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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Fitzroy Victoria
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Melbourne, Fitzroy Victoria, Australia, 3065
- St. Vincent's Hospital, Melbourne
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
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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
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.
|
3 Months
|
|
Sensitivity and Specificity
Time Frame: 3 Months
|
To assess the sensitivity and specificity of the iStatis HBsAg POC test with four different sample types.
|
3 Months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLS-016A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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