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https://observatorio.fm.usp.br/handle/OPI/17054
Title: | A Low-Cost HPV Immunochromatographic Assay to Detect High-Grade Cervical Intraepithelial Neoplasia |
Authors: | MARIANO, Vania Sammartino; LORENZI, Adriana Tarla; SCAPULATEMPO-NETO, Cristovam; STEIN, Maira Degiovani; RESENDE, Julio Cesar Possati; ANTONIAZZI, Marcio; VILLA, Luisa Lina; LEVI, Jose Eduardo; LONGATTO-FILHO, Adhemar; FREGNANI, Jose Humberto Tavares Guerreiro |
Citation: | PLOS ONE, v.11, n.10, article ID e0164892, 12p, 2016 |
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. |
Appears in Collections: | Artigos e Materiais de Revistas Científicas - FM/MDR Artigos e Materiais de Revistas Científicas - HC/InCor Artigos e Materiais de Revistas Científicas - LIM/14 Artigos e Materiais de Revistas Científicas - LIM/24 Artigos e Materiais de Revistas Científicas - LIM/52 Artigos e Materiais de Revistas Científicas - ODS/03 |
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File | Description | Size | Format | |
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art_MARIANO_A_LowCost_HPV_Immunochromatographic_Assay_to_Detect_HighGrade_2016.PDF | publishedVersion (English) | 1.32 MB | Adobe PDF | View/Open |
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