Development and validation of streamlined serodiagnosis of hepatitis delta virus

초록

Hepatitis Delta virus (HDV), the most severe form of viral hepatitis in humans, exacerbates the liver disease caused by hepatitis B virus. Despite an estimated global prevalence of 12 - 20 million, HDV infections often go under-diagnosed due to insufficient training, testing, and funding. To address this challenge, we developed and validated anti-HDV antibody rapid diagnostics test (anti-HDV Ab RDT). The anti-HDV Ab RDT utilizes a defectfree bi-layer lipid membrane which enhances biofouling resistance, minimizing non-specific binding and significantly increasing the sensitivity of molecular detection. The total population of 1007 encompasses 548 HDV-RNA or anti-HDV Ab positives, 138 HDV-RNA negative but HBsAg positives, and 321 healthy participants. To increase the validity of the results, 702 samples were randomized prior to testing. For these samples, a blinded testing protocol was utilized. Results were recorded by photo at all minute marks. The anti-HDV Ab RDT demonstrated high performance with 547 true positives, 445 true negatives, 14 false positives, and 1 false negative sample, resulting in sensitivity of 99.8 % (95 % CI: 98.9-99.9 %), specificity of 96.9 % (95 % CI: 94.9-98.1 %), and an accuracy of 98.5 % when compared to reference tests. In conclusion, the anti-HDV Ab RDT emerges as an accessible, reliable tool for screening and diagnosis. Its high sensitivity and specificity make the anti-HDV Ab RDT an invaluable tool for both individual patient care and broader public health initiatives.

키워드