Clinical validation of the Cervista^® high-risk human papillomavirus test in Chinese women from Fujian province: a cross-sectional study

Abstract

PurposeTo estimate the high-risk human papillomavirus (HR-HPV) prevalence in a hospital-based population using the Cervista® and to determine the clinical value and significance of Cervista for cervical cancer screening in Fujian Province, China.Patients and methodsIn a hospital-based population, a total of 10,771 women from the Fujian Province were screened for cervical cancer and precancerous lesions using the thinprep cytologic test (TCT) and/or the Cervista. Women with HR-HPV infection and/or abnormal TCT were referred for colposcopy and biopsy. Pathological diagnosis was used as the gold standard.ResultsThe overall HR-HPV prevalence was 16.57%. Among 10,229 cases, 976 had abnormal cytology results, of which, the HR-HPV positivity rate was 60.35% in this opportunistic screening population. The most common HR-HPV infection style was a simple infection. The most common species was A9 which was also the most prevalent species in all age. The women with CIN2+ (high-grade squamous intraepithelial lesion [HSIL]), especially cancer, were mostly concentrated in the age from 51 to 60 years old. The peak of CIN1 (low-grade squamous intraepithelial lesion, LSIL) prevalence was in the women aged 31–40. When using CIN1+, CIN2+ and CIN3+ as observed endpoints, the sensitivities were 86.07%, 92.73%, and 93.30% and negative likelihood ratio (NPV) were 99.15%, 99.75% and 99.83%, respectively. Cervista and TCT co-testing achieved the highest sensitivity and the lowest NLR.ConclusionThe Cervista could be easily introduced in clinical practice in combination with TCT for cervical cancer screening in China. Patients with species A9 infection require a more actively clinical intervention.

Evaluation of p16/Ki‐67 dual‐stain as triage test for high‐risk HPV‐positive women: A hospital‐based cross‐sectional study

“…It is well known that HPV‐16 and HPV‐18 are the predominant high‐risk types found in cervical cancer worldwide, whereas the prevalence of the other high‐risk HPV types may show geographical and regional variation. According to our data, the most common types of HPV in Shenzhen, a city in the southeast of China with a population of 18 million, were HPV‐52, 53, 16, 58, and 51, whereas HPV‐35, 45, 73, and 82 were consistently the least frequently detected (Figure 2), which were consistent with the data from single‐center or multicenter studies in China 30,32 …”

“…According to our data, the most common types of HPV in Shenzhen, a city in the southeast of China with a population of 18 million, were HPV-52, 53, 16, 58, and 51, whereas HPV-35, 45, 73, and 82 were consistently the least frequently detected (Figure 2), which were consistent with the data from single-center or multicenter studies in China. 30,32 In this cohort of patients, the highest HPV prevalence (13.52%) was found in women older than 50 years of age, which was discordant from the results reported in many studies, as the prevalence of HPV infection was higher at younger age and decreased with age. Reasons for such conflicting results remain unclear but the most possible explanation could be the opportunistic screening program in which women tend to participate at a later age.…”

“…31 In another hospital-based population, a total of 10,771 women from the Fujian Province underwent the Cervista HPV HR test (Hologic) and the overall high-risk HPV prevalence was 16.57%. 32 In a cervical screening program of 8556 healthy volunteers in Peking University Shenzhen Hospital (Shenzhen, China) between April 2009 and April 2010, the HPV prevalence was 13.6% by the HC2 method and 11.1% by the Cervista HPV HR test (Hologic). 33 In the present study, a total of 100,801 women were evaluated by HPV DNA test and overall high-risk HPV prevalence was 10.42% (10,500 of 100,801), during the 3-year study period from March 2018 to December 2020.…”

“…Meanwhile, another clinical trial with 60,732 women, across 20 primary health care centers in urban and rural areas of China, reported that the high‐risk HPV prevalence was 9.5% for urban women and 12.7% for rural women 31 . In another hospital‐based population, a total of 10,771 women from the Fujian Province underwent the Cervista HPV HR test (Hologic) and the overall high‐risk HPV prevalence was 16.57% 32 . In a cervical screening program of 8556 healthy volunteers in Peking University Shenzhen Hospital (Shenzhen, China) between April 2009 and April 2010, the HPV prevalence was 13.6% by the HC2 method and 11.1% by the Cervista HPV HR test (Hologic) 33 .…”

Cost-effectiveness and accuracy of cervical cancer screening with a high-risk HPV genotyping assay vs a nongenotyping assay in China: an observational cohort study

“…The detailed experimental procedures of the Cervista ® HR-HPV assay can be found online ( https://www.hologic.com/sites/default/files/package-insert/15-3100_105_01.pdf ). Our study and previous studies [ 21 , 22 ] have demonstrated that the Cervista ® HR-HPV assay is an effective HR-HPV detection method.…”