Background & Objective: Accurate identification of dengue virus (DENV) serotypes is essential for clinical management and epidemiological surveillance, especially in hyper endemic regions where co-infections are increasingly reported. While serological assays are limited in serotype differentiation, RT-PCR-based diagnostics offer both sensitivity and specificity. This study evaluated the diagnostic performance of three commercially available RT-PCR-based dengue serotyping kits in detecting and differentiating among the four DENV serotypes in clinical serum samples.
Method: A total of 80 serum samples (40 NS1-positives and 40 negatives by CLIA) were tested using each kit. Assay performance was assessed in terms of sensitivity, specificity and overall agreement using MedCalc software. Ct values were analyzed to compare relative analytical sensitivity.
Results: All three kits showed high specificity and comparable sensitivity, with TRUST gen-DS demonstrating 100% agreement with NS1-positive samples. Variability in DENV-1 and DENV-2 detection and co-infection patterns was observed across kits, likely due to differences in assay design and analytical stringency. Ct value distributions were not significantly different among kits.
Conclusion: All three kits show promise for routine clinical and surveillance use. However, standardized molecular diagnostics with high analytical sensitivity are crucial for reliably detecting co-infections and ensuring accurate serotype surveillance. Further validation against sequencing-based methods in larger datasets is recommended.
Keywords: Dengue virus serotype, Real Time RT-PCR, Sensitivity, Specificity, Overall Agreement, Co-infection
Citation: S. Ramanthan et.al.,(2025). Assessing the Diagnostic Accuracy of Three RT-PCR Kits for Dengue Virus Serotyping and Co-infection Identification in Clinical Samples. I J Infectious Disea 6(3):1-7.
DOI : https://doi.org/10.47485/2693-2326.1041