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Prediction of cervical intraepithelial neoplasia grade 2+ (CIN2+) using HPV DNA testing after a diagnosis of atypical squamous cell of undetermined significance (ASC-US) in Catalonia, Spain.
BMC Infect Dis 2012; 12:25BI

Abstract

BACKGROUND

A protocol for cervical cancer screening among sexually active women 25 to 65 years of age was introduced in 2006 in Catalonia, Spain to increase coverage and to recommend a 3-year-interval between screening cytology. In addition, Human Papillomavirus (HPV) was offered as a triage test for women with a diagnosis of atypical squamous cells of undetermined significance (ASC-US). HPV testing was recommended within 3 months of ASC-US diagnosis. According to protocol, HPV negative women were referred to regular screening including a cytological exam every 3 years while HPV positive women were referred to colposcopy and closer follow-up. We evaluated the implementation of the protocol and the prediction of HPV testing as a triage tool for cervical intraepithelial lesions grade two or worse (CIN2+) in women with a cytological diagnosis of ASC-US.

METHODS

During 2007-08 a total of 611 women from five reference laboratories in Catalonia with a novel diagnosis of ASC-US were referred for high risk HPV (hrHPV) triage using high risk Hybrid Capture version 2. Using routine record linkage data, women were followed for 3 years to evaluate hrHPV testing efficacy for predicting CIN2+ cases. Logistic regression analysis was used to estimate the odds ratio for CIN2 +.

RESULTS

Among the 611 women diagnosed with ASC-US, 493 (80.7%) had at least one follow-up visit during the study period. hrHPV was detected in 48.3% of the women at study entry (mean age 35.2 years). hrHPV positivity decreased with increasing age from 72.6% among women younger than 25 years to 31.6% in women older than 54 years (p < 0.01). At the end of the 3 years follow-up period, 37 women with a diagnosis of CIN2+ (18 CIN2, 16 CIN3, 2 cancers, and 1 with high squamous intraepithelial lesions--HSIL) were identified and all but one had a hrHPV positive test at study entry. Sensitivity to detect CIN2+ of hrHPV was 97.2% (95%confidence interval (CI) = 85.5-99.9) and specificity was 68.3% (95%CI = 63.1-73.2). The odds ratio for CIN2+ was 45.3 (95% CI: 6.2-333.0), when among ASC-US hrHPV positive women were compared to ASC-US hrHPV negative women.

CONCLUSIONS

Triage of ASC-US with hrHPV testing showed a high sensitivity for the detection of CIN2+ and a high negative predictive value after 3 years of follow-up. The results of this study are in line with the current guidelines for triage of women with ASC-US in the target age range of 25-65. Non adherence to guidelines will lead to unnecessary medical interventions. Further investigation is needed to improve specificity of ASC-US triage.

Authors+Show Affiliations

Unit of Infections and Cancer, Cancer Epidemiology Research Programme, IDIBELL, Catalan Institute of Oncology, Av, Gran Vía, 199-203L'Hospitalet de Llobregat, 08907 Barcelona, Spain.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22280073

Citation

Ibáñez, Raquel, et al. "Prediction of Cervical Intraepithelial Neoplasia Grade 2+ (CIN2+) Using HPV DNA Testing After a Diagnosis of Atypical Squamous Cell of Undetermined Significance (ASC-US) in Catalonia, Spain." BMC Infectious Diseases, vol. 12, 2012, p. 25.
Ibáñez R, Moreno-Crespi J, Sardà M, et al. Prediction of cervical intraepithelial neoplasia grade 2+ (CIN2+) using HPV DNA testing after a diagnosis of atypical squamous cell of undetermined significance (ASC-US) in Catalonia, Spain. BMC Infect Dis. 2012;12:25.
Ibáñez, R., Moreno-Crespi, J., Sardà, M., Autonell, J., Fibla, M., Gutiérrez, C., ... de Sanjosé, S. (2012). Prediction of cervical intraepithelial neoplasia grade 2+ (CIN2+) using HPV DNA testing after a diagnosis of atypical squamous cell of undetermined significance (ASC-US) in Catalonia, Spain. BMC Infectious Diseases, 12, p. 25. doi:10.1186/1471-2334-12-25.
Ibáñez R, et al. Prediction of Cervical Intraepithelial Neoplasia Grade 2+ (CIN2+) Using HPV DNA Testing After a Diagnosis of Atypical Squamous Cell of Undetermined Significance (ASC-US) in Catalonia, Spain. BMC Infect Dis. 2012 Jan 26;12:25. PubMed PMID: 22280073.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prediction of cervical intraepithelial neoplasia grade 2+ (CIN2+) using HPV DNA testing after a diagnosis of atypical squamous cell of undetermined significance (ASC-US) in Catalonia, Spain. AU - Ibáñez,Raquel, AU - Moreno-Crespi,Judit, AU - Sardà,Montserrat, AU - Autonell,Josefina, AU - Fibla,Montserrat, AU - Gutiérrez,Cristina, AU - Lloveras,Belen, AU - Alejo,María, AU - Català,Isabel, AU - Alameda,Francesc, AU - Casas,Miquel, AU - Bosch,F Xavier, AU - de Sanjosé,Silvia, Y1 - 2012/01/26/ PY - 2011/06/15/received PY - 2012/01/26/accepted PY - 2012/1/28/entrez PY - 2012/1/28/pubmed PY - 2012/7/25/medline SP - 25 EP - 25 JF - BMC infectious diseases JO - BMC Infect. Dis. VL - 12 N2 - BACKGROUND: A protocol for cervical cancer screening among sexually active women 25 to 65 years of age was introduced in 2006 in Catalonia, Spain to increase coverage and to recommend a 3-year-interval between screening cytology. In addition, Human Papillomavirus (HPV) was offered as a triage test for women with a diagnosis of atypical squamous cells of undetermined significance (ASC-US). HPV testing was recommended within 3 months of ASC-US diagnosis. According to protocol, HPV negative women were referred to regular screening including a cytological exam every 3 years while HPV positive women were referred to colposcopy and closer follow-up. We evaluated the implementation of the protocol and the prediction of HPV testing as a triage tool for cervical intraepithelial lesions grade two or worse (CIN2+) in women with a cytological diagnosis of ASC-US. METHODS: During 2007-08 a total of 611 women from five reference laboratories in Catalonia with a novel diagnosis of ASC-US were referred for high risk HPV (hrHPV) triage using high risk Hybrid Capture version 2. Using routine record linkage data, women were followed for 3 years to evaluate hrHPV testing efficacy for predicting CIN2+ cases. Logistic regression analysis was used to estimate the odds ratio for CIN2 +. RESULTS: Among the 611 women diagnosed with ASC-US, 493 (80.7%) had at least one follow-up visit during the study period. hrHPV was detected in 48.3% of the women at study entry (mean age 35.2 years). hrHPV positivity decreased with increasing age from 72.6% among women younger than 25 years to 31.6% in women older than 54 years (p < 0.01). At the end of the 3 years follow-up period, 37 women with a diagnosis of CIN2+ (18 CIN2, 16 CIN3, 2 cancers, and 1 with high squamous intraepithelial lesions--HSIL) were identified and all but one had a hrHPV positive test at study entry. Sensitivity to detect CIN2+ of hrHPV was 97.2% (95%confidence interval (CI) = 85.5-99.9) and specificity was 68.3% (95%CI = 63.1-73.2). The odds ratio for CIN2+ was 45.3 (95% CI: 6.2-333.0), when among ASC-US hrHPV positive women were compared to ASC-US hrHPV negative women. CONCLUSIONS: Triage of ASC-US with hrHPV testing showed a high sensitivity for the detection of CIN2+ and a high negative predictive value after 3 years of follow-up. The results of this study are in line with the current guidelines for triage of women with ASC-US in the target age range of 25-65. Non adherence to guidelines will lead to unnecessary medical interventions. Further investigation is needed to improve specificity of ASC-US triage. SN - 1471-2334 UR - https://www.unboundmedicine.com/medline/citation/22280073/Prediction_of_cervical_intraepithelial_neoplasia_grade_2+__CIN2+__using_HPV_DNA_testing_after_a_diagnosis_of_atypical_squamous_cell_of_undetermined_significance__ASC_US__in_Catalonia_Spain_ L2 - https://bmcinfectdis.biomedcentral.com/articles/10.1186/1471-2334-12-25 DB - PRIME DP - Unbound Medicine ER -