A Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites

From each enrolled patient, a total of 2 different blood samples (capillary and venous whole blood) will be collected, processed, and categorized under the following categories:

• Sample 1: 50μL of Capillary (fingerstick) (see section 8.6.2) Sample 2: 16ml of Venous whole blood (further extraction of serum, and plasma samples) (see section 8.6.2) Sample 1 consisting of capillary (fingerstick) and Sample 2 venous whole blood sample will be tested on iStatis HBsAg Test on site according to the 'Test Procedure' described in the Instructions for Use (IFU) supplied with the reagents. Sample 2 containing of 1 EDTA and SST venous whole blood samples will be separately processed to obtain plasma and serum samples, respectively, and will be tested onsite on the iStatis. An aliquot of the serum sample stored and frozen at -20ᵒC at the testing site will be transferred to the central laboratory to establish further reference testing. Upon arrival of the sample, it will undergo an initial test using DiaSorin Liaison XL Murex HBsAg Quant Assay, REF. [310250] following the IFU of this reference assay. If the first run of the assay yields a "non-reactive/Negative" result, it will be reported as such. However, if the sample is "Reactive/Positive" in the first run of the assay testing, it will be retested on the same assay in duplicate, following the manufacturer's instructions. A final "Reactive/Positive" result means that at least one of the duplicate repeat tests was reactive, if neither of the duplicate repeat tests yields a reactive results, the final report in the DiaSorin Liaison XL Murex HBsAg Quant Assay requires three tests to confirm. Samples with a reportable "Reactive/Positive" result in the DiaSorin Liaison XL Murex HBsAg Quant Assay will undergo further testing using DiaSorin Murex HBsAg Confirmatory assay, REF. [9F80-01]. A "Reactive/Positive" result in this test will confirm the presence of the relevant marker.

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.

Exclusion criteria

• Patient younger than 18 years old
• Patients unable to provide written informed consent.
• Patients currently undergoing treatment