title: Performance of self-collected cervical samples in screening for future precancer using human papillomavirus DNA testing.
abstract: BACKGROUND
  Self-collected human papillomavirus (HPV) testing could reduce barriers to cervical cancer screening, with performance comparable to clinician-collected specimens. The ability of self-collected specimens to cross-sectionally and prospectively detect precursor lesions was investigated in an HPV vaccine randomized trial in Costa Rica.
  
  
  METHODS
  In the trial, 7466 women age 18 to 25 years received an HPV16/18 or control vaccine and were followed at least annually for four years. In this secondary analysis, we included all women who provided a self-collected cervicovaginal specimen six months after enrollment (5109 women = full analytical cohort). A subset (615 women = restricted cohort) also had clinician-collected specimens at the six-month postenrollment visit. High-grade squamous intraepithelial lesion or repeat low-grade squamous intraepithelial lesion prompted colposcopic referral throughout the study. HPV testing was performed with SPF10PCR/DEIA/LiPA25. Cross-sectional and prospective sensitivity, specificity, and predictive values were estimated.
  
  
  RESULTS
  In the full cohort, one-time HPV testing on self-collected samples detected prevalent CIN2+ with a sensitivity of 88.7% (95% confidence interval [CI] =77.0% to 95.7%) and a specificity of 68.9% (95% CI = 67.6% to 70.1%). For predicting incident CIN2+ in the subsequent four years, sensitivity was 73.9% (95% CI = 65.8% to 81.0%) and specificity 69.4% (95% CI = 68.1% to 70.7%). In the restricted cohort, for incident CIN2+, self-collected HPV was much more sensitive than cytology (80.0% vs 10.0%); relative sensitivity was 0.1 (95% CI = 0.03% to 0.5%). Furthermore, three times more women with normal baseline cytology developed incident CIN2+ than those with negative self-collected HPV. Self-collected and clinician-collected HPV testing had comparable performance. Agreement between self- and clinician-collected samples was 89.7% (kappa = 0.78, McNemar χ2 = 0.62) for carcinogenic HPV types.
  
  
  CONCLUSIONS
  Self-collected specimens can be used for HPV-based screening, providing sensitivity and specificity comparable with clinician-collected specimens and detecting disease earlier than cytology.
authors.affiliation: Affiliations of authors: Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica (CP, PG, ACR, SJ, DG); Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD (AH, MS, SW, ARK); DDL Diagnostic Laboratory, Rijswijk, the Netherlands (WQ); Prevention and Implementation Group, International Agency for Research on Cancer, World Health Organization, Lyon, France (PG, RH). cporras@proyectoguanacaste.org.
authors.forename: Carolina
authors.initials: C
authors.lastname: Porras
authors.affiliation: Affiliations of authors: Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica (CP, PG, ACR, SJ, DG); Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD (AH, MS, SW, ARK); DDL Diagnostic Laboratory, Rijswijk, the Netherlands (WQ); Prevention and Implementation Group, International Agency for Research on Cancer, World Health Organization, Lyon, France (PG, RH).
authors.forename: Allan
authors.initials: A
authors.lastname: Hildesheim
authors.affiliation: Affiliations of authors: Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica (CP, PG, ACR, SJ, DG); Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD (AH, MS, SW, ARK); DDL Diagnostic Laboratory, Rijswijk, the Netherlands (WQ); Prevention and Implementation Group, International Agency for Research on Cancer, World Health Organization, Lyon, France (PG, RH).
authors.forename: Paula
authors.initials: P
authors.lastname: González
authors.affiliation: Affiliations of authors: Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica (CP, PG, ACR, SJ, DG); Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD (AH, MS, SW, ARK); DDL Diagnostic Laboratory, Rijswijk, the Netherlands (WQ); Prevention and Implementation Group, International Agency for Research on Cancer, World Health Organization, Lyon, France (PG, RH).
authors.forename: Mark
authors.initials: M
authors.lastname: Schiffman
authors.affiliation: Affiliations of authors: Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica (CP, PG, ACR, SJ, DG); Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD (AH, MS, SW, ARK); DDL Diagnostic Laboratory, Rijswijk, the Netherlands (WQ); Prevention and Implementation Group, International Agency for Research on Cancer, World Health Organization, Lyon, France (PG, RH).
authors.forename: Ana Cecilia
authors.initials: AC
authors.lastname: Rodríguez
authors.affiliation: Affiliations of authors: Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica (CP, PG, ACR, SJ, DG); Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD (AH, MS, SW, ARK); DDL Diagnostic Laboratory, Rijswijk, the Netherlands (WQ); Prevention and Implementation Group, International Agency for Research on Cancer, World Health Organization, Lyon, France (PG, RH).
authors.forename: Sholom
authors.initials: S
authors.lastname: Wacholder
authors.affiliation: Affiliations of authors: Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica (CP, PG, ACR, SJ, DG); Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD (AH, MS, SW, ARK); DDL Diagnostic Laboratory, Rijswijk, the Netherlands (WQ); Prevention and Implementation Group, International Agency for Research on Cancer, World Health Organization, Lyon, France (PG, RH).
authors.forename: Silvia
authors.initials: S
authors.lastname: Jiménez
authors.affiliation: Affiliations of authors: Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica (CP, PG, ACR, SJ, DG); Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD (AH, MS, SW, ARK); DDL Diagnostic Laboratory, Rijswijk, the Netherlands (WQ); Prevention and Implementation Group, International Agency for Research on Cancer, World Health Organization, Lyon, France (PG, RH).
authors.forename: Wim
authors.initials: W
authors.lastname: Quint
authors.affiliation: Affiliations of authors: Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica (CP, PG, ACR, SJ, DG); Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD (AH, MS, SW, ARK); DDL Diagnostic Laboratory, Rijswijk, the Netherlands (WQ); Prevention and Implementation Group, International Agency for Research on Cancer, World Health Organization, Lyon, France (PG, RH).
authors.forename: Diego
authors.initials: D
authors.lastname: Guillen
authors.affiliation: Affiliations of authors: Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica (CP, PG, ACR, SJ, DG); Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD (AH, MS, SW, ARK); DDL Diagnostic Laboratory, Rijswijk, the Netherlands (WQ); Prevention and Implementation Group, International Agency for Research on Cancer, World Health Organization, Lyon, France (PG, RH).
authors.forename: Aimée R
authors.initials: AR
authors.lastname: Kreimer
authors.affiliation: Affiliations of authors: Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica (CP, PG, ACR, SJ, DG); Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD (AH, MS, SW, ARK); DDL Diagnostic Laboratory, Rijswijk, the Netherlands (WQ); Prevention and Implementation Group, International Agency for Research on Cancer, World Health Organization, Lyon, France (PG, RH).
authors.forename: Rolando
authors.initials: R
authors.lastname: Herrero
mesh_terms: D000328:Adult; D000368:Aged; D052685:Alphapapillomavirus / Q000235:genetics / Q000302:isolation & purification*; D015331:Cohort Studies; D003127:Colposcopy; D003364:Costa Rica; D003430:Cross-Sectional Studies; D004279:DNA, Viral / Q000032:analysis*; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D053918:Papillomavirus Vaccines / Q000008:administration & dosage; D011230:Precancerous Conditions / Q000517:prevention & control / Q000821:virology*; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods*; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control / Q000821:virology*; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000517:prevention & control / Q000821:virology*
chemical_list: D004279:DNA, Viral; D053918:Papillomavirus Vaccines