HbsAg Rapid Test Device - HBsAg-P23
The HBsAg Rapid Test Device (Serum/Plasma) is an in vitro diagnostic rapid immunochormatographic assay for the qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma specimens. The Hepatitis B (HBsAg) Test may be used as an aid in the diagnosis of hepatitis B viral infection. A reactive result should be confirmed by other supplemental assay(s).
Description
INTENDED USE
The HBsAg Rapid Test Device (Serum/Plasma) is an in vitro diagnostic rapid immunochormatographic assay for the qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma specimens. The Hepatitis B (HBsAg) Test may be used as an aid in the diagnosis of hepatitis B viral infection. A reactive result should be confirmed by other supplemental assay(s).
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MATERIALS |
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Materials Provided Test devices Droppers Package insert
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Materials Required But Not Provided • Specimen collection equipment and container • Centrifuge • Timer
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TEST PROCEDURE
Bring the hepatitis B antigen (HBsAg) test device and specimen to room temperature (15-30°C) prior to testing.
1. Remove the test device from its sealed pouch and use it as soon as possible. For best results, the assay should be performed within one hour.
2. Place the test device on a clean, level surface. Label with specimen ID.
Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 µL) to the sample well (S) of the test device, and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
3. Wait for the colored band(s) to appear. Read results for 15 minutes.
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