Abstract
Quantitative hepatitis B core antigen (anti-HBc) measurements could play an important role in evaluating therapeutic outcomes and optimizing the antiviral therapy of chronic hepatitis B infection. In this study, we have developed a simple and rapid fluorescence point-of-care test based on a lateral flow immunoassay (LFIA) method integrated with Eu (III) chelate microparticles to quantitatively determine anti-HBc concentrations in serum. This assay is based on a direct competitive immunoassay performed on lateral flow test strips with an assay time of 15 min. The Eu (III) chelate microparticle-based LFIA assay could quantitatively detect anti-HBc levels with a limit of detection of 0.31 IU mL−1, and exhibited a wide linear range (0.63–640 IU mL−1). The intra- and inter-assay coefficients of variation for anti-HBc were both less than 10% and a satisfactory dilution test and accuracy were demonstrated. There were no statistically significant differences in sensitivity or specificity in serum samples between the Eu (III) chelate microparticle-based LFIA strips and the Abbott Architect kit. A simple, rapid and effective quantitative detection of anti-HBc was possible using the Eu (III) chelate microparticle-based LFIA strips. The strips will provide diagnostic value for clinical application.
Highlights
Hepatitis B virus (HBV) infection is a global public health problem, which has a wide range of clinical consequences, from acute and chronic infection to severe chronic liver disease, including cirrhosis and hepatocellular carcinoma[1,2,3]
We reported that lateral flow immunoassay (LFIA) based Polystyrene Eu (III) chelate microparticles could be used for quantitative detection of AFP and creatine kinase MB23,24
With the aid of the capillarity of the absorbent pad, the sample buffer containing anti-HBc was added onto the sample pad and the conjugates of CM-EUs with anti-Hepatitis B core antigen (HBcAg) monoclonal antibody (McAb) migrated across the NC membrane and reacted with the HBcAg on the test line while the conjugates of CM-EUs with Rabbit IgG (RIgG) were captured by anti-RIgG coated on the control line, resulting in a fluorescent band on the test and control lines, respectively
Summary
Hepatitis B virus (HBV) infection is a global public health problem, which has a wide range of clinical consequences, from acute and chronic infection to severe chronic liver disease, including cirrhosis and hepatocellular carcinoma[1,2,3]. QAnti-HBc could be useful as a marker of HBV-induced liver-disease to discriminate between major phases of chronic HBV infection and to predict a sustained response to antiviral therapies[10]. Measurements could play an important role in diagnosing, evaluating therapeutic outcomes and optimizing the antiviral therapy of CHB They will help to create a deeper understanding of the natural course of CHB. We reported that LFIA based Polystyrene Eu (III) chelate microparticles could be used for quantitative detection of AFP and creatine kinase MB23,24. Like most commercially available anti-HBc kits that adopt a competitive format, we used carboxylate-modified polystyrene Eu (III) chelate microparticles (CM-EUs) as a reporter to establish a direct competitive LFIA system for the detection of qAnti-HBc in human serum. The experimental results show that the proposed method is highly suited for the quantitative analysis of anti-HBc levels
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