A multidisciplinary collaboration between Near East University, Manisa Celal Bayar University, and Kocaeli University has resulted in the successful development of a domestic real-time PCR diagnostic kit designed for the early and accurate detection of Hepatitis D Virus (HDV). This joint project, funded by the Manisa Celal Bayar University Scientific Research Projects Unit and carried out at the DESAM Research Institute’s Kit Production Laboratory, marks a major achievement in molecular diagnostics and exemplifies the growing national capacity for biotechnological innovation.
Hepatitis D Virus (HDV), first identified in the 1970s by Mario Rizzetto in patients positive for Hepatitis B Virus (HBV), remains a major global health concern. Classified within the Kolmioviridae family, HDV possesses a single-stranded, negative-sense circular RNA genome and relies on HBV surface antigens (HBsAg) for replication, making HBV co-infection essential. HDV infection may occur as a co-infection with HBV or as a superinfection in chronic HBV carriers. The presence of HDV significantly aggravates the clinical course of Hepatitis B, accelerating progression toward severe liver disease such as cirrhosis and hepatocellular carcinoma.
Early diagnosis of HDV is therefore critical for timely therapeutic intervention. Detecting the virus before the onset of severe hepatic inflammation allows clinicians to implement appropriate treatment strategies and control disease progression. However, despite its clinical importance, a standardized and widely accessible PCR test for HDV has not yet been established. Most existing diagnostic protocols are two-step assays, requiring prior cDNA synthesis before real-time PCR amplification. This process increases both turnaround time and contamination risk.
The newly developed HDV Real-Time qRT-PCR Diagnostic Kit overcomes these limitations by employing a single-step amplification process, which minimizes contamination risk and reduces analysis time. Furthermore, the use of an HDV-specific probe enhances detection efficiency, offering high sensitivity and specificity in viral RNA identification.
An additional innovative feature of this kit is the integration of the human RP gene as an internal control, which verifies sample integrity and ensures the absence of RNA degradation. From a production perspective, the kit’s domestic design reduces dependency on technology transfer and offers significant cost advantages, aligning with Türkiye’s and the TRNC’s health innovation policies that promote the development of local diagnostic technologies.
This pioneering kit stands out as the first locally developed HDV-specific diagnostic test in the TRNC, holding potential for widespread routine use. Designed to be compatible with standard laboratory workflows, it can compete with limited commercial alternatives while remaining cost-effective and reliable for public health applications.
The project’s success reflects the collective expertise of its research team: Prof. Dr. Kıvanç Günhan, Prof. Dr. H. Seda Vatansever, Prof. Dr. Tamer Şanlıdağ, Prof. Dr. Murat Sayan, Prof. Dr. Sinem Akçalı, Dr. Hilal Kabadayı Ensarioğlu, Dr. Gökçe Akan, Dr. Gülten Tuncel Dereboylu, Dr. Ferdi Çetin, and Melis Kalaycı. Their collaborative effort exemplifies how multidisciplinary approaches can lead to high-impact translational outcomes in biomedical science.
