Clinical trials: Specificity
Coccidioidomycosis
A Multi-center Study of Spherule-Derived Coccidioidin
Adult volunteers were skin tested with 1.27 ug spherule-derived coccidioidin. The skin test antigen was evaluated in three different populations of adult volunteers to determine the safety and efficacy of the product in the…
- Trial name
- NCT00690092
- Testing
- Spherule-derived coccidioidin
- Where
- 4 sites in United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Nielsen BioSciences, Inc.
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
Tuberculosis Infection
Equivalence Study of Specificity of PPD
Determine if investigational products and reference standard produce similar responses.
- Trial name
- 03 (NCT01798095)
- Testing
- Aplisol@ PPD material, Reference Standard
- Where
- United States
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- JHP Pharmaceuticals LLC
Breast Cancer
A Pilot Study on Use of Liquid Crystal Contact Thermography to Detect Early Breast Cancer
The study was a multicentre, observational, cross-sectional, open and monitored trial involving 274 females who were subject to an examination using liquid crystal contact thermography device as a complementary tool to standard…
- Trial name
- NCT03858738
- Testing
- Thermographic breast examination performed by Braster device
- Volunteers
- 274 people, healthy volunteers welcome
- Sponsor
- Braster S.A.
Non Muscle Invasive Bladder Cancer, Non-Muscle Invasive Bladder Urothelial Carcinoma
Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
This is a prospective study to establish the analytical specificity of Bladder EpiCheck test in urine samples from healthy population and urology patients without prior history or evidence of bladder cancer.
- Trial name
- NCT06020807
- Testing
- Bladder EpiCheck
- Where
- United States
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Nucleix Ltd.
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
Human Papillomavirus Infection
Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System
The purpose of this study is to provide data on the performance of the APTIMA HPV Assay using the TIGRIS System in detecting HPV types that may cause cervical cancer.
- Trial name
- NCT00973362
- Testing
- APTIMA HPV Assay, FDA-Approved HPV DNA Test
- Where
- 17 sites in United States
- Volunteers
- 12,896 people, healthy volunteers welcome
- Sponsor
- Gen-Probe, Incorporated
Healthy
In Vivo Specificity of KUC 7483 CL Co-administered With Bisoprolol, Propranolol, and Acipimox in Healthy Male Subjects
Study to compare the metabolic and electrolyte effects of a single oral dose of 320 mg ritobegron administered alone or with a pre- and comedication with bisoprolol, propranolol and acipimox.
- Trial name
- NCT02256722
- Testing
- KUC 7483 CL, Bisoprolol, Propranolol
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Syphilis Infection, Syphilis
Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites
This study is a prospective cross-sectional study in which surgically non-invasive sample- taking is done only for the purpose of the study.
- Trial name
- NCT06365606
- Testing
- iStatis Syphilis Ab Test
- Where
- South Africa
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
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.
Anthrax
Evaluation of the SRI B. Anthracis Lethal Factor Diagnostic System
This study is intended to estimate the Anthrax LF Dx System specificity. Sensitivity will be estimated with 10% of the samples spiked with recombinant Bacillus anthracis lethal factor (LF) used to prepare contrived positive…
- Trial name
- NCT05672875
- Testing
- Anthrax LF Dx System
- Where
- 3 sites in United States
- Volunteers
- 343 people, healthy volunteers welcome
- Sponsor
- SRI International
Hepatocellular Carcinoma by AJCC Stage
Performance Evaluation (Sensitivity/Specificity) of HelioLiver Test for Detection of HCC
De-identified whole blood and serum samples are collected for the purpose of evaluating the performance (sensitivity/specificity) of the HelioLiver Test for the detection of hepatocellular carcinoma (HCC).
- Trial name
- ENCORE (NCT05059665)
- Testing
- Helio Liver Test
- Where
- 2 sites in China
- Volunteers
- 290 people, healthy volunteers welcome
- Sponsor
- Helio Genomics
Asthma
A Study to Evaluate the Sensitivity and Specificity of Inhaled Methacholine in Bronchial Provocation Test
A multicenter, open-label study to evaluate the sensitivity and specificity of inhaled methacholine in bronchial provocation test
- Trial name
- NCT05634473
- Testing
- Methacholine Chloride
- Where
- 12 sites in China
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Asthma
A Comparative Bronchial Provocation Study With Mannitol and Methacolinie in a Korean Population
Asthmatic patients and non-asthmatic controls were recruited prospectively from four referral hospitals in Korea. Participants were challenged with each of methacholine and mannitol inhalation on different days.
- Trial name
- NCT02104284
- Testing
- methacholine and mannitol bronchial challenge tests
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- BL&H Co., Ltd
MCI
Accexible Speech Analysis for MCI Detection and Monitoring in Colombia
Mild Cognitive Impairment (MCI) is frequently underdiagnosed due to its subtle clinical presentation. This study evaluates the diagnostic performance of AcceXible, a speech analysis-based machine learning platform, compared to…
- Trial name
- NCT07553117
- Testing
- Accexible
- Where
- Colombia
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Accexible
Syphilis Infection, Syphilis
Evaluation of the Sensitivity, Specificity, and Utility of the Reveal® TP (Syphilis) Antibody POCT
This study is to test the Reveal® TP (Syphilis) antibody POCT (MedMira, Inc., Halifax, Nova Scotia) for its performance in an urban STI clinic in Vancouver, British Columbia and compare its performance in parallel with the usual…
- Conditions
- Syphilis Infection, Syphilis, Early Syphilis, Symptomatic
- Trial name
- NCT05831098
- Testing
- Reveal TP (Syphilis) Antibody Test
- Where
- Canada
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- MedMira Laboratories Inc.
Allergy, Hypersensitivity, Immediate
Head-to-Head Comparison Study Between Different FDA Registered Allergy Skin Test Applicators
This clinical study, titled "Head-to-Head Comparison Study between Different FDA Registered Allergy Skin Test Applicators," aims to compare the reliability and clinical performance of three skin prick test (SPT) devices…
- Conditions
- Allergy, Hypersensitivity, Immediate, Ig-E Mediated Food
- Trial name
- NCT07400718
- Testing
- AllerTest-10 Multi-Head Skin Test Device, Skintestor OMNI Multi-Head Skin Test Device, Multi-Test II Multi-Head Skin Test Device
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- QHSLab, Inc.
Lung Cancer, Breast Cancer
Non Invasive Detection of Lung and Breast Cancer by Odor Signature
The investigators have developed an early detection solution for lung and breast cancer. A system which can distinguish between different medical odors based on biosensors.
- Trial name
- NCT02195076
- Testing
- non-invasive detection of cancer odor
- Where
- Israel
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- BioSense Medical LTD
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
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.