Hepatitis BNCT06368479
Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings
A study testing iStatis HBsAg Test in people with Hepatitis B and Hepatitis B Infection, run by bioLytical Laboratories at 1 site in South Africa.
Trial 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. 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
- 1,400 participants
- Where
- 1 siteSouth Africa
- Study dates
- 19 Mar 2024to 19 Jul 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
- 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.
Who cannot join
- Participant younger than 18 years old
- Participants unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Epicentre Health Research
Hillcrest, KwaZulu-Natal, 3650
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 Site Settings
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.
Read the 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.
- 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 to be tested on the iStatis HBsAg Test at the point of care setting.
| Study group | Role | What they receive |
|---|---|---|
| iStatis Testing Onsite | Experimental | Capillary (fingerstick) blood samples are tested using iStatis HBsAg Test onsite. Receives: Device: iStatis HBsAg Test |
| iStatis Testing In Lab | Experimental | Venous whole blood collected in Ethylenediaminetetraacetic acid tube, plasma and serum samples are tested using iStatis HBsAg Test Receives: Device: iStatis HBsAg Test |
| Reference Test | No intervention | Either serum or plasma sample will be tested on Abbott Architect HBsAg Qualitative Confirmatory Assay and ADVIA Centaur (depending on the test result outcome). |
What is being measured
The primary outcome is the main question the study is designed to answer.
iStatis Performance
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.
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 start19 Mar 2024
- Primary completion19 Jul 2024
- Study completion19 Jul 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- bioLytical Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368479
- Sponsor's protocol ID
- CLS-016B
- 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 Site Settings
- ClinicalTrials.gov ID
- NCT06368479
- Acronym / sponsor ID
- CLS-016B
- 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
- 1,400 participants (actual)
- Lead sponsor
- bioLytical LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 19 Jul 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 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iStatis Testing Onsite | Experimental | Device: iStatis HBsAg TestCapillary (fingerstick) blood samples are tested using iStatis HBsAg Test onsite. |
| iStatis Testing In Lab | Experimental | Device: iStatis HBsAg TestVenous whole blood collected in Ethylenediaminetetraacetic acid tube, plasma and serum samples are tested using iStatis HBsAg Test |
| Reference Test | No intervention | –Either serum or plasma sample will be tested on Abbott Architect HBsAg Qualitative Confirmatory Assay and ADVIA Centaur (depending on the test result outcome). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants/subjects (males, females, and pregnant women) getting tested for Hepatitis B virus for one or more of the following reasons:
- Participants/subjects of 18 years or older and, who are able to give/sign the informed consent.
Key exclusion criteria (2 listed)
- Participant younger than 18 years old
- Participants unable to provide written informed consent
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 to be tested on the iStatis HBsAg Test at the point of care setting. | Device | iStatis Testing In Lab, iStatis Testing Onsite |
Primary outcome
iStatis Performance
Time frame: 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.
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
Related trials for Hepatitis B
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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 South Africa.
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 5 inclusion and 2 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 South Africa. 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?
iStatis Performance (time frame: 3 Months). 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.