Investigator
Unknown Institution
Clinical Performance of HPV DNA and HPV RNA Assays for the Detection of High-Grade Cervical Lesions.
Objective The aim of this study was to evaluate the clinical performance of 2 DNA-based assays (DNA-xGT, DNA-lGT) and 1 RNA-based assay (mRNA), using specimens from women with cervical carcinoma or high-grade cervical lesions (≥CIN3). Methods Liquid-based cytology samples collected from 154 patients with ≥CIN3 histology results were tested with DNA-xGT, DNA-lGT, and mRNA assays. The clinical sensitivities of the HPV testing for disease detection were evaluated. Genotype-specific agreement was also assessed between the assays. Results The clinical sensitivity of the DNA-xGT, DNA-lGT, and mRNA in detecting ≥CIN3 were 96.8%, 96.1%, and 91.6%, respectively. The overall high-risk HPV positive percent agreement ranged from 92.6% to 99.3% across different assay pairs analyzed. Composite comparator analysis demonstrated no significant difference between the DNA assays; however, a significant difference was observed between the RNA assay and the DNA assays. Conclusions While no statistically significant difference was observed between DNA-xGT and DNA-lGT assays in disease detection rate, the mRNA test showed a significantly lower detection rate when compared to the DNA-xGT assay. Most of the missed infections (8/13) were identified as HPV16 or HPV18.
Comparative clinical performance of Alinity m HR HPV, cobas 4800 HPV, and cobas 6800 HPV for cervical cancer screening
ABSTRACT Primary high-risk human papillomavirus (HPV) testing is recommended for cervical cancer screening due to its sensitivity and high negative predictive value. Most of the cervical cancers are caused by HPV16 and HPV18, and their presence has been used to guide patient management. Here, we compared the clinical performance of the Alinity m HR HPV, cobas 4800 HPV, and cobas 6800 HPV assays in the context of cervical cancer screening. Clinical sensitivity and specificity were evaluated with 125 ≥CIN3 (cervical intraepithelial neoplasia grade 3) cases and 244 controls (≤CIN1). The genotype agreements between the assays were also evaluated for the case and control groups. The clinical sensitivities were 96.0% for Alinity m and cobas 6800 assays, and 95.2% for cobas 4800 assay. The clinical specificities observed were 67.6%, 68.0%, and 68.4% for Alinity m, cobas 6800, and cobas 4800 assays, respectively. Overall, the three HPV assays demonstrated similar clinical performance. In the ≥CIN3 group, genotype-specific positive agreement was ≥98.4% between Alinity m and cobas 4800 assays, and ≥85.7% between cobas 6800 and cobas 4800 assays. In the ≤CIN1 group, overall positive agreement among the three assays was ≥94.8%. This study showed similar clinical sensitivity and specificity for Alinity m HR HPV, cobas 4800 HPV, and cobas 6800 HPV assays. Alinity m was more specific in detecting HPV16 and HPV18, which could reduce unnecessary immediate referrals of women to colposcopy. IMPORTANCE This study provides evidence that the Alinity m HR human papillomavirus (HPV) assay has similar clinical performance in comparison with the cobas 4800 HPV and cobas 6800 HPV, two widely used tests. Validation of HPV assays in a clinical setting is crucial to ensure that they can provide a balanced sensitivity and specificity for detecting high-grade cervical intraepithelial neoplasia, potentially improving patient management by enabling proper follow-up or treatment and avoiding unnecessary procedures.
