Evaluation of C-C Motif Chemokine Receptor 5 (CCR5) as a Sample Adequacy Control in HPV Molecular Diagnostics

<b>Background:</b> Reliable Human Papillomavirus (HPV) testing and genotyping are essential for quality assurance in HPV-based primary screening, disease management and for monitoring the impact of HPV vaccination. The clinical validation of HPV molecular diagnostic assays has significantly contributed to these objectives; however, little emphasis has been placed on assuring sample quality. This study aimed to evaluate the accuracy of sample cellularity assessment using the <i>C-C Motif Chemokine Receptor 5</i> (<i>CCR5</i>) gene target as a marker of sample adequacy in molecular diagnostics. <b>Methods:</b> Jurkat cell line samples were counted using both a Thoma cell-counting chamber and Fluorescence-Activated Cell Sorting (FACS). Jurkat cell line samples at three different concentrations were subsequently evaluated using the OncoPredict HPV Quality Control (QC) real-time PCR assay, employing <i>CCR5</i> for molecular cellularity quantification. <b>Results:</b> The cellularity values obtained were comparable across the three different methods for all dilutions of the cell line tested. <b>Conclusions</b>: The results obtained from this study show that <i>CCR5</i> represents a promising molecular marker for the accurate quantification of sample cellularity, confirming its use as a reliable sample adequacy control, thus reducing the risk of "false-negative" results.