By now, molecular diagnostics of HPV is not implemented in cervical cancer screening program in Russian Federation. Nonetheless, HPV testing becomes more and more popular among clinicians, gynecologists and oncologists. Thus, need for modern screening test consistent with new scientific data and acceptable under restricted conditions has emerged.
“AmpliSens HPV HCR screen-titr–14-FL” assay allows quantifying of 14 most oncogenic HPV types with simultaneous typing of 16, 18, and 45 types in one tube. By amplifying two HPV genome region (E1/E6) the assay can distinguish non-integrated and fully integrated forms of 16, 18 and 45 types.
For clinical validation 900 samples were tested in compare to HC2 test (Qiagen). Among them 100 specimens diagnosed HSIL/CC and 800 – NILM/LSIL. Besides them, 6246 samples were tested to establish clinically meaningful cutoff based on HPV viral load. The samples were obtained during screening testing in commercial laboratories and oncological centers of Russian Federation.
Considering samples tested against comparator test there was 97.7% overall agreement, an 96.4% positive agreement, kappa value 0.94 (95% CI 0.92 – 0.96). Negative cytology specimens showed 97.8% overall agreement, 93.3% positive agreement, kappa value 0.93 (95% CI 0.89 – 0.96). For abnormal cytology (only 45 specimens) there was 97.7% overall agreement, 100% positive agreement, kappa value 0.95 (95% CI 0.87 – 1).
Considering clinical samples, specimens with HSIL/CC diagnose have mean viral load 5.9lg (CI 95% 4.8 – 7.0). In 228 NILM/LSIL samples mean viral load was 4.5 lg (CI 95% 2.1-6.9 lg). The cutoff was established by 3.0 lg per 105 epithelial cells with clinical sensitivity 98.6% (CI 95% 88.8 – 98.6) and clinical specificity 87.5% (CI 95% 85.2-89.9).