Clinical trials: Immunoassay
Occult Gastrointestinal Bleeding
Performance Value of Research of Occult Gastrointestinal Bleeding by Immunoassay in the Diagnostic Process of Iron Deficiency Anemia in Patients Over 75 Years
This study aims to characterize the diagnostic performance of immunological testing of occult gastrointestinal bleeding in stool in the population aged over 75 years with iron deficiency anemia.
- Trial name
- STRATAGANEMIE (NCT02727075)
- Where
- France
- Volunteers
- 79 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Sinusitis Bacterial
Point-of-Care Immunoassay for Detection of Bacterial Sinusitis
This study is conducted to evaluate the performance of a rapid, point-of-care in vitro diagnostic device (Sinu-Test®) for the qualitative detection of the three most common pathogens responsible for causing bacterial sinusitis.
- Trial name
- NCT03584737
- Testing
- rapid in vitro diagnostic test, bacterial culture, PCR assay
- Where
- 7 sites in United States
- Volunteers
- 800 people
- Sponsor
- ENTvantage Dx
Treponema Pallidum, Treponema Pallidum Infection
This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests.
This study will evaluate the clinical performance of two investigational diagnostic kits developed by ALPCO: the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit.
- Conditions
- Treponema Pallidum, Treponema Pallidum Infection, Syphilis Infection, Serum
- Trial name
- NCT07089836
- Testing
- ALPCO Syphilis-T, ALPCO Syphilis-NT CLIA Kits
- Where
- 6 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- American Laboratory Products Company
Pneumonia, Bacterial, Viral Infection
Diagnostic and Prognostic Biomarkers for Childhood Bacterial Pneumonia
Clinical pneumonia is a leading cause of pediatric hospitalization. The etiology is generally bacterial or viral. Prompt and optimal treatment of pneumonia is critical to reduce mortality.
- Conditions
- Pneumonia, Bacterial, Viral Infection, Clinical Pneumonia, Plasmodium Falciparum Malaria
- Trial name
- NCT03996967
- Where
- 3 sites in United States, Netherlands and 1 more
- Volunteers
- 837 people
- Sponsor
- Boston University
Breast Cancer, Colorectal Cancer
Immunoassay and Regulation of Traditional Chinese Medicine on Cancer Patients
The immune system is our body's defense mechanism, which helps us to resist foreign pathogens and cancer cells in the body. However, if the immune system is too weak, too strong, or unbalanced, it will be susceptible to get…
- Conditions
- Breast Cancer, Colorectal Cancer, Cancer of Ovary, Cancer of Endometrium
- Trial name
- NCT04438564
- Testing
- Cases for patients diagnosed with breast cancer, colonrectal cancer, ovarian cancer and endometrial cancer
- Where
- Taiwan
- Volunteers
- 300 people
- Sponsor
- China Medical University Hospital
Bladder Cancer
Predicting BCG Response
To date, there are no diagnostics capable of predicting treatment response to intravesical BCG. Because of this severe limitation, nearly 50% of patients treated with BCG fail therapy and will a) require additional intravesical…
- Trial name
- NCT04564781
- Where
- 6 sites in United States, Australia and 1 more
- Volunteers
- 400 people
- Sponsor
- Cedars-Sinai Medical Center
Risk Reduction
Point-of-care Urine Monitoring of Adherence: Testing a Real-Time Urine Assay of Tenofovir in PrEP
Worldwide expansion of pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) will be critical to ending the HIV epidemic.
- Trial name
- PUMA (NCT03935464)
- Testing
- PUMA
- Where
- Kenya
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Time of Death
Estimate of the TSD Based on the Quantification of the Tau Protein in CSF
Background: The accurate estimation of the time of death is a challenge in forensic medicine, as the methods routinely used to assess the post-mortem interval (PMI) are far from being precise.
- Trial name
- NCT03845439
- Testing
- Lumbar puncture
- Where
- France
- Volunteers
- 80 people
- Sponsor
- University Hospital, Montpellier
Febrile Illness
Clinical Usefulness of a Multi-analyte Immunoassay for Distinguishing Bacterial and Viral Infections in Children
Fever can be a clinical manifestation present in pediatric infections, posing a challenge for the doctor who must decide whether or not to prescribe an antibiotic therapy.
- Trial name
- PED_BIOMARKERS (NCT06852846)
- Testing
- Biological sample
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Meyer Children's Hospital IRCCS
Colorectal Cancer
Circulating-free DNA Assessment as a Tool to Predict Colorectal Cancer in Subjects With a Positive Fecal Immunoassay.
Colorectal cancer (CRC): is one of the most frequent cancers, with almost 42152 new cases estimated in France for 2012. There are 3 levels of risk of developing CRC: moderate, high or very high.
- Trial name
- DEPLR (NCT03981679)
- Testing
- Biological collection
- Where
- France
- Volunteers
- 278 people
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
Ulcerative Colitis (UC)
The Fecal Immunoassay Occult Blood Test Combined With Calprotectin Sequential Linkage Imaging Endoscopy Screening Strategy for Monitoring Tumor Changes Associated With Long-duration Ulcerative Colitis
Ulcerative colitis (UC) is a chronic inflammatory bowel disease associated with an increased risk of colorectal cancer, known as UC-associated neoplasia (UCAN).
- Trial name
- DETECT-UCAN (NCT07742410)
- Volunteers
- 250 people
- Sponsor
- Qilu Hospital of Shandong University
Preterm Premature Rupture of Fetal Membranes
Detection of PPROM With AmniSure PAMG-1 Rapid Immunoassay
The investigators will test the hypothesis that in a preterm population with a gestational age of 16+0 and 36+6 weeks AmniSure PAMG-1 rapid immunoassay will be more accurate than conventional methods (speculum examination for…
- Trial name
- NCT01637610
- Where
- Canada
- Volunteers
- 85 people
- Sponsor
- University of Saskatchewan
Covid19
Evaluation of Commercial SARS-CoV-2 Antibody Immunoassays for COVID-19
Achieved serum samples of persons with or without evidence of COVID-19 infection are tested using the different commercial SARS-CoV-2 antibody immunoassays.
- Trial name
- NCT04496141
- Testing
- SARS-CoV-2 antibody immunoassays
- Where
- Hong Kong
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Hong Kong Sanatorium & Hospital
Thyroid Neoplasms
Clinical Evaluation of a New Highly Sensitive Thyroglobulin Assay in Differentiated Thyroid Carcinoma
Human thyroglobulin (Tg) is the most sensitive biochemical marker for recurrence of differentiated cancer (DTC), especially after the complete removal of thyroid tissue through surgery and radioiodine therapy (RIT).
- Trial name
- NCT00148213
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- University Hospital Muenster
Sepsis, Sepsis Bacterial
Analytical Validation of the abioSCOPE Device With the IVD CAPSULE PSP Test: Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood.
Abionic has developed a targeted, rapid test for pancreatic stone protein (PSP) in human K2-EDTA venous whole blood using the abioSCOPE instrument.
- Trial name
- NCT05627076
- Testing
- Blood Sampling
- Where
- France
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Abionic SA
Pregnant Woman With Premature Rupture of Amnion Membranes
A Comparison of Rapid Immunoassay Tests 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
- NCT01668472
- Where
- Sri Lanka
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Colombo