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

NCT06368479 | Completed

• 1 other identifier: CLS-016B
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B; Hepatitis B Infection

Keywords

Hepatitis B rapid test; Hepatitis B infection; Hepatitis B iStatis test; Hepatitis B point of care test

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

iStatis Testing Onsite

EXPERIMENTAL

Capillary (fingerstick) blood samples are tested using iStatis HBsAg Test onsite.

Device: iStatis HBsAg Test

iStatis Testing In Lab

EXPERIMENTAL

Venous whole blood collected in Ethylenediaminetetraacetic acid tube, plasma and serum samples are tested using iStatis HBsAg Test

Device: iStatis HBsAg Test

Reference Test

NO INTERVENTION

Either serum or plasma sample will be tested on Abbott Architect HBsAg Qualitative Confirmatory Assay and ADVIA Centaur (depending on the test result outcome).

Interventions

iStatis HBsAg Test DEVICE

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; iStatis Testing Onsite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participant younger than 18 years old
• Participants unable to provide written informed consent

Sponsors & Collaborators

• bioLytical Laboratories: lead

Study Sites (1)

Epicentre Health Research

Hillcrest, KwaZulu-Natal, 3650, South Africa

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 16, 2024
• Study Start: March 19, 2024
• Primary Completion: July 19, 2024
• Study Completion: July 19, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)