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

Not Applicable

Completed

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

• Registration Number: NCT06368466
• 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 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.

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 Timeline

• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-16
• Study Start: 2024-04-30
• Primary Completion: 2024-07-05
• Study Completion: 2024-12-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Performance	3 Months	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.
Sensitivity and Specificity	3 Months	To assess the sensitivity and specificity of the iStatis HBsAg POC test with four different sample types.

Trial Locations

Locations (1)

St. Vincent's Hospital, Melbourne; 🇦🇺 Melbourne, Fitzroy Victoria, Australia