Clinical Evaluation of a Commercial Real-Time PCR Kit for Diagnosis of Acute Dengue Infection

Dengue virus (DENV), a mosquito-borne flavivirus, has emerged as a major global public health concern, with outbreaks occurring with increasing frequency worldwide, including in India. Laboratory confirmation is essential for accurate diagnosis, effective clinical management, and timely public health response. Real-time PCR (RT-PCR) is recognized as a sensitive and specific method for early diagnosis. This study evaluated the performance of the NeoDX Dengue Virus Screening Real-Time PCR Kit (NeoDX, Bengaluru, India), a pan-DENV assay, against the Centers for Disease Control and Prevention (CDC) DENV-1-4 RT-PCR assay. RNA extracted from 51 sera, obtained from suspected dengue cases, was tested by both assays. Of the 51 samples, 23 were positive by the CDC assay (DENV-1: 6, DENV-2: 4, DENV-3: 10, DEN-4: 3). The NeoDX Dengue Virus Screening Real-Time PCR detected 24 positive samples, including all 23 positive samples by CDC assay, yielding a sensitivity of 100% and specificity of 96.4%. The kappa value (0.961; 95% confidence interval: 0.88-1.0) indicated very good agreement, supporting NeoDX Dengue Virus Screening Real-Time PCR as a reliable assay for early DENV detection.