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The Wondfo® Combination Test for Hepatitis B Markers (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb) is a rapid immunochromatographic assay designed for the qualitative determination of hepatitis B virus (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb) in whole blood/serum/plasma.
For in vitro diagnosis only.
SHORT DESCRIPTION
Hepatitis B virus (HBV) is one of the most common infectious diseases that can be transmitted by blood transfusion and has now been transmitted to a large number of patients.
HBV is a member of the hepadnaviridae family, which refers to DNA-containing viruses. Its nucleus contains circular double-stranded DNA and polymerases. Its envelope contains a lipoprotein. There are five signal proteins in serum that are considered the main serological hallmarks of HBV infection. These include hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B envelope antigen (HBeAg), hepatitis B envelope antibody (HBeAb) and hepatitis B nuclear antibody (HBcAb).
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PRECAUTIONS
1 This kit is for in vitro use only. Do not swallow.
2. All samples should be considered as a potential source of infectious disease.
3. the test must not be used more than once.
4. Do not use the test kit after the expiration date.
5. Do not use the test kit if the packaging is damaged or not well sealed.
6. Keep out of the reach of children.
STORAGE AND STABILITY
Store at 2ºC - 30ºC in a closed container until expiration date.
Store in a place protected from light, moisture and high temperature.
Do not freeze.
COLLECTION AND PREPARATION OF SAMPLES
1. Collect whole blood. Use whole blood directly or separate serum or plasma as soon as possible to avoid hemolysis. Only clear, unhemolized samples can be used.
2 The test should be performed immediately after the samples have been collected. Do not leave samples at room temperature for an extended period of time. Samples can be stored at 2°C to 8°C for up to 3 days. For long term storage the samples should be stored at temperatures below -20°C.
Whole blood samples that have been stored at 2 ° C to 8 ° C for more than 7 days should not be used for the test.
3. Bring samples to room temperature before performing the test. Frozen samples should be completely thawed and well mixed before testing. Samples should not be refrozen and thawed repeatedly.
TEST PROCEDURE
1. Pull the test cassette with the sachet from the foil by tearing at the tear line and place it on a horizontal surface.
2. For the whole blood test:
a) Holding the pipette vertically, add two drops of whole blood (approximately 50 µl) to each sample well (marked with an arrow). b) Add two drops (approximately 50 µl) of buffer solution (included in the kit) from the vial directly to each sample well.
For serum/plasma analysis: Holding the pipette vertically, add four drops (80-100 µl) of serum or plasma into the sample well.
3. Wait 15 minutes and evaluate the results. Do not interpret the test results after 30 minutes.
RESULT INTERPRETATION
Positive (+)
(1) For HBsAg, HBsAb, HBeAg
A pale pink band is visualized in the control region and in the corresponding test region.
(2) For HBeAb and HBcAb
A pale pink band is visualized only in the control area. The colored band does not appear in the corresponding test region.
Negative (-)
(1) For HBsAg, HBsAb, HBeAg
A pale pink band is only visualized in the control region. A colored band does not appear in the corresponding test region.
(2) For HBeAb and HBcAb
A pale pink band is visualized in the control area and in the corresponding test area.
Invalid
No bands at all, or a band appears only in the test region and not in the control region. Repeat the test using a new test kit. If the test fails again, please contact the distributor or store where you purchased the product and report the lot number.