Hepatitis B (HBsAg) Rapid Test Kit (40 pcs/box)

Hepatitis B (HBsAg) Rapid Test Kit (40 pcs/box)

The Hepatitis B (HBsAg) Rapid Test is a rapid, reliable immunochromatographic assay for the detection of hepatitis B virus surface antigen (HBsAg) in human whole blood, serum or plasma.

The test aids in the screening for hepatitis B virus infection and supports its diagnosis, in both symptomatic and asymptomatic individuals. The result can be read in just 15 minutes.

What is hepatitis B, and why is screening important?

Hepatitis B is an infectious liver disease of viral origin caused by the hepatitis B virus (HBV). The virus primarily attacks the liver, may cause inflammation, and in some cases can lead to serious long-term health consequences.

Hepatitis B infection can be acute (short-term) or chronic (long-lasting). The body of many infected people is able to clear the virus, but in some cases the infection becomes persistent. Over many years, chronic hepatitis B can lead to liver damage, cirrhosis of the liver, or liver cancer.

How is hepatitis B transmitted?

The hepatitis B virus can be transmitted through infected blood and certain body fluids. The most common routes of transmission are:

• Unprotected sexual contact with an infected person.
• Direct contact with infected blood.
• Use of shared needles or other blood-contaminated equipment.
• Use of improperly sterilized tattooing or piercing equipment.
• Transmission from an infected mother to her child, primarily during childbirth.
• Sharing of personal hygiene items that may become contaminated with blood, such as razors or toothbrushes.

Hepatitis B is not transmitted through casual contact, such as shaking hands, hugging, sharing meals or coughing.

What symptoms may hepatitis B infection cause?

One of the most important characteristics of hepatitis B is that the infection is in many cases completely asymptomatic, especially in the early period. As a result, a person may carry the virus without knowing it.

If symptoms do occur, they may include:

• Fatigue, weakness, malaise.
• Loss of appetite, nausea, vomiting.
• Abdominal pain, especially below the right rib cage.
• Dark urine.
• Light-colored stools.
• Yellowing of the skin and the whites of the eyes (jaundice).
• Joint pain.

The absence of symptoms does not mean that the infection is not present, therefore laboratory screening plays a key role in the detection of hepatitis B.

What does the HBsAg rapid test detect?

HBsAg is the surface antigen of the hepatitis B virus and one of the most important laboratory markers of infection. It can appear in the blood as early as the early stage of infection, so its detection may help in identifying a current hepatitis B infection.

The presence of HBsAg may indicate either acute or chronic infection. Further laboratory tests are required to differentiate between the two conditions.

Vaccination is an effective protection against hepatitis B, and timely detection of the infection is important for appropriate medical care and for preventing further transmission.

Advantages of the Hepatitis B rapid test

• High diagnostic sensitivity: >99.9%
• High diagnostic specificity: 99.9%
• Rapid result: in just 15 minutes
• Simple test procedure: no special instrument required
• Multiple specimen types: whole blood, serum or plasma
• CE 0344 marked in vitro diagnostic device according to IVDR
• Also suitable to support screening for asymptomatic infections

How does the Hepatitis B rapid test work?

The rapid test detects the hepatitis B surface antigen (HBsAg) using an immunochromatographic method.

The specimen is applied to the sample well of the test cassette and, as it migrates along the test strip, reacts with specific antibodies.

If the specimen contains a detectable amount of HBsAg, a colored line appears in the test region.

To perform the test, dispense 2 drops (approx. 50 µl) of specimen in the case of a serum or plasma sample, or 2 drops of blood in the case of whole blood, onto the test cassette, then add 1 drop of assay buffer.

The result can be read after 15 minutes.

Interpretation of results

Positive result:

Two colored lines appear: one in the control region (C) and one in the test region (T). This indicates that hepatitis B surface antigen (HBsAg) is detectable in the specimen.

The color intensity of the test line may vary. A faint colored line in the test region should also be considered a positive result.

Negative result:

Only the control line (C) appears; no colored line is visible in the test region (T).

This indicates that HBsAg is not detectable in the specimen, or that its concentration is below the detection limit of the test.

Invalid result:

If the control line (C) does not appear, the test is invalid, regardless of whether a line is visible in the test region.

In this case, the test must be repeated with a new test.

Important: the result must be read after 15 minutes. After 30 minutes, the result is no longer valid.

Product characteristics of the Hepatitis B rapid test

• Product type: Hepatitis B (HBsAg) antigen rapid test
• Test method: immunochromatographic rapid test
• Marker detected: hepatitis B surface antigen (HBsAg)
• Specimen type: human whole blood, serum or plasma
• Result: 15 minutes
• Diagnostic sensitivity: >99.9%
• Diagnostic specificity: 99.9%
• Overall diagnostic agreement: 99.9%
• Analytical sensitivity: 1 IU/ml
• Storage: between 2–30 °C
• Intended use: for professional in vitro diagnostic use only
• Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418, MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, 50 CHINA, imd.assuretech@diareagent.com
• EC REP: Lotus NL B.V. Koningin Julianaplein 10, le Verd, 2595AA,The Hague,Netherlands, peter@lotusnl.com
• CE marking: CE 0344
• Expiry date: 15.05.2028.

Package contents

• Individually packaged HBsAg test cassette
• Dropper
• Assay buffer
• Instructions for use

Important information and warnings

The Hepatitis B (HBsAg) rapid test is intended only for the qualitative detection of hepatitis B surface antigen and does not determine its concentration.

A positive result requires further laboratory confirmation and medical evaluation. A negative result does not completely rule out hepatitis B infection, especially if the concentration of the viral surface antigen is below the detection limit of the test.

Test results must always be evaluated together with clinical symptoms, medical history and other laboratory findings.

The test is for single use only. Do not use after the expiry date. Store in the original, sealed packaging at 2–30 °C until use. Do not freeze.

The test may only be used by competent professional staff and healthcare professionals! Carbon Web Kft. accepts no liability for its use for self-testing purposes.