INTRODUCTION
One step HBsAg test strip is a rapid direct binding test for the visual detection of hepatitis B antigen (HBsAg) as an aid in the diagnosis of hepatitis B infection. This one step test is very sensitive and only takes about 15-20 minutes. Test results are read visually without any instrument.
SPECIMEN COLLECTION
For serum, collect blood into a container without anticoagulant. If the specimen cannot be tested on the day of collection, store the serum specimen in a refrigerator or freezer
Bring the specimens to room temperature before testing.
TEST PROCEDURE
1. To begin testing; open the sealed pouch by tearing along the notch. Remove the test from the pouch.
2. Immerse the strip into the sample with the arrow end pointing towards the sample. Do not immerse past the MAX (maximum) line. Take the strip out after 8-10 seconds--and lay the-strip flat on a clean, dry, nonabsorbent surface
3. Draw 0.1ml (about 3 drops) sample into the pipette, and dispense it into the sample well on the cassette.
4. Wait 15-20minutes and read result. Do not read results after 30 minutes.
LIMITATIONS OF THE ASSAY1. based on a single reactive test result, a sample should not be considered HBsAg positive. Further testing, including confirmatory testing, should be performed before a specimen is considered positive for HBsAg. A non-reactive test result does not exclude the possibility of exposure to hepatitis B virus. Levels of HBsAg may be undetected both in early infection and late after infection. Specimens containing precipitate may give inconsistent test results.2. As the other sensitive immunoassays, there is the possibility that non-repeatable reaction may occur due to inadequate washing. So do aspirate the well or get rid of entire content of wells completely before adding the washing solution.3. The positive control in the test kit is not to be used to quantify assay sensitivity. The positive control is used to verify that the test kit components are capable of detecting a reactive specimen provided the procedure is followed as defined in the kit and the storage conditions have been strictly adhered to.