Clinical trials: Immunoassay, active
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
Performance Verification
Clinical Application Research Plan for Fully Automated Chemiluminescent Immunoassay Reagents
For the remaining serum, plasma, urine or other body fluid samples from clinical tests, chemiluminescence immunoassay reagents are used (covering eleven types of markers such as infectious diseases, tumors, hormones, thyroid…
- Trial name
- NCT07918820
- Testing
- performance verification
- Volunteers
- 2,800 people
- Sponsor
- BangShun He
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
Quantification of 25-(OH)D in Physiological Condition
Comparison of Maglumi X3 SNIBE With Other Analytical Methods in Laboratory Medicine for 25-(OH)D Quantification
The aim of this study is to assess the agreement among the results obtained using the Maglumi X3 SNIBE method and other analytical methods for the measurement of 25-(OH) vitamin D.
- Trial name
- NCT07337499
- Testing
- blood sampling
- Where
- Italy
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
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
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
Cervical Intraepithelial Neoplasia Grade I/ II/ III (CIN I/II/III), Human Papillomavirus (HPV) Infections
A Study to Assess the Reduction of Human Papillomavirus (HPV) Viral Infectivity and Transmission in HPV-Positive Women After Vaccination With 9vHPV (RIFT-HPV)
This is a non-randomized, open label study to assess the reduction of Human Papillomavirus (HPV) infectivity and transmission in women positive for HPV16 and/or 18 in a cervical, oral and anal sample and vaccinated with…
- Conditions
- Cervical Intraepithelial Neoplasia Grade I/ II/ III (CIN I/II/III), Human Papillomavirus (HPV) Infections, High-risk HPV, HPV-16/ 18
- Trial name
- RIFT-HPV (NCT05334706)
- Testing
- Nonavalent HPV vaccine (9vHPV/Gardasil-9™).
- Where
- Spain
- Volunteers
- 69 people
- Sponsor
- Miquel Angel Pavon Ribas
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
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
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
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