Size: 96T
Samples: Serum, plasma
Species Reactivity: Human
Intended use
The CD anti-HBs ELISA kit (quantitative) is an enzyme-linked immunosorbent assay (ELISA) for the quantitative in vitro determination of antibodies against the surface antigen of the hepatitis virus B (anti-HBs) in human serum or plasma for clinical purposes and for evaluation of antibody response levels to the HBsAg vaccine.
Kit Contents
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
Storage
Kit components will remain stable until the expiration date stated on the label and package when stored at 2-8 ° C, do not freeze. To ensure the maximum performance of the ELISA kit (quantitative) anti-human HBs, during storage, protect the reagents from contamination with microorganisms or chemical substances.
Sensitivity
Analytical sensitivity (lower detection limit): When monitoring vaccinated individuals, the value of 20 WHO mIU / mL is the minimum concentration at which the receptor is considered protected. This kit shows a sensitivity of 5 mIU / mL.
Clinical sensitivity: The performance characteristics of this assay were evaluated using a panel of samples obtained from 600 people who received HBV vaccines in which anti-HBs titers were evaluated in a direct comparison with another anti-HBs ELISA kit. commercially available. Of this group, 594 individuals showed an antibody titer greater than 10 mIU / mL, which was confirmed with the reference anti-HBs ELISA kit.
In another group of 220 people with a confirmed history of hepatitis B vaccination, 220 of the samples tested showed an antibody titer greater than 10 mIU / ml. From this study, an 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 patients with early recovery hepatitis B (confirmed HBsAg-, anti-HBc + and anti-HBs +), a sensitivity of 100% was calculated compared to the reference test.
General description
Hepatitis B virus (HBV) is an enveloped double-stranded DNA virus that belongs to the Hepadnaviridae family and is recognized as the main cause of blood-borne hepatitis along with hepatitis C virus (HCV). HBV infection induces a spectrum of clinical manifestations ranging from mild and inapparent disease to fulminant hepatitis, severe chronic liver disease, which in some cases can lead to cirrhosis and liver carcinoma.
The 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 various diagnostic tests are used for the detection, clinical diagnosis, and treatment 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 the detection and diagnosis of HBV.
Clearance during treatment shows recovery and the development of neutralizing antibodies (anti-HBs) occurs in 90% of patients. Due to the introduction of hepatitis B vaccination programs, the detection of anti-HBs has become an important method for monitoring recipients after vaccination with natural and synthetic HBsAg. The absence of anti-HBs indicates susceptibility to HBV infection. For this, the detection of anti-HBs in high-risk populations is recommended to identify people who may benefit from vaccination.
