A Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites

NCT06368466 | Completed

• 1 other identifier: CLS-016A
• Study Type: interventional
• Target: 175
• 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 the study. Capillary (fingerstick) whole blood and EDTA venipuncture whole blood are collected by a healthcare professional. The collected samples of capillary and EDTA whole blood are tested on iStatis and EDTA whole blood sample will be processed to obtain serum and plasma samples to be tested on the iStatis. An aliquot of the collected serum sample will be shipped to the central laboratory for confirmatory testing. The results from iStatis HBsAg Test results will not be used for patient management decisions.

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 (2)

• Performance

  To evaluate the performance of the iStatis HBsAg POC test with the RT-PCR test at the point of care sites by a healthcare professional.

  3 Months

• Sensitivity and Specificity

  To assess the sensitivity and specificity of the iStatis HBsAg POC test with four different sample types.

  3 Months

Study Arms (2)

iStatis Performance

EXPERIMENTAL

capillary (fingerstick) blood, EDTA venous whole blood, serum and plasma samples will be tested on iStatis HBsAg Test

Device: iStatis HBsAg Test

Reference Test to evaluate iStatis Performance

NO INTERVENTION

Either serum or plasma samples will undergo reference lab testing using DiaSorin Liaison XL Murex HBsAg Quant Assay and DiaSorin Murex HBsAg Confirmatory assay

Interventions

iStatis HBsAg Test DEVICE

capillary (fingerstick) blood, EDTA venous whole blood, serum and plasma samples are tested on the iStatis HBsAg Test

iStatis Performance

Eligibility Criteria

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

You may qualify if:

• Patients/subjects (males, females, and pregnant women) getting tested for HBV for one or more of the following reasons:
• at risk for HBV
• having signs and symptoms indicative of HBV
• pregnant and have HBV.
• Re-infected with HBV (previously positive)
• Patients/subjects of 18 years or older and, who are able to give/sign the informed consent.

You may not qualify if:

• Patient younger than 18 years old
• Patients unable to provide written informed consent.
• Patients currently undergoing treatment

Sponsors & Collaborators

• bioLytical Laboratories: lead
• St Vincent's Hospital Melbourne: collaborator

Study Sites (1)

St. Vincent's Hospital, Melbourne

Melbourne, Fitzroy Victoria, 3065, Australia

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: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 16, 2024
• Study Start: April 30, 2024
• Primary Completion: July 5, 2024
• Study Completion: December 19, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)