None listed
Conditions
Brief summary
This is a single visit, observational study to assess the equivalence of blood sample collection methods for use on the Orbis Diagnostic HBV Triplex Assay. Matched microsample and venous blood samples will be collected from a minimum of 40 adults who are either HBV positive, have a resolved HBV infection, HBV vaccinated, or HBV naïve. Samples collected by both the microsampling device and a venous blood draw will be tested on the Orbis Diagnostic HBV Triplex Assay at Orbis Diagnostics. A second venous blood sample will be assessed by a commercially available HBV gold standard test for each separate HBV serology marker; Roche Elecsys® HBV tests will be performed at Awanui Laboratories, an accredited diagnostic facility. This study will assess agreement between blood sample collection methods, refine diagnostic sensitivity and specificity estimates for test and clinical outcomes using thresholds established in prior research, and support verification of the HBV Triplex Assay for use in both clinical and community-based HBV screening.
Interventions
Prior to any study procedures, participants will be provided with a Participant Information
Sheet and Consent Form (PISCF). Written informed consent will be obtained before any samples are collected. Baseline study data will then be recorded
Participants will undergo blood collection during the single study visit. Blood samples will be collected by trained and certified phlebotomists or equivalent qualified personnel, using both a microsampling device (capillary collection) and a venous blood dr
Prior to any study procedures, participants will be provided with a Participant Information Sheet and Consent Form (PISCF). Written informed consent will be obtained before any samples are collected. Baseline study data will then be recorded Participants will undergo blood collection during the single study visit. Blood samples will be collected by trained and certified phlebotomists or equivalent qualified personnel, using both a microsampling device (capillary collection) and a venous blood draw. Sample collection visit will last between 20-30 minutes.
Sponsors
University of Auckland
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria: - Patients 18 years of age and older - Able to provide informed consent - Able and willing to undergo both microsampling and venous blood collection during the same visit - One of the following: o Confirmed chronic HBV positive status (HBsAg +, anti-HBc +, anti-HBs -), as defined by previous clinical diagnosis or medical record o Confirmed previous HBV infection, now resolved (HBsAg -, Anti-HBc +, anti-HBs +) defined by previous clinical diagnosis or medical record o Previous HBV vaccination (HBsAg -, anti-HBc -, anti-HBs +) self-reported, healthy participants o HBV naïve (HBsAg -, anti-HBc -, anti-HBs -) self-reported, healthy participants
Exclusion criteria
- Under 18 years of age - Vulnerable groups such as prisoners, individuals with known cognitive impairment, or institutionalised individuals - Are unable to provide informed consent - Are unable or unwilling to undergo both blood collection methods - Have a known bleeding disorder or condition that contraindicates blood sampling - Has received HBV vaccination within the past 8 weeks - Have unknown HBV infection or vaccination status
Outcome results
None listed