Viral hepatitis poses a significant global health burden,with chronic hepatitis B and C causing about 1 million annual deaths from liver cancer and cirrhosis.Over 1.5 million new hepatitis C virus(HCV)cases arise year...Viral hepatitis poses a significant global health burden,with chronic hepatitis B and C causing about 1 million annual deaths from liver cancer and cirrhosis.Over 1.5 million new hepatitis C virus(HCV)cases arise yearly,especially among vulnerable groups like American Indians and Alaska Natives(AI/AN).Despite effective direct-acting antivirals,early HCV diagnosis remains challenging,particularly in resource-limited settings.Current twostep testing methods are costly and prone to patient dropout.Point-of-care(POC)HCV antigen(Ag)testing offers a promising early detection approach,but no US Food and Drug Administration(FDA)-approved POC test meets the sensitivity and specificity needed for low viral loads.To address this,we developed a fully automated bioluminescence-based POC assay using a cascade-based signal amplification strategy.Evaluated on 71 AI/AN samples,it showed 97%sensitivity,94%specificity,and 96%accuracy.This technology can improve health equity by enabling accessible and reliable HCV testing for disproportionately affected populations.展开更多
基金supported by the National Institutes of Health under award numbers R01AI187513,R01EB033866,R01AI138800,R01AI138800-05S1,U54HL119145,R01HD115677,R33AI140489,and R61AI140489,all to H.S.
文摘Viral hepatitis poses a significant global health burden,with chronic hepatitis B and C causing about 1 million annual deaths from liver cancer and cirrhosis.Over 1.5 million new hepatitis C virus(HCV)cases arise yearly,especially among vulnerable groups like American Indians and Alaska Natives(AI/AN).Despite effective direct-acting antivirals,early HCV diagnosis remains challenging,particularly in resource-limited settings.Current twostep testing methods are costly and prone to patient dropout.Point-of-care(POC)HCV antigen(Ag)testing offers a promising early detection approach,but no US Food and Drug Administration(FDA)-approved POC test meets the sensitivity and specificity needed for low viral loads.To address this,we developed a fully automated bioluminescence-based POC assay using a cascade-based signal amplification strategy.Evaluated on 71 AI/AN samples,it showed 97%sensitivity,94%specificity,and 96%accuracy.This technology can improve health equity by enabling accessible and reliable HCV testing for disproportionately affected populations.
