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Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06368479
Study type Interventional
Source bioLytical Laboratories
Contact Ana Subramanian
Phone 16042046784
Email asubramanian@biolytical.com
Status Recruiting
Phase N/A
Start date March 20, 2024
Completion date July 1, 2024

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