The Abbott Determine HBsAg 2 Rapid card is an in vitro, visually read, qualitative immunochromatographic assay. It is designed for the detection of Hepatitis B Surface Antigen (HBsAg) in human serum, plasma, or whole blood. This test serves as an aid in the diagnosis of Hepatitis B infection in infected individuals.
Utilizing a lateral flow immunoassay format, the test provides results within 15 to 30 minutes. It is intended for professional use only and is suitable for various healthcare settings.
The Abbott Determine HBsAg 2 Rapid card has obtained CE Mark and is included in the WHO list of prequalified in vitro diagnostics for specific product codes, including the 100-test pack.
Key Features :
Qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum, plasma, or whole blood.
Provides rapid results within 15 to 30 minutes, supporting timely clinical decision-making.
Features an analytical sensitivity of 0.1 IU/mL and a specificity of 99.6%.
Capable of detecting major HBsAg vaccine escape mutants.
Utilizes an immunochromatographic lateral flow assay for visual interpretation.
Holds CE Mark and WHO prequalification for relevant product codes.
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