Comparative Evaluation of HPV PLUS ELITe MGB® and Allplex™ HPV HR Assays for High-Risk Human Papillomavirus...

To compare the performance of the HPV PLUS ELITe MGB® (ELITechGroup) and Allplex™ HPV HR (Seegene) assays for the detection and genotyping of high-risk HPV (HR-HPV) in cervical samples. HPV typing results using both techniques were obtained for 491/500 cervical samples. The ELITe assay provides individual detection of HPV16, 18, 31 and 45, and pooled detection of other HR-HPV into HR1 (33/52/58) and HR2 (35/39/51/56/59/66/68), whereas the Allplex™ assay provides individual detection of all HR-HPV types. Cytological data were available for 283 samples. Concordance, percent agreements, and kappa coefficient were calculated. Ct values, discordances, and associations with cytology were analyzed. Overall agreement was 88.6% (κ = 0.77, substantial). HPV DNA was detected in 40.5% (199/491) of samples with the ELITe assay and 47.9% (235/491) with the Allplex™ assay. The Allplex™ assay showed significantly higher detection than the ELITe assay for HPV16 (50 vs. 36), HPV18 (37 vs. 26), and HR1 genotypes (66 vs. 48, particularly HPV52). Most ELITe - /Allplex+ cases occurred in NILM and ASCUS samples (58% showing Ct ≤ 35), but with no significant difference regardless of cytology. The Allplex™ assay demonstrated higher analytical sensitivity for clinically relevant genotypes. This increased detection could reflect earlier identification before lesion onset or, conversely, detection of transient infections of uncertain clinical relevance, underscoring the need to balance analytical performance with clinical utility.