Cassette Hepatitis B Panel Test Serum Plasma Whole Blood 5 In 1 HBV Combo Test Panel

Hepatitis B virus 5 in 1 cassette HBV Combo Test Panel

INTENDED USE

The HBV One Step Hepatitis B Virus Combo Test Device (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb in serum or plasma.

INTRODUCTION

Hepatitis B is a liver disease that can range from mild to a serious, lifelong illness. The hepatitis B virus causes inflammation of the liver, which may lead to liver cancer, liver failure and even death.

The HBV Test is a diagnostic device to detect the 5 markers associated with Hepatitis B infection.

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.

MAIN CONTENTS

• One pouch containing a reaction test Cassette with desiccant.

• Buffer

• Disposable pipettes.

• Instructions for use.

HBV TEST STORAGE

The test kit can be stored at temperatures from 2°C to 30°C in the sealed pouch up to the date of expiration.

The test kit should be kept away from direct sunlight and moisture.

Do not freeze the test kit.

PRECAUTIONS

• For in vitro diagnostic use only.

• Do not use after the expiration date.