Clinical trials: Immunoassay
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
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
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
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.
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
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
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
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
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.
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.
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.
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
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
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
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
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
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
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