Hepatitis B Clinical Trial
Official title:
A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings
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.
Participants are prospctively recruited and enrolled to participate in the study. The collected Capillary (fingerstick) whole blood, SST and EDTA venous whole blood (VWB) samples are collected by a healthcare professional. Serum and plasma samples will be extracted through laboratory processing of the collected SST and EDTA VWB, respectively. The collected samples of capillary will be tested on iStatis HBsAg Test. The collected EDTA and SST VWB will be shipped to the central laboratory to appropriately process and extract serum and plasma samples. EDTA 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. ;
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