Development and validation of streamlined serodiagnosis of hepatitis delta virus

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 defect-free 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.