scholarly journals Self-collected versus clinician-collected cervical samples for the detection of HPV infections by 14-type DNA and 7-type mRNA tests

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
C. E. Aranda Flores ◽  
G. Gomez Gutierrez ◽  
J. M. Ortiz Leon ◽  
D. Cruz Rodriguez ◽  
S. W. Sørbye
Keyword(s):  
Study Participant ◽  
Hpv Infection ◽  
Sampling Procedure ◽  
The Self ◽  
Molecular Testing ◽  
Sample Collection ◽  
Dna Test ◽  
Hpv Dna ◽  
The Difference ◽  
Hpv Dna Test

Abstract Background HPV self-sampling has been widely supported by the scientific community following a strong body of literature on the subject. Self-sampling is important in cervical cancer screening as it has been shown to improve participation. It is well documented that HPV-testing has proven superior to cytology with regards to sensitivity in detection of CIN and cancer. The value of self-collected samples is reliant on the quality of the molecular testing performed, as well as the patients’ preference in sampling procedure and compliance to follow up on positive test results. Due to the incompatibility of self-samples and cytology, triage of HPV-DNA positives by testing for molecular biomarkers is highly warranted. Methods Our objective was to compare the detection rate of genital Human Papillomavirus (HPV) infection in self- and clinician-collected samples by a 14-type HPV-DNA test and a 7-type mRNA E6/E7 test. Results Five hundred five women were recruited. Each study participant had two sample collection procedures performed upon the same visit, alternating order in execution of the self-collection or the clinician-taken procedure first or second, 1010 samples in total. HPV-DNA prevalence was 22.8% in self-collected versus 19.2% in clinician-collected samples (P = 0.19). Overexpression of mRNA E6/E7 from 7 HPV types was 7.1 and 6.3%, respectively (P = 0.71). The difference between HPV-DNA and HPV-mRNA positivity rates were statistically significant in both self-collected (22.8% versus 7.1%, P < 0.001) and clinician-collected samples (19.2% versus 6.3%, P < 0.001). Overall agreement between the two collection methods was fair, with a concordance rate of 78.2% (390/505), k = 0.34 (95% CI: 0.25–0.44), P < 0.001, for the HPV-DNA test and 92.5% (467/505), k = 0.40 (95% CI, 0.25–0.56), P < 0.001, for the mRNA test, respectively. 96.8% of the participants reported they felt confident carrying out the self-collection themselves, and 88.8% reported no discomfort at all performing the procedure. Conclusions This comparative study of two sampling methods reports fair agreement of HPV positivity rates between the self-collected and clinician-collected specimens using Abbott hrHPV and PreTect HPV-Proofer’7 tests. Only one third of HPV-DNA positive women had overexpression of mRNA E6/E7. Trial registration ISRCTN77337300.

The Evaluation of p16ink4a Immunoexpression/Immunostaining and Human Papillomavirus DNA Test in Cervical Liquid-Based Cytological Samples

2011 ◽  
Vol 21 (1) ◽  
pp. 79-85 ◽  
Author(s):  
Maria Nasioutziki ◽  
Angelos Daniilidis ◽  
Kostos Dinas ◽  
Maria Kyrgiou ◽  
George Valasoulis ◽  
...  
Keyword(s):  
High Risk ◽  
Hpv Infection ◽  
Low Grade ◽  
Squamous Intraepithelial Lesion ◽  
Dna Test ◽  
Hpv Dna ◽  
Squamous Cells ◽  
Intraepithelial Lesion ◽  
High Risk Hpv ◽  
Hpv Dna Test

Aim:To evaluate the role of p16INK4a immunoexpression and human papillomavirus (HPV) DNA test for the detection of dyskaryotic cells in high-risk women.Materials and Methods:This work was a retrospective diagnostic study conducted in the University Hospital of Thessaloniki from January to December 2008. The subjects were women with current or previous HPV infection and current or previous cervical intraepithelial lesion (with or without treatment) or clinical warts. All liquid-based cytological samples were tested for P16INKa and HPV DNA test. The accuracy parameters used for the outcome included sensitivity, specificity, and positive predictive value.Results:A total of 226 women were included; the mean age was 29 years. Expression of p16INK4a was detected in the cytological samples of 13% of the negative cases, 44% of the cases of atypical squamous cells of undetermined significance, 46% of the cases of low-grade squamous intraepithelial lesion, and 78% of the cases of high-grade squamous intraepithelial lesion. A total of 91 women tested positive for high-risk HPV infection, and 54 of those had p16INK4a-positive staining reaction cells. The concordance between the 2 tests, HPV DNA and p16, was 59% regarding infection-positive cases. Diffuse strong parabasal p16INK4a immunostaining (nuclear score >2) was observed in 17 cases of the abnormal cytological findings (atypical squamous cells of undetermined significance, 2 cases; low-grade squamous intraepithelial lesion, 8 cases; high-grade squamous intraepithelial lesion, 7 cases). Colposcopy-directed biopsies were used as the criterion standard for the detection of cervical intraepithelial neoplasia in 91 women. The sensitivity of p16INK4a was 95% and the specificity was 92%, whereas the sensitivity of high-risk HPV was 100% and the specificity was 78%. The positive predictive value of p16INK4a was 71%, whereas that of HPV DNA was 44%.Conclusion:The findings suggest that p16INK4a immunostaining can improve the accuracy of cytological examination and HPV DNA test and may be particularly useful in the triage of low-grade lesions.

Dry self-sampling versus provider-sampling of cervicovaginal specimens for human papillomavirus detection in the Inuit population of Nunavik, Quebec

2012 ◽  
Vol 19 (1) ◽  
pp. 42-48 ◽  
Author(s):  
Helen Cerigo ◽  
François Coutlée ◽  
Eduardo L Franco ◽  
Paul Brassard
Keyword(s):  
Human Papillomavirus ◽  
Study Participant ◽  
The Self ◽  
Kappa Statistics ◽  
Cross Sectional ◽  
Dna Test ◽  
Hpv Dna ◽  
Hpv Types ◽  
Sectional Measurement ◽  
Inuit Population

Objective To assess the comparability of self-collected cervicovaginal samples and provider-collected cervical samples for the detection of human papillomavirus (HPV) DNA among Inuit women in Nunavik, Quebec, avoiding the use of liquid-based storage and transport of the self-collected samples. Methods Ninety-three women aged 18–69 years were recruited from a previously formed cohort on the natural history of HPV to this cross-sectional measurement study. This study utilized HPV DNA test results from 89 paired specimens collected by study participant and health provider with Dacron swabs. Samples were tested for 36 HPV types with the PGMY-primer PCR protocol and genotyping with the linear array method. Unweighted kappa statistics and McNemar tests were used to measure the agreement between sampling techniques. Results In the self-collected samples, 30 different HPV types were found, compared with 29 types found in the provider-collected samples. The prevalence of high-risk (HR) HPV was 38.2% in the self-collected samples and 28.1% in the provider-collected samples. The agreement between collection methods for the detection of HR-HPV DNA (85.4%) was good. HR-HPV and type-specific HPV 16/18 were as likely to be detected in the self-collected samples compared with the provider-obtained samples. Conclusions Women in this population were easily able to collect adequate cervicovaginal specimens for HPV testing. As self-sampling has a high recovery of HR-HPV and is comparable with provider-sampling, we conclude that self-sampling with dry storage and transport could be a good cervical cancer screening alternative for Inuit women in Nunavik who have traditionally avoided speculum examination.

scholarly journals Prevalence of High-Risk Human Papillomavirus (HPV) among Negative Visual Inspection of Acetic Acid (VIA)

2016 ◽  
Author(s):  
Tofan W Utami
Keyword(s):  
Cervical Cancer ◽  
High Risk ◽  
Screening Method ◽  
Hpv Infection ◽  
Low Risk ◽  
Dna Test ◽  
Hpv Dna ◽  
Hybridization Test ◽  
High Risk Hpv ◽  
Hpv Dna Test

Objective: Persistence of high-risk HPV infection is known to be the major cause of cervical cancer. It is important to differentiate the genotype of HPV infection, whether it is high, intermediate or low risk. The aim of this study was to assess the prevalence of high-risk HPV types among Indonesian women with negative VIA. Method: We analyzed cervical swabs from 1,214 patients with negative VIA. By using INNO-Lipa HPV DNA test, we detected the HPV DNA and its genotype. Result: From the 1,214 women with negative VIA, 48 (3.95%) samples were confirmed to have positive HPV DNA by using PCR and electrophoresis. However, hybridization test were not able to detect HPV genotypes in 9 samples. These 9 samples were tested again with PCR and electrophoresis and resulted in negative HPV DNA. Among the remaining 39 samples (3.21%), we detected 19 types of HPV, consisting of 13 types of high-risk HPV, 5 types of low-risk HPV, and 1 type of unknown HPV (type X). Conclusion: Among patients with negative VIA, 3.21% was found to be positive for HPV DNA. From this percentage, the prevalence of high-risk HPV is higher than the low-risk and unknown HPV. Therefore we cannot ignore results of negative VIA, particularly in highrisk group, because there is a slight possibility that presence of HPV can be identified, especially the high risk ones which have a tendency to be persistent. We support the importance of HPV DNA test as cervical cancer screening method. [Indones J Obstet Gynecol 2014; 3: 153-156] Keywords: cervical cancer, high-risk HPV, negative VIA

scholarly journals Evaluation of the concordance in HPV type between self- and physician-collected samples using a brush-based device and a PCR-based HPV DNA test in Japanese referred patients with abnormal cytology or HPV infection

2020 ◽  
Vol 25 (10) ◽  
pp. 1854-1860
Author(s):  
Toshimichi Onuma ◽  
Tetsuji Kurokawa ◽  
Akiko Shinagawa ◽  
Yoko Chino ◽  
Yoshio Yoshida
Keyword(s):  
Health Care ◽  
Perfect Match ◽  
Hpv Infection ◽  
University Hospital ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Dna Test ◽  
Hpv Dna ◽  
Match Rate ◽  
Care Association ◽  
Hpv Dna Test

Abstract Background To adopt HPV self-sampling in Japan, we assessed the concordance between self- and physician-collected human papillomavirus (HPV) samples from Japanese patients and examined the performance of HPV self-sampling for cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Methods Patients who had previously tested negative for intraepithelial lesions or malignancy/HPV-positive, and patients with atypical squamous cells of undetermined significance or worse (ASCUS+) cytology were eligible for this cross-sectional study. Participants performed HPV self-sampling using an Evalyn brush, which was submitted at the Fukui Prefectural Health Care Association. The Evalyn brush heads were stored in ThinPrep vials. The physician, however, performed HPV and cell sampling using an endocervical brush and immediately stored the brush heads in ThinPrep vials. All participants underwent colposcopy and biopsy. Histopathological diagnoses were made by pathologists at Fukui University Hospital. HPV infection was confirmed using a PCR-based Cobas 4800 HPV DNA test. Cytological analysis was performed at Fukui Prefectural Health Care Association. Results HPV-positive rates for physician-collected samples and self-collected samples were 51 and 50%, respectively. The perfect match rate of HPV type between the groups was 88% (κ = 0.76). HPV16/18 showed higher agreement rates than other HPVs (99%, kappa 0.96 and 89% kappa 0.77, respectively). Both groups showed 100% sensitivity to CIN2+, but specificity was 57.0 and 58.1%, respectively. Conclusion For HPV typing, a good concordance rate was seen between self- and physician-collected samples. Self-sampling showed high sensitivity for CIN2+. Self-sampling using the Evalyn brush and Cobas 4800 may be feasible for screening Japanese individuals.

scholarly journals Triage of human papillomavirus infected women by methylation analysis in first-void urine

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Severien Van Keer ◽  
Annina P. van Splunter ◽  
Jade Pattyn ◽  
Annemie De Smet ◽  
Sereina A. Herzog ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Host Cell ◽  
Intraepithelial Neoplasia ◽  
Underlying Disease ◽  
Hpv Infection ◽  
Molecular Testing ◽  
High Grade ◽  
Methylation Analysis ◽  
Hpv Dna ◽  
Screening Attendance

AbstractHost cell DNA methylation analysis in urine provides promising triage markers for women diagnosed with a high-risk (HR) human papillomavirus (HPV) infection. In this study, we have investigated a panel of six host cell methylation markers (GHSR, SST, ZIC1, ASCL1, LHX8, ST6GALNAC5) in cervicovaginal secretions collected within the first part of the urine void (FVU) from a referral population. Cytology, histology, and HPV DNA genotyping results on paired FVU and cervical samples were available. Urinary median methylation levels from HR-HPV (n = 93) positive women were found to increase for all markers with severity of underlying disease. Significantly elevated levels were observed for GHSR and LHX8 in relation to high-grade cervical intraepithelial neoplasia (CIN2 +; n = 33), with area under de curve values of 0.80 (95% Confidence Interval (CI) 0.59–0.92) and 0.76 (95% CI 0.58–0.89), respectively. These findings are the first to support the assertion that methylation analysis of host cell genes is feasible in FVU and holds promise as molecular, triage strategy to discern low- from high-grade cervical disease in HR-HPV positive women. Molecular testing on FVU may serve to increase cervical cancer screening attendance in hard-to-reach populations whilst reducing loss to follow-up and await further optimization and validation studies.

Relevance of the Pap Test: A Report of HPV-DNA Test-Negative High-Grade Squamous Intraepithelial Lesions of the Female Lower Genital Tract

2016 ◽  
Vol 60 (5) ◽  
pp. 445-450 ◽  
Author(s):  
Yiang Hui ◽  
Katrine Hansen ◽  
Jayasimha Murthy ◽  
Danielle Chau ◽  
C. James Sung ◽  
...  
Keyword(s):  
High Risk ◽  
Pap Test ◽  
Human Papillomaviruses ◽  
High Grade ◽  
Squamous Intraepithelial Lesions ◽  
Cytologic Examination ◽  
Dna Test ◽  
Hpv Dna ◽  
Intraepithelial Lesions ◽  
Hpv Dna Test

Objective: A vast majority of cervicovaginal intraepithelial lesions are caused by high-risk human papillomaviruses (HPVs). The Pap test has been the sole method used for the screening of cervicovaginal squamous intraepithelial lesions (SIL). Recently, the FDA approved an HPV-DNA assay as a method of primary screening. We report on a series of FDA-approved HPV-DNA test-negative SIL with HPV genotyping, using an alternative method on the corresponding surgical biopsy specimens. Study Design: A retrospective review identified cytology-positive HPV-negative cases over a 15-month period at a tertiary care gynecologic oncology institution. Corresponding biopsies were reviewed and genotyped for high-risk HPVs. Results: Of the 18,200 total cases, 17 patients meeting the study criteria were selected with 27 surgical specimens corresponding to their cytologic diagnoses. Four patients with high-grade lesions were identified, 3 of whom (75%) were positive for HPV. One of these 4 patients (25%) showed high-grade SIL on biopsies from 4 separate sites in the cervix and vagina. Multiviral HPV infections were frequent. Conclusions: We discuss the relevance of cotesting for screening cervical SILs and emphasize that false-negative results are possible with the FDA-approved HPV screening assay, also in patients with high-grade SIL. These cases may be detectable by cytologic examination and this suggests that the Pap test remains an important diagnostic tool.

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