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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06368466




Registration number
NCT06368466
Ethics application status
Date submitted
10/04/2024
Date registered
16/04/2024

Titles & IDs
Public title
A Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites
Scientific title
A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites
Secondary ID [1] 0 0
CLS-016A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 0 0
Hepatitis B Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - iStatis HBsAg Test

Experimental: iStatis Performance - capillary (fingerstick) blood, EDTA venous whole blood, serum and plasma samples will be tested on 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


Treatment: Devices: iStatis HBsAg Test
capillary (fingerstick) blood, EDTA venous whole blood, serum and plasma samples are tested on the iStatis HBsAg Test
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Performance
Timepoint [1] 0 0
3 Months
Primary outcome [2] 0 0
Sensitivity and Specificity
Timepoint [2] 0 0
3 Months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient younger than 18 years old
* Patients unable to provide written informed consent.
* Patients currently undergoing treatment

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
Accrual to date
Final
175
Recruitment in Australia
Recruitment state(s)
Fitzroy VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital, Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
bioLytical Laboratories
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St Vincent's Hospital Melbourne
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06368466