A rapid and sensitive recombinase aided amplification assay to detect hepatitis B virus without DNA extraction-CDC

Background: Hepatitis B virus (HBv) infection is the major public health problem worldwide. in clinical practiceserological and molecular assays are the most commonly used diagnostic methods to detect HBV infection inclinical practices
Methods: Here we present a rapid and sensitive recombinase aided amplification assay (RAA) to detect HBV at39.0 'c for 30 min without DNA extraction from serum samples. The analytical sensitivity of RAA assay was 100copies per reaction and showed no cross reaction with human immunodeficiency virus (Hiv) and hepatitis C virus(HCV). The universality of RAA assay was validated by testing of 41 archived serum samples with predefined HBVgenotypes (B, C and D).
Results: A total of 130 archived suspected HBV infected serum samples were detected by commercial gPcR withDNA extraction and RAA assay without DNA extraction (heat-treatment). Compared with gPCR assay as areference, the RAA assay obtained 95.796 sensitivity and 10096 specificity and a kappa value of 0.81 8.

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