Hepatitis B Surface Antigen ELISA Kit (DEIA001)

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

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Species Reactivity
Intended Use
1. For screening of blood donors.
2. As an aid in the diagnosis of liver disease.
Contents of Kit
1. Coated Microplate: 1 plate (96 tests), twelve 8-well strips per plate.
2. Conjugate: 1 vial of 6.2 mL (HRP-labeled anti-HBs).
3. Positive Control: 1 vial of 1.0 mL.
4. Negative Control: 1 vial of 1.0 mL.
5. Washing solution: 1 bottle of 40 mL concentrated.
6. Chromogen A: 1 vial of 8.0 mL (contains hydro-peroxide).
7. Chromogen B: 1 vial of 8.0 mL (contains TMB).
8. Stopping solution: 1 vial of 7.0 mL (0.5M sulphuric acid).
1. If kept at 2 to 8°C, all the test reagents are stable until the expiry date printed on the kit.
2. When the aluminum bag has been opened, the unused strips can be safely stored at 2-8°C in the sealable plastic pouch along with the silica gel placed inside for about two weeks.
General Description
CD HBsAg is an in vitro diagnostic kit for the detection of hepatitis B surface antigen (HBsAg) in human serum or plasma.


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Prognostic value of chronic hepatitis B virus infection in patients with breast cancer in a hepatitis B virus endemic area


Authors: Xiao, Weikai; Zhou, Ying; Yu, Ping; Yang, Anli; Zheng, Shaoquan; Tang, Hailin; Xie, Xiaoming

Background: Except for hepatocellular carcinoma, chronic hepatitis B virus (HBV) infection has also been reported to be associated with increased morbidity and mortality of other cancers. However, the impact of chronic HBV infection on the prognosis of breast cancer (BC) remains unclear. Our study aimed to evaluate the prognostic value of HBV infection for BC in an endemic area of HBV in China. Methods: There was a total of 1,904 patients with early BC who underwent mastectomy or breast-conserving surgery enrolled in our study. HBV infection on overall survival (OS) and hepatic metastasis-free survival (I IMFS) was the main research indicator for this study. Results: A total of 212 patients (11.1%) were identified with chronic HBV infection due to serum hepatitis B surface antigen (H BsAg) positive. HBsAg-positive patients had inferior OS (84.9% vs. 90.4%, P=0.005) and HMFS (92.5% vs. 97.1%, P=0.016) at 5 years than HBsAg-negative patients. Chronic HBV infection was an independent predictor of poor OS in patients with BC [multivariate analysis; hazard ratio (I IR), 1.52; P=0.038], but not for HMFS. Subgroup analysis showed that chronic HBV infection was an unfavorable independent prognostic factor for OS in patients with stage II/III BC (HR, 1.59; P=0.025). The 5-year OS and HMFS rates of HBsAg-positive patients were 81.9% and 90.5% for patients with stage II/III BC, while those rates of HBsAg-negative patients were 88.5% and 96.3%, respectively. In stage I patients, there was no significant difference in 5-year OS (95.8% vs. 97.1%; P=0.629) and HMFS (100.0% vs. 99.0%; P=0.447). Conclusions: In conclusion, chronic HBV infection predicts a worse prognosis in patients with stage BC, but not stage I BC.

Quasispecies characteristic in "a" determinant region is a potential predictor for the risk of immunoprophylaxis failure of mother-to-child-transmission of sub-genotype C2 hepatitis B virus: a prospective nested case-control study


Authors: Xiao, Yiwei; Sun, Kuixia; Duan, Zhongping; Liu, Zhixiu; Li, Yi; Yan, Ling; Song, Yarong; Zou, Huaibin; Zhuang, Hui; Wang, Jie; Li, Jie

Objective This study was performed to explore the correlation between the characteristics of hepatitis B virus (HBV) quasispecies in HBV-infected pregnant women and the risk of immunoprophylaxis failure for their infants. Design In this prospective nested case-control study, the characteristics of HBV quasispecies in mothers whose infants were immunoprophylaxis success (control group) and those whose infants were immunoprophylaxis failure (case group) were analysed by the clone-based sequencing of full-length HBV genome and next-generation sequencing (NGS) of "a" determinant region, and were compared between the two groups. Results The quasispecies characteristics including mutant frequency, Shannon entropy and mean genetic distance at amino acid level of "a" determinant region were significantly lower in case group than that in control group, using the full-length HBV genome clone-based sequencing assay. These results were confirmed by NGS assay. Notably, we discovered that the differences were also significant at nucleotide level by NGS assay. Furthermore, the risk of immunoprophylaxis failure could be predicted by analysing the three HBV quasispecies characteristics either at nucleotide level or at amino acid level of "a" determinant region, and the corresponding predictive values were tentatively set up. Conclusions HBV quasispecies with a more complex mutant spectrum in "a" determinant region might be more vulnerable to extinct through mother-to-child-transmission (MTCT). More importantly, analysing HBV quasispecies characteristics in pregnant women with high HBV DNA load might be helpful to predict the high-risk population of immunoprophylaxis failure, and consequently provide accurate intervention against MTCT of HBV.

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