The document describes a rapid test strip method for detecting hepatitis B surface antigen (HBsAg) in serum or plasma. Hepatitis B virus (HBV) is a major cause of liver disease and cancer worldwide. The test works by detecting HBsAg, which appears early in hepatitis B infection, on a strip using monoclonal antibodies and colloidal gold. To use the test, serum is placed on the strip and results are read after 15 minutes, with lines at the test and control regions indicating a positive result. The test is designed to quickly detect HBsAg qualitatively but has limitations if antigen levels are low or interfering substances are present.

1. HEPATITIS B(SURFACE
ANTIGEN) STRIP METHOD
A rapid one step test for qualitative detection of
hepatitis B surface Antigen in serum or plasma
MASSAB BASHIR

2. WHAT IS HBV.
 Hepatitis B is a serious liver infection caused by the hepatitis B virus
(HBV). For some people, hepatitis B infection becomes chronic,
meaning it lasts more than six months. Having chronic hepatitis B
increases your risk of developing liver failure, liver cancer or cirrhosis —
a condition that causes permanent scarring of the liver.
CAUSES
 Hepatitis B infection is caused by the hepatitis B virus (HBV). The virus is
passed from person to person through blood, semen or other body
fluids.

3. SUMMARY OF HEPATITIS B VIRUS
 Hepatitis B virus is most common cause of persistent viremia and most
important cause of chronic liver disease and hepatocellular carcinoma.
Clinically apparent HBV infection may have extant several millennia.it is
estimated that there are 300mollion chronic carriers of HBV in world.

4.  HBV is a hepatotropic DNA virus. The core of virus contains a DNA
polymerase, th
 e core antigen (HBcAg),and e antigen (HBeAg).the core of HBV is coat
that contain lipid, protein and carbohydrate and expressed an antigen
terms hepatitis B surface antigen (HBsAg)…..
 HBsAg is first marker to appear in blood in acute hepatitis, Being
detected 1 week to 2 month after exposure and 2 week to 2 month
before onset of symptoms.

5.  Three weeks after onset of acute hepatitis about half oh the patient still
b positive for HBsAg. In chronic carrier state ,the HBsAg persists for
long time (2 to 6 month).with no seroconversion to the corresponding
antibodies .therefore screening for HBsAg is highly desirable for all
donors pregnant women and people in high risk groups.

7. TEST PRINCIPLE
 One step HBsAg colloidal gold enhanced immunoassay that detects
Hepatitis B surface antigen in serum or plasma. The sample initially
reacts with monoclonal antibody colloidal gold conjugate on sample
pad. This mixture migrates across the membrane by the capillary action
and reacts with anti HBsAg in test region. If sample contains HBsAg a
line will form on the membrane at this point indicate positive result. If
antigen is not present no line will form indicating negative result. This
mixture continue to flow on control area of membrane should exhibit a
color band of immunocomplex of goat anti mouse antibody (igG)

8. REAGENT
 The test device contains anti_HBsAg particles and anti-HBsAg coated
on membrane

9. STORAGE &STABILITY
 The kit can be stored at room temperature or refrigerator (2 to 30c)

10. MATERIALS
 Test strip
 Instruction
 60ul transfer pipette
 One desiccant.

11. TEST PROCEDURE
 Bring sealed pouch to room temperature.
 Open the pouch .remove the device
 Dispense two drops of serum on device
 Waite for 15 mint

12. INTERPRETATION AND RESULT
 Positive result.in addition to C line T line also appear
 Negative result. Only C region show line
 Invalid result. No line appear in C and T region

13. LIMITATION OF RESULT
 HBsAg rapid testis limited to qualitative detection
 Negative result also show when HBsAg present in specimen is below
the detection limits of assay (lower than 2ng/mL)
 HBsAg that are detected are not present during the stage of disease
 Some specimen contain usually high titer of heterophile antibody or
rheumatoid factor may affect the result