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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References


Entecavir combining Chinese herbal medicine for HBeAg-positive chronic hepatitis B patients: a randomized, controlled trial

HEPATOLOGY INTERNATIONAL

Authors: Li, Xiaoke; Zhou, Daqiao; Chi, Xiaoling; Li, Qin; Wang, Li; Lu, Bingjiu; Mao, Dewen; Wu, Qikai; Wang, Xianbo; Zhang, Mingxiang; Xue, Jingdong; Li, Yong; Lu, Wei; Guo, Jianchun; Jiang, Feng; Zhang, Xinwei; Li, Zhiguo; Yang, Xianzhao; Guo, Hui; Gan, Danan; He, Liyun; Luo, Lin; Zhang, Ludan; Du, Hongbo; Ye, Yong'an

Background and aim Traditional Chinese medicine (TCM) is widely accepted and prescribed in China alongside Nucleoside analogs (NAs). In this double-blind, placebo-controlled, randomized, multi-center trial, we evaluated whether entecavir (ETV) plus TCM formulas Tiao-Gan-Yi-Pi granule (TGYP) and Tiao-Gan-Jian-Pi-Jie-Du granule (TGJPJD) increase the rate of hepatitis B e antigen (HBeAg) loss in Chinese patients. Methods 596 eligible participants were randomly assigned, in a 1:1 ratio, to two study groups in this 108-week trial: The experiment group was assigned ETV plus the TCM formula. The control group was assigned ETV plus a TCM placebo. We compared the rate of HBeAg loss by the end of week 108 between the two arms as the primary outcome. Secondary outcomes included hepatitis B surface antigen (HBsAg) level, proportion of undetectable HBV-DNA, and liver enzymes (ALT, AST, GGT) at week 108. Results The combination therapy achieved superior HBeAg loss at 108 weeks, without additional adverse events. The rate of HBeAg loss at week 108 was 37.54% (95% CI 31.9-43.2%) in the experiment group and 27.21% (95% CI 22.0-32.4%) in the control group. There was a statistically significant difference between the two arms of 10.33% (95% CI 8.4-12.3%, p = 0.008). The DNA loss rate, serum HBsAg level, and liver enzymes were similar between the groups by the end of 108th week. Conclusion Combining the Chinese herbal formula with ETV therapy demonstrated superior HBeAg clearance compared with ETV monotherapy. This finding indicates that this combined therapy could produce an improved therapeutic effect and safety profile.

Clinical characteristics of chronic hepatitis B cured by peginterferon in combination with nucleotide analogs

INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES

Authors: Bao, Xuli; Guo, Jia; Xiong, Fang; Qu, Yachao; Gao, Yao; Gu, Na; Lu, Jun

Objectives: The purpose of this study was to analyze the clinical characteristics of chronic hepatitis B (CHB) cured by antiviral therapy. Methods: Forty-two patients with CHB were enrolled. All patients had been treated with peginterferon (Peg-IFN) in combination with nucleoside analogue (NA) therapy for variable amounts of time, and all had been successfully cured of the disease. Results: The combined treatment time for all participants was 124.7 +/- 58.8 weeks, and the average Peg-IFN treatment time was 102.6 +/- 56.1 weeks. At 24 weeks, Hepatitis B surface antigen (HBsAg) and Hepatitis B e antigen (HBeAg) had decreased more than 50% from baseline. Multivariate logistic regression analysis of the week 96 HBsAg-clearing group and the non-HBsAg-clearing group showed a statistically significant difference in baseline HBV DNA levels and week 48 HBsAg levels. Those which baseline HBV DNA was < 2.75 log(10) IU/mL, and week 48 HBsAg levels were < 0.88 log(10) IU/mL were more likely to achieve rapid HBsAg clearance at 96 weeks. This suggests that low levels of baseline HBV DNA and week 48 HBsAg are a predictor of rapid HBsAg clearance at 96 weeks. Conclusions: Individualized extension of combination therapy to more than 96 weeks depending on the patient's response and adverse reaction conditions can help achieve a clinical cure. Patients with low baseline HBV DNA and low HBsAg levels at 48 weeks achieve HBsAg clearance more quickly than other populations. (C) 2020 The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases.

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