A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hepatitis B
- Sponsor
- bioLytical Laboratories
- Enrollment
- 1400
- Locations
- 1
- Primary Endpoint
- iStatis Performance
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of testing the samples on iStatis HBsAg Test at the point of care.
Detailed Description
Participants are prospctively recruited and enrolled to participate in the study. The Capillary (fingerstick) whole blood, and venous whole blood samples (in serum separating tube (SST) and Ethylenediaminetetraacetic acid (EDTA) tube) are collected by a healthcare professional. Serum and plasma samples will be extracted through laboratory processing of the collected serum separating tube and Ethylenediaminetetraacetic acid VWB, respectively. The collected samples of capillary will be tested on iStatis HBsAg Test. The collected Ethylenediaminetetraacetic acid and serum separating tube VWB will be shipped to the central laboratory to appropriately process and extract serum and plasma samples. Ethylenediaminetetraacetic acid 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants/subjects (males, females, and pregnant women) getting tested for Hepatitis B virus for one or more of the following reasons:
- •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
- •Participant younger than 18 years old
- •Participants unable to provide written informed consent
Outcomes
Primary Outcomes
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.