Evaluation of the cervista HPV A9 group in screening patients for cervical cancer

Abstract

Objective: To exploit the prevalence of HPV genotypes 52/58 in a Chinese population, we evaluated algorithms that the use the Cervista Assay A9 group for primary cervical cancer screening. Methods: The SHENCCAST II trial database was re-analyzed, focussing on the A9 pool of the Cervista HR-HPV Assay. Results for the detection CIN2þ and CIN3þ were correlated with a genotyping assay (MALDI-TOF) and cervical cytology to explore various screening algorithms. Results: This analysis included 8,556 women with a mean age of 38.9. CIN 2þ rates were 2.7% (233/8556); CIN 3þ rates were 1.7% (141/8556). Overall HPV infection rates were 11.1% (950/8556) for Cervista, in which A5/A6, A7 and A9 groups were 26.5% (227/950), 22.9% (218/950) and 67.8% (644/950), respectively. The HPV A9 group is highly predictive of high-grade cervical lesions (CIN2þ OR¼103.61, CIN3þ OR¼128.059). Sensitivity and specificity for Cervista A9 group for CIN 2þ was 85.4% and 94.7%, and for CIN 3þ 89.4% and 93.8% respectively. Cervista A9 Assay followed by triagec ytology for non-A9 positives has sensitivity and specificity for CIN2þ of 91.5% of 93.5%, and for CIN 3þ 94.3% and 92.6%. Conclusion: Using the Cervista A9 as the primary screen instead of the full Cervista assay, the percentage referred to colposcopy would decrease from 11.1% to 8.8% and percentage requiring cytology would decrease from 11.1% to 3.6%. Sensitivity of detecting CIN 2þ(91.5%), CIN3þ(94.3%) would remain similar to the complete Cervista HR-HPV assay for CIN 2þ(93.1%), CIN3þ(95.0%).