scholarly journals The Role of Self-Collection by Vaginal Lavage for the Detection of HPV and High-Grade Intraepithelial Neoplasia

2017 ◽  
Vol 61 (6) ◽  
pp. 425-433 ◽  
Author(s):  
Larissa de Melo Kuil ◽  
Adriana Tarla Lorenzi ◽  
Maíra Degiovani Stein ◽  
Júlio César Possati Resende ◽  
Márcio Antoniazzi ◽  
...  
Keyword(s):  
High Risk ◽  
Positive Predictive Value ◽  
Predictive Value ◽  
Pap Test ◽  
Intraepithelial Neoplasia ◽  
Cervical Cytology ◽  
High Grade ◽  
Vaginal Lavage ◽  
Hpv Test ◽  
High Risk Hpv

Objective: To compare the results of cervical cytology and high-risk HPV tests using samples obtained using two different collection modalities in a population of Brazilian women: self-collection (vaginal lavage) and cervical Pap testing. Methods: We enrolled 204 women who were aged 18-64 years and had previously obtained abnormal cervical cytology test results; 83.8% of them agreed to participate. The sample was divided into two aliquots: one for the cytological study and one for the molecular analysis of high-risk HPV. Results: Fifty-eight percent of the participants preferred to utilize self-collection as an alternative screening method. However, we noticed that the HPV positivity rate was significantly lower in self-collected samples when compared to those obtained using the conventional collection method (p = 0.035). The cytology tests of the samples obtained via self-collection were sensitive and had a positive predictive value and an area under the curve (AUC) that were significantly lower than those of the Pap test. However, the specificity and negative predictive value of these tests were similar. When compared with the HPV test, the self-collected samples demonstrated lower accuracy in predicting high-grade cervical intraepithelial neoplasia or worse, with a significantly lower sensitivity, positive predictive value, and AUC than the cervical Pap test samples. Conclusion: Self-collection by vaginal lavage is simple and well accepted by women. Due to its limitations, however, self-collection by lavage should be utilized with caution.

Role of HPV genotyping in risk assessment among cytology diagnosis categories: analysis of 4562 cases with cytology–HPV cotesting and follow-up biopsies

2019 ◽  
Vol 29 (2) ◽  
pp. 234-241 ◽  
Author(s):  
Yimin Ge ◽  
Paul Christensen ◽  
Eric Luna ◽  
Donna Armylagos ◽  
Jiaqiong Xu ◽  
...  
Keyword(s):  
High Risk ◽  
Positive Predictive Value ◽  
Predictive Value ◽  
High Grade ◽  
Squamous Intraepithelial Lesions ◽  
Squamous Cells ◽  
Hpv Genotyping ◽  
High Risk Hpv ◽  
Intraepithelial Lesions ◽  
Undetermined Significance

ObjectiveHuman papilloma virus (HPV) detection and genotyping are increasingly used in clinical risk assessment. We aimed to analyze HPV genotyping performance in risk stratification among cytology diagnosis categories.MethodsBetween January 1, 2015 and December 31, 2016, 4562 cases with cytology–HPV co-testing and biopsy follow-up were identified. HPV tests were performed on Cobas (n=3959) or Aptima (n=603) platforms. Of the biopsies, 669 demonstrated high-grade squamous intraepithelial lesions or worse.ResultsPooled high-risk HPV testing had high overall sensitivity (97%) but low specificity (20%) and positive predictive value (20%) for biopsy-confirmed high-grade squamous intraepithelial lesions or worse. HPV16/18 genotyping had considerably improved specificity (81%) and positive predictve value (35%) in predicting high-grade squamous intraepithelial lesions or worse, especially in atypical squamous cells of undetermined significance and low-grade squamous intraepithelial lesion categories. Significantly more biopsy-confirmed high-grade squamous intraepithelial lesions or worse were detected by Aptima than Cobas testing, as measured by HPV16/18 (48% vs 33%, p<0.001), non-16/18 high-risk HPV (18% vs 13%, p=0.029), or all high-risk HPV genotypes (27% vs 19%, p<0.001). Aptima genotyping showed a significantly higher positive predictive value than Cobas genotyping for biopsy-confirmed high-grade squamous intraepithelial lesions or worse in the atypical squamous cells of undetermined significance category (47% vs 23%, p<0.05).ConclusionsHPV genotyping was sensitive for biopsy-confirmed high-grade squamous intraepithelial lesions or worse in all cytologic categories, and is particularly valuable in risk evaluation for women with atypical squamous cells of undetermined significance and low-grade squamous intraepithelial lesions. The triaging role was greatly diminished in high-risk lesions (atypical glandular cells, atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesions and high-grade squamous intraepithelial lesions) due to low specificity and positive predictive value. Aptima performance in risk management was superior to Cobas, with significantly higher positive predictive value for biopsy-confirmed high-grade squamous intraepithelial lesions or worse. Our results highlight the importance of careful data interpretation from studies using different HPV testing methods and the need to incorporate HPV E6/E7-mRNA testing into management guidelines.

HPV screening performance indicators in women who previously tested HPV-negative: The second round of Vallecamonica screening programme, Northern Italy

2020 ◽  
Vol 27 (4) ◽  
pp. 207-214
Author(s):  
Luigi Pasquale ◽  
Paolo G Rossi ◽  
Francesca Carozzi ◽  
Serena Domenighini ◽  
Cristina Ruggeri ◽  
...  
Keyword(s):  
Positive Predictive Value ◽  
Cervical Intraepithelial Neoplasia ◽  
Performance Indicators ◽  
Predictive Value ◽  
Screening Programme ◽  
Intraepithelial Neoplasia ◽  
Female Population ◽  
Hpv Test ◽  
Hpv Screening ◽  
One Year

Objective To present performance indicators from the second round of the Vallecamonica-Sebino HPV screening programme in women who had tested negative about four years earlier (mean 45 months). Methods From 2010 to 2012, the target female population (aged 25–64) was invited to the first HPV screening round. In 2013–2017, women were rescreened for the second round. HPV-negative women at the first round were initially rescreened after three years. The interval was gradually increased to five years. HPV-positive women underwent cytology triage: positives were referred to colposcopy and negatives to repeat testing after one year. If HPV was persistently positive, women were referred to colposcopy, if negative, to normal interval rescreening. Results In the second round, of 13,824 previously HPV-negative women, 598 were HPV-positive (4.3%), of whom 297 were positive at cytology triage. Of those referred to one-year HPV test, 291 complied (98.0%), 133 (50.2%) of whom were persistently positive. Total referral was 3.1% compared with 6.6% in the first round (age-adjusted relative referral 0.59, 95% CI: 0.53–0.65). There were 24 cervical intraepithelial neoplasia 2+ (three cervical intraepithelial neoplasia 3+). Detection was 0.17%, compared with 0.9% in the first round. Age-adjusted relative detections were 0.25 (95% CI: 0.16–0.39) and 0.18 (95% CI: 0.05–0.61) for cervical intraepithelial neoplasia 2+ and cervical intraepithelial neoplasia 3+, respectively. Positive predictive value was 5.7%, compared with 14.6% in the first round. Conclusions At second round, referral was half that at first round, while cervical intraepithelial neoplasia 2+ detection decreased nine-fold. Consequently, positive predictive value decreased dramatically. Rescreening four years after an HPV-negative test makes the process inefficient due to the low prevalence of lesions.

scholarly journals The value of p16INK4a immunostaining for high-grade squamous intraepithelial lesions in human papillomavirus–negative patients

2020 ◽  
Author(s):  
Dai Zhang ◽  
Jie Song ◽  
Xiaosong Zhang ◽  
Hui Bi
Keyword(s):  
Human Papillomavirus ◽  
Predictive Value ◽  
Intraepithelial Neoplasia ◽  
Pathological Diagnosis ◽  
High Grade ◽  
Squamous Intraepithelial Lesions ◽  
P16 Ink4a ◽  
Objective Detection ◽  
High Risk Hpv ◽  
Intraepithelial Lesions

Abstract Background : This study aims to evaluate the value of p16 INK4a immunostaining for high-grade squamous intraepithelial lesions in human papillomavirus–negative patients in Beijing, China. Methods: In this study, we evaluated the value of p16 INK4a immunostaining, as well as cytology and colposcopy, for predicting high-grade squamous intraepithelial lesions (HSIL) in human papillomavirus (HPV)-negative patients by comparing the methods with the haematoxylin and eosin (H&E) staining pathological diagnosis of HPV-negative patients. Results: Of 122 patients negative for the high-risk HPV (HR-HPV) subtype, 26 (21.3%) underwent colposcopically directed multiple punch cervical biopsy with a H&E pathological diagnosis of HSIL and above (HSIL+), 11 patients (9.0%) had cervical intraepithelial neoplasia (CIN)2, nine patients (7.4%) had CIN3, and six patients (4.9%) had infiltrating carcinoma. Cytology, colposcopy, and p16 INK4a immunostaining had 52.4%, 38.5%, and 92.3% sensitivity, respectively, and 76.2%, 94.8%, and 99% specificity, respectively. The positive predictive value of cytology, colposcopy, and p16 INK4a immunostaining was 31.4%, 66.7%, and 96%, respectively, and the negative predictive value was 88.5%, 85.1%, and 97.9%, respectively. Compared with H&E staining, the kappa of cytology, colposcopy, and p16 INK4a immunostaining was 0.327, 0.323, and 0.926, respectively. Conclusion: Positive p16 INK4a immunostaining is very strongly consistent with an H&E diagnosis of CIN2+, and it can be used as an objective detection index for HSIL+ diagnosis of HPV-negative patients with CIN2+.

scholarly journals Self-Collected Samples in Cervical Cancer Screening: Results of HPV and Pap Self-Collected Samples Compared to Physician-Obtained Specimens

2019 ◽  
Vol 63 (5) ◽  
pp. 379-384
Author(s):  
Bernhard Reinhold Mangold
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Positive Predictive Value ◽  
Predictive Value ◽  
Pap Test ◽  
Pap Tests ◽  
Test Sensitivity ◽  
Self Testing ◽  
Hpv Test ◽  
Very High

Objective: In order to increase overall participation in cervical cancer screening, several investigators propose a concept of introducing self-tests. The study presented here compared test results of the Pap test and 4 different HPV test systems of self-collected and physician-collected vaginal specimens. Study Design: 208 patients of a colposcopy clinic had physician-taken and self-taken vaginal samples. All cell samples enabled a liquid-based Pap test and testing for carcinogenic HPV genotypes. In addition, all patients had a colposcopy with or without cervical biopsy and/or conisation. Results: 99 patients had the histological diagnosis of CIN2+. The HPV test sensitivity of self-collected samples differed significantly in this patient group depending on the test system performed. The sensitivity of the self-collected Pap test was significantly lower than HPV testing, but the positive predictive value of the Pap self-test was very high. Conclusion: The results of this study indicate that under the circumstances of self-testing HPV test systems differ in test sensitivity and specificity. Self-collected Pap tests can provide a test result with a very high positive predictive value and introduce therapeutic strategies. In order to improve screening strategies, it could be an opportunity to combine HPV and Pap tests in self-taken vaginal samples, especially in countries with a low income level. In countries with a good medical infrastructure, self-testing has to be introduced with caution.

High grade squamous intraepithelial lesion on high-risk HPV negative patients: Why we still need the Pap test

2018 ◽  
Vol 46 (11) ◽  
pp. 908-913 ◽  
Author(s):  
Hongxia Sun ◽  
Ramya P. Masand ◽  
Shobhanaben Jagdishbhai Patel ◽  
Vijayalakshmi Padmanabhan
Keyword(s):  
High Risk ◽  
Pap Test ◽  
High Grade ◽  
Squamous Intraepithelial Lesion ◽  
Intraepithelial Lesion ◽  
High Risk Hpv

Hybrid capture 2 and cobas® 4800: Comparison of performance of two clinically validated tests for human papillomavirus primary screening of cervical cancer

2021 ◽  
pp. 096914132199282
Author(s):  
A Mongia ◽  
G Pompeo ◽  
C Sani ◽  
E Burroni ◽  
G Fantacci ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
High Risk ◽  
Positive Predictive Value ◽  
Cervical Intraepithelial Neoplasia ◽  
Predictive Value ◽  
Screening Program ◽  
Intraepithelial Neoplasia ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Hybrid Capture ◽  
Hybrid Capture 2

Objective To compare, in a primary human papillomavirus screening setting, two different validated human papillomavirus tests, considering their analytical and clinical screening performances. Methods In Tuscany, a human papillomavirus screening program was implemented in 2013. Hybrid capture 2 (Qiagen) was used for testing until May 2016, when it was replaced by the cobas® 4800 human papillomavirus test (Cobas; Roche). We evaluated the performance of Hybrid capture 2 and Cobas on: the same screening population in two different periods (before and after changing to Cobas); the same Hybrid capture 2-positive consecutive samples. Discordant samples (Hybrid capture 2-positive/Cobas negative) were typed on the L1 gene (reverse line blot, AB Analitica) and E6/E7 genes (BD Onclarity assay). Results In the considered time period ( n = 37,775), human papillomavirus positivity was 9.8% and 7.4%, respectively, for Hybrid capture 2 and Cobas ( p < 0.0001). At immediate colposcopy, the cervical intraepithelial neoplasia, grade 2 positive predictive value was, respectively, 23.8% and 34% ( p < 0.001). At one-year recall, human papillomavirus persistence was, respectively, 40.6% and 62.2% ( p < 0.0001). Of Hybrid capture 2-positive re-tested samples ( n = 620), 32.4% were Cobas negative. Of discordant samples typed on L1, 7% were positive for the 12 high-risk human papillomavirus. Of the samples found to be negative for the 12 high-risk human papillomavirus types on L1, 14.5% were positive on E6/E7 typing. Among the discordant samples, the only two cervical intraepithelial neoplasia (CIN) grade 3 lesions were non-high-risk human papillomavirus positive on both L1 and E6/E7 typing. Conclusion At baseline, Hybrid capture 2 showed greater human papillomavirus positivity and a lower CIN2+ positive predictive value than Cobas, which was more specific than Hybrid capture 2 in detection of high-risk human papillomavirus: 80% of discordant samples were confirmed as high-risk human papillomavirus negative. This higher analytical specificity determined the non-identification of two CIN3 lesions.

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