Serum Plasma HBsAg Test Card 15mins Rapid Blood Test Card for Hepatitis B Surface Antigen

HBsAg Hepatitis B Surface Antigen Test Card Rapid Test Kit

INTENDED USE

The HBsAg Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of HBsAg in human whole blood, serum, or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HBV infection.

INTRODUCTION

Hepatitis B virus (HBV) is the prototypic member of the hepadnaviruses. Hepatitis B surface antigen (HBsAg) is located in the lipid envelope of this small DNA virus. During the replicative phase of the virus, this surface antigen is produced in excess and is detectable in the blood of the infected. The incubation period of HBV is 6 weeks to 6 months.

MAIN CONTENTS

• One pouch containing a reaction test Cassette with desiccant.

• Buffer

• Disposable pipettes.

• Instructions for use.

STORAGE AND STABILITY

• Store at 39~ 86 º F (4 ~ 30 º C) in the sealed pouch for 18 months.

PRECAUTIONS

• For in vitro diagnostic use only.

• Do not use after expiration date.

• The test Cassette should remain in the sealed pouch until use.

• The used test Cassette should be discarded according to local regulations.

DIRECTION OF USE

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 device with patient or control identification. For best results, the assay should be performed within one hour.

2. Transfer 3 drops of whole blood/serum/plasma to the specimen well (S) of the device with the provided disposable pipette, and start the timer.

Or

Allow 3 hanging drops of fingerstick whole blood to fall into the center of the specimen 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 window.

As the test begins to work, color will migrate across the membrane.

3. If the test fails to migrate across the membrane after 1 minute, add 1 drop of buffer to the specimen well (S).

4. 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

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.