Intended Use

The HBsAg Rapid Test (Serum/Plasma/Whole blood) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B Surface Antigen in serum, plasma or whole blood.

Viral hepatitis is a systemic disease primarily involving the liver. Most cases of acute viral hepatitis are caused by Hepatitis A virus, Hepatitis B virus (HBV) or Hepatitis C virus. The complex antigen found on the surface of HBV is called HBsAg. Previous designations included the Australia or Au antigen. The presence of HBsAg in serum, plasma or whole blood is an indication of an active Hepatitis B infection, either acute or chronic. In a typical Hepatitis B infection, HBsAg will be detected 2 to 4 weeks before the ALT level becomes abnormal and 3 to 5 weeks before symptoms or jaundice develop. HBsAg has four principal subtypes: adw, ayw, adr and ayr. Because of antigenic heterogeneity of the determinant, there are 10 major serotypes of Hepatitis B virus.The HBsAg Rapid Test (Serum/Plasma/Whole blood) is a rapid test to qualitatively detect the presence of HBsAg in serum, plasma or whole blood specimen. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of HBsAg in serum, plasma or whole blood.

The HBsAg Rapid Test (Serum/Plasma/Whole blood) is a qualitative, lateral flow immunoassay for the detection of HBsAg in serum, plasma or whole blood. The membrane is precoated with anti-HBsAg antibodies on the test line region of the cassette. During testing, the serum or plasma specimen reacts with the particle coated with anti-HBsAg antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-HBsAg antibodies on the membrane and generate a colored line. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. 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.

Specification

Read time	10-20 min
Shelf life	36 months
Store temperature	2-30℃
Operation temperature	15-30℃
Sensitivity	100.0%
Specificity	100.0%
Accuracy	100.0%

Why To Test

1. What is HBsAg?

HBsAg, or Hepatitis B surface Antigen, is a protein found on the surface of the Hepatitis B virus (HBV). Its presence in the blood indicates a current Hepatitis B infection. This antigen is typically detectable within 1-2 weeks after exposure to the virus. If HBsAg persists for more than six months, it signifies a chronic (long-term) infection.

2. How Does HBsAg Spread?

The Hepatitis B virus is spread through contact with infected blood or certain body fluids. The main transmission routes are:

Blood Contact: This is the most efficient route. It can happen through sharing contaminated needles or syringes, receiving unscreened blood or blood products, or using unsterilized medical or tattooing equipment.
Mother-to-Child: An infected mother can pass the virus to her baby during childbirth.
Sexual Contact: The virus can be transmitted through unprotected sexual intercourse with an infected person.

It is crucial to know that Hepatitis B is not spread through casual contact. You cannot get infected through hugging, shaking hands, sharing food, or via coughing or sneezing.

3. What Are The Symptoms Of HBsAg And Severe HBsAg ?

Symptoms vary depending on whether the infection is acute (short-term) or chronic (long-term).

Acute Infection: Symptoms, if they appear, show up after an incubation period of 1 to 4 months. Many people, especially children, may have no symptoms (asymptomatic). When present, symptoms can include:

Fatigue and general body weakness
Loss of appetite
Nausea and vomiting
Abdominal discomfort
Dark urine and pale stools
Jaundice (yellowing of the skin and eyes)

Chronic Infection and Severe Disease:A chronic infection is defined by the presence of HBsAg for over six months. Many individuals with chronic Hepatitis B have no obvious symptoms for years, but the virus can still slowly damage the liver. Without proper monitoring and management, chronic Hepatitis B can lead to serious complications like cirrhosis (severe liver scarring) and liver cancer.

Test Method

POSITIVE:* Two colored lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of TP antibodies present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.