Hepatitis B Surface Antibody Rapid Test

Description

Intended Use

Hepatitis B Surface Antibody Rapid Test (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of HBsAb in human whole blood, serum or plasma specimens. Hepatitis B Surface Antibody Rapid Test is intended for use as an aid in the diagnosis of HBV infection.

Introduction

Hepatitis B virus (HBV) is the most thoroughly characterized and complex hepatitis virus. The infective particle consists of a viral core plus an outer surface coat. HBV has at least 3 distinct antigen-antibody systems that can be tested: HBsAg, HBcAg, and HBeAg. HBV surface coat can be detected in serum as HBsAg. HBsAg characteristically appears during the incubation period, usually 1 to 6 weeks before clinical or biochemical illness develops, and implies infectivity of the blood. The corresponding protective antibody (anti-HBs or HBsAb) appears weeks or months later, after clinical recovery, and usually persists for life; thus, its detection indicates past HBV infection and relative immunity. Unfortunately, in 5 to 10% of patients, HBsAg persists and antibodies do not develop; these patients become asymptomatic carriers of the virus or develop chronic hepatitis. Since this antibody is recognized as the marker of immunity to HBV, the World Health Organization (WHO) includes a HBsAg diagnostic procurement program for the control of Hepatitis B. Many people, especially newborn infants, receive vaccination. The minimum standard titer of HBsAb for protective immunity to HBV is 10 mIU/mL.

Materials

• Individually packed test devices
• Package insert
• Droppers
• Buffer

Test Procedure

Bring the test device, buffer and specimen to room temperature (15-30°C) prior to testing.

1. Remove the test device from its sealed pouch and use it as soon as possible. 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) 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) and start the timer.

For serum or plasma specimens:

Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 µL) to the sample 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 area.

Wait for the colored band(s) to appear. Read results at 15 minutes.