Comparison of CINtec PLUS cytology and cobas HPV test for triaging Canadian patients with LSIL cytology referred to colposcopy: A two-year prospective study

OBJECTIVES & METHODS: CINtec PLUS and cobas HPV tests were compared for triaging patients referred to colposcopy with a history of LSIL cytology in a 2-year prospective study. Cervical specimens were tested once at enrollment, and test positivity rates determined. Test performance was ascertained with cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and CIN3 or worse (CIN3+) serving as clinical endpoints. RESULTS: In all ages, (19–76 years, n= 598), 44.3% tested CINtec PLUS positive vs. 55.4% HPV positive (p< 0.001). To detect CIN2+ (n= 99) CINtec PLUS was 81.8% sensitive vs. 93.9% for HPV testing (p= 0.009); genotype 16/18-specific sensitivity was 46.5%. Specificity was 52.9% vs. 36.6%, respectively (p< 0.001). In all ages, to detect CIN3+ (n= 44), sensitivity was 93.2% for both tests; genotype 16/18-specific sensitivity was 52.3%. Specificity was 48.4% for CINtec PLUS vs. 31.1% for HPV testing (p< 0.001). In patients < 30 years, CINtec was 91.7% sensitive vs 95.8% for HPV testing (p= 0.549). CONCLUSIONS: CINtec PLUS or cobas HPV test could serve as a predictor of CIN3+ with high sensitivity in patients referred to colposcopy with a history of LSIL regardless of age while significantly reducing the number of LSIL referral patients requiring further investigations and follow-up in colposcopy clinics.

Disparities in Cervical Cancer Screening with HPV Test among Females with Diabetes in the Deep South

Background: Due to diabetes being linked with poorer cervical cancer prognosis, this study aimed to evaluate HPV testing behaviors among females with and without diabetes across the U.S. by geographic area in 2016, 2018, and 2020. Methods: This cross-sectional study used the Behavioral Risk Factor Surveillance System (BRFSS) from 2016, 2018, and 2020. The study population included females aged 25–69 years old, stratified by self-reported diabetes status. The primary outcome measure was cervical cancer screening behavior, which was evaluated by self-reported HPV test uptake/receipt (yes/no). Results: A total of 361,546 females from across the U.S. were sampled. Within the study population combined from all study years, the overall likelihood of receiving an HPV test was significantly lower among females with diabetes [37.95% (95% CI: 36.87–39.04)] compared to those without diabetes [46.21% (95% CI: 45.84–46.58)] (p < 0.001). Screening rates with HPV tests were lowest among females with diabetes in the South in 2016 (29.32% (95% CI: 26.82–31.83)), 2018 (39.63% (95% CI: 36.30–42.96)), and 2020 (41.02% (95% CI: 37.60–44.45)). Conclusions: Females with diabetes are screening with HPV tests less frequently than females without diabetes, and females living in the South, particularly states in the Deep South, report the lowest rates of HPV testing.

Knowledge and awareness of human papillomavirus infection and human papillomavirus vaccine among Kazakhstani women attending gynecological clinics

Cervical cancer remains one of the top causes of cancer-related morbidity and mortality all over the world. Currently, however, there are no published studies to assess the knowledge of HPV and cervical cancer in Kazakhstan. This study aimed to assess the awareness of HPV, the knowledge of HPV as a cause of cervical cancer, and the awareness of HPV vaccination among Kazakhstani women visiting gynecological clinics across the country. In addition, the study aimed to identify the factors associated with the awareness of HPV and the HPV vaccine and knowledge of HPV as a major cause of cervical cancer. This was a cross-sectional survey-based study with 2,272 women aged between 18–70 years attending gynecological clinics, who were administered paper-based questionnaires. Data analysis included descriptive statistics consisting of mean values, standard deviations, and frequencies, where applicable. Differences in categorical variables between groups were analyzed using the Chi-square test with a significance value of <0.005. Crude odds ratio (OR) and adjusted odds ratio (AOR) with 95% corresponding confidence intervals were calculated in regression analysis using univariate and multivariable logistic regression models. The mean age of participants was 36.33±10.09 years. More than half (53%) of the participants had been screened for cervical cancer. Among those who were aware of HPV, 46% knew that HPV causes cervical cancer and 52% were aware of the HPV vaccine. The key factors related to outcome variables were age, ethnicity, education, family, number of deliveries, and menarche. From a subgroup analysis, results from the HPV test and Pap smear test were factors related to dependent variables such as awareness of HPV and awareness of HPV vaccination.

Incidence of Oncogenic HPV and HPV-Related Dysplasia Five Years After a Negative HPV Test by Self-Sampling in Elderly Women

PURPOSE: Cervical cancer prevention for older women can be challenging since there are no specific guidelines for this group. This study aimed to determine the incidence of oncogenic HPV and HPV-related dysplasia in elderly women 5 years after being HPV negative. METHODS: Invited women participated five years earlier in a study where self-sampling for HPV testing was applied, at this time, they were all HPV negative. The women were now invited to perform self-sampling for HPV testing. Women with a positive result performed a repeat HPV test. Those with a positive repeat HPV test were examined by colposcopy, biopsy and cytology. RESULTS: Of the 804 invited women, 634 (76.9%) agreed to participate in the study and a self-sampling kit was sent to them. Of these, 99.6% (632/634) sent a sample to the HPV laboratory. The participation rate in each age group was 93.3% at age 65, 74.0% at age 70, 80.7% at age 75 and 64.6 % at age 80. Overall 18 women (2.8%, 95% CI 3.2 to 6.0) were HPV positive in the first test and 8 (1.3%, 95% CI 0.6 to 2.6) in the second test. Sampling for the second test was done on average 5.4 months after the first test. Fifty per cent (4/8) of the women with a positive repeat test had dysplasia in histology. CONCLUSION: The incidence of HPV in previously HPV-negative elderly women was low. Among women who were HPV positive in a repeat test, there was a high prevalence of low grade dysplasia.

Οικονομική αξιολόγηση της δοκιμασίας HPV DNA ως πρωταρχικής μεθόδου προσυμπτωματικού ελέγχου για καρκίνο τραχήλου της μήτρας στην Ελλάδα

Ο καρκίνος του τραχήλου της μήτρας αποτελεί την 7η συχνότερη μορφή καρκίνου στις γυναίκες στην Ελλάδα. Η αποτελεσματική διαχείριση της νόσου βασίζεται στην πρόληψη και δει στον προσυμπτωματικό έλεγχο ο οποίος έως πρόσφατα βασιζόταν στην κυτταρολογική εξέταση. Η σύνδεση του καρκίνου του τραχήλου της μήτρας με τον ιό των ανθρωπίνων θηλωμάτων οδήγησε στην ανάπτυξη της δοκιμασίας HPV DNA, η κλινική αποτελεσματικότητα της οποίας αποδεικνύεται πως υπερέχει της καθιερωμένης πρακτικής της κυτταρολογικής εξέτασης. Παρά την κλινική του υπεροχή η εισαγωγή του σε εθνικά προγράμματα προσυμπτωματικού ελέγχου απαιτεί τον έλεγχο της οικονομικής του αποδοτικότητα καθώς υπό τον περιορισμό των σπανίων πόρων η χρηματοδότησή του οφείλει να μεγιστοποιεί την αξία της επένδυσης. Στο πλαίσιο αυτό, σκοπό της παρούσας διατριβής αποτελεί η διερεύνηση της οικονομικής αποδοτικότητας εναλλακτικών στρατηγικών προσυμπτωματικού. Η προσέγγιση της υπόθεσης εργασίας επιτευχθεί με την ανάπτυξη μαρκοβιανών υποδειγμάτων τα οποία εξέτασαν την αποτελεσματικότητα και το κόστος εννέα εναλλακτικών στρατηγικών προσυμπτωματικού ελέγχου στην Ελλάδα. Οι στρατηγικές ελέγχθηκαν με ενναλακτικές προσεγγίσεις των βασικών παραμέτρων τους όπως η πρωταρχική μέθοδος, το διάστημα επανελέγχου, τα ηλικιακά όρια του πληθυσμού-στόχου και το επίπεδο συμμόρφωσης. Οι αναλύσεις διεξήχθησαν υπό την οπτική του συστήματος υγείας και βασίστηκαν ως επί το πλείστων στην κλινική μελέτη HERMES (HEllenic Real life Multicentric cErvical Screening), για τις κλινικές και επιδημιολογικές παραμέτρους των υποδειγμάτων και σε δεδομένα της κοινωνικής ασφάλισης για τις τιμές των παρεμβάσεων υγείας και των ιατρικών πράξεων. Δεδομένης της απουσίας δεδομένων σχετικά με το κόστος διαχείρισης της νόσου χρησιμοποιήθηκαν ευρωπαϊκά δεδομένα τα οποία μετατράπηκαν σε ελληνικές σχετικές τιμές με την χρήση των Δεικτών Τιμών Καταναλωτή (Consumer Price Index, CPI) ιατροτεχνολογικών υπηρεσιών και προϊόντων και των δεικτών Ισοτιμίας Αγοραστικής Δύναμης (Purchasing Power Parity, PPP). Τέλος, για τον έλεγχο της αξιοπιστίας των αποτελεσμάτων διεξήχθη μια σειρά από ντερμινιστικές (one way sensitivity analyses) και πιθανολογικές αναλύσεις ευαισθησίας (probabilistic sensitivity analyses). Η αποτελεσματικότητα των στρατηγικών προέκυψε ότι μεγιστοποιείται με τις 4 στρατηγικές (HPV test ταυτόχρονη γονοτύπηση, HPV test μετέπειτα γονοτύπηση, συνδυασμός κυτταρολογικής εξέτασης & HPV test μετέπειτα γονοτύπηση, συνδυασμός κυτταρολογικής εξέτασης & HPV test ταυτόχρονη γονοτύπηση,) οι οποίες προσφέρουν HPV test με γονοτύπηση ανά 3 έτη και απευθύνονται σε γυναίκες 25-69 με πλήρη συμμόρφωση στον έλεγχο (100%). Οι στρατηγικές αυτές δύνανται να μειώσουν την επίπτωση της νόσου σε γυναίκες 25-85 ετών κατά 24,5% σε σχέση με την τρέχουσα πρακτική (7,64 περιστατικά/100.000 γυναίκες, 95% CI 7,56 – 7,69 έναντι 10,12, 95% CI 9,99 – 10,26) και κατά 34,9% σε σχέση με της χαμηλότερης αποτελεσματικότητας στρατηγικής HPV test χωρίς γονοτύπηση ανά 5 έτη (11,47, 95% CI 11,30 – 11,61). Ο λόγος κόστους-χρησιμότητας της στρατηγικής με HPV test και ταυτόχρονη γονοτύπηση ανά 3 ή 5 έτη σε σχέση με την τρέχουσα πρακτική εκτιμήθηκε στα 3.918€/QALY και στα –162.843€/QALY, αντίστοιχα, αρκετά χαμηλότερα από το συμβατικό όριο των 52.437€/QALY. Η υιοθέτηση ενός προγράμματος προσυμπτωματικού ελέγχου με HPV test και ταυτόχρονη γονοτύπηση ανά 3 ή 5 έτη για γυναίκες 25-69 ετών αποτελεί μια οικονομικά αποδοτική επιλογή η οποία βελτιώνει τις εκβάσεις υγείας των γυναικών και βελτιστοποιεί την κατανομή των πόρων που επενδύονται στην πρόληψη του καρκίνου του τραχήλου της μήτρας στην Ελλάδα.

The prevalence of human papillomavirus and bacterial vaginosis among young women in China: a cross-sectional study

Background The natural history of human papillomavirus (HPV) is influenced by vaginal microenvironment disorders, such as bacterial vaginosis (BV). The objective of this study was to assess the epidemiology of HPV combined with BV prevalence among Chinese women aged 20–35 years. Methods A total of 2000 sexually active women aged 20–35 years voluntarily enrolled in this study and underwent a ThinPrep cytologic test and PCR-reverse dot blot human papillomavirus genotyping (PCR-RDB HPV test). BV was diagnosed if clue cells were observed (20% more than epithelial cells). Results The overall HPV infection rate in this population was 16.2% (324/2000). Compared with HPV-negative individuals, BV prevalence was higher in the High-risk human papillomavirus (HR-HPV) (5.9% vs. 3.1%, P < 0.001). BV and HPV-51, -52 infection were more commonly associated with each other. In patients with cervical lesions (≥ CIN 1), the BV prevalence rate was higher than in patients with negative for intraepithelial lesion or malignancy (NILM) (11.9% vs. 3.8%, P = 0.002). Conclusion BV was found to be related to HPV-51, -52 infections and cervical lesions. To better manage HPV infected population, more attention should be paid to the prevention and proper treatment of BV.

HPV and Pap testing among white, black, and hispanic women: results from a survey study

While the Pap test, HPV vaccine, and HPV test are important tools to promote cervical health, the American Cancer Society (ACS) recently updated its cervical cancer prevention recommendations to give primacy to HPV testing for cervical cancer screening. We investigate how women’s health providers view these changes, and the extent to which they have reached American women. To do so, we present results from a novel two-survey study of women’s health providers (N = 558) and White, Black, and Hispanic women (N = 1900). We find that a minority of providers report that the HPV test alone is adequate for cervical cancer screening (18%, CI = 14%, 21%) while 96% (CI = 94%, 97%) indicated that women should regularly have both Pap and HPV screenings. Black (88% CI = 86%, 91%) and Hispanic (87% CI = 84%, 89%) women report lower rates of Pap tests compared to White women (94%, CI = 92%, 96%). Only 35% (CI = 33%, 37%) of women report having had an HPV test, and these levels were similar across groups. White (29%, CI = 25%, 33%) and Hispanic women (26% CI = 23%, 29%) report statistically similar levels of provider recommendation for joint Pap-HPV testing, while Black women report statistically lower rates (22%, CI = 18%, 25%). These patterns hold after controlling for several important socio-demographic variables in logistic regression models. The continued lower rates of Pap tests among Black and Hispanic women, combined with low rates of HPV testing is likely to hinder the ability to reduce cervical cancer incidence and mortality, particularly for Hispanic and Black women.

A Comprehensive HPV-STI NGS Assay for Detection of 29 HPV Types and 14 non-HPV Sexually Transmitted Infections

Sexually transmitted infections (STIs) are prevalent throughout the world and impose a significant burden on individual health and public health systems. Missed diagnosis and late treatment of STIs can lead to serious complications such as infertility and cervical cancer. Although sexually transmitted co-infections are common, most commercial assays target one or a few STIs. The HPV-STI ChapterDx Next Generation Sequencing (NGS) assay detects and quantifies 29 HPVs and 14 other STIs in a single-tube and single-step PCR reaction and can be applied to tens to thousands of samples in a single sequencing run. The assay was evaluated in this study, and the limit of detection was 100% at 50 copies for all targets, and 100%, 96%, 88% at 20 copies for 34, 8, and 1 target, respectively. The performance of this assay has been compared to Roche cobas HPV test, showing an overall agreement of 97.5% for hr-HPV, and 98.5% for both, HPV16 and HPV18. The assay also detected all HPV-infected CIN2/3 with 100% agreement with Roche cobas HPV results. Moreover, several co-infections with non-HPV STIs, such as C. trachomatis, T. vaginalis, M. genitalium, and HSV2 were identified. The Chap-terDx HPV-STI NGS assay is a user-friendly, easy to automate and cost-efficient assay, which provides accurate and comprehensive results for a wide spectrum of HPVs and STIs.