IMMUNIS HBV Genotype EIA

Institute of Immunology

Catalog No.: IIM-202501

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 the PreS2 region.

Many studies indicate that HBV genotypes influence the severity of chronic hepatitis B and the response to interferon therapy. HBV genotypes have been traditionally determined by tedious methods such as direct sequencing, genotype-specific PCR, PCR-RFLP, line-probe assay (LiPA), or PCR-invader assay.

Background

There are eight genotypes (A to H) of hepatitis B virus (HBV), 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, and genotype E is confined to Central and Western Africa.

Features and Advantages

• First diagnostic reagent for HBV genotype determination launched in the Japanese market
• Fast and easy detection using a one-step EIA method
• 98% of samples with HBsAg concentration >3 IU/mL can be genotyped (unpublished data)
• Sample volume: 80 μL of HBsAg-positive serum
• Stored samples can be used

Application Sample

Serological genotyping of Hepatitis B Virus in human serum (Genotypes A, B, C, or D)

Determine genotypes based on the positive/negative combinations (serotypes) of four epitopes (‘m’, ‘k’, ‘s’, or ‘u’) in accordance with the table below. Samples showing serotypes other than ‘su’, ‘m’, 'ks’, or ‘ksu’ cannot be classified by this kit.

PreS2 epitope				PreS2 serotype	HBV genotype
m	k	s	u
-	-	+	+	su	A
+	-	-	-	m	B
-	+	+	-	ks	C
-	+	+	+	ksu	D
				Others	Unclassified

Kit Contents

Content	Quantity
Microplate coated with anti-HBs (8 wells x 12 strips)	2 plates
HRP-labeled mAbs (anti-PreS2 mouse 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
Negative control	1 mL x 1 vial
Positive controls
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
HRP substrate (3,3′,5,5′-tetramethylbenzidine)	20 mL x 1 vial
Reaction stopper	20 mL x 1 vial
Washing solution (20× concentrated)	50 mL x 2 vials
Plate seal	6 sheets

References

• Okamoto H, et al. (1988). J Gen Virol 69:2575–2583.
• Arauz-Ruiz P, et al. (2002). J Gen Virol 83:2059–2073.
• Orito E, et al. (2001). Hepatology 34:590–594.
• Usuda S, et al. (1999). J Virol Methods 80:97–112.
• 田中靖人、菅内文中、松浦健太郎、他 (2009). 臨床病理 57:42–47.
• Kobayashi M, et al. (2004). J Gastroenterol 39:844–850.
• Suzuki Y, et al. (2005). J Med Virol 76:33–39.
• Ozasa A, et al. (2006). Hepatology 44:326–334.
• Kao JH, et al. (2000). J Hepatol 33:998–1002.
• Wai CT, et al. (2002). Hepatology 36:1425–1430.
• McMahon BJ (2009). Hepatol Int 3:334–342.

This product was previously listed under catalog number IIM-1A65