angel Pavon Ribas
Covid19
ANTIBODY BASED TESTS FOR SARSCoV-2 COVID-19) - Evaluation of Patients and Healthcare Providers in the Confines of Healthcare Settings
This study will be conducted as a registry to identify asymptomatic or symptomatic persons to determine whether they carry SARS-CoV-2 antibodies.
- Trial name
- NCT04352764
- Testing
- CoronaCideTM COVID-19 IgM/IgG Rapid Test and Premier Biotech COVID-19 IgM/IgG Rapid Test
- Where
- United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Texas Cardiac Arrhythmia Research Foundation
Membranous Nephropathy - PLA2R Induced, Kidney Diseases-except Membranous Nephropathy
Clinical Trial of PLA2R-IgG4 Detection Kit (Time-resolved Fluorescence Immunoassay)
The goal of this observational clinical trial is to compare assessment reagents with clinical diagnostic criteria in patients with membranous nephropathy.
- Trial name
- NCT05861869
- Where
- China
- Volunteers
- 450 people
- Sponsor
- Zhejiang Biostar Biotechnology Co.
Thrombocytopenia, Platelet Transfusion Refractoriness
Complement (C1q) Binding to HLA Antibodies in a Solid-phase Immunoassay and Clinical Effect on Platelet Transfusion
Background: Platelets are blood cells that help blood clot. Some people have what is called thrombocytopenia. This means they have a low blood platelet count. They need platelet transfusions very often.
- Trial name
- NCT02858323
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- National Institutes of Health Clinical Center (CC)
Plague, Plague, Bubonic
Yersinia Pestis Lateral Flow Immunoassay for Blood Samples
Plague is a deadly but highly treatable disease caused by the bacterium Y. pestis. Due to the historical development of Y. pestis as a bioweapon by several nation states, it is listed by the US as a potential bioweapon that could…
- Conditions
- Plague, Plague, Bubonic, Plague, Pneumonic, Yersinia Pestis Plague
- Trial name
- SMARTPRT (NCT04688996)
- Testing
- Lateral Flow Assay for Pathogens of the Plague
- Where
- 2 sites in United States, Madagascar
- Volunteers
- 500 people
- Sponsor
- Brimrose Technology Corporation
Sepsis
Evaluation of Immunoassay Measurements of Pancreatic Stone Protein Performed on abioSCOPE® Device With the PSP Assay on ICU Patients at Risk of Sepsis as an Aid in Identifying Sepsis
This is a multicenter, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on ICU patients at…
- Trial name
- NCT04105699
- Testing
- Blood sampling
- Where
- 5 sites in United States
- Volunteers
- 544 people
- Sponsor
- Abionic SA
Quantification of 25-(OH)D in Physiological Condition
Comparison of Maglumi X3 SNIBE With Other Analytical Methods in Laboratory Medicine for 25-(OH)D Quantification
The aim of this study is to assess the agreement among the results obtained using the Maglumi X3 SNIBE method and other analytical methods for the measurement of 25-(OH) vitamin D.
- Trial name
- NCT07337499
- Testing
- blood sampling
- Where
- Italy
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Tuberculosis
Quantiferon for Detection of Latent Tuberculosis in Healthcare Workers
The accuracy of tuberculin skin test (TST) for detecting latent tuberculosis is limited in countries with a high proportion of population having received vaccination with the BCG.
- Trial name
- QUANTIPS (NCT00797836)
- Testing
- Quantiferon Gold
- Where
- France
- Volunteers
- 1,024 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Sepsis, Septic Shock
Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population
This is a single center, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on generally…
- Conditions
- Sepsis, Septic Shock, Healthy
- Trial name
- NCT04409561
- Testing
- Blood collection
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Abionic SA