| Full text | |
| Author(s): |
Mariano, Vania Sammartino
;
Lorenzi, Adriana Tarla
;
Scapulatempo-Neto, Cristovam
;
Stein, Maira Degiovani
;
Possati Resende, Julio Cesar
;
Antoniazzi, Marcio
;
Villa, Luisa Lina
;
Levi, Jose Eduardo
;
Longatto-Filho, Adhemar
;
Tavares Guerreiro Fregnani, Jose Humberto
Total Authors: 10
|
| Document type: | Journal article |
| Source: | PLoS One; v. 11, n. 10 OCT 20 2016. |
| Web of Science Citations: | 3 |
| Abstract | |
Objective To evaluate the reproducibility and accuracy of the HPV16/18-E6 test. Methods The study population was comprised of 448 women with a previously abnormal Pap who were referred to the Barretos Cancer Hospital (Brazil) for diagnosis and treatment. Two cervical samples were collected immediately before colposcopy, one for the hr-HPV-DNA test and cytology and the other for the HPV16/18-E6 test using high-affinity monoclonal antibodies (mAb). Women with a histologic diagnosis of cervical intraepithelial neoplasia grade 2 or 3 were considered to be positive cases. Different strategies using a combination of screening methods (HPV-DNA) and triage tests (cytology and HPV16/18-E6) were also examined and compared. Results The HPV16/18-E6 test exhibited a lower positivity rate compared with the HPV-DNA test (19.0% vs. 29.3%, p<0.001) and a moderate/high agreement (kappa = 0.68, 95% CI: 0.60-0.75). It also exhibited a significantly lower sensitivity for CIN2+ and CIN3+ detection compared to the HPV-DNA test and a significantly higher specificity. The HPV16/18-E6 test was no different from cytology in terms of sensitivity, but it exhibited a significantly higher specificity in comparison to ASCH+. A triage test after HPV-DNA detection using the HPV16/18-E6 test exhibited a significantly higher specificity compared with a triage test of ASCH+ to CIN2+ (91.8% vs. 87.4%, p = 0.04) and CIN3+ (88.6% vs. 84.0%, p = 0.05). Conclusion The HPV16/18-E6 test exhibited moderate/high agreement with the HPV-DNA test but lower sensitivity and higher specificity for the detection of CIN2+ and CIN3+. In addition, its performance was quite similar to cytology, but because of the structural design addressed for the detection of HPV16/18-E6 protein, the test can miss some CIN2/3+ lesions caused by other high-risk HPV types. (AU) | |
| FAPESP's process: | 12/51221-4 - Analysis of sensitivity and specificity of four algorithms for cervical cancer screening combining cervical cytology and Human Papillomavirus molecular test (HPV) |
| Grantee: | Adhemar Longatto Filho |
| Support Opportunities: | Research Grants - Research in Public Policies for the National Health Care System (PP-SUS) |
| FAPESP's process: | 08/57889-1 - Institute of Science and Technology to study Diseases Associated with Papillomavirus |
| Grantee: | Luisa Lina Villa |
| Support Opportunities: | Research Projects - Thematic Grants |