Clinical trials: Immunoassay
Parathyroid; Anomaly, Parathyroid Dysfunction
STP.168 Clinical Study Protocol Parakeet
STUDY PURPOSE The purpose of this study is to demonstrate the performance of the Parakeet Rapid Parathyroid Testing Kit by comparing Parakeet results with histopathologic Diagnosis.
- Conditions
- Parathyroid; Anomaly, Parathyroid Dysfunction, Hyperparathyroidism, Parathyroid Gland Adenoma
- Trial name
- Parakeet (NCT06499142)
- Testing
- Parakeet:The Parakeet Rapid Parathyroid Testing Kit is a rapid immunoassay designed to detect Parathormone (PTH) in a test sample.
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Neurovision Medical Products Inc
Active Tuberculosis
Serological Test for the Diagnosis of TB
TB remains a health problem in France with about 5,000 new cases per year. Development of new screening tests is a priority for TB.
- Trial name
- MycoTB (NCT02898623)
- Testing
- No intervention
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Montpellier
PROM
Efficacy Study of Rapid Immunoassay Diagnostic Test Utilizing PP12 and AFP, ROM Plus
The study is designed to establish the level of agreement between the ROM Plus test and the diagnosis of ROM as defined by the patient's clinical course, with respect to a population of pregnant women who present to the clinical…
- Trial name
- NCT02524691
- Testing
- Use of Rapid Immunoassay Tests for the Detection of PROM
- Where
- 3 sites in United States
- Volunteers
- 324 people
- Sponsor
- Clinical Innovations, LLC
Transgender Persons, Hormone Replacement Therapy
Trans & Non-binary Reference Intervals While on Hormone Therapy Study
This study will find out what the reference intervals are for common blood tests in transgender people taking hormone therapy. Reference intervals help doctors interpret blood test results.
- Conditions
- Transgender Persons, Hormone Replacement Therapy, Reference Values
- Trial name
- TransRIHTS (NCT04478760)
- Where
- United Kingdom
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- King's College Hospital NHS Trust
Immunoassay, Antipsychotic
Whole Blood and Plasma Sample Collection for the Development of Antipsychotic Immunoassays From Participants Taking Aripiprazole, Olanzapine, Paliperidone, or Risperidone
The purpose of this study is to collect whole blood and plasma venous and capillary samples from participants taking aripiprazole, olanzapine, paliperidone, or risperidone for the development of antipsychotic immunoassays.
- Trial name
- NCT02634463
- Testing
- Aripiprazole, Olanzapine, Paliperidone
- Where
- Belgium
- Volunteers
- 81 people
- Sponsor
- Janssen Research & Development, LLC
Screening for Syphilis Infections
Syph-Check Syphilis Antibody Point of Care (POC) Test
The study is designed to evaluate the performance of a rapid membrane test in a clinic or doctor's office setting to identify potential patients infected with syphilis and compare the results to currently licensed laboratory…
- Trial name
- SyphPoc (NCT00732355)
- Testing
- Syph-Check POC
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Healthcare Providers Direct, Inc.
Chronic Pain
Accuracy of Point of Care (POC) or In-office Urine Drug Testing (Immunoassay) in Chronic Pain Patients
Accuracy of Point of Care (POC) or In-office Urine Drug Testing (Immunoassay) in Chronic Pain Patients: A Prospective Analysis of Immunoassay and Liquid Chromatography Tandem Mass Spectometry (LC/MS/MS)
- Trial name
- NCT01052155
- Testing
- Urine Drug Testing
- Volunteers
- 1,000 people
- Sponsor
- Pain Management Center of Paducah
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
Breast Cancer
Early Detection and Prediction of Chemotherapy Induced Cardiac Toxicity in Breast Cancer Patients
The goal of this clinical research study is to learn whether different ways of viewing echocardiogram pictures along with blood tests can help to see heart-related side effects of chemotherapy and trastuzumab earlier than the…
- Trial name
- NCT00806507
- Testing
- Echocardiograms, Blood Test
- Where
- 2 sites in United States
- Volunteers
- 45 people
- Sponsor
- M.D. Anderson Cancer Center
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
Anthrax
Evaluation of the Clinical Specificity of the Active Anthrax Detect™ Plus (AAD Plus) Lateral Flow Immunoassay (LFI)
The primary objective of the study is to determine the estimated clinical specificity of the AAD Plus. A secondary objective is to determine the estimated sensitivity of the AAD Plus as 10% of the study subject samples will be…
- Trial name
- NCT04320485
- Testing
- Active Anthrax Detect™ Plus (AAD Plus)
- Where
- 4 sites in United States
- Volunteers
- 450 people
- Sponsor
- InBios International, Inc.
Prostate Cancer
Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer
Background: Flutamide is an approved drug for prostate cancer that blocks the effects of testosterone on prostate cancer cells and may slow the progression of the disease.
- Trial name
- NCT00450463
- Testing
- Sargramostim (GM-CSF, Leukine), Flutamide (Eulexin), PROSTVAC-F/ TRICOM
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- National Cancer Institute (NCI)
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
Bladder Cancer
A Diagnostic for the Early Detection of Bladder Cancer
To improve upon the non-invasive detection of bladder cancer by further validating a multiplex ELISA assay directed at a bladder cancer-associated diagnostic signature in voided urine samples of patients with a high risk of…
- Trial name
- NCT05347342
- Where
- 2 sites in United States
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- Cedars-Sinai Medical Center
Hypertension
The Construction of Precision Medicine in Chinese Medicine
"Precise medicine" is also called "personal medicine". With the development of big data database, genetic testing and artificial intelligence, the concept of precision medicine has been applied to the diagnosis, treatment and…
- Trial name
- NCT04434924
- Where
- Taiwan
- Volunteers
- 600 people
- Sponsor
- China Medical University Hospital
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
Covid19
Sustained Immunity to COVID-19 as Measured by SARS-CoV-2 Serology Assays
The primary objective is to assess the ability of COVID-19 IgG and IgM assays to detect an immune response in COVID-19 patients in the Henry Ford Health System (HFHS), both during hospitalization and over the following 12 months.
- Trial name
- NCT04562285
- Testing
- Serologic immunoassays to SARS-CoV-2 antibodies
- Where
- United States
- Volunteers
- 829 people, healthy volunteers welcome
- Sponsor
- Henry Ford Health System
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