Field applicable detection of hepatitis B virus using internal controlled duplex recombinase‐aided amplification assay and lateral flow dipstick assay（乙肝）-华北理工

Hepatitis B virus (HBV)is a widespread blood-borne pathogen associated withthe complication of liver cirhosis and hepatocellular carcinoma, particularly insouth-east Asian and African countries where HBV is highly endemic and the budgetand resources are limited. Therefore, simple, rapid, and portable field detectionmethods are crucial to efficiently control HBV infection. in this study, using heat-treated DNA, we developed two-field applicable detection assays for HBV based onrecombinase-aided amplification (RAA). One was an intemnal controlled duplex RAAassay using a portable rea-time fluorescence detection device, another was aninstrument-free visual observation assay using lateral flow dipsticks. The entireexperimental time was greatly shortened to less than 40 minutes at 39.0c. Thesensitivities, specificities, and clinical performance of both assays were evaluated.Compared with quantitative polymerase chain reaction assay as a reference, ourresults demonstrated that the two RAA-based assay obtained 97.18% and 95.77%of sensitivity, respectively, and the specificity was 100%, by testing a total of157 serum samples with HBsAg positive. We conclude that the advantages ofrapidity, simplicity, portability, and visualization of proposed two assays make themgreat potentials in point-of-care testing of HBV infection by untrained people inresource-limited situations.

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