hbsag rapid test strip
 

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 test kit is intended to be used as an aid in the diagnosis of HBV infection.

Procedure

1.Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with 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 pad of the strip with a disposable pipette provided in the kit, then add 1 drop of buffer and start the timer.

OR

Transfer 2 drop of whole blood to the specimen pad of the strip 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 pad of the strip, 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 the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.

• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Do not freeze.
• Cares should be taken to protect components in this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results.

Certificates