Personal HBV Combo Rapid HIV Test Kit Detect Hepatitis B Virus Multiple Cassette

Personal use HBV combo Home Testing kits, detecting Hepatitis B virus at home, multiple cassette, individual package

Product Name: HBV combo Home Testing kits

INTENDED USE:

The HBV 5-Parameter Home Testing kit is a lateral flow chromatographic immunoassay for the qualitative detection of HBsAg, HBsAb, HBeAg, HBeAb, and HBcAb in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HBV. Any reactive specimen with the HBV 5-Parameter Rapid Test must be confirmed with alternative testing method(s) and clinical finding

BACKGROUND

Hepatitis virus B (HBV) is the most common cause of persistent viremia and the most important cause of chronic liver disease and hepatocellular carcinoma. Clinically apparent HBV infections may have been extant for several millennia. It is estimated that there are 300 million chronic carriers of HBV in the world. The carrier rates vary from as little as 0.3% (Western countries) to 20% (Asia, Africa).

HBV is a hepatotropic DNA virus. The core of the virus contains a DNA polymerase, the core antigen (HBcAg) and the e antigen (HBeAg) . The core of HBV is enclosed in a coat that contains lipid, protein and carbohydrate and expresses an antigen terms hepatitis B surface antigen (HBsAg) .

HBsAg is the first marker to appear in the blood in acute hepatitis B, being detected 1 week to 2 months after exposure and 2 weeks to 2 months before the onset of symptoms. Simultaneous with or shortly after the disappearance of HBsAg, antibody to HBsAg (anti-HBs) is found in the blood. Its appearance heralds complete recovery, and its presence provides lifelong immunity.

Antibody to HBcAg (anti-HBc) appears shortly after HBsAg, roughly at the time that serum ALT begins to rise. Anti-HBc also remains elevated for life and is a useful marker of previous HBV infection. HBcAg itself does not circulate freely in the serum of such infected persons.

HBeAg is seen in the blood before the onset of clinical disease and after the appearance of HBsAg. HBeAg generally disappears within about 2 weeks, while HBsAg is still present. AntiHBe appears shortly after the disappearance of the antigen and is detectable for up to 2 years or more after resolution of the hepatitis. The presence of HBeAg in the serum correlates with a period of intense viral replication and hence, maximal infectivity of the patient.

Clinically, HBsAg, HBsAb, HBeAg, HBeAb and HBcAb are the important markers in the diagnosis of HBV infection.

The HBV 5-Parameter Rapid Test is a 5-panel rapid test that can detect HBsAg, HBsAb, HBeAg, HBeAb and HBcAb simultaneously by untrained or minimally skilled personnel, without laboratory equipment.

Test Principle

The HBV 5-Parameter Home testing kit is lateral flow chromatographic immunoassay consisting of 5 test panel strips assembled in one cassette. Each strip of the panel member is composed of a sample pad, colloid gold conjugate pad, nitrocellulose membrane (NC membrane) strip pre-coated with control band (C band) and test band (T band), and absorbent pad.

The HBsAg strip is an antibody based sandwich immunoassay. The conjugate pad contains polyclonal anti-HBsAg antibodies conjugated with colloid gold and the NC membrane is precoated with a monoclonal anti-HBsAg. When an adequate volume of test specimen is applied into the sample well of the strip, the test specimen migrates by capillary action across the test strip. HBsAg if present in the specimen will bind to the anti-HBsAg gold conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-HBsAg antibody, forming a burgundy colored T band, indicating a HBsAg positive test result. Absence of the T band suggests a negative result.

The HBeAg strip is also an antibody based sandwich immunoassay. The test utilizes a pair of anti-HBeAg antibodies to detect HBeAg in the test specimen (see the HBsAg principle for explanation). A burgundy colored T band indicates a HBeAg positive test result and absence of the T band suggests a negative result.

The HBsAb strip is an antigen based sandwich immunoassay. The conjugated pad contains HBsAg conjugated with colloid gold and the NC membrane is pre-coated with un-conjugated HBsAg. HBsAb if present in the patient specimen will bind to the HBsAg gold conjugates. The immunocomplex is then captured on the membrane by the pre-coated HBsAg, forming a burgundy colored T band, indicating a HBsAb positive test result. Absence of the T band suggests a negative result.

The HBeAb strip is a competitive immunoassay. The conjugate pad contains anti-HBe antibody conjugated with colloid gold (HBeAb conjugates) and the NC membrane is pre-coated with HBeAg. If no HBeAb or its level in the specimen is below the test sensitivity, the HBeAb conjugates will have enough binding sites to bind to the HBeAg coated on the NC membrane, therefore forming HBeAb conjugates-HBeAg immunocomplex and leading to a burgundy colored T band, indicating a negative result. If the levels of HBeAb in the specimen is at or higher than the test sensitivity, it will bind to the HBeAg on the NC membrane, competing the binding of the HBeAb conjugates to the HBeAg. Therefore, absence of the T band indicates a positive test result.

The HBcAb strip is also a competitive immunoassay. The conjugate pad contains anti-HBc antibody conjugated with colloid gold and the NC membrane is pre-coated with HBcAg (See the HBeAb principle for the explanation). A burgundy colored T band suggests a negative result and absence of the T band indicates a positive test result.

All the panel strips have an internal quality control system consisting of a mouse IgG antibody conjugated with colloid gold and an NC membrane pre-coated with goat anti-mouse IgG (C band). When an adequate volume of test specimen is applied into the sample well of the strip, a burgundy colored C band should be always visible regardless of the color development on the T band. Otherwise, the test result is invalid and the specimen must be retested with another device.

TEST PROCEDURE

Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.

Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.

Step 3: Be sure to label the device with specimen’s ID number.

Step 4: Fill the pipette dropper with the specimen. Holding the dropper vertically, dispense 2-3 drops (about 60-90 µL) of specimen into each of the sample well making sure that there are no air bubbles.

Step 5: Set up timer.

Step 6: Results can be read in 15 minutes. Positive results can be visible in as short as 1 minute.

Don’t read result after 15 minutes. To avoid confusion, discard the test device after interpreting the result.

INTERPRETATION OF RESULTS

1. NEGATIVE RESULT: If only the C band is developed on the HBsAg, HBsAb, HBeAg strip, or both C and T bands are developed on either the HBeAb or the HBcAb strip, the test indicates a negative result on the parameter being tested.

2. POSITIVE RESULT: If both C and T bands are developed on the HBsAg, or HBsAb, or HBeAg strip or only the C band is developed on the HBeAb or HBcAb strip, the test indicates presence of the parameter being tested. The result is positive.

3. INVALID: If no C band is developed, the assay on the strip is invalid regardless of color development on the T band as indicated below. Repeat the assay with a new device.