Advanced search
Start date
Betweenand
Related content
(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

A Low-Cost HPV Immunochromatographic Assay to Detect High-Grade Cervical Intraepithelial Neoplasia

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