Detection and Quantification of Hepatitis B Virus Infection with Biosensor based on Imaging Ellipsometry

摘要

The concept of biosensor with imaging ellipsometry was proposed over ten years ago, and its application has been extended to a broad range of various biological systems. Here, it was used for popular serological marker detection as a trial for clinic purpose. For the detection of Hepatitis B virus surface antigen (HBsAg), a low concentration 1 ng/ml of HBsAg was achieved with the biosensor, which proved to fulfill the requirements of clinic in principle. However, the technique without a standard cut-off point has not been used in clinical diagnosis of HBsAg yet. In order to set up the cut-off point, the receiver operating characteristic (ROC) analysis was introduced to the high sensitive biosensor. The biosensor flexibility for detecting HBsAg as a clinical diagnosis was investigated and compared with a diagnosis standard of ELISA. Fifty serum samples have been detected, in which the results of forty-six sera were in good agreement with ELISA's. The ROC analysis for the biosensor detection of HBsAg was quantitatively plotted and the area under the curve (AUC) was up to 0.935. The cut-off point optimized from the ROC curve was 0.118, where the sensitivity and the specificity were 0.923 and 0.982, respectively. The combination of the biosensor detection of HBsAg and the ROC analysis presented a potential for a clinical test of HBsAg.