Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings
NCT ID: NCT06368479
Last Updated: 2025-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1400 participants
INTERVENTIONAL
2024-03-19
2024-07-19
Brief Summary
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Detailed Description
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The results from iStatis HBsAg Test results will not be used for participant management decisions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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iStatis Testing Onsite
Capillary (fingerstick) blood samples are tested using iStatis HBsAg Test onsite.
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.
iStatis Testing In Lab
Venous whole blood collected in Ethylenediaminetetraacetic acid tube, plasma and serum samples are tested using iStatis HBsAg Test
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.
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).
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* at risk for Hepatitis B virus
* having signs and symptoms indicative for Hepatitis B virus
* 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
* Participants unable to provide written informed consent
18 Years
ALL
No
Sponsors
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bioLytical Laboratories
INDUSTRY
Responsible Party
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Locations
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Epicentre Health Research
Hillcrest, KwaZulu-Natal, South Africa
Countries
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Other Identifiers
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CLS-016B
Identifier Type: -
Identifier Source: org_study_id
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