Hepatitis B is an infectious disease caused by the hepatitis B virus (HBV). To address the challenges in diagnosing hepatitis B, our company invests in advanced technologies and skilled professionals, dedicated to the development of IVD solutions. Our innovative diagnostic kits and equipment will significantly enhance the sensitivity, specificity, and stability of testing.
Overview of Hepatitis B
Hepatitis B, a viral infection that impacts the liver, imposes a substantial worldwide health challenge. Referred to as HBV, this virus can result in either acute or chronic hepatitis, potentially inducing significant liver harm gradually. Although less prevalent in the United States due to successful vaccination initiatives, Hepatitis B continues to be a significant health issue in areas with elevated infection rates. Hence, it is imperative to create precise and effective diagnostic methods for timely identification and successful therapeutics of this contagious illness.
Fig. 1 Pathogenesis of Hepatitis B. (Schollmeier A, et al., 2023)
Diagnostic Biomarkers for Hepatitis B
Diagnostic biomarkers are fundamental components in the identification and control of hepatitis B (HBV) infection. These markers, which are quantifiable signals, are essential for the timely detection, surveillance, and evaluation of the advancement of the disease.
Hepatitis B Surface Antigen (HBsAg)
This antigen is one of the first markers to appear during acute HBV infection and persists during chronic infection. Its presence indicates active viral replication.
Hepatitis B Core Antibody (Anti-HBc)
This antibody appears shortly after HBsAg and signifies previous or ongoing HBV infection. It is useful in identifying past exposure.
HBV DNA
Direct measurement of HBV DNA levels in the blood provides information on viral replication activity and helps monitor treatment response and disease progression.
Alanine Aminotransferase (ALT)
Elevated levels of ALT in the blood indicate liver inflammation and damage, often associated with acute or chronic HBV infection.
IVD Development for Hepatitis B
In the realm of hepatitis B diagnosis, in vitro diagnostic (IVD) kits are meticulously crafted to precisely and swiftly identify specific HBV markers in samples, aiding in the prompt diagnosis and vigilant monitoring of the disease. An array of potential IVD kits that can be developed for hepatitis B diagnosis include:
|
Kits |
Applications |
Detection Methods |
| HBsAg Rapid Test Kits |
These kits are designed to detect HBsAg in blood or serum samples, indicating active HBV infection. |
Immunoassay |
| Anti-HBc Antibody Detection Kits |
Targeting Anti-HBc, these kits can identify past or ongoing HBV infection in individuals. |
ELISA |
| HBV DNA Quantification Kits |
These kits enable the quantification of HBV DNA levels in samples, providing information on viral load. |
PCR |
| ALT Measurement Kits |
Kits measuring ALT levels can help in evaluating liver inflammation and damage associated with HBV infection. |
Enzyme kinetics assay |
| Point-of-Care Testing (POCT) Kits |
Rapid POCT kits for HBV can be developed for use in resource-limited settings, enabling quick diagnosis and immediate therapeutic decisions. |
Immunoassay or nucleic acid amplification technique |
Our Services
Our company is dedicated to pioneering inventive IVD solutions that precisely pinpoint and effectively control hepatitis B. Our services encompass the development of IVD kits for detecting antigens, antibodies, DNA, disease-linked metabolites and microorganisms. Our mission is to transform the landscape of hepatitis B diagnosis through the innovation of state-of-the-art IVD products.
IVD Product Development Services
Recognizing the importance of point-of-care testing (POCT) in resource-limited settings, our scientists excel in developing rapid diagnostic tests for on-site hepatitis B detection. Our companion diagnostic development service focuses on integrating diagnostic tests with specific therapies to achieve personalized therapeutics for hepatitis B management.
If you are interested in our services, please feel free to contact us for more details and quotation information of related services.
Reference
- Schollmeier A, Glitscher M, Hildt E. Relevance of HBx for hepatitis B virus-associated pathogenesis[J]. International Journal of Molecular Sciences, 2023, 24(5): 4964.
All of our services and products are intended for preclinical research use
only and cannot be used to diagnose, treat or manage patients.
