A Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites
NCT ID: NCT06368466
Last Updated: 2025-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
175 participants
INTERVENTIONAL
2024-04-30
2024-12-19
Brief Summary
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Detailed Description
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\- 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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SCREENING
DOUBLE
Study Groups
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iStatis Performance
capillary (fingerstick) blood, EDTA venous whole blood, serum and plasma samples will be tested on iStatis HBsAg Test
iStatis HBsAg Test
capillary (fingerstick) blood, EDTA venous whole blood, serum and plasma samples are tested on the iStatis HBsAg Test
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
No interventions assigned to this group
Interventions
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iStatis HBsAg Test
capillary (fingerstick) blood, EDTA venous whole blood, serum and plasma samples are tested on the iStatis HBsAg Test
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients unable to provide written informed consent.
* Patients currently undergoing treatment
18 Years
ALL
No
Sponsors
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St Vincent's Hospital Melbourne
OTHER
bioLytical Laboratories
INDUSTRY
Responsible Party
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Locations
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St. Vincent's Hospital, Melbourne
Melbourne, Fitzroy Victoria, Australia
Countries
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Other Identifiers
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CLS-016A
Identifier Type: -
Identifier Source: org_study_id
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