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

Not Applicable

Completed

• Conditions: Hepatitis B; Hepatitis B Infection
• Interventions: Device: iStatis HBsAg Test

• Registration Number: NCT06368479
• Lead Sponsor: bioLytical Laboratories

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.

Study Timeline

• Study Start: 2024-03-19
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-16
• Primary Completion: 2024-07-19
• Study Completion: 2024-07-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1400

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iStatis Testing Onsite	iStatis HBsAg Test	Capillary (fingerstick) blood samples are tested using iStatis HBsAg Test onsite.
iStatis Testing In Lab	iStatis HBsAg Test	Venous whole blood collected in Ethylenediaminetetraacetic acid tube, plasma and serum samples are tested using iStatis HBsAg Test

Primary Outcome Measures

Name	Time	Method
iStatis Performance	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.

Trial Locations

Locations (1)

Epicentre Health Research; 🇿🇦 Hillcrest, Kwazulu Natal, South Africa