HBV Rapid Test Panel

HBV Rapid Test Panel
 
INTENDED USE
Rapid HBV Panel Test, hereinafter referred to HBV Panel Test, is a rapid immunochromatography assay for the qualitative detection of the markers of Hepatitis B virus including Hepatitis B virus surface antigen (HBsAg), Hepatitis B virus surface antibody (anti-HBs/HBsAb), Hepatatis B virus envelope antigen (HBeAg), Hepatatis B virus envelope antibody (HBeAb/anti-HBe) and Hepatatis B virus core antibody (anti-HBc/HBcAb) in human serum, plasma or whole blood specimens. It is intended for use in medical institution as an aid for diagnosis and management of patients related to infection with hepatitis B as well for screening of blood donors or blood products.
 
SUMMARY
Hepatitis B virus (HBV) is an enveloped; double- stranded DNA virus belonging to the Hepadnaviridae family and is recognized as the major cause of blood transmitted hepatitis together with hepatitis C virus (HCV). Infection with HBV induces acute or chronic liver diseases and in some cases that can lead to cirrhosis and carcinoma of the liver. Hepatitis B surface antigen or HBsAg, which was previously described as Australia antigen is the most important protein of the envelope of Hepatitis B Virus. The surface antigen contains the determinant “a”, common to all known viral subtypes, immunologically distinguished in two distinct subgroups (ay and ad). HBV has 10 major serotypes and four HBsAg subtypes have been recognized (adw, ady, ayw, and ayr). HBsAg can be detected 2 to 4 weeks before the ALT levels become abnormal and 3 to 5 weeks before symptoms develop.
 
TEST PRINCIPLE
HBsAg test is a double antibody sandwich immunoassay. Colloidal gold conjugated anti-HBsAg antibody complexes are dry-immobilized in the test device. When the sample is added, it migrates by capillary diffusion through the strip rehydrating the gold conjugate complexes. If present, HBsAg will react with the gold conjugate complexes forming particles. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by anti-HBsAg antibodies immobilized there and a visible red line appears. If there is no HBsAg in sample, no red line will appear in the Test Zone (T). The gold conjugate complexes will continue to migrate alone until they are captured in the Control Zone (C) by immobilized goat anti-mouse IgG antibody aggregating a red line, which indicates the validity of the test.
HBsAb test is a double antigen sandwich immunoassay. Colloidal gold conjugated HBsAg complexes are dry-immobilized in the test device. When the sample is added, it migrates by capillary diffusion through the strip rehydrating the gold conjugate complexes. If present, HBsAb will react with the gold conjugate complexes forming particles. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by HBsAg immobilized there and a visible red line appears. If there is no HBsAb in sample, no red line will appear in the Test Zone (T). The gold conjugate complexes will continue to migrate alone until they are captured in the Control Zone (C) by immobilized goat anti-HBsAg antibody aggregating a red line, which indicates the validity of the test.
HBeAg test is a double antibody sandwich immunoassay. Colloidal gold conjugated anti-HBeAg antibody complexes are dry-immobilized in the test device. When the sample is added, it migrates by capillary diffusion through the strip rehydrating the gold conjugate complexes. If present, HBeAg will react with the gold conjugate complexes forming particles. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by anti-HBeAg antibodies immobilized there and a visible red line appears. If there is no HBeAg in sample, no red line will appear in the Test Zone (T). The gold conjugate complexes will continue to migrate alone until they are captured in the Control Zone (C) by immobilized goat anti-mouse IgG antibody aggregating a red line, which indicates the validity of the test.
HBeAb test is a competitive immunoassay. Colloidal gold conjugated anti-HBeAg antibody complexes are dry-immobilized in the test device. When the specimen is added, it migrates with the gold conjugate complexes by capillary diffusion through the strip. If present, HBeAb will compete with gold conjugate complexes for the limited amount HBeAg immobilized in the Test Zone (T). It will prevent the gold conjugate complexes from reacting with HBeAg and no red line appears in the Test Zone (T). If there is no HBeAb in the specimens, gold conjugate complexes will react with HBeAg and a visible red line appears. To serve as a procedural control, a red line will always appears in the Control Zone (C) which indicates the validity of the test.
HBcAb test is a competitive immunoassay. Colloidal gold conjugated anti-HBcAg antibody complexes are dry-immobilized in the test device. When the specimen is added, it migrates with the gold conjugate complexes by capillary diffusion through the strip. If present, HBcAb will compete with gold conjugate complexes for the limited amount HBcAg immobilized in the Test Zone (T). It will prevent the gold conjugate complexes from reacting with HBcAg and no red line appears in the Test Zone (T). If there is no HBcAb in the specimens, gold conjugate complexes will react with HBcAg and a visible red line appears. To serve as a procedural control, a red line will always appears in the Control Zone (C) which indicates the validity of the test.
 
MATERIAL PROVIDED
1.Rapid HBV Panel Test
2. Instructions for use
3. Disposable transfer pipet
 
MATERIALS REQUIRED BUT NOT SUPPLIED
1. Whole blood or plasma: Vacutainer tube, or other appropriate tube, containing heparin or EDTA as an anticoagulant
2. Serum: Vacutainer tube, or other appropriate tube, without anticoagulant
3. Timer or clock
 
STORAGE
Store the test device at 4 to 30oC. Do Not Freeze.
 
PRECAUTIONS
1. For in vitro diagnostic use only.
2. Do not use product beyond the expiration date.
3. Handle all specimens as potentially infectious.

Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10^th and 11^th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.
 
Our mission:

• Always best of all and always pay attention to innovation.
• Special customized service tightly following customers’ requests.
• Integrated excellent quality, competitive prices and super service together.