title: A Low-Cost HPV Immunochromatographic Assay to Detect High-Grade Cervical Intraepithelial Neoplasia.
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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Molecular Oncology Research Center, Barretos Cancer Hospital/Pio XII Foundation, Barretos, Sao Paulo, Brazil.
authors.forename: Vânia Sammartino
authors.initials: VS
authors.lastname: Mariano
authors.affiliation: Molecular Oncology Research Center, Barretos Cancer Hospital/Pio XII Foundation, Barretos, Sao Paulo, Brazil.
authors.forename: Adriana Tarlá
authors.initials: AT
authors.lastname: Lorenzi
authors.affiliation: Pathology Department, Barretos Cancer Hospital/Pio XII Foundation, Barretos, Sao Paulo, Brazil.
authors.forename: Cristovam
authors.initials: C
authors.lastname: Scapulatempo-Neto
authors.affiliation: Pathology Department, Barretos Cancer Hospital/Pio XII Foundation, Barretos, Sao Paulo, Brazil.
authors.forename: Maíra Degiovani
authors.initials: MD
authors.lastname: Stein
authors.affiliation: Cancer Prevention Department, Barretos Cancer Hospital/Pio XII Foundation, Barretos, Sao Paulo, Brazil.
authors.forename: Julio Cesar Possati
authors.initials: JC
authors.lastname: Resende
authors.affiliation: Cancer Prevention Department, Barretos Cancer Hospital/Pio XII Foundation, Barretos, Sao Paulo, Brazil.
authors.forename: Márcio
authors.initials: M
authors.lastname: Antoniazzi
authors.affiliation: Department of Radiology and Oncology, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.
authors.forename: Luisa Lina
authors.initials: LL
authors.lastname: Villa
authors.affiliation: Virology Laboratory, LIM 52.The Institute of Tropical Medicine of the University of Sao Paulo, Sao Paulo, Brazil.
authors.forename: José Eduardo
authors.initials: JE
authors.lastname: Levi
authors.affiliation: Molecular Oncology Research Center, Barretos Cancer Hospital/Pio XII Foundation, Barretos, Sao Paulo, Brazil.|Laboratory of Medical Research Laboratory, LIM 14.Department of Pathology, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.|Life and Health Sciences Research Institute (ICVS), School of Health Sciences, University of Minho, Braga, Portugal.|ICVS/3B's-PT Government Associate Laboratory, Braga/Guimaraes, Portugal.
authors.forename: Adhemar
authors.initials: A
authors.lastname: Longatto-Filho
authors.affiliation: Molecular Oncology Research Center, Barretos Cancer Hospital/Pio XII Foundation, Barretos, Sao Paulo, Brazil.
authors.forename: José Humberto Tavares Guerreiro
authors.initials: JH
authors.lastname: Fregnani
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002846:Chromatography, Affinity / Q000191:economics; D003127:Colposcopy; D004279:DNA, Viral / Q000032:analysis; D004268:DNA-Binding Proteins / Q000378:metabolism; D005260:Female; D061809:Human Papillomavirus DNA Tests / Q000191:economics; D052162:Human papillomavirus 16 / Q000235:genetics*; D052161:Human papillomavirus 18 / Q000235:genetics*; D006801:Humans; D008875:Middle Aged; D060787:Neoplasm Grading; D009856:Oncogene Proteins, Viral / Q000378:metabolism; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000473:pathology / Q000821:virology; D011446:Prospective Studies; D012097:Repressor Proteins / Q000378:metabolism; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000821:virology; D014626:Vaginal Smears; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000473:pathology / Q000821:virology
chemical_list: D004279:DNA, Viral; D004268:DNA-Binding Proteins; C068651:E6 protein, Human papillomavirus type 16; C052603:E6 protein, Human papillomavirus type 18; D009856:Oncogene Proteins, Viral; D012097:Repressor Proteins