HBsAg Hepatitis B Surface Antigen Test Card Rapid Test Kit
INTENDED USE
The HBsAg Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of HBsAg in human whole blood, serum, or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HBV infection.
INTRODUCTION
Hepatitis B virus (HBV) is the prototypic member of the hepadnaviruses. Hepatitis B surface antigen (HBsAg) is located in the lipid envelope of this small DNA virus. During the replicative phase of the virus, this surface antigen is produced in excess and is detectable in the blood of the infected. The incubation period of HBV is 6 weeks to 6 months.
MAIN CONTENTS
• One pouch containing a reaction test Cassette with desiccant.
• Buffer
• Disposable pipettes.
• Instructions for use.
STORAGE AND STABILITY
• Store at 39~ 86 º F (4 ~ 30 º C) in the sealed pouch for 18 months.
PRECAUTIONS
• For in vitro diagnostic use only.
• Do not use after expiration date.
• The test Cassette should remain in the sealed pouch until use.
• The used test Cassette should be discarded according to local regulations.
DIRECTION OF USE
Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.
2. Transfer 3 drops of whole blood/serum/plasma to the specimen well (S) of the device with the provided disposable pipette, and start the timer.
Or
Allow 3 hanging drops of fingerstick whole blood to fall into the center of the specimen well (S) of the test device, and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result window.
As the test begins to work, color will migrate across the membrane.
3. If the test fails to migrate across the membrane after 1 minute, add 1 drop of buffer to the specimen well (S).
4. Wait for the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
What do you know about HBsAg:
| 1 |
What does HBsAg positive mean? |
A positive HBsAg test result means that you are infected and can spread the hepatitis B virus to others through your blood. anti-HBs or HBsAb (Hepatitis B surface antibody) - A "positive" or "reactive" anti-HBs (or HBsAb) test result indicates that a person is protected against the hepatitis B virus. |
| 2 |
What is the main cause of HBsAg? |
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. It does not spread by sneezing or coughing. |
| 3 |
Can HBsAg positive be cured? |
Most people who get hepatitis B recover shortly on their own. But if you develop a chronic infection, hepatitis B is lifelong. There's no cure yet for hepatitis B, but regular testing and treatment can minimize the damage it does. |
| 4 |
How is HBsAg transmitted? |
Hepatitis B is transmitted when blood, semen, or another body fluid from a person infected with HBV enters the body of someone who is not infected. This can happen through sexualcontact; sharing needles, syringes, or other drug-injection equipment; or from mother to baby at birth. |
| 5 |
Is hepatitis B positive good or bad? |
Hepatitis B is an infection of the liver caused by the hepatitis B virus. The infection can be acute (short and severe) or chronic (long term). Hepatitis B can cause a chronic infection and puts people at high risk of death from cirrhosis and liver cancer. |
| 6 |
What is a normal HBsAg level? |
For example, a hepatitis B surface antigen (HBsAg) level of less than 1 s/c is considered negative, while a level of more than 5 s/c is considered positive. Any value between 1 and 5 s/c is indeterminate and should be repeated. |
| 7 |
What are the 4 stages of hepatitis B? |
The natural history of chronic HBV infection is complex. It comprises the immune‐tolerant phase, immune‐active chronic phase, inactive HBsAg phase and reactivation. The four phases differ from each other in certain parameters such as serum ALT level, HBeAg status and viral load. |
| 8 |
How to convert hepatitis B positive to negative? |
Some people with chronic hepatitis B may be treated with antiviral drugs. These medicines can decrease or remove hepatitis B from the blood. Examples include pills such as tenofovir and lamivudine or an injection called interferon. They also help to reduce the risk for cirrhosis and liver cancer. |
| 9 |
Is hepatitis B 100% curable? |
Is hepatitis B curable? There's no cure for hepatitis B. The good news is it usually goes away by itself in 4 to 8 weeks. More than 9 out of 10 adults who get hepatitis B totally recover. |
| 10 |
Can I get Hepatitis B from my husband? |
Hepatitis B is usually spread when blood, semen, or other body fluids from a person infected with the Hepatitis B virus enter the body of someone who is not infected. |
| 11 |
What a hepatitis B patient should not eat? |
Avoid processed foods and limit sugary drinks (sodas and fruit juices) and foods with added sugar. Limit red and fatty cuts of meat and limit foods deep fried in unhealthy oils. Avoid processed meats (like hot dogs and deli meats). |
| 12 |
Who is at risk of hepatitis B? |
Health care providers and emergency responders due to the nature of their work and potential for exposure. ALL pregnant women – because infants are so vulnerable to HBV (90% of infected infants will remain chronically infected, and HBV is very effectively transmitted from infected mother to baby.) |
| 13 |
Can you live a long life with hepatitis B? |
The most important thing to remember is that hepatitis B is a chronic medical condition (such as diabetes and high blood pressure) that can be successfully managed if you take good care of your health and your liver. You should expect to live a long, full life. |
| 14 |
How is HBsAg detected? |
A blood sample is taken from a vein in your arm and then sent to a laboratory for analysis. The results of the test will be available within a few days. The Hepatitis B Surface Antigen Test is a very important test for people who are at risk for hepatitis B infection. |
| 15 |
Can HBsAg positive become negative? |
It can happen, especially in older adults after a long period of “inactive” hepatitis B infection. About 1 to 3 percent of people with chronic hepatitis B lose HBsAg each year, and about half of all people with chronic infections who live up to age 75 will lose HBsAg, depending on the amount of HBV DNA in their blood. |
| 16 |
What is the treatment of HBsAg positive? |
Treatment for chronic hepatitis B may include: Antiviral medications. Several antiviral medicines — including entecavir (Baraclude), tenofovir (Viread), lamivudine (Epivir), adefovir (Hepsera) and telbivudine — can help fight the virus and slow its ability to damage your liver. These drugs are taken by mouth. |
| 17 |
How long is HBsAg positive? |
It can take up to six months, however, for a person to get rid of the hepatitis B virus. And it can take up to six months for a hepatitis B blood test to show whether as person has recovered from an acute infection or has become chronically infected . |
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