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INTENDED USE
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.
Operation Procedure
Bring tests, specimens and/or controls to room temperature (15-30°C) before use.
1
Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test patient or control identification. To obtain a best result, the assay should be performed within one hour.
2
For Serum/Plasma: Transfer 2 drops to the specimen well (S) with the disposable pipette and start the timer.
For Whole Blood: Transfer 2 drops of whole blood to the specimen well (S), then add 1 drop of buffer and start the timer.
For Fingerstick: Allow 2 hanging drops of fingerstick whole blood to fall into the center of the specimen well (S), then add 1 drop of buffer and start the timer.
3
Wait for colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.