HBV DNA assay using PCR-microfluidic chips for blood screening / 中国输血杂志

ABSTRACT

Objective To test HBV DNA by using PCR-microfluidic chip assay. Methods Pooled sera ( 5?50ul ) negative for ELISA serological tests were tested for HBV DNA using PCR-microfluidic chips assay. Individual donor samples were tested if the pooled sera were positive. The sensitivity of PCR-microfluidic chips assay was determined by serial dilutions of the standard control serum. The specificity of PCR-microfludic chips assay was also determined by testing 56 various serum samples. Serial dilutions of the standard control sera were tested repeatedly for understanding the inter- and intra-assay variation of this method. Results Seven of 545 nonrenumerated donors (1.28%) were found positive for HBV DNA. The sensitivity of PCR-microfluidic chips assay was 4.81?102copies/ml. The HBV DNA was positive for all 37 samples from HBeAg positive patients. The HBV DNA tests of samples from HCV RNA positive patients, anti-HAV IgM positive patients were all negative. The inter- and intra assay CV ranges were 15.6%~40.2% and 11.9%~30.6% respectively. Conclusion It is necessary to test HBV DNA for improving blood safety and it is feasible to test pooled serum samples for HBV DNA by PCR-microfluidic chips assay, because it is convenient, time-saving, sensitive, specific and the results are reproducible.