Clinical trials: Immunoassay
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
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
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
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
HIV Infections, Hepatitis C
Prevalence of Hepatitis C Virus Infection in HIV-Infected Children
The purpose of this study is to find out how many children who are infected with HIV are also infected with hepatitis C virus (HCV). HCV infection is a major health concern.
- Trial name
- NCT00037076
- Where
- 39 sites in United States, Puerto Rico
- Volunteers
- 600 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Group B Strep Infection
mulTiplex Immunoassay qualiTy assuRance Panel
Collection of serum from women not living with HIV, who received the GBS6 vaccine in the "a placebo-controlled clinical trial investigating the safety and immunogenicity of GBS6 in pregnant women with and without human…
- Trial name
- TITRE (NCT07562061)
- Testing
- Collection of 50mls of blood
- Where
- Uganda
- Volunteers
- 50 people
- Sponsor
- St George's, University of London
Fever
Host-based Immunoassay for Differentiating Bacterial From Viral Infections (Post-marketing Study of ImmunoXpert™ - SPIRIT Study)
This is a retrospective external field study of a novel in vitro diagnostic (IVD) assay (ImmunoXpert™). The study will involve reviewing the medical charts of about 4500 pediatric patients that were tested using ImmunoXpert™ as…
- Trial name
- NCT03075111
- Testing
- ImmunoXpert
- Where
- 2 sites in Israel
- Volunteers
- 3,000 people
- Sponsor
- MeMed Diagnostics Ltd.
Premature Rupture of Membranes
Rapid Immunoassay Tests for the Detection of Ruptured Membranes
The aim of the study is to demonstrate substantial equivalence of IGFBP-1/AFP tests with the "predicate device" Amnisure® in detecting pre labor rupture of membranes.
- Trial name
- NCT02495441
- Testing
- Use of Rapid Immunoassay Tests for the Detection of PROM
- Where
- Sri Lanka
- Volunteers
- 100 people
- Sponsor
- De Soysa Hospital for Women
Pneumonia, Pneumonia - Bacterial
Urine Pneumococcal Antigen Project
Background: Pneumonia caused by the bacteria Streptococcus pneumoniae is a leading cause of death among children under five years of age, especially in sub-Saharan Africa.
- Trial name
- UPAP (NCT07181200)
- Where
- Malawi
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Liverpool School of Tropical Medicine
Solid Organ Transplant Recipients, Autoimmune Diseases
Mass Evaluation of Lateral Flow Immunoassays for the Detection of SARS-CoV-2 (Covid-19) Antibodies
DESIGN Observational epidemiological study AIMS - To determine: 1. The proportion of immunosuppressed people who have detectable SARS-CoV-2 antibodies following a primary vaccine course (3 doses), and the demographic, disease…
- Conditions
- Solid Organ Transplant Recipients, Autoimmune Diseases, Haematological Malignancies
- Trial name
- MELODY (NCT05148806)
- Testing
- self-administered lateral flow assays
- Where
- 4 sites in United Kingdom
- Volunteers
- 28,411 people
- Sponsor
- Imperial College London
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
Visceral Leishmaniasis
LAMP Assay for the Diagnosis of Visceral Leishmaniasis
This study will evaluate the of the loop-mediated amplification assay (LAMP) as a diagnostic as well as a Test-of-Cure (ToC) for visceral leishmaniasis (VL) in an endemic area in Ethiopia.
- Trial name
- EvaLAMP (NCT04003532)
- Where
- Ethiopia
- Volunteers
- 500 people
- Sponsor
- Prof. Dawit Wolday
Lyme Disease
Comparison of IFA and LIAISON® for Diagnosis of Early Disseminated Lyme Borreliosis in Children, Younger Than 18 Years
The aim of this study is to compare two different serological tests, IFA and LIAISON, for detection of Borrelia burgdorferi sensu lato IgM and IgG antibiodies in children with early disseminated Lyme borreliosis.
- Trial name
- NCT03798704
- Testing
- IFA, LIAISON
- Where
- Slovenia
- Volunteers
- 349 people
- Sponsor
- University Medical Centre Ljubljana
HIV Infection
A Novel Method to Determine HIV Incidence Among Youth
Identifying young people with early HIV-1 infection is important for increasing linkage to care, for behavioral counseling, and for enrolling individuals into programs that can provide effective interventions to disease…
- Trial name
- NCT00103883
- Where
- 15 sites in United States, Puerto Rico
- Volunteers
- 440 people
- Sponsor
- University of North Carolina, Chapel Hill
Sepsis, Septicemia
Observational Study of Sepsis and Pneumonia to Develop Diagnostic Tests
We propose to develop novel diagnostic tests for severe sepsis and community acquired pneumonia (CAP). This program, entitled Community Acquired Pneumonia \& Sepsis Outcome Diagnostics (CAPSOD), is a multidisciplinary…
- Conditions
- Sepsis, Septicemia, Sepsis Syndrome, Shock, Septic
- Trial name
- NCT00258869
- Where
- 3 sites in United States
- Volunteers
- 1,200 people
- Sponsor
- National Center for Genome Resources
Strep Throat
Strep A Fluorescent Immunoassay and Analyzer Field Study
The purpose of this study is to demonstrate the ability of the Strep A Fluorescent Immunoassay Analyzer to accurately detect a throat swab specimen for the presence or absence of Strep A when compared to culture.
- Trial name
- NCT01441479
- Testing
- In Vitro Diagnostic Device aid in diagnosing
- Where
- 7 sites in United States
- Volunteers
- 1,282 people
- Sponsor
- Quidel Corporation
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