Hepatitis B Virus Combo Test

Description

Intended Use

Hepatitis B Virus Combo Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb in whole blood, serum or plasma. Do not use Hepatitis B Virus Combo Test if the foil pouch is damaged.

Principle

HBsAg and HBeAg

The HBsAg and HBeAg tests are qualitative, two-site sandwich immunoassays for the detection of HBsAg or HBeAg in serum or plasma. The membrane is pre-coated with anti-HBsAg or anti-HBeAg antibodies on the test line region of the strip. During testing, the serum or plasma specimen reacts with the particle coated with anti-HBsAg or anti-HBeAg antibodies.2 The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-HBsAg or anti-HBeAg antibodies on the membrane and generate a colored line. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result.

HBsAb

Hepatitis B surface Antibody (HBsAb) is also known as anti-Hepatitis B surface Antigen (anti-HBs). This test is a qualitative, lateral flow immunoassay for the detection of HBsAb in serum or plasma. The membrane is pre-coated with HBsAg on the test line region of the strip. During testing, the serum or plasma specimen reacts with the particle coated with HBsAg. The mixture migrates upward on the membrane chromatographically by capillary action to react with HBsAg on the membrane and generate a colored line. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result.

HBeAb and HBcAb

Hepatitis B envelope Antibody (HBeAb) is also known as anti-Hepatitis B envelope Antigen (anti-HBe). Hepatitis B core Antibody (HBcAb) is also known as anti-Hepatitis B core Antigen (anti-HBc). These tests are immunoassays based on the principle of competitive binding.

During testing, the mixture migrates upward on the membrane chromatographically by capillary action. The membrane is pre-coated with HBeAg or HBcAg on the test line region of the strip. During testing, anti-HBe antibody or anti-HBc antibody, if present in the specimen, will compete with particle coated anti-HBe antibody or anti-HBc antibody for limited amount of HBeAg or HBcAg on the membrane, and no line will form in the test line region, indicating a positive result. A visible colored line will form in the test line region if there is no anti-HBe antibody or anti-HBc antibody in the specimen because all the antibody coated particles will be captured by the antigen coated in the test line region.

To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

Test Procedure

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. 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.

For venous whole blood specimens:

Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 µL) to the sample well (S) of the test device, then add 1 drop of buffer (approximately 40 µL) respectively , and start the timer.

For fingerstick whole blood specimens:

Dispense 2 drops of fingerstick whole blood onto the sample well (S) of the test device, then add 1 drop of buffer (approximately 40 µL) respectively, and start the timer.

For serum or plasma specimens

Using the provided disposable pipette, transfer 3 drops of serum or plasma (approximately 75 µL) to each specimen well (S) of the device respectively, then 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. Wait for the colored band(s) to appear. The result should be read at 15 minutes.