Performance of the Roche AMPLICOR® Human papillomavirus (HPV) test in prediction of cervical intraepithelial neoplasia (CIN) in women with abnormal PAP smear

2005 ◽  
Vol 99 (1) ◽  
pp. 160-168 ◽  
Author(s):  
Joseph Monsonego ◽  
Jean Marc Bohbot ◽  
Giuseppe Pollini ◽  
Claude Krawec ◽  
Catherine Vincent ◽  
...  
2009 ◽  
Vol 133 (9) ◽  
pp. 1426-1430 ◽  
Author(s):  
Henry Armah ◽  
R. Marshall Austin ◽  
David Dabbs ◽  
Chengquan Zhao

Abstract Context.—Reflex human papillomavirus (HPV) testing has been designated in consensus guidelines as “preferred” for women with atypical squamous cells of undetermined significance (ASC-US) liquid-based cytology (LBC) results, and colposcopy is currently recommended for patients with HPV-positive ASC-US results. Data from large clinical practices using newer screening methods and current cytology terminology are limited. Objectives.—We analyzed data from patients with ASC-US LBC and positive HPV test results. We also assessed the impact of the presence or absence of an endocervical cell/ transformation zone sample (EC/TZS) on biopsy diagnoses. Design.—The information system of a large women's hospital serving an older-than-average population was searched over a 21-month period between July 1, 2005, and March 31, 2007, for HPV-positive cases interpreted as ASC-US (Bethesda System 2001) using computer-imaged LBC. Histologic diagnoses, patient ages, and presence or absence of an EC/TZS were analyzed. The average follow-up period was 7.5 months. Results.—Among 4273 women with HPV-positive ASC-US results, the cumulative cervical intraepithelial neoplasia 2 or 3 (CIN 2/3) and CIN 1 rates for 2192 women with available biopsies were 5.1% and 43.6%, respectively. Cervical intraepithelial neoplasia 2/3 and CIN 1 rates for women with HPV-positive ASC-US results were not significantly different for women with and without an EC/TZS. Conclusions.—The risk of CIN 2/3 in the study population was significantly lower than reported in widely cited trial data. Neither presence nor absence of an EC/TZS, nor the age of the patient, had a statistically significant impact on the likelihood of biopsy diagnoses of CIN 2/3 and CIN 1 for patients with HPV-positive ASC-US test results.


2004 ◽  
Vol 128 (11) ◽  
pp. 1257-1262
Author(s):  
Michelle Howard ◽  
John W. Sellors ◽  
Alice Lytwyn ◽  
Paula Roth ◽  
James B. Mahony

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.


2008 ◽  
Vol 18 (5) ◽  
pp. 1060-1064 ◽  
Author(s):  
J. F. Bragança ◽  
L. O. Sarian ◽  
D. R. Pitta ◽  
A. B. Maito ◽  
J. Vassallo ◽  
...  

The objective of the study was to investigate the expression of p53 and p16INK4a in cervical intraepithelial neoplasia (CIN) and their relation with disease severity and high-risk human papillomavirus (HR-HPV) status. A series of 125 women with previous positive Pap smear were selected for this cross-sectional study. All patients underwent gynecological examination, including colposcopy. Specimens for Pap smears, Hybrid Capture 2 (HC2) test, and pathologic analysis were obtained. After evaluation of CIN grade, immunohistochemical detection of proteins p53 and p16INK4a was performed on paraffin-embedded sections. The extent of immunoexpression of both proteins was analyzed in relation to CIN grade and HR-HPV status. CIN was graded as 1 in 21, 2 in 17, and 3 in 87 specimens. p16INK4a positivity (at least 5% of epithelial cells stained) was found in 99 of 125 cases (79.2%) and was significantly higher in high-grade lesions as compared to low-grade CIN (P< 0.001). The expression of p53 did not differ across histologic strata. Protein expression neither of p16INK4a nor of p53 correlated with HR-HPV status. Expression of p16INK4a was not related with that of p53. Our study gives further support to previous findings of strong association of p16INK4a immunostaining with severity of epithelial atypia, but this protein may not be considered a predictor of HR-HPV status determined with HC2. By contrast, immunoexpression of p53 was related neither to CIN grade nor to HR-HPV status.


2020 ◽  
Author(s):  
Linghua Kong ◽  
Xiaoping Xiao ◽  
Huiping Lou ◽  
Pengfei Liu ◽  
Shuhui Song ◽  
...  

Abstract Background: Cervical cancer is the second-most common gynecological cancer, early screening plays a key role in the diagnosis and treatment of cervical intraepithelial neoplasia (CIN). Sustained E7 protein expression is the pathological basis for CIN and cervical cancer. Methods: We collected the cervical cell samples of 205 women who visited the gynecological clinic of Peking Union Medical College Hospital between September 2018 and September 2019 and submitted them to the high-risk human papillomavirus (Hr-HPV) test. We performed a magnetic particle–based chemiluminescence enzyme immunoassay to analyze the Hr-HPV16/18 E7 protein level in CIN of different severities and compared the results with those of cervical pathology (gold standard) and the Hr-HPV test. Results: The positive rate of Hr-HPV16/18 E7 protein increased with the severity of CIN: 26.55% in normal tissue, 58.33% in CIN1, and 70.59% in CIN2/CIN3. For CIN2 and above, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the E7 protein were 70.59%, 67.88%, 52.17%, and 82.30%, respectively. These values of the Hr-HPV test were 86.76%, 44.53%, 43.70%, and 87.14%, respectively. With the combination of the E7 protein assay and Hr-HPV test, the specificity for diagnosing CIN2 and above was 78.10%, which was significantly higher than that of the Hr-HPV test alone. Conclusions: Hr-HPV16/18 E7 protein level is correlated with the severity of CIN and has a high concordance rate with the pathological result. For cervical cancer screening, the combination of HPV16/18 E7 protein assay and Hr-HPV test improves the CIN diagnostic specificity, detection rate, and detection accuracy.


2013 ◽  
Author(s):  
Esther van der Heijden ◽  
Alberto D Lopes ◽  
Andrew Bryant ◽  
Ruud Bekkers ◽  
Khadra Galaal ◽  
...  

2020 ◽  
Author(s):  
Linghua Kong ◽  
Xiaoping Xiao ◽  
Huiping Lou ◽  
Pengfei Liu ◽  
Shuhui Song ◽  
...  

Abstract Background: Cervical cancer is the second-most common gynecological cancer, early screening plays a key role in the diagnosis and treatment of cervical intraepithelial neoplasia (CIN). Sustained E7 protein expression is the pathological basis for CIN and cervical cancer. Methods: We collected the cervical cell samples of women who visited the gynecological clinic of Peking Union Medical College Hospital between September 2018 and September 2019 and submitted them to the high-risk human papillomavirus (Hr-HPV) test. We performed a magnetic particle–based chemiluminescence enzyme immunoassay to analyze the HPV16/18 E7 protein level in CIN of different severities and compared the results with those of cervical pathology (gold standard) and the HPV test. Results: The positive rate of HPV16/18 E7 protein increased with the severity of CIN: 26.6% in normal tissue, 58.3% in CIN1, and 70.6% in CIN2 or higher (CIN2+). For CIN2+, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the E7 protein were 70.6%, 67.9%, 52.2%, and 82.3%, respectively. These values of the HPV test were 86.8%, 44.5%, 43.7%, and 87.1%, respectively. With the combination of the E7 protein assay and HPV test, the specificity for diagnosing CIN2+ was 78.1%, which was significantly higher than that of the HPV test alone. Conclusions: HPV16/18 E7 protein level is correlated with the severity of CIN and has a high concordance rate with the pathological result. For cervical cancer screening, the combination of HPV16/18 E7 protein assay and HPV test improves the CIN diagnostic specificity, detection rate, and detection accuracy.


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