- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06368479
A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants are prospctively recruited and enrolled to participate in the study. The collected Capillary (fingerstick) whole blood, SST and EDTA venous whole blood (VWB) samples are collected by a healthcare professional. Serum and plasma samples will be extracted through laboratory processing of the collected SST and EDTA VWB, respectively. The collected samples of capillary will be tested on iStatis HBsAg Test. The collected EDTA and SST VWB will be shipped to the central laboratory to appropriately process and extract serum and plasma samples. EDTA VWB, plasma and serum will be tested on iStatis HBsAg Test in the laboratory. An aliquot of the obtained plasma sample will be further tested for reference and confirmatory testing.
The results from iStatis HBsAg Test results will not be used for participant management decisions.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ana Subramanian
- Phone Number: 16042046784
- Email: asubramanian@biolytical.com
Study Locations
-
-
Kwazulu Natal
-
Hillcrest, Kwazulu Natal, South Africa, 3650
- Recruiting
- Epicentre Health Research
-
Contact:
- Cherie Cawood
- Phone Number: +27828202955
- Email: cheriec@epicentre.org.za
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants/subjects (males, females, and pregnant women) getting tested for HBV for one or more of the following reasons:
- at risk for HBV
- having signs and symptoms indicative for HBV
- Routine testing Unknown or other reasons will be captured
- Participants/subjects of 18 years or older and, who are able to give/sign the informed consent.
Exclusion Criteria:
- Participant younger than 18 years old
- Participants unable to provide written informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: iStatis Testing Onsite
Capillary (fingerstick) blood samples are tested using iStatis HBsAg Test onsite.
|
Capillary (fingerstick) blood, EDTA venous whole blood, serum and plasma samples to be tested on the iStatis HBsAg Test at the point of care setting.
|
Experimental: iStatis Testing In Lab
EDTA venous whole blood, plasma and serum samples are tested using iStatis HBsAg Test
|
Capillary (fingerstick) blood, EDTA venous whole blood, serum and plasma samples to be tested on the iStatis HBsAg Test at the point of care setting.
|
No Intervention: Reference Test
Either serum or plasma sample will be tested on Abbott Architect HBsAg Qualitative Confirmatory Assay and ADVIA Centaur (depending on the test result outcome).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
iStatis Performance
Time Frame: 3 Months
|
To evaluate the device performance i.e. diagnostic sensitivity and diagnostic specificity of the iStatis Hepatitis B surface Antigen (HBsAg) Test compared to comparator assay.
|
3 Months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLS-016B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatitis B
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Gilead SciencesNot yet recruiting
-
Ain Shams UniversityCompleted
-
National Taiwan University HospitalChiayi Christian Hospital; E-DA Hospital; Taipei City Hospital; Taipei Tzu Chi... and other collaboratorsRecruitingChronic Hepatitis b | Hepatitis B ReactivationTaiwan
-
Mahidol UniversityUnknownChronic Hepatitis B, HBsAg, Hepatitis B VaccineThailand
-
Nanfang Hospital of Southern Medical UniversityRecruiting
-
IlDong Pharmaceutical Co LtdRecruitingChronic Hepatitis bKorea, Republic of
-
Antios Therapeutics, IncTerminatedChronic Hepatitis bUnited States
-
Xi'an Xintong Pharmaceutical Research Co.,Ltd.Unknown
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRecruitingChronic Hepatitis b | Cirrhosis Due to Hepatitis BChina
-
Tongji HospitalGilead SciencesRecruiting
Clinical Trials on iStatis HBsAg Test
-
bioLytical LaboratoriesSt Vincent's Hospital MelbourneNot yet recruitingHepatitis B | Hepatitis B InfectionAustralia
-
Medical Mission Institute, GermanyCatholic University of Health and Allied SciencesCompletedHepatitis BTanzania
-
bioLytical LaboratoriesCompletedCOVID-19 | SARS-CoV-2 Infection | COVID-19 Pandemic | COVID-19 Virus Infection | Coronavirus Disease-19United States
-
bioLytical LaboratoriesRecruitingSyphilis | Syphilis InfectionSouth Africa
-
bioLytical LaboratoriesActive, not recruiting
-
GlaxoSmithKlineRegion of Wallonia; Public Private Partnership with Institute for Medical Immunology...Completed
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRuijin Hospital; Second People's Hospital of Yunnan ProvinceCompletedChronic Hepatitis BChina
-
Dynavax Technologies CorporationTerminated
-
MedMira Laboratories Inc.WithdrawnHIV Infections | Hepatitis B Infections | Hepatitis C InfectionsUnited States
-
Chulalongkorn UniversityUnknownHBsAg(+) Donor Kidney Allograft | HBsAg(-) Donor Kidney AllograftThailand