ISO13485 HBsAg Blood Test Strips Whole Blood Rapid Test Card

HBsAg Rapid Test (whole blood)
Catalog No.: BG101C BG101S

INTENDED USE
For The Qualitative Assessment of HBsAg in Human Serum, Plasma or Whole Blood. This test is for In Vitro Diagnostic Use and/or professional use only. For export only.

TEST PROCEDURE
For Serum/Plasma Specimen:
1.Allow the strip or cassette and sample to reach room temperature if necessary.
2.Take the strip or cassette out of the pouch. Immerse the strip vertically into the specimen for about 15seconds. Do not past the MAX Line on the strip. Or Draw 0.1ml (about 3 drops) sample into the pipette, and dispense it into the sample well on the cassette
3.Take out the strip or cassette and place it on a clean and flat surface. Start the timer.
For Whole Blood Specimen:
1.Allow the strip or cassette and sample to reach room temperature if necessary.
2.Take the strip or cassette out of the pouch. Transfer 1 drop of whole blood on the specimen pad of the strip or cassette; and then add 1 or 2 drops of buffer. Start the timer.
3.Wait for the red line(s) to appear. The result should be read at the 15th minute. Do not read results after 20minutes.
Positive sample may show positive results within a few minutes after the sample is added. However, to confirm a negative result, please wait until 30 minutes.
Results after 30 minutes may not be accurate.

INTERPRETATION OF RESULT
Positive Results: Two red lines appear, indicating that HBsAg has been detected using HBsAg Rapid Test.
Negative Results: Only one red line appears in the Control Zone (C), indicating that no HBsAg have been detected with this HBsAg Rapid Test. However, this does not exclude the possibility for infection with HBV.
Quality Control: One red line always appears next to Control Zone (C) if no red line appears in the Control Zone (C), the test is invalid - discard the test and repeat with new sample and new strip