Basic Information
| Model NO. | HBsAg Test Kit |
| Storage and Stability | 4-30°C |
| Specimen Collection | Serum and Plasma |
| Certification | CE |
| Transportation | Air, Sea |
| Transport Package | Carton or OEM |
| Specification | 1 test/box, 30 tests/box, 50 tests/box |
| Trademark | Brand or OEM |
| Origin | China |
Product Description
What is Hepatitis B?
Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). It can cause chronic infection and puts people at high risk of death from cirrhosis and liver cancer.
Transmission
- Most commonly transmitted from mother to child during birth and delivery.
- Through contact with infected blood or other body fluids such as saliva and menstrual, vaginal and seminal fluids.
- Through the reuse of contaminated needles and syringes or sharp objects.
Symptoms
Most people do not experience any symptoms when newly infected. However, acute hepatitis may present symptoms as shown below:
Who Should Be Tested?
- Household and sexual contact of people with hepatitis B
- People who inject drugs and people with HIV
- Pregnant women and infants born to mothers with hepatitis B
- People with end-stage renal disease or hepatitis C
- People with elevated ALT levels
Early identification enables necessary care and treatment to prevent the progression of liver disease.
Detailed Specifications
HBsAg Test kit (Colloidal Gold) is used for the qualitative detection of Hepatitis B surface Antigen (HBsAg) in human serum and plasma samples. HBsAg is the hepatitis B virus coat protein. While not contagious itself, it is a primary sign of hepatitis B virus infection.
Sample Requirements
- Serum and plasma can be used (EDTA, heparin, and sodium citrate are compatible).
- Use fresh samples whenever possible.
- Collection should be under sterile conditions; avoid hemolysis.
- Store at 2-8°C for up to 7 days, or freeze for longer storage.
Test Procedure
Test Cassette Method
- Equilibrate the test box to room temperature. Use within 1 hour after opening.
- Place the cassette on a level surface.
- Add 3 drops (approx. 100 uL) of serum/plasma to the sample well.
- Read result at 15 minutes. Do not interpret after 20 minutes.
Test Strip Method
- Immerse the reagent strip into the sample for 15-20 seconds.
- Lay flat on the table and wait for results.
- Read after 15 minutes. Results after 20 minutes are invalid.
Interpretation of Results
NEGATIVE: Only the C band is present. No HBsAg detected.
POSITIVE: Both C band and T band are developed. HBsAg detected.
INVALID: Control line (C) fails to appear. Repeat with a new test.
Warnings and Precautions
- For professional In Vitro diagnostic use only. Do not use past expiration date.
- Strictly follow instructions to achieve accurate results.
- A definitive clinical diagnosis should be made by a physician after all findings are evaluated.
- Dispose of all materials in biohazard containers according to local regulations.
- Test is for single use only. Do not reuse.
Production & Quality Control
Frequently Asked Questions
How accurate is the HBsAg Rapid Test?
The kit provides high sensitivity and specificity for qualitative detection, but results should always be confirmed with clinical findings.
Can I use whole blood for this test?
According to the current specification, this specific kit is optimized for human serum and plasma samples.
What is the required storage temperature?
The kit should be stored between 4°C and 30°C in a dry environment, away from direct sunlight.
How long does it take to see the result?
The result is typically visible at 15 minutes. Do not interpret results after 20 minutes as they may be inaccurate.
Does this test kit have CE certification?
Yes, the product is CE certified, meeting European safety and performance standards for diagnostic devices.
What should I do if the test is positive?
A positive result indicates the presence of HBsAg. You should consult a medical professional immediately for further diagnostic testing and care.
Nordi Medical
