Clinical trials: Immunoassay
Human Immunodeficiency Virus, Hypogonadism, Male
Gonadal Function in Young to Middle Aged HIV-infected Men
HIV infection is associated to premature decline of serum testosterone. However, prevalence and biochemical characterization of hypogonadism in HIV-infected men are still to be well defined.
- Conditions
- Human Immunodeficiency Virus, Hypogonadism, Male, Erectile Dysfunction
- Trial name
- NCT03747003
- Testing
- No intervention is provided
- Where
- Italy
- Volunteers
- 315 people
- Sponsor
- Azienda Ospedaliero-Universitaria di Modena
Gastric Neoplasms, Pancreatic Neoplasms
Chromogranin A as Blood Marker in Cancer Patients
Gastroentero-pancreatic neuroendocrine tumors (GEP-NETs) are a heterogenous group of neoplasms that arise from enterochromaffin cells of the gastrointestinal (GI) tract and pancreas. They account for 50-70% of all incident NETs.
- Conditions
- Gastric Neoplasms, Pancreatic Neoplasms, Small Intestinal Neoplasms, Colorectal Neoplasms
- Trial name
- NCT03817866
- Testing
- BRAHMS CgA II KRYPTOR
- Where
- 4 sites in United States, Germany
- Volunteers
- 175 people
- Sponsor
- Brahms AG
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
COVID
Validation of an Immunochromatographic Assay for IgG/IgM Antibodies to 2019- nCoV
In COVID-19 pandemic, it is of critical importance to identify a rapid and simple diagnostic method to be used in clinical settings to timely inform and refine strategies that can prevent, control, and stop the spread of…
- Trial name
- I-GLOBAL (NCT04434417)
- Testing
- 2019-nCoV IgG/IgM Rapid Test Cassette
- Where
- 5 sites in Italy
- Volunteers
- 1,000 people
- Sponsor
- European Institute of Oncology
Healthy Volunteers, Syphilis Serologic Assay Development
Blood Donation Study for ALPCO Syphilis-T and Syphilis-NT Assay Development
This prospective, single-center study will collect blood from approximately 50 adult volunteers aged 22 years or older. Participants will provide informed consent, complete an eligibility review, and undergo one blood draw of…
- Conditions
- Healthy Volunteers, Syphilis Serologic Assay Development, Blood Specimen Collection, Diagnostic Assay Development
- Trial name
- NCT07830550
- Testing
- ALPCO Syphilis-T, ALPCO Syphilis-NT CLIA Kits
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- American Laboratory Products Company
Thyroid Disorders, Thyroid Stimulating; Hormone, C
Harmonization of Thyroid-stimulating Hormone Immunoassays Reagents
Given the prevalence and gravity of thyroid disorders, timely diagnosis, initiation, and monitoring of therapy are important to restrict the impact of the disease on public health.
- Trial name
- IFCC-TSH (NCT05151120)
- Testing
- blood sample
- Where
- 2 sites in France
- Volunteers
- 28 people
- Sponsor
- Hospices Civils de Lyon
Aldosteronism
Establishment of Aldosterone and Renin Reference Range
Elevated aldosterone levels were also shown to contribute to the excess morbidity and mortality. Literature shows aldosterone and renin levels differ between ethnicity and gender.
- Trial name
- ARR (NCT05232162)
- Where
- Malaysia
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University Malaysia Sarawak
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
Coeliac Disease
Diagnostic Accuracy of IgA Anti-transglutaminase Antibodies Measured by CLIA for Predicting Villous Atrophy in Coeliac Disease
Celiac disease (CD) is an autoimmune disorder in which ingestion of gluten leads to immune-mediated damage of the small intestine. Diagnosis has traditionally required histological confirmation of duodenal villous atrophy.
- Trial name
- NCT07364461
- Where
- Spain
- Volunteers
- 765 people, healthy volunteers welcome
- Sponsor
- Hospital Mutua de Terrassa
Heparin-induced Thrombocytopenia (HIT)
Rapid Diagnosis of Heparin-Induced Thrombocytopenia in Surgical Critically Ill Patients
The early diagnosis of heparin-induced thrombocytopenia is particularly difficult in surgical critically ill patients. If the use of rapid immunological diagnostic methods and pretest scoring systems has been proposed in the…
- Trial name
- TIH (NCT02790567)
- Testing
- HEP score, 4Ts score, ID-PaGIA test
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Antiphospholipid Syndrome
Measurement of Anti-dsDNA by Both CLIFT & ELISA
detection of anti-ds DNA in patients with rheumatic diseases by two methodes : immunofluorescence \& ELISA
- Trial name
- NCT03303508
- Testing
- anti-ds DNA
- Volunteers
- 100 people
- Sponsor
- Assiut University
Covid19
SARS-CoV-2 IgG and IgM Serologic Assays
The primary objective is to assess and validate the ability of the Beckman Coulter Access COVID-19 IgG and IgM assays to detect immunity in COVID-19 patients in the Henry Ford Hospital Health System.
- Trial name
- NCT04562246
- Testing
- Serologic assays for antibodies to SARS-CoV-2
- Where
- United States
- Volunteers
- 214 people
- Sponsor
- Henry Ford Health System
Clostridium Difficile Infection, Hematologic Diseases
Vancomycin for C Difficile NAAT+/EIA- Hematology Oncology Patients
This study will randomized hematology oncology patients with active diarrhea and a NAAT positive/toxin EIA negative to either 14 days of oral vancomycin capsules or placebo.
- Conditions
- Clostridium Difficile Infection, Hematologic Diseases, Bone Marrow Transplant, Oncologic Disorders
- Trial name
- NCT03030248
- Testing
- Vancomycin Oral Capsule
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Medical College of Wisconsin
Anemia, Iron Deficiency
Serum Hepcidin Immunoassay - Laboratory to Marketplace
This is a single center, prospective, observational study to demonstrate the clinical validity of the Intrinsic LifeSciences (ILS) Intrinsic Hepcidin IDx™ Test in the diagnosis and management of iron deficiency (ID) in…
- Trial name
- NCT03310736
- Testing
- Intrinsic Hepcidin IDx™ Test
- Where
- United States
- Volunteers
- 494 people, healthy volunteers welcome
- Sponsor
- Intrinsic LifeSciences, LLC
Neonatal Infection
Exploring Vancomycin Disposition in Neonates
Vancomycin is already used for decades in neonates. However, there are remaining questions concerning vancomycin disposition in this population.
- Trial name
- NCT02096536
- Testing
- Vancomycin
- Where
- Belgium
- Volunteers
- 120 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Testosterone, Androgens
Comparison Between Calculated Bioavailable Testosterone Level With Radio-immunoassay Result.
Currently, the gold standard to obtain bioavailable testosterone results is radioimmunoassay (RIA). However, this assay requires specific equipment.
- Trial name
- TESTOBIO (NCT04807231)
- Testing
- Blood withdrawal
- Where
- France
- Volunteers
- 270 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens