Noely P C Lorenzi1,2, Lara Termini3, Edson S Ferreira-Filho1,4, Rafaella A L Nunes3, Gabriela A F Silva3, Ana P Lepique5, Adhemar Longatto-Filho6,7,8,9,10, Maricy Tacla4, Edmund C Baracat1,4, Luisa L Villa3,11, José M Soares-Júnior1,4. 1. Disciplina de Ginecologia, Departamento de Obstetricia e Ginecologia, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil. 2. Departamento de Ginecologia, Hospital Universitario, Universidade de São Paulo, São Paulo, Brazil. 3. Center for Translational Investigation in Oncology, Instituto do Câncer do Estado de São Paulo, Hospital das Clinicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil. 4. Divisao de Clínica Ginecologica, Hospital das Clinicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil. 5. Instituto de Ciencias Biomedicas, Universidade de São Paulo, São Paulo, Brazil. 6. Molecular Oncology Research Center, Barretos Cancer Hospital/Pio XII Foundation, São Paulo, Brazil. 7. Medical Laboratory of Medical Investigation 14, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil. 8. Department of Pathology, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil. 9. Research Institute of Life and Health Sciences, University of Minho, Braga, Portugal. 10. 8ICVS/3B's-Associated Laboratory to the Government of Portugal, Braga/Guimaraes, Portugal. 11. Department of Radiology and Oncology, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
Abstract
BACKGROUND: The development of efficient strategies for managing high-risk human papillomavirus (HR-HPV)-positive women is a major challenge when human papillomavirus-based primary screening is being performed. The objectives of this study were to evaluate the comparative effectiveness of HR-HPV testing based on self-collection (SC) and HR-HPV testing based on collection by a health professional (HP) and to assess the potential usefulness of HR-HPV testing combined with testing with the biomarkers p16/Ki-67, α-mannosidase, and superoxide dismutase 2 (SOD2). METHODS: This was a cross-sectional study of 232 women admitted for colposcopy because of an abnormal Papanicolaou smear. The collected material underwent liquid-based cytology, HR-HPV detection, and immunocytochemical testing (p16/Ki-67, α-mannosidase, and SOD2). The gold standard was the histopathological result; the positive reference was CIN2+. RESULTS: The overall accuracy of HR-HPV testing was 76.6%; the results for the SC group (78.1%) and the HP group (75.2%) were similar. The positive predictive values (HP, 76.5%; SC, 80.0%), the negative predictive values (HP, 66.7%; SC, 64.3%), the positive likelihood values (HP, 1.35; SC, 1.36), and the negative likelihood values (HP, 0.21; SC, 0.19) were also similar. p16/Ki-67 showed higher sensitivity than the other 2 biomarkers: 78.1% versus 45.8% for α-mannosidase and 44.5% for SOD2. The specificities of the biomarkers were equivalent: 71.4% for p16/Ki-67, 77.8% for α-mannosidase, and 71.2% for SOD2. In the HP group, accuracy also leaned more heavily toward the final score (using α-mannosidase and SOD2) without statistical significance (80.8% vs 77.9%). The contrast with the SC group yielded the same level of accuracy. CONCLUSIONS: SC, when associated with testing with biomarkers, is as accurate as collection by HPs in the detection of women at risk for cervical cancer.
BACKGROUND: The development of efficient strategies for managing high-risk human papillomavirus (HR-HPV)-positive women is a major challenge when human papillomavirus-based primary screening is being performed. The objectives of this study were to evaluate the comparative effectiveness of HR-HPV testing based on self-collection (SC) and HR-HPV testing based on collection by a health professional (HP) and to assess the potential usefulness of HR-HPV testing combined with testing with the biomarkers p16/Ki-67, α-mannosidase, and superoxide dismutase 2 (SOD2). METHODS: This was a cross-sectional study of 232 women admitted for colposcopy because of an abnormal Papanicolaou smear. The collected material underwent liquid-based cytology, HR-HPV detection, and immunocytochemical testing (p16/Ki-67, α-mannosidase, and SOD2). The gold standard was the histopathological result; the positive reference was CIN2+. RESULTS: The overall accuracy of HR-HPV testing was 76.6%; the results for the SC group (78.1%) and the HP group (75.2%) were similar. The positive predictive values (HP, 76.5%; SC, 80.0%), the negative predictive values (HP, 66.7%; SC, 64.3%), the positive likelihood values (HP, 1.35; SC, 1.36), and the negative likelihood values (HP, 0.21; SC, 0.19) were also similar. p16/Ki-67 showed higher sensitivity than the other 2 biomarkers: 78.1% versus 45.8% for α-mannosidase and 44.5% for SOD2. The specificities of the biomarkers were equivalent: 71.4% for p16/Ki-67, 77.8% for α-mannosidase, and 71.2% for SOD2. In the HP group, accuracy also leaned more heavily toward the final score (using α-mannosidase and SOD2) without statistical significance (80.8% vs 77.9%). The contrast with the SC group yielded the same level of accuracy. CONCLUSIONS: SC, when associated with testing with biomarkers, is as accurate as collection by HPs in the detection of women at risk for cervical cancer.