Hepatitis BNCT06368466
A Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites
A study testing iStatis HBsAg Test in people with Hepatitis B and Hepatitis B Infection, run by bioLytical Laboratories at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Hepatitis B Infection
- What is being tested?
- iStatis HBsAg Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Apr 2024to 19 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient younger than 18 years old
- Patients unable to provide written informed consent.
- Patients currently undergoing treatment
Trial locations and contacts
1 site in 1 country.
Australia1 site
St. Vincent's Hospital, Melbourne
Melbourne, Fitzroy Victoria, 3065
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatitis B, Hepatitis B Infection
- Being tested
- iStatis HBsAg Test
- Keywords
- Hepatitis B rapid test, Hepatitis B infection, Hepatitis B iStatis test, Hepatitis B point of care test
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iStatis HBsAg TestDevice
capillary (fingerstick) blood, EDTA venous whole blood, serum and plasma samples are tested on the iStatis HBsAg Test
| Study group | Role | What they receive |
|---|---|---|
| iStatis Performance | Experimental | capillary (fingerstick) blood, EDTA venous whole blood, serum and plasma samples will be tested on iStatis HBsAg Test Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months
Sensitivity and Specificity
To assess the sensitivity and specificity of the iStatis HBsAg POC test with four different sample types.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start30 Apr 2024
- Primary completion5 Jul 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- bioLytical Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St Vincent's Hospital Melbourne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368466
- Sponsor's protocol ID
- CLS-016A
- Status last verified
- Feb 2025
- First submitted
- 10 Apr 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites
- ClinicalTrials.gov ID
- NCT06368466
- Acronym / sponsor ID
- CLS-016A
- Conditions
- Hepatitis B, Hepatitis B Infection
- Keywords
- Hepatitis B rapid test, Hepatitis B infection, Hepatitis B iStatis test, Hepatitis B point of care test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- bioLytical LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- St Vincent's Hospital Melbourne
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iStatis Performance | Experimental | Device: iStatis HBsAg Testcapillary (fingerstick) blood, EDTA venous whole blood, serum and plasma samples will be tested on 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients/subjects (males, females, and pregnant women) getting tested for HBV for one or more of the following reasons:
- Patients/subjects of 18 years or older and, who are able to give/sign the informed consent.
Key exclusion criteria (3 listed)
- Patient younger than 18 years old
- Patients unable to provide written informed consent.
- Patients currently undergoing treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iStatis HBsAg Testcapillary (fingerstick) blood, EDTA venous whole blood, serum and plasma samples are tested on the iStatis HBsAg Test | Device | iStatis Performance |
Primary outcome
Performance
Time frame: 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
Time frame: 3 Months
To assess the sensitivity and specificity of the iStatis HBsAg POC test with four different sample types.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iStatis HBsAg Test in people with Hepatitis B and Hepatitis B Infection, run by bioLytical Laboratories at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (time frame: 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.