The HBsAg Rapid Test Device 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.
Bring tests, specimens and/or controls to room temperature (15-30°C) before use.
- 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.
- For Serum/Plasma: Transfer 2 drops of serum/plasma to the specimen well of the device with the disposable pipette provided and start the timer.
- For Whole Blood: Transfer 2 drops of whole blood to the specimen well, then add 1 drop of buffer and start the timer.
- For Fingerstick Whole Blood: Allow 2 hanging drops to fall into the center of the specimen well (S), 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 the observation window.
- Wait for colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.
Frequently Asked Questions (FAQ)
What is the intended use of this rapid test kit?
The kit is designed for the qualitative presumptive detection of HBsAg in human whole blood, serum, or plasma to aid in the diagnosis of HBV infection.
How long does it take to get the test results?
The results should be read at 15 minutes. Results interpreted after 20 minutes may not be accurate.
What is the accuracy and specificity of the HBsAg Rapid Test?
The test features a 100% accuracy rate and a relative specificity of 99.9%.
What are the storage and usage temperature requirements?
The test and specimens should be brought to room temperature (15-30°C) before performing the assay.
What is the shelf life of the product?
The product has a shelf life of 2 years when stored correctly in its sealed pouch.
Can fingerstick whole blood be used for this test?
Yes, the device is compatible with fingerstick whole blood specimens, as well as serum and plasma.
Evolve Medical
