Welcome to Beijing Wantai

Welcome to Beijing Wantai

Manufacturer of Infectious Diseases Diagnostics

HEPATITIS B

HBV is an enveloped, double-stranded DNA virus belonging to the Hepadnaviridae family and is recognized as the major cause of blood transmitted hepatitis. Classification of a HBV infection requires the identification of several serological markers expressed during three phases (incubation, acute and convalescent) of the infection.

HBsAg: is the most important protein of the envelope of HBV. The surface antigen contains the determinant “a”, common to all known viral subtypes and immunologically distinguished in two distinct subgroups (ay and ad). Four HBsAg subtypes have been recognized (adw, ady, ayw, and ayr). HBsAg can be detected 3 to 5 weeks before symptoms develop. The serological detection of HBsAg is a powerful method for the diagnosis and prevention of HBV infection and for screening of blood donors.

Anti-HBc is a marker of acute, chronic or resolved HBV infection and screening for anti-HBc provides information on the prevalence of the disease in different groups. In clinical diagnosis, the detection of anti-HBc is an important marker for diagnosis and management of disease. In the absence of other HBV markers (HBsAg-negative persons), anti-HBc may be the only indication of an existing HBV infection.

HBcAb IgM: Antibodies to HBcAg appear shortly after the appearance of HBsAg and persist for life both in persons who have recovered from a hepatitis B infection and in those who develop HBsAg carrier status. In chronic hepatitis, however, spikes of anti-HBc IgM synthesis are present, confirming reactivation of HBV in hepatocytes and giving origin to permanent IgM low titers.

HBsAb: During the acute phase of hepatitis B infection,increasing titers of HBsAg neutralizing antibodies are marker for recovery. The serological detection of anti-HBs has become an important method for the follow up of patients infected by HBV and it is also important for monitoring of recipients upon vaccination. The absence of anti-HBs indicates susceptibility to HBV infection.

HBeAg: The “e” antigen (or HBeAg) is virus protein which is associated with HBV replication, indicating high degree of infectivity. HBeAg appears shortly after HBsAg and is detecable for few days to several weeks. In chronic hepatitis B infections, elevated leves of HBeAg can be detected for years, which is a marker for large quantity of virus.

HBeAb: After treatment, in the recovery phase following acute hepatitis B, HBeAg is the first serological marker that becomes negative and is replaced by the corresponding antibody (anti-Hbe). The presence of anti-HBe in blood is recognized to be a clinical sign of recovery from the infection.

HBV NRAg: Hepatitis B virus particle is composed of outer membrane proteins (S protein, pre-S1 protein, pre-S2 protein) and core-shell. HBV pre-S1 antigen and core antigen are not only the marker of HBV infection, also the marker of viral replication, and they are highly correlated with HBV DNA, collectively known as hepatitis B virus nucleic acid related antigen (HBV NRAg).

Catalog No.	Products	IFU	MSDS
WB-2296	HBsAg ELISA (Normal - 0.5IU/ml)
WB-22H96	HBsAg ELISA (High Sensitivity - 0.1IU/ml) New
WB-2396	HBsAb ELISA
WB-2496	HBeAg ELISA
WB-2596	HBeAb ELISA
WB-2696	HBcAb ELISA
WB-26S96	HBcAb ELISA (Sandwhich Principle) New
WB-2796	HBcAb IgM ELISA
WB-2896	HBsAb (Quantitative) ELISA
WB-2996	HBV NRAg ELISA
WJ-11	HBsAg Rapid Test (whole blood)
WJ-12	HBsAg Rapid Test (serum/plasma)

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HBsAg (High Sensitivity) ELISA brochure

Wantai HBsAg (High Sensitivity) ELISA - Performance Study

Clinical Specificity: The clinical specificity of this assay was determinate by a panel of negative samples obtained from 4476 healthy blood donors and 6344 hospitalized patients.

	Number	Wantai HBsAg ELISA
	Number	-	+	Specificity
Donors	4476	4471	5	99.89%
Patients	6344	6340	4	99.94%
Total	10820	10811	9	99.92%

Clinical Sensitivity: A panel of 108 samples sequenced by PCR method.

Background		Number	Wantai HBsAg ELISA
adr (+)	wildtype	35	33
adr (+)	4 mutations	5	4
adw (+)	wildtype	37	34
adw (+)	16 mutations	25	24
ayw (+)	wildtype	2	2
ayw (+)	2 mutations	2	2
ayr (+)	2 mutations	2	2
Total		108	101

Analytical Sensitivity: The sensitivity of the assay has been calculated by a panel of series of dilutions of WHO reference standard. The assay shows that lower detection limit reaches 0.1IU/ml.