Anna Daniela Iacobone

Clinical performance assessment of the Papilloplex HR-HPV assay on self-taken urine and vaginal swab samples: findings from a multicentre European study

Aims Given the increasing adoption of self-sampling in cervical cancer screening, it is essential to evaluate the performance of human papillomavirus (HPV) tests in this context. The aim of the present work was to assess the accuracy of the Papilloplex high-risk (HR)-HPV test on self-taken samples. Methods Women provided a clinician-taken cervical sample (CS), a urine sample and a vaginal swab according to the VALidation of HUman papillomavirus assays and collection Devices for Self-samples and urine samples protocol. Relative sensitivity and specificity for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) of the Papilloplex HR-HPV assay on self-taken samples versus CS were assessed. Additionally, type-specific concordance and viral load signals (expressed in Ct (crossing thershold) values) between the two self-taken sample types and the CS were evaluated. Results At the manufacturers’ cut-off, the assay showed a relative clinical sensitivity and specificity for CIN2+of 0.95 (95% CI 0.88 to 1.03) and 0.95 (95% CI 0.88 to 1.03) for urine versus CS. Corresponding values for vaginal samples versus CS were 1.05 (95% CI 1.01 to 1.09) and 0.81 (95% CI 0.74 to 0.89). Cut-off optimisation led to relative sensitivity and specificity that included unity for vaginal swabs. Median Ct values were lower in vaginal swabs versus CS, although higher in urine versus CS samples. No relationship between mean Ct values and disease outcome was observed. Conclusions The clinical sensitivity of the Papilloplex HR-HPV test was similar on self-collected vaginal swabs and urine compared with CS; clinical specificity on urine was similar to CS yet lower on vaginal samples. Cut-off optimisation resulted in a similar assay specificity on vaginal swabs and CS with no significant detriment to sensitivity.

Clinical Performance of OncoPredict HPV Screening Assay on Self‐Collected Vaginal and Urine Specimens Within the VALHUDES Framework

ABSTRACT The introduction of self‐sampling in cervical cancer screening has raised the importance of HPV test validation on self‐collected samples. This study aimed to evaluate the clinical accuracy of the OncoPredict HPV Screening (SCR) assay on self‐collected vaginal and first‐void urine (FVU) samples, relative to cervical specimens, using the VALHUDES Framework. FVU and vaginal self‐samples followed by a clinician‐collected cervical brushing were collected from 500 women referred to colposcopy and tested using OncoPredict HPV SCR assay. The assay demonstrated clinical sensitivity to detect cervical intraepithelial neoplasia grade 2 or worse (≥ CIN2) similar to cervical samples in FVU (ratio: 0.95, [95% CI: 0.88–1.02]) and vaginal self‐samples (ratio: 0.96 [95% CI: 0.90–1.02]). The clinical specificity for < CIN2 was lower in vaginal (ratio: 0.90 [95% CI: 0.84–0.96]) but not in FVU samples (ratio: 1.03 [95% CI: 0.96–1.12) when compared to cervical samples. However, the relative specificity improved following cut‐off optimization (ratio: 0.94, 95% CI: [0.88–1.01]). Moderate to excellent agreement in HPV detection between self‐collected and cervical samples was demonstrated (Kappa values: 0.53–1.00). To conclude, OncoPredict HPV SCR assay demonstrated similar accuracy on FVU and cervical samples. On vaginal compared to cervical samples sensitivity was similar with a lower specificity, which improved with cut‐off optimization.

Reply to letter to editor on “Expectant management of borderline ovarian tumor during pregnancy”

The Potential Impact of High-Risk Human Papillomavirus–Negative Cervical Intraepithelial Neoplasia 2+ on Primary Human Papillomavirus Screening

Abstract Objectives To investigate the prevalence of high-risk human papillomavirus (HPV)–negative cervical intraepithelial neoplasia (CIN) and invasive cervical carcinoma (ICC) and to analyze the distribution of other genotypes in this subset. Methods In total, 431 women who underwent excisional surgical treatment for CIN or ICC at the European Institute of Oncology, Milan, Italy, from January 2016 to December 2017 were retrospectively analyzed. The Linear Array HPV genotyping test (Roche Diagnostics) was performed on a postaliquot from high-risk-HPV–negative liquid-based cervical specimens, when available. Patient characteristics and the prevalence of high-risk-HPV–negative CIN grade 2 or worse (CIN2+) were tabulated. We used t tests to compare age between high-risk-HPV–positive and high-risk-HPV–negative patients. Results Overall, 8.9% of CIN2+ and 7.5% of ICC cases were high-risk HPV negative. There was no age difference between high-risk-HPV–negative CIN2+ women (mean [SD], 41.3 [8.7] years) and high-risk-HPV–positive women (mean [SD], 39.5 [9.0] years) (P = .28). The Linear Array result was available in 22 cases. Most high-risk-HPV–negative patients were positive for a single other genotype infection (32.6%). HPV 73 was the most prevalent genotype, followed by HPV 53 and HPV 84. HPV 26 was detected in 1 case of ICC. Conclusions Our results showed a not-negligible proportion of high-risk-HPV–negative CIN2+, suggesting that cotesting would not miss these cases.