There are eight genotypes (genotype A to H) of hepatitis B virus (HBV) which are distinguished by > 8 % difference in the nucleotide sequence of the HBV genome. Genotypes A and D are common in Europe and the United States, while genotypes B and C are prevalent in Asia. Genotype F is frequent in Latin America, while genotype E is confined to Central and Western Africa.
Many studies indicate that HBV genotypes influence the severity of chronic hepatitis B and the response to interferon therapy. HBV genotypes have been determined by tedious methods such as direct sequencing, genotype-specific PCR, PCR-RFLP, line-probe assay (LiPA), or PCR-invader assay.
This product is an enzyme immunoassay (EIA) based HBV genotyping kit, designed to determine genotype (A, B, C, or D) by detecting genotype-specific epitopes in PreS2 region .
☆ The first diagnostic reagent for determination of HBV genotype launched in the Japanese market
☆ Fast and easy detection based on one-step EIA method
☆ 98% of samples with HBsAg concentration of >3 IU/mL can be genotyped (unpublished data)
☆ Sample volume: 80μL of HBsAg positive serum
☆ Stored sample can be used
☆ 4 wells/sample
☆ Reaction time : 2.5 hours
Hepatitis B Virus serological genotyping in human serum (Genotype A, B, C, or D)
Determine genotypes by the positive/negative combinations (serotypes) of four epitopes (‘m’, ‘k’, ‘s’, or ‘u’) in accordance with the table below.Sample sera showing serotypes other than ‘su’, ‘m’, 'ks’, or ‘ksu’ can not be classified by this kit.
|1||Microplate coated with anti-HBs (8 wells x12 strips)||2 plates.|
|2||HRP-labeled mAbs (HRP-labeled anti-PreS2mouse monoclonal antibodies)|
|1) HRP-labeled anti-‘m’ mAb (green)||5 mL x 1 vial|
|2) HRP-labeled anti-‘k’ mAb (yellow)||5 mL x 1 vial|
|3) HRP-labeled anti-‘s’ mAb (blue)||5 mL x 1 vial|
|4) HRP-labeled anti-‘u’ mAb (red)||5 mL x 1 vial|
|3||Negative control||1 mL x 1 vial|
|1) Positive control ‘m’ (green)||0.25 mL x 1 vial|
|2) Positive control ‘k’ (yellow)||0.25 mL x 1 vial|
|3) Positive control 's’ (blue)||0.25 mL x 1 vial|
|4) Positive control ‘u’ (red)||0.25 mL x 1 vial|
|5||HRP substrate (3, 3', 5,5'-tetramethylbenzidine)||20 mL x 1 vial|
|6||Reaction stopper||20 mL x 1 vial|
|7||Washing solution (20x concentrated)||50 mL x 2 vials l|
|8||Plate seal||6 sheets|
1. Okamoto H, Tsuda F, Sakugawa H, et al:Typing hepatitis B virus by homology in nucleotide sequence:comparison of surface antigen subtypes. J Gen Virol 69:2575-2583, 1988.
2. McMahon BJ:The influence of hepatitis B virus genotype and subgenotype on the natural history of chronic hepatitis B. Hepatol Int 3:334-342, 2009.
IMMUNIS HBV Genotype EIA