Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings

bioLytical Laboratories

Status: Completed

Conditions: Hepatitis B Infection; Hepatitis B

Treatments: Device: iStatis HBsAg Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT06368479

CLS-016B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Participant younger than 18 years old
• Participants unable to provide written informed consent

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,400 participants in 3 patient groups

iStatis Testing Onsite

Experimental group

Description:

Capillary (fingerstick) blood samples are tested using iStatis HBsAg Test onsite.

Treatment:

Device: iStatis HBsAg Test

iStatis Testing In Lab

Experimental group

Description:

Venous whole blood collected in Ethylenediaminetetraacetic acid tube, plasma and serum samples are tested using iStatis HBsAg Test

Treatment:

Device: iStatis HBsAg Test

Reference Test

No Intervention group

Description:

Either serum or plasma sample will be tested on Abbott Architect HBsAg Qualitative Confirmatory Assay and ADVIA Centaur (depending on the test result outcome).