Detection Of High-grade Cervical Neoplasia Research Articles

Detection of high-grade cervical neoplasia using extended genotyping: Performance data from the longitudinal phase of the Onclarity trial

ObjectivesThe Onclarity cervical cancer screening trial was designed to establish the clinical validity of the Onclarity HPV assay for extended genotyping (xGT) during detection of high-grade cervical neoplasia grades 2 or 3 (≥CIN2 or ≥CIN3). Here, three-year follow up data is presented to evaluate the overall efficacy of these screening strategies, compared to the baseline data. MethodsAt baseline 29,513 women, ≥25 years, had evaluable cytology and valid high-risk HPV results. Women with atypical squamous cells-undetermined significance or worse cytology or a positive HPV test were referred for colposcopy/biopsy. Participants that did not reach the study end point (treatment for ≥CIN2) continued into the longitudinal phase that included the same protocol as baseline. ResultsThe three-year cumulative incident risk (CIR) for ≥CIN3 in HPV-negative women was 0.15% [95%CI: 0.06, 0.26] and for HPV- and cytology-negative women was 0.12% [95% CI: 0.03,0.23]. HPV16 carried the highest baseline and three-year ≥CIN3 CIR, followed by HPV31 and HPV18. At least one year of genotype-specific persistence increased ≥CIN3 risk for xGT results compared to genotype non-persistence, HPV clearance, or new infection over the same time period. Risk-based screening with immediate colposcopy for HPV16/18/31 and further xGT triage resulted in better ≥CIN3 sensitivity (79.2% versus 72.3%; relative difference of 6.9 [95%CI: 3.3, 10.4]) and a lower colposcopy/≥CIN3 ratio (9.2 versus 11.2; relative difference of −1.9 [95%CI: −2.6, −1.3]) when compared to primary HPV16/18-based screening. ConclusionsAn HPV-negative result offers the same assurance of no disease over three years of follow up as that offered by a negative co-testing result. xGT facilitates risk-based screening and persistence tracking and can help optimize disease detection during screening without excessive colposcopic procedures.

Comparison of Human Papilloma Virus Testing and Spectroscopy Combined With Cervical Cytology for the Detection of High-grade Cervical Neoplasia

This study compared the performance of cervical cytology plus human papilloma virus testing (Pap + HPV) or cervical spectroscopy (Pap + CS) for identifying high-grade cervical neoplasia in a high-risk population of women referred for colposcopy. Each of 113 subjects underwent spectroscopy, thin-layer cytology, HPV testing, colposcopy, biopsy when indicated, and/or endocervical curettage. Evaluable data for analysis were collected for 102 of the subjects. Sensitivity and specificity were calculated for both strategies. Pap + HPV and Pap + CS achieved equivalent sensitivities (95%) for high-grade lesions, with both detecting 17 of 18 histology confirmed cervical intraepithelial neoplasia (CIN) 2+ lesions. Pap + HPV had a specificity of only 27.4% compared with 65.5% for Pap + CS (p < .0001). Spectroscopic interrogation of the cervix is equally sensitive and 2-fold more specific than HPV testing when combined with cervical cytology for identifying high-grade cervical neoplasia.

DNA- versus RNA-based methods for human papillomavirus detection in cervical neoplasia

Objective. To compare DNA-based and mRNA-based methods for detection of high-grade cervical neoplasia in Norway. Methods. HPV prevalence was analyzed in 383 women with positive index cytology, selected from gynecology clinics. All patients were investigated by a new PAP smear, histology, and two commercially available HPV tests: Hybrid Capture II (Digene, Gaithersburg, MD) and the Pre Tect HPV-Proofer (NorChip AS). Cases with positive DNA test and negative mRNA test and cases with high-grade histology and negative HPV tests were retested with PCR and sequencing. We regarded the infection as latent or transient if sequencing revealed an HPV type included in both assays. Results. High-risk HPV was detected in 99.7% of the histological confirmed high-grade lesions (CIN2+) (290/291). The DNA test was positive in 95% (275/291), and the mRNA test was positive in 77% (225/291) of the histological confirmed high-grade lesions. All invasive carcinomas were mRNA positive. The DNA test was significantly more often positive in benign and low-grade lesions, some of which were found to be false positive due to cross-contamination with unrelated types. High-grade histology was detected in 83% of women with normal cytology and positive mRNA test. Latent or transient infections were detected in 11 low-grade and 12 high-grade preinvasive lesions. Sequencing revealed high-risk HPV types included only in the DNA test in 35 high-grade preinvasive lesions, HPV 52 and 58 were the most prevalent HPV types. Conclusions. These HPV tests have the potential to improve the detection rate of high-grade cervical neoplasia, with some limitations. The mRNA test seems to be more appropriate for risk-evaluation. Larger scale, population based studies are necessary to evaluate the predictive values of HPV testing in Norway.

Optical Detection of High-Grade Cervical Neoplasia In Vivo

Optical Detection of High-Grade Cervical Neoplasia In Vivo

Optical detection of high-grade cervical neoplasia in vivo: results of a 604-patient pilot study

Optical detection of high-grade cervical neoplasia in vivo: results of a 604-patient pilot study