Antibody to HBsAg ELISA Kit (DEIA060)

Regulatory status: For research use only, not for use in diagnostic procedures.

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Size
96T
Sample
serum, plasma
Species Reactivity
Human
Intended Use
CD anti-HBs ELISA (Quantitative) kit is an enzyme linked immunosorbent assay (ELISA) for in vitro quantitative determination of antibodies to hepatitis B virus surface antigen (anti-HBs) in human serum or plasma for clinical purposes and assessing antibody response levels to HBsAg-vaccine.
Contents of Kit
1. Microwell plate: one
2. Calibration Curve Standards: 6 x 0.5 mL
3. HRP-Conjugate: 1 x 6.5 mL
4. Wash Buffer: 1 x 30 mL
5. Chromogen Solution A: 1 x 7 mL
6. Chromogen Solution B: 1 x 7 mL
7. Stop Solution
Storage
The components of the kit will remain stable through the expiration date indicated on the label and package when stored between 2-8°C, do not freeze. To assure maximum performance of the Human anti-HBs ELISA (Quantitative) Kit, during storage, protect the reagents from contamination with microorganism or chemicals.
Sensitivity
Analytical Sensitivity (lower detection limit): In the follow-up of vaccinated individuals the value of 20 WHO mIU/mL is the minimum concentration at which the recipient is considered protected. This kit shows sensitivity of 5 mIU/mL.

Clinical Sensitivity: The performance characteristics of this assay were evaluated by a panel of samples obtained from 600 individuals receiving HBV vaccines in which the titers of anti-HBs were evaluated in a direct comparison with another commercially available anti-HBs ELISA kit. From this group, 594 individuals showed antibody titer higher than 10 mIU/mL, which was confirmed with the reference anti-HBs ELISA kit. In another group of 220 individuals with confirmed hepatitis B vaccination history, 220 of the tested samples showed antibody titer higher than 10 mIU/mL. From this study, overall agreement of 100% was obtained between this kit and the reference test in linear regression analysis.

In a panel of 240 samples obtained from early recovery hepatitis B patients (confirmed HBsAg-, anti-HBc+ and anti-HBs+), sensitivity of 100% was calculated in comparison with the reference test.
General Description
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 a spectrum of clinical manifestations ranging from mild, inapparent disease to fulminant hepatitis, severe chronic liver diseases, which in some cases can lead to cirrhosis and carcinoma of the liver. Classification of a hepatitis B infection requires the identification of several serological markers expressed during three phases (incubation, acute and convalescent) of the infection. Now several diagnostic tests are used for screening, clinical diagnosis and management of the disease.
Hepatitis B surface antigen (HBsAg) is an important viral envelope protein, which appears shortly after infection and is a key serological marker for detection and diagnosis of HBV. Clearance during treatment shows recovery and development of neutralizing antibodies (anti-HBs) occurs in 90% of the patients. Due to the introduction of hepatitis B vaccination programs, the detection of anti-HBs has become important method for monitoring of recipients upon vaccination with synthetic and natural HBsAg. The absence of anti-HBs indicates susceptibility to HBV infection. For this, screening for anti-HBs in high-risk populations is recommended for identifying individuals who may benefit from vaccination.
Standard Curve

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