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.