Introduction

During the acute phase of infection with Hepatitis B Virus (HBV) and the initial period of chronic infection, DNA is episomally (free or extrachromosomal) and replicates in hepatocytes producing among other virions, DNA polymerase and virus surface antigen (HBsAg).

Objective

Validate an ELISA to quantify HBsAg levels in patients with chronic hepatitis B.

Method

An experimental study of technological developmentwas conducted. The normalization and validation of heterogeneous double antibody enzyme linked inmunoassay for quantitation of HBsAg in human sera was carried out. 115 serum samples from patients with chronic hepatitis B with viral load results were correlated with its HBsAg concentrations.

Results and discussion

The developed method presented variation coefficients intra and interassay of 9.8 and 13.2% respectively. The working range was estimated between 0.15 and 60 ng/mL. The recovery rate was between 90 and 110% and the linear fit of the standard curve presented a determination coefficient greater than 0, 99. The correlation between the DNA levels and HBsAg concentration was 62.5%.

Conclusions

The assessment of the ELISA for quantitation of HBsAg developed in the laboratory showed that it achieved validation parameters for its clinical use.