scholarly journals Sensitivity, Specificity, and Clinical Value of Human Papillomavirus (HPV) E6/E7 mRNA Assay as a Triage Test for Cervical Cytology and HPV DNA Test

2011 ◽  
Vol 49 (7) ◽  
pp. 2643-2650 ◽  
Author(s):  
Maria Benevolo ◽  
Amina Vocaturo ◽  
Donatella Caraceni ◽  
Deborah French ◽  
Sandra Rosini ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Cervical Cytology ◽  
Clinical Value ◽  
Dna Test ◽  
Hpv Dna ◽  
Hpv E6 ◽  
Sensitivity Specificity ◽  
Triage Test ◽  
Hpv Dna Test

scholarly journals Feasibility study of a human papillomavirus E6 and E7 oncoprotein test for the diagnosis of cervical precancer and cancer

2018 ◽  
Vol 46 (3) ◽  
pp. 1033-1042 ◽  
Author(s):  
Jin-Jun Zhang ◽  
Xin-Chun Cao ◽  
Xiang-Yu Zheng ◽  
Hai-Ying Wang ◽  
Yong-Wei Li
Keyword(s):  
Human Papillomavirus ◽  
Intraepithelial Neoplasia ◽  
Clinical Value ◽  
Early Screening ◽  
Protein Assay ◽  
Dna Test ◽  
Hpv Dna ◽  
E7 Oncoprotein ◽  
Hpv E6 ◽  
E6 And E7

Objective To evaluate the clinical value of human papillomavirus (HPV) E6 and E7 oncoprotein (HPV E6/E7) detection in the early screening of cervical cancer. Methods This prospective study evaluated all patients with suspected cervical intraepithelial neoplasia (CIN) as identified by the presence of at least one positive indicator from a ThinPrep cytologic test (TCT) and/or a Hybrid Capture 2 (HC2) HPV DNA test. The levels of E6/E7 oncoproteins were determined using Western blot analysis. The diagnostic value of the HPV E6/E7 protein assay was compared with the clinical diagnosis from TCT, HC2 and the gold standard of cervical biopsy histology. Results A total of 450 patients were enrolled in the study and based on histological findings, 102 patients were diagnosed with CIN1 (22.7%), 241 with CIN2 (53.6%), 96 with CIN3 (21.3%) and 11 with squamous cell carcinoma (2.4%). For a diagnosis of CIN2+, although the sensitivity of the HPV E6/E7 assay was lower than HC2 (65.5% versus 96.6%, respectively), the specificity was higher (38.2% versus 5.9%, respectively). The sensitivity of the HPV E6/E7 assay was higher than TCT (65.5% versus 36.2%, respectively). Conclusion Measuring HPV E6/E7 oncoprotein levels is a potential new biomarker for HPV type 16.

scholarly journals Validation of a Human Papillomavirus (HPV) DNA Cervical Screening Test That Provides Expanded HPV Typing

2018 ◽  
Vol 56 (5) ◽  
Author(s):  
Maria Demarco ◽  
Olivia Carter-Pokras ◽  
Noorie Hyun ◽  
Philip E. Castle ◽  
Xin He ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Excellent Agreement ◽  
Cervical Screening ◽  
Weighted Kappa ◽  
Clinical Value ◽  
Becton Dickinson ◽  
Major Question ◽  
Dna Test ◽  
Hpv Dna ◽  
Hpv Test

ABSTRACT As cervical cancer screening shifts from cytology to human papillomavirus (HPV) testing, a major question is the clinical value of identifying individual HPV types. We aimed to validate Onclarity (Becton Dickinson Diagnostics, Sparks, MD), a nine-channel HPV test recently approved by the FDA, by assessing (i) the association of Onclarity types/channels with precancer/cancer; (ii) HPV type/channel agreement between the results of Onclarity and cobas (Roche Molecular Systems, Pleasanton, CA), another FDA-approved test; and (iii) Onclarity typing for all types/channels compared to typing results from a research assay (linear array [LA]; Roche). We compared Onclarity to histopathology, cobas, and LA. We tested a stratified random sample ( n = 9,701) of discarded routine clinical specimens that had tested positive by Hybrid Capture 2 (HC2; Qiagen, Germantown, MD). A subset had already been tested by cobas and LA ( n = 1,965). Cervical histopathology was ascertained from electronic health records. Hierarchical Onclarity channels showed a significant linear association with histological severity. Onclarity and cobas had excellent agreement on partial typing of HPV16, HPV18, and the other 12 types as a pool (sample-weighted kappa value of 0.83); cobas was slightly more sensitive for HPV18 and slightly less sensitive for the pooled high-risk types. Typing by Onclarity showed excellent agreement with types and groups of types identified by LA (kappa values from 0.80 for HPV39/68/35 to 0.97 for HPV16). Onclarity typing results corresponded well to histopathology and to an already validated HPV DNA test and could provide additional clinical typing if such discrimination is determined to be clinically desirable.

scholarly journals A prospective study of women with ASCUS or LSIL pap smears at baseline and HPV E6/E7 mRNA positive: a 3-year follow-up

2018 ◽  
Vol 146 (5) ◽  
pp. 612-618 ◽  
Author(s):  
M. T. Bruno ◽  
M. Ferrara ◽  
V. Fava ◽  
G. Barrasso ◽  
M. M. Panella
Keyword(s):  
High Risk ◽  
Prospective Study ◽  
Messenger Rna ◽  
Low Grade ◽  
Dna Test ◽  
Hpv Dna ◽  
Hpv E6 ◽  
Hpv Test ◽  
Hpv Dna Test

AbstractHuman papillomavirus (HPV) testing is used in the triage of women with a borderline smear result. The efficiency of testing women with a low-grade squamous intraepithelial lesion (LSIL) and atypical squamous cells of undetermined significance (ASCUS) is less clear. For this reason we used a new HPV test that detects E6/E7 messenger RNA (mRNA), which might have a higher specificity. The objective of this prospective study was to assess whether HPV E6/E7 mRNA positivity in women with ASCUS and LSIL at baseline, is able to predict those women who have a high risk of developing a histological cervical intraepithelial neoplasia (CIN2) or worse lesion. We took into consideration the women's age and HPV DNA genotype and followed them up for 3 years. Cervical samples from women with high-risk HPV (HR-HPV) DNA-positive ASCUS (n = 90) or LSIL (n = 222) were tested for the presence of HR-HPV E6/E7 mRNA and the women were monitored for the development of histopathologically verified CIN2+. Thirteen patients with ASCUS and 17 with LSIL did not complete follow-up. All patients with LSIL and ASCUS, enrolled in this study, had confirmed lesions at the colposcopic examination. Follow-up was available for 312 women, 193 were positive in the HR-HPV DNA test and 93 had a HPV E6/E7 mRNA positive test. Finally, 22 women positive in the HPV DNA test for high-risk genotypes and with positive E6/E7 mRNA had a histologically confirmed CIN2+. Only two cases with negative HPV E6/E7 mRNA had CIN2+. The study shows that women positive in the HPV E6/E7 mRNA test have a greater risk of malignant progression of cervical lesions and therefore deserve greater attention and earlier check-ups.

scholarly journals Determinants of Viral Oncogene E6-E7 mRNA Overexpression in a Population-Based Large Sample of Women Infected by High-Risk Human Papillomavirus Types

2017 ◽  
Vol 55 (4) ◽  
pp. 1056-1065 ◽  
Author(s):  
Paolo Giorgi Rossi ◽  
Simonetta Bisanzi ◽  
Elena Allia ◽  
Alessandra Mongia ◽  
Francesca Carozzi ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Positive Result ◽  
New Technologies ◽  
High Sensitivity ◽  
Population Based ◽  
Hpv Dna ◽  
Screening Programs ◽  
Hpv E6 ◽  
Triage Test

ABSTRACT Cervical cancer screening by human papillomavirus (HPV) DNA testing with cytology triage is more effective than cytology testing. Compared to cytology, the HPV DNA test's higher sensitivity, which allows better protection with longer intervals, makes it necessary to triage the women with a positive result to compensate its lower specificity. We are conducting a large randomized clinical trial (New Technologies for Cervical Cancer 2 [NTCC2]) within organized population-based screening programs in Italy using HPV DNA as the primary screening test to evaluate, by the Aptima HPV assay (Hologic), the use of HPV E6-E7 mRNA in a triage test in comparison to cytology. By the end of June 2016, data were available for 35,877 of 38,535 enrolled women, 2,651 (7.4%) of whom were HPV DNA positive. Among the samples obtained, 2,453 samples were tested also by Aptima, and 1,649 (67.2%) gave a positive result. The proportion of mRNA positivity was slightly higher among samples tested for HPV DNA by the Cobas 4800 HPV assay (Roche) than by the Hybrid Capture 2 (HC2) assay (Qiagen). In our setting, the observed E6-E7 mRNA positivity rate, if used as a triage test, would bring a rate of immediate referral to colposcopy of about 4 to 5%. This value is higher than that observed with cytology triage for both immediate and delayed referrals to colposcopy. By showing only a very high sensitivity and thus allowing a longer interval for HPV DNA-positive/HPV mRNA-negative women, a triage by this test might be more efficient than by cytology.

Colposcopic and Histologic Findings and Human Papillomavirus (HPV) DNA Test Variability in Young Women Positive for HPV DNA

1992 ◽  
Vol 166 (5) ◽  
pp. 951-957 ◽  
Author(s):  
A.-B. Moscicki ◽  
J. M. Palefsky ◽  
J. Gonzales ◽  
G. Smith ◽  
G. K. Schoolnik
Keyword(s):  
Human Papillomavirus ◽  
Young Women ◽  
Dna Test ◽  
Hpv Dna ◽  
Test Variability ◽  
Hpv Dna Test

scholarly journals Effects of Human Papillomavirus Infection with Pre-invasive Cervical Lesions: Bangladesh Perspectives

2019 ◽  
Vol 33 (1) ◽  
pp. 5-10
Author(s):  
Mita Joarder ◽  
Shirin Akter Begum ◽  
Md Rasel Ahmad ◽  
Md Immam Hossin ◽  
Shanjida Islam ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Viral Load ◽  
Cervical Lesions ◽  
Predictive Values ◽  
Dna Test ◽  
Hpv Dna ◽  
Cin Iii ◽  
Papillomavirus Infection ◽  
I 11 ◽  
Hpv Dna Test

Background: Cervical cancer remains a major public health problem worldwide – particularly in less developed countries. Around 85% of their new cases and 86% of deaths occur in less development countries (IARC, 2012). In Bangladesh, Cervical cancer is the second most common disease among female with an estimated 11,956 new cases and 6,582 deaths in 2012. Objectives: The present study was undertaken to identify the Effects of Human Papillomavirus infection with Pre-invasive cervical lesions in Bangladesh. Methods: This cross sectional study was carried out at the colposcopy clinic of Gynaecology and Obstetrics department of Bangabandhu Sheikh Mujib Medical University during the study period January 2015 - December 2015. A total of 65 consecutive women with VIA +ve cases of all three grades of CIN (CIN I, CIN II, CIN III) were enrolled in this study. Women having invasive cervical disease and women who not interested were excluded from this study. Results: More than one third (35.3%) patients were in 3rd decade. More than one third (35.4%) patients had normal colposcopic findings followed by 23(35.4%) was CIN I, 11(16.9%) was CIN II and 8(12.3%) was CIN III. Majority (42.6%) patients was found CIN I, 11(26.1%) was CIN II, 8(19.4%) was CIN III and 5(11.9%) had normal in Histopathology. CIN I histopathological finding was found 18 cases, among them 8(44.4%) in positive HC-2/Viral load/ RLU index. In multivariate analysis CIN III was significantly increased 1.34 times in HC-2/Viral load/RLU index positive (human Papillomavirus) cases (95% CI 0.22 – 8.9%, <0.05). Validity test of benign HPV DNA test of the study women showed that HPV DNA had sensitivity 51.4%, specificity 92.9%, accuracy 69.2%, positive predictive values 90.5% and negative predictive values 59.1%. Benign Colposcopic finding had had sensitivity 86.5%, specificity 64.3%, accuracy 76.9%, positive predictive values 76.2% and negative predictive values 78.3%. CIN III significantly 1.34 times increased HC-2/Viral load/ RLU index positive (human Papillomavirus) in multivariate analysis. Conclusion: From the findings of the study it was observed that colposcopy had a high sensitivity and optimum specificity; HPV DNA test had lower sensitivity and higher specificity. Colposcopic findings were closely associated with Histopathology, where the validity test was high when compared to HPV DNA test. So it can be concluded that the Colposcopy is a useful screening test for detection of cervical lesions and Human Papillomavirus is associated with pre-invasive cervical lessons. So the HPV DNA test can be used as a co-test with Colposcopy for screening of cervical lesions. Bangladesh J Obstet Gynaecol, 2018; Vol. 33(1) : 5-10

The diagnostic value of HPV E6/E7 mRNA test in young women with cervical squamous intraepithelial lesion: A Retrospective Analysis

2021 ◽  
Author(s):  
Jing Wang ◽  
Xiaomin Xu
Keyword(s):  
Young Women ◽  
Predictive Value ◽  
Diagnostic Value ◽  
Squamous Intraepithelial Lesion ◽  
Abnormal Cytology ◽  
Dna Test ◽  
Hpv Dna ◽  
Hpv E6 ◽  
Intraepithelial Lesion ◽  
Hpv Dna Test

Abstract Background At present, the HPV DNA test is used to triage young female patients with abnormal cytology. Still, it is not suitable to precisely identify the population with persistent HPV infection. The purpose of this study was to evaluate the diagnostic value of HPV E6/E7 mRNA test in young women with abnormal cytology by comparing HPV DNA test.Methods A total of 258 young women aged 20 to 29 years,with squamous cell abnormalities on the cervical cytology, were enrolled in this study between January 2015 and December 2019.All patients were subject to HPV DNA test, HPV E6/E7mRNA test,colposcopy biopsy, and histopathological examination.A comparative analysis of the diagnostic performance of the HPV DNA test and HPV E6/E7mRNA test was conducted according to the histological diagnosis(CIN II and CIN II+were defined as high-grade squamous intraepithelial lesion+(HSIL+)).Results The results showed that HPV E6/E7 mRNA test had a higher specificity of 47.3%(40.0%-55.1%) for HSIL+ compared to HPV DNA test that had specificity of 16.0% (11.0%-22.6%)in young women(P<0.01). The HPV E6/E7 mRNA test presented high rates of specificity,positive predictive value (PPV), and negative predictive value(NPV), which were 92.1%(86.0%-96.0%), 62.1%(42.4%-78.7%), 92.1%(85.9%-95.8%), respectively, compared to that of HPV DNA,which were 15.8%(10.4%-23.2%),14.6%(9.40%-21.9%), and 71.0%(51.8%-85.1%),respectively(P<0.01)in young women with mildly abnormal cytology(ASC-US and LSIL). Yet, with severe abnormal cytology(ASC-H and HSIL), HR-HPV test was similar to HPV E6/E7 mRNA test in sensitivity(χ2=0.98,P=0.322),specificity(χ2=0.938,P=0.333),PPV(χ2=0.074,P=0.786) and NPV(χ2=0.00,P=1.000).Conclusions Compared to the HPV DNA test,the HPV E6 /E7mRNA test has better clinical value in screening cervical cancer and predicting the risk of HSIL+ in young women, especially those with mild abnormal cytology.

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