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NCT06368479 Clinical Trial

Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings

Hepatitis B Clinical Trial

Official title:
A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06368479
Other study ID # CLS-016B
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 20, 2024
Est. completion date July 1, 2024

Study information
Verified date May 2024
Source bioLytical Laboratories
Contact Ana Subramanian
Phone 16042046784
Email asubramanian@biolytical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 4400
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 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.

Locations
Country Name City State
South Africa Epicentre Health Research Hillcrest Kwazulu Natal

Sponsors (1)
Lead Sponsor Collaborator
bioLytical Laboratories

Country where clinical trial is conducted

South Africa, 

Outcome
Type Measure Description Time frame Safety issue
Primary iStatis Performance 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
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