A Biotechnological Review of Potential Patents for Serological Diagnosis of Hepatitis Delta Virus.

Delta hepatitis, caused by the Hepatitis Delta Virus (HDV), is considered a satellite virus as it uses proteins from the hepatitis B virus for its assembly and release. Currently, serological and molecular tests are available for the diagnosis of HDV, with limitations such as standardization, for molecular tests, a short detection window in the acute phase, and the formation of antigen-antibody complexes during the chronic phase, for serological tests, which can cause variability in sensitivity and specificity values. Furthermore, molecular tests are more expensive and require specialized infrastructure as compared to serological tests. Due to these limitations, studies focused on the development of diagnostic tests are crucial, and the commercialization of these tests would help fill existing gaps in the detection and management of the disease. However, despite the severity of the disease and the limitations of diagnostic tests, publications, such as articles and patents using serological diagnosis, are scarce. Literature reviews are fundamental for disseminating information, describing advances related to the topic and its difficulties, and fostering academic and commercial interest among researchers. Therefore, the objective of this review is to explore patent databases for serological diagnostic technologies for HDV infection. The results identified only nine patents related to serological diagnosis. Most of these patents showed promising results, achieving a sensitivity and specificity above 90%. However, the small number of registered patents highlights the need for greater investment and partnerships to boost research, validate technologies, and facilitate the commercialization of tests.