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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B; Hepatitis B Infection
• Intervention / Treatment: Device: iStatis HBsAg Test

Detailed Description

From each enrolled patient, a total of 2 different blood samples (capillary and venous whole blood) will be collected, processed, and categorized under the following categories:

- Sample 1: 50μL of Capillary (fingerstick) (see section 8.6.2) Sample 2: 16ml of Venous whole blood (further extraction of serum, and plasma samples) (see section 8.6.2) Sample 1 consisting of capillary (fingerstick) and Sample 2 venous whole blood sample will be tested on iStatis HBsAg Test on site according to the 'Test Procedure' described in the Instructions for Use (IFU) supplied with the reagents. Sample 2 containing of 1 EDTA and SST venous whole blood samples will be separately processed to obtain plasma and serum samples, respectively, and will be tested onsite on the iStatis. An aliquot of the serum sample stored and frozen at -20ᵒC at the testing site will be transferred to the central laboratory to establish further reference testing. Upon arrival of the sample, it will undergo an initial test using DiaSorin Liaison XL Murex HBsAg Quant Assay, REF. [310250] following the IFU of this reference assay. If the first run of the assay yields a "non-reactive/Negative" result, it will be reported as such. However, if the sample is "Reactive/Positive" in the first run of the assay testing, it will be retested on the same assay in duplicate, following the manufacturer's instructions. A final "Reactive/Positive" result means that at least one of the duplicate repeat tests was reactive, if neither of the duplicate repeat tests yields a reactive results, the final report in the DiaSorin Liaison XL Murex HBsAg Quant Assay requires three tests to confirm. Samples with a reportable "Reactive/Positive" result in the DiaSorin Liaison XL Murex HBsAg Quant Assay will undergo further testing using DiaSorin Murex HBsAg Confirmatory assay, REF. [9F80-01]. A "Reactive/Positive" result in this test will confirm the presence of the relevant marker.

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Fitzroy Victoria
    • Melbourne, Fitzroy Victoria, Australia, 3065
      • St. Vincent's Hospital, Melbourne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iStatis Performance; capillary (fingerstick) blood, EDTA venous whole blood, serum and plasma samples will be tested on iStatis HBsAg Test	Device: iStatis HBsAg Test; capillary (fingerstick) blood, EDTA venous whole blood, serum and plasma samples are tested on the iStatis HBsAg Test
No Intervention: Reference Test to evaluate iStatis Performance; Either serum or plasma samples will undergo reference lab testing using DiaSorin Liaison XL Murex HBsAg Quant Assay and DiaSorin Murex HBsAg Confirmatory assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: bioLytical Laboratories
• Collaborators: St Vincent's Hospital Melbourne

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Actual): July 5, 2024
• Study Completion (Actual): December 19, 2024

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Hepatitis B infection; Hepatitis B rapid test; Hepatitis B iStatis test; Hepatitis B point of care test
• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis A; Hepatitis; Hepatitis B
• Other Study ID Numbers: CLS-016A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No