HBsAg Rapid Test Device (Whole Blood/Serum/Plasma)
Principle
The HBsAg Rapid Test Device (Whole Blood/Serum/Plasma) has been designed to detect the HBsAg through visual interpretation of color development in the strip. The membrane was immobilized with anti‐ HBsAg antibodies on the test region. During the test, the specimen is allowed to react with colored anti‐HBsAg antibodies colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough HBsAg in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.
Procedure
HBsAg Rapid Test Strip（Whole Blood/Serum/Plasma）
Bring tests, specimens and/or controls to room temperature (15‐30°C) before use.
1. Remove the test strip from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. For Serum or Plasma specimens: Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50μL) onto the Specimen Pad of the test strip, then start the timer. For Venipuncture Whole Blood specimens: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50μL) onto the Specimen Pad of the test strip, then add 2 drops of buffer (approximately 80μL) and start the timer.
For Fingerstick Whole Blood specimens:
Fill the capillary tube and transfer approximately 50μL (or 2 drops) of fingerstick whole blood specimen onto the Specimen Pad of the test strip, then add 2 drops of buffer (approximately 80 μL) and start the timer.
3. Wait for the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes. HBsAg Rapid Test Device（Whole Blood/Serum/Plasma）
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 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 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
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
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 the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.
Interpretation Of Results
