Clinical trials: Specificity
Syphilis, Syphilis Infection
Retrospective Study of iStatis Syphilis Ab Test (POC)
The purpose of this retrospective clinical trial is to establish the clinical performance of the iStatis Syphilis AbTest. The data will be used to demonstrate the product is safe and effective for its intended use.
- Trial name
- NCT06367621
- Testing
- iStatis Syphilis Antibody Test
- Where
- South Africa
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Syphilis Infection
Evaluation of the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.
This is a prospective, multi-centre study which will evaluate the diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test.
- Trial name
- NCT06584214
- Testing
- Diagnostic test: Determine™ Syphilis Advanced test
- Where
- Uganda
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Abbott Rapid Dx
Asthma
Ability of Aridol to Detect Bronchial Hyperresponsiveness in Suspected Asthmatics
This is a Phase 3 study to determine the sensitivity and specificity of the Aridol bronchial challenge test to detect bronchial hyperresponsiveness in patients with suspected asthma.
- Trial name
- NCT00252291
- Testing
- Aridol, Methacholine, Exercise challenge
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Syntara
Infectious Diseases
Specificity Study of Diagnostic for Chagas Disease
This study assesses the specificity of Chagas Detect™ Plus (CDP) rapid test versus standard reference tests (e.g. RIPA or IFA) for Chagas diagnosis in the US.
- Trial name
- NCT02544139
- Testing
- Chagas Detect Plus
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- InBios International, Inc.
Febrile Infection, Anthrax
Febrile Whole Blood Specimen Collection and Testing
Whole blood samples will be collected from febrile patients presenting with fever of unknown origin and flu-like syndromes. Collection sites will consent patients and collect one (1) 4 mL whole blood sample from adults and either…
- Trial name
- NCT03498027
- Testing
- TaqMan Bacillus anthracis Detection Kit
- Where
- 3 sites in United States
- Volunteers
- 97 people
- Sponsor
- MRI Global
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
Allergy
Sensitivity and Specificity of 3 Solutions of Allergen Extract for Diagnosis by Skin Prick Testing
A Phase III study to determine the sensitivity and specificity of three solutions of different allergen extracts for diagnosis by skin prick-test: 5 Grasses pollen, Birch pollen, Dermatophagoides pteronyssinus mite
- Trial name
- NCT01964768
- Testing
- Skin prick-test
- Volunteers
- 324 people
- Sponsor
- Stallergenes Greer
Post-natal Cytogenetics
Method Comparison and Clinical Specificity Study: Evaluation of the Infinium HD Cytogenetic Abnormality Test
The study will determine the performance of the Infinium HD Test. The primary objective of the study is to assess the performance of the Infinium HD Test using banked DNA samples extracted from whole blood patient samples derived…
- Trial name
- NCT01426308
- Where
- 3 sites in United States
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Illumina, Inc.
Syphilis, Treponema Pallidum
A Cross-sectional Investigational Study to Evaluate the Sensitivity, Specificity, and Utility of the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) to Diagnose Infectious Syphilis in Participants Attending the Sexual Health Clinic in Ottawa, Ontario.
Due to the recent resurgence of infectious syphilis in Canada and the changing epidemiology of the disease to involve heterosexuals and females of child bearing age leading to a record number of congenital syphilis cases and…
- Trial name
- NCT06586905
- Testing
- Medical Device
- Where
- Canada
- Volunteers
- 1,300 people, healthy volunteers welcome
- Sponsor
- MedMira Laboratories Inc.
Cow's Milk Allergy
Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children
Study to assess the diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of DBV1605 for the diagnosis of non-Immunoglobulin E (IgE) mediated cow's milk allergy (CMA) in children with symptoms…
- Trial name
- APTITUDE (NCT04492683)
- Testing
- DBV1605
- Where
- 33 sites in United States, Canada and 2 more
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- DBV Technologies
Hemophilia A
Study Evaluating Inhibitor Specificity in Hemophilia A
This investigation will utilize a systematic determination of anti-FVIII antibody specificity in PTPs (> 50 ED) with hemophilia A who have developed inhibitors in response to treatment with any FVIII product(s).
- Trial name
- NCT00151385
- Testing
- single blood draw
- Where
- 23 sites in United States, Belgium and 5 more
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Immune System Diseases
Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa
The main objective is to evaluate the concentration of allergen extract of Betula verrucosa that elicit a papule equivalent to that produced by a solution of histamine dihydrochloride 10 mg / ml in size.
- Trial name
- T502 (NCT02527187)
- Testing
- 10 HEP/mL Betula verrucosa allergen extract, 25 HEP/mL Betula verrucosa allergen extract, 50 HEP/mL Betula verrucosa allergen extract
- Where
- Spain
- Volunteers
- 201 people
- Sponsor
- Inmunotek S.L.
Infectious Diseases
Specificity Study of Diagnostic for Early Detection of Dengue Infection
This study assesses the specificity of DENV Detect™ NS1 ELISA versus standard reference tests (e.g. PCR or viral culture) for dengue diagnosis in the US.
- Trial name
- NCT02107677
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- InBios International, Inc.
Conjunctivitis
A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis
To engage in a multi-center, prospective, masked clinical trial to investigate a non-invasive, rapid diagnostic test, the RPS Adeno Detector IV's ability to detect the presence of the adenovirus (ADV) antigen in cases of acute…
- Trial name
- NCT00921895
- Testing
- RPS Adeno Detector IV
- Where
- 8 sites in United States
- Volunteers
- 128 people
- Sponsor
- Rapid Pathogen Screening