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.
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.
Transfer 2 drops of serum/plasma to the specimen well of the device with a disposable pipette provided in the kit and then start the timer.
OR
Transfer 2 drop of whole blood to the specimen well of the device with a disposable pipette provided in the kit, then add 1 drop of buffer and start the timer.
OR
Allow 2 hanging drop of fingerstick whole blood specimen to fall into the center of the specimen well (S) on the device, then add 1 drop of buffer and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.
As the test begins to work, you will see color move across the membrane.
2. Wait for colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.