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Specifications
- Reading time: 15 minutes
- Sensitivity: >99.9%
- Specificity: >99.9%
-Certification: CE2265/ ISO9001/ ISO13485
Intended Use of HBsAg Rapid Test Device
The HBsAg Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of HBsAg in human whole blood, serum, or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HBV infection.
Principle of HBsAg Rapid Test Device
The HBsAg Rapid Test Device (Whole Blood/Serum/Plasma) detects HBsAg through visual interpretation of color development on the internal strip. Anti-HBsAg antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with anti-HBsAg antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient HBsAg in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
