Singclean Wholesale CE Approved Ivd Human Serum and Plasma HBV Hepatitis B Hbsag Rapid Virus Medical Test Kit Surface Antigen (Colloidal Gold) for HBV Infection

• Type: IVD Reagent
• Pack Formats: Strip: 50 Tests/Box Cassette: 20 Tests/Box
• Storage and Stability: The Kit Can Be Stored at Temperature (4-30°c).
• Specimen Collection: Serum and Plasma
• Transport Package: Carton or OEM
• Specification: 1 test/box, 30 tests/box, 50 tests/box
• Model NO.: Singclean HBsAg Test Kit
• Trademark: Singclean 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. Sexual transmission is more prevalent in unvaccinated persons with multiple sexual partners.
- 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 have symptoms like:

Who Should Be Tested for Hepatitis B?

1. Household and sexual contact of people with hepatitis B
2. People who inject drugs
3. People with HIV
4. Men who have sex with men
5. Pregnant women
6. Infants born to mothers with hepatitis B
7. People requiring immunosuppressive therapy
8. People with end-stage renal disease (including people on dialysis)
9. People with hepatitis C
10. People with elevated ALT levels

Early identification of persons with chronic HBV infection will enable them to receive the necessary care and treatment to prevent or delay the progression of liver disease.

About Singclean

HBsAg Test kit (Colloidal Gold) Singclean HBsAg Test kit (Colloidal Gold) is used for the qualitative detection of Hepatitis B surface Antigen (HBsAg) in human serum and plasma samples. Hepatitis B surface Antigen (HBsAg) is the hepatitis B virus coat protein. It is not contagious, only the antigenicity. But it is usually accompanied by the presence of hepatitis B virus, so it is a sign of hepatitis B virus infection.
 

 

Sample Requirements

1. Serum and plasma can be used for testing. The commonly used anticoagulants (EDTA, heparin, and sodium citrate) in the clinic did not affect the test results of plasma samples.
2. Use fresh samples whenever possible.
3. The collection of venous serum and plasma should be under sterile conditions and should avoid sample hemolysis.
4. If serum or plasma samples are tested within 7 days after collection, the samples must be stored at 2-8C or frozen if greater than 7 days.

Test Procedure
Allow the test box to equilibrate to room temperature prior to testing.

Test cassette

1. Remove the test cassette from the sealed foil bag and use it as soon as possible. After opening the sealed pouch, use the test as soon as possible within 1 hour.
2. Place the test cassette on a clean, level surface.
3. Aspirate the serum/plasma sample using a pipette, and add 3 drops (approximately 100 uL) of the sample to the sample well. Start the timer.
4. Wait for the colored line(s)to appear. The result should be read after 15 minutes. Do not interpret the result after 20 minutes.

Test Strip

1. Remove the test strip from the sealed foil bag and use it as soon as possible. After opening the sealed pouch, use the test as soon as possible within 1 hour.
2. Dip the reagent strip into the sample, If the sample level is within the water ripple range, immerse for 15-20 seconds, flat on the table.
3. Waiting for results. Results should be read after 15 minutes. The results after 20 minutes are not convincing.

Interpretation of Results
NEGATIVE
If only the C band is present, the absence of any burgundy color in the T band indicates that no HBsAg is detected in the specimen. The result is HBsAg negative.
POSITIVE
In addition to the presence of the C band, if the T band is developed, the test indicates the presence of HBsAg in the specimen. The result is HBsAg positive.
INVALID
The 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 cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Warnings and Precautions

1. For professional In Vitro diagnostic use.Do not use after the expiration date.This test kit is only for the test of human serum, plasma.
2. These instructions must be strictly followed by a trained heath care professional to achieve accurate results.All users have to read the instruction prior to performing a test.
3. A negative result can occur if the quantity of the HBsAg antigen present in the specimen is below the detection limits of the assay.
4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.Do not use it if the pouch or package is damaged or broken.
5. Wear protective while handling specimens and wash hands thoroughly after wards.
6. Clean up spills thoroughly using an appropriate disinfectant.
7. Decontaminate and dispose of all specimens, reaction kit and potentially contaminated materials in a biohazard container as if they were infectious waste and dispose according to applicable local regulations.Do not mix or interchange different specimens.
8. Do not store the test kit in direct sunlight.
9. Test is for single use only. Do not re-use under any circumstances.Do not perform the test in a room with strong air flow, i.e. electric fan or strong air-conditioning.
10. ln case of positive samples, seek medical attention in time.
11. In case of any serious incident related to the device, it shall be reported to the manufacturer, distributor, or the competent authority.