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

2021 ◽  
pp. 1-12
Author(s):  
Laura Gilbert ◽  
Sam Ratnam ◽  
Dan Jang ◽  
Reza Alaghehbandan ◽  
Miranda Schell ◽  
...  
Keyword(s):  
Prospective Study ◽  
Test Performance ◽  
High Sensitivity ◽  
Intraepithelial Neoplasia ◽  
Hpv Testing ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Clinical Endpoints ◽  
Specific Sensitivity ◽  
Hpv Test ◽  
History Of

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.

scholarly journals CoCoss-Trial: Concurrent Comparison of Self-Sampling Devices for HPV-Detection

2021 ◽  
Vol 18 (19) ◽  
pp. 10388
Author(s):  
Faruk Cem Ertik ◽  
Johanna Kampers ◽  
Fabienne Hülse ◽  
Claudia Stolte ◽  
Gerd Böhmer ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Clinical Performance ◽  
Participation Rate ◽  
High Sensitivity ◽  
Intraepithelial Neoplasia ◽  
Hpv Infection ◽  
Multicenter Trial ◽  
Hpv Testing ◽  
Hpv Test ◽  
Excisional Surgery

High-risk human papillomavirus (hr-HPV) infection of the cervicovaginal tract is known to be the major cause of cervical cancer. Similar to various other countries, Germany introduced an organized combined screening including cytology and HPV testing in 2020. The participation rate was around 70% in the past. Self-testing for hr-HPV infections could be an option to increase the participation rate. Two dry vaginal self-sampling devices and a device for the self-collection of first-void urine were evaluated in combination with a PCR-based hr-HPV test regarding their clinical performance (sensitivity for high-grade cervical intraepithelial neoplasia, CIN 2+). A cervical smear taken by a clinician during colposcopy was used as reference. This open prospective multicenter trial recruited patients referred to the two participating colposcopy clinics (Hannover Medical School and IZD Hannover, Germany) with abnormal results from cervical cancer screening from 05/2020 to 11/2020. All patients received three CE-certified self-sampling devices (FLOQSwabs, COPAN, Italy; Evalyn Brush, Rovers Medical Devices, the Netherlands; Colli-Pee FV-5000, Novosanis, Wijnegem, Belgium) with instructions to read and apply at home in a pre-specified alternating order without medical assistance. HPV testing was performed after adequate preservation and DNA extraction. Histological results from colposcopy or cervical excisional surgery after self-sampling were used as the gold-standard. The data of 65 patients were analyzed. All invasive cancer cases and over 90% of the CIN 3 lesions were found to be hr-HPV positive with all three self-collection devices. All devices were considered easy to use without any difficulties following the written instructions. Hr-HPV testing of self-collected first-void urine and dry vaginal self-samples showed a high sensitivity for CIN 3+ comparable to that of a clinician-taken smear. Self-sampling was well accepted as it is convenient and easy to use.

scholarly journals Long-Lasting Increased Risk of Human Papillomavirus–Related Carcinomas and Premalignancies After Cervical Intraepithelial Neoplasia Grade 3: A Population-Based Cohort Study

2017 ◽  
Vol 35 (22) ◽  
pp. 2542-2550 ◽  
Author(s):  
Renée M.F. Ebisch ◽  
Dominiek W.E. Rutten ◽  
Joanna IntHout ◽  
Willem J.G. Melchers ◽  
Leon F.A.G. Massuger ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Cervical Intraepithelial Neoplasia ◽  
Incidence Rate ◽  
Intraepithelial Neoplasia ◽  
Population Based ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Increased Risk ◽  
History Of ◽  
Grade 3 ◽  
Rate Ratios

Purpose The aim of this study was to determine the risk of human papillomavirus (HPV)–related carcinomas and premalignancies in women diagnosed with cervical intraepithelial neoplasia grade 3 (CIN3). Knowledge of this risk is important to preventing the development and progression of other HPV-related premalignancies and carcinomas, by considering prophylactic HPV vaccination and/or by paying increased attention to other HPV-related carcinomas and premalignancies when CIN3 is identified. Methods Women diagnosed with a CIN3 between 1990 and 2010 were identified from the Dutch nationwide registry of histopathology and cytopathology (PALGA) and matched with a control group of women without CIN3. Subsequently, all cases of high-risk (hr) HPV–associated high-grade lesions and carcinomas in the anogenital region and oropharynx between 1990 and 2015 were extracted. Incidence rate ratios were estimated for carcinomas and premalignancies of the vulva, vagina, anus, and oropharynx. Results A total of 178,036 women were identified: 89,018 with a previous diagnosis of CIN3 and 89,018 matched control subjects without a history of CIN3. Women with a history of CIN3 showed increased risk of HPV-related carcinomas and premalignancies, with incidence rate ratios of 3.85 (95% CI, 2.32 to 6.37) for anal cancer, 6.68 (95% CI, 3.64 to 12.25) for anal intraepithelial neoplasia grade 3, 4.97 (95% CI, 3.26 to 7.57) for vulvar cancer, 13.66 (93% CI, 9.69 to 19.25) for vulvar intraepithelial neoplasia grade 3, 86.08 (95% CI, 11.98 to 618.08) for vaginal cancer, 25.65 (95% CI, 10.50 to 62.69) for vaginal intraepithelial neoplasia grade 3, and 5.51 (95% CI, 1.22 to 24.84) for oropharyngeal cancer. This risk remained significantly increased, even after long-term follow-up of up to 20 years. Conclusion This population-based study shows a long-lasting increased risk for HPV-related carcinomas and premalignancies of the anogenital and oropharyngeal region after a CIN3 diagnosis. Studies that investigate methods to prevent this increased risk in this group of patients, such as intensified screening or vaccination, are warranted.

scholarly journals HrHPV testing vs liquid-based cytology in cervical cancer screening among women aged 50 and older: a prospective study

2020 ◽  
Vol 30 (11) ◽  
pp. 1678-1683
Author(s):  
Berit Andersen ◽  
Sisse Helle Njor ◽  
Anne Marie Schak Jensen ◽  
Tonje Johansen ◽  
Ulla Jeppesen ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Prospective Study ◽  
Cervical Cancer Screening ◽  
Gynecological Cancer ◽  
Dna Amplification ◽  
Hpv Testing ◽  
Promising Alternative ◽  
Hpv Test ◽  
Liquid Based Cytology

IntroductionEvidence supports high-risk human papilloma virus (HPV) testing as the primary cervical cancer screening tool. However, benefits and harms should be carefully considered before replacing liquid-based cytology. In women age 50 and older, we evaluated how a commercially available DNA amplification HPV test compares with routine liquid-based cytology.MethodsThis prospective study included 4043 patients who had a cervical sample analyzed from September 2011 to September 2012. Patients were followed between 64 and 76 months (median: 70 months). Samples were analyzed using both liquid-based cytology and the Cobas 4800 HPV DNA test. We calculated the diagnostic efficacy of liquid-based cytology and HPV, with or without the opposite test as triage, using cervical intraepithelial neoplasia (CIN2+/CIN3+) as reference.ResultsThe patients had a median age of 58 years, (range; 50–90). At baseline, HPV prevalence was 8.0%: a total of 3.7% of patients had atypical squamous cells of undetermined significance or worse (ASCUS+). Positive test results were 1.9% for liquid-based cytology with HPV triage and 3.0% for HPV with liquid-based cytology triage. The cumulative incidence of CIN3+ was 1.0% (40/4043). Sensitivities for CIN3+ were: liquid-based cytology 47.5% (31.5%–63.9%); liquid-based cytology with HPV triage 45.0% (29.3%–61.5%); HPV 90.0% (76.3%–97.2%); and HPV with liquid-based cytology triage 67.5% (50.9%–81.4%). Corresponding specificities were: liquid-based cytology 96.6% (96.0%–97.2%); liquid-based cytology with HPV triage 98.5% (98.0%–98.8%); HPV 92.8% (92.0%–93.6%); and HPV with liquid-based cytology triage 97.7% (97.2%–98.1%). At baseline, HPV testing overlooked five cases of gynecological cancer other than cervical cancer. Five cervical cancers were detected, two had been overlooked at baseline by liquid-based cytology and two by HPV testingConclusionHPV screening using DNA amplification is a promising alternative to liquid-based cytology in women age 50 and older, but evaluation of alternative triage methods is warranted. The risk of overlooking cancers needs consideration when replacing liquid-based cytology with HPV testing as a method for primary screening.

Combining Human Papillomavirus Testing or Cervicography With Cytology to Detect Cervical Neoplasia

2004 ◽  
Vol 128 (11) ◽  
pp. 1257-1262
Author(s):  
Michelle Howard ◽  
John W. Sellors ◽  
Alice Lytwyn ◽  
Paula Roth ◽  
James B. Mahony
Keyword(s):  
Human Papillomavirus ◽  
Cervical Intraepithelial Neoplasia ◽  
Intraepithelial Neoplasia ◽  
Low Grade ◽  
Invasive Squamous Cell Carcinoma ◽  
Hpv Testing ◽  
Cross Sectional ◽  
Hpv Test ◽  
Atypical Cells ◽  
Sectional Analysis

Abstract Context.—Cervicography and oncogenic human papillomavirus (HPV) testing have been proposed for improving the accuracy of cervical cancer screening. Objective.—To examine whether cervicography and HPV testing can improve beyond chance the detection of cervical intraepithelial neoplasia (CIN) 2 or 3 in women with atypical cells of undetermined significance or low-grade squamous intraepithelial lesions on cytology. Design.—Cross-sectional analysis. Oncogenic HPV testing by Hybrid Capture II assay or cervicography combined with cytology was compared with the reference standard of colposcopy with directed biopsy. Setting.—Community family practices. Participants.—Three hundred four women with low-grade cytologic abnormality. Main Outcome Measures.—The gain in accuracy for detecting histologic CIN 2 or 3 or carcinoma. Because an adjunct test may improve sensitivity by chance alone, the sensitivity or specificity if the second test performed randomly was estimated. Results.—Cervical intraepithelial neoplasia 2 or 3 was found in 11.8% (36/304) of the women and invasive squamous cell carcinoma in 0.3% (1/304). The sensitivity of cytology for detecting CIN 2 or 3 was 73.0% and increased by 21.6% to 94.6% with the addition of a cervigram showing a low-grade lesion or higher or a positive HPV test result. These gains were reduced to 8.1% and 10.8% above the sensitivities expected if the additional tests performed randomly. The corresponding specificities decreased from 49.1% to 32.2% and 33.0%. There was insufficient power to determine whether observed sensitivities were statistically significantly higher than the expected sensitivities. Conclusion.—Adjunctive HPV testing or cervicography may provide similar gains in sensitivity, but they can appear misleadingly large if chance increases are not taken into account.

scholarly journals Head-to-Head Comparison of the RNA-Based Aptima Human Papillomavirus (HPV) Assay and the DNA-Based Hybrid Capture 2 HPV Test in a Routine Screening Population of Women Aged 30 to 60 Years in Germany

2015 ◽  
Vol 53 (8) ◽  
pp. 2509-2516 ◽  
Author(s):  
Thomas Iftner ◽  
Sven Becker ◽  
Klaus-Joachim Neis ◽  
Alejandra Castanon ◽  
Angelika Iftner ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Precancerous Lesions ◽  
Cervical Screening ◽  
Intraepithelial Neoplasia ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Hybrid Capture ◽  
Test Characteristics ◽  
Hpv Test ◽  
Screening Population ◽  
Hybrid Capture 2

Testing for E6/E7 mRNA in cells infected with high-risk (HR) human papillomavirus (HPV) might improve the specificity of HPV testing for the identification of cervical precancerous lesions. Here we compared the RNA-based Aptima HPV (AHPV) assay (Hologic) and the DNA-based Hybrid Capture 2 (HC2) HPV test (Qiagen) to liquid-based cytology (LBC) for women undergoing routine cervical screening. A total of 10,040 women, 30 to 60 years of age, were invited to participate in the study, 9,451 of whom were included in the analysis. Specimens were tested centrally by LBC, the AHPV test, and the HC2 test, and women who tested positive on any test were referred for colposcopy. Genotyping was performed on all HR-HPV-positive samples. Test characteristics were calculated based on histological review. As a result, we identified 90 women with cervical intraepithelial neoplasia grade 2+ (CIN2+), including 43 women with CIN3+. Sensitivity differences between the AHPV test and the HC2 test in detecting CIN2+ ( P = 0.180) or CIN3+ ( P = 0.0625) lesions were statistically nonsignificant. Of three CIN3 cases that were missed with the AHPV test, two cases presented lesion-free cones and one had a non-HR HPV67 infection. The specificity (<CIN2) and positive predictive value (CIN2+) of the AHPV test were significantly higher (both P < 0.001) than those of the HC2 test. The overall agreement between the tests was substantial (κ = 0.77). Finally, we present results for several possible triage strategies, based on the primary screening test being either the AHPV test or the HC2 test. In summary, the AHPV assay is both specific and sensitive for the detection of high-grade precancerous lesions and may be used in primary cervical cancer screening for women ≥30 years of age.

HPV testing can reduce the number of follow-up visits in women treated for cervical intraepithelial neoplasia grade 3

2003 ◽  
Vol 91 (1) ◽  
pp. 67-73 ◽  
Author(s):  
G.Denise Zielinski ◽  
Lawrence Rozendaal ◽  
Feja J Voorhorst ◽  
Johannus Berkhof ◽  
Peter J.F Snijders ◽  
...  
Keyword(s):  
Cervical Intraepithelial Neoplasia ◽  
Intraepithelial Neoplasia ◽  
Hpv Testing ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Grade 3
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