title: SNIPER: a novel assay for human papillomavirus testing among women in Guizhou, China.
abstract: OBJECTIVE
  Clinically validate the SNIPER human papillomavirus (HPV) DNA assay for the detection of cervical intraepithelial neoplasia (CIN)2 or higher and CIN2 or higher in a prospective cross-sectional screening study in Guizhou Province, China.
  
  
  METHODS
  Between March and April, 2008, 1000 nonpregnant women aged 30 or older were recruited in Guizhou Province, China. Women positive by SNIPER or cytological examination were requested to return for follow-up. A biopsy of all colposcopically detected abnormalities was performed by quadrant. In normal quadrants, biopsies were obtained at the squamocolumnar junction (2-, 4-, 8-, and 10-o'clock positions depending on the quadrant). Samples were placed in 2 mL of saline solution and maintained between 2 degrees C and 30 degrees C for up to 1 week. One milliliter of this suspension was then prepared and tested. For polymerase chain reaction amplification, a pool of HPV primers was designed to amplify HPV DNA from 13 high-risk-HPV genotypes (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68). Test characteristics were calculated according to standard definitions.
  
  
  RESULTS
  One thousand women were screened; 175 tested HPV positive, 36 women tested negative but had positive Papanicolaou test results. All but 21 (90%) returned for follow-up. Median age and proportions having CIN2 or higher and CIN3 or higher differed by HPV status. Twenty-five women had CIN2 or higher and 16 had CIN3 or higher. The SNIPER assay was 93.3% and 94% sensitive and 86% and 85% specific for the detection of CIN2 or higher and CIN3 or higher, respectively. The positive predictive value was 17.4 % and 9.9% for CIN2 or higher and CIN3 or higher, respectively. Negative predictive value approached 100% for CIN2 or higher and CIN3 or higher.
  
  
  CONCLUSIONS
  The SNIPER assay is functionally competitive and in terms of cost holds an advantage over Hybrid Capture 2 in a Chinese healthcare market, and potentially others, around the world.
authors.affiliation: Preventive Oncology International, Inc, Cleveland Heights, Ohio 44118, USA. seb@poiinc.org
authors.forename: Suzanne E
authors.initials: SE
authors.lastname: Belinson
authors.forename: Na
authors.initials: N
authors.lastname: Wulan
authors.forename: Ruizhen
authors.initials: R
authors.lastname: Li
authors.forename: Wei
authors.initials: W
authors.lastname: Zhang
authors.forename: Xuan
authors.initials: X
authors.lastname: Rong
authors.forename: Yasha
authors.initials: Y
authors.lastname: Zhu
authors.forename: Ruifang
authors.initials: R
authors.lastname: Wu
authors.forename: Jerome L
authors.initials: JL
authors.lastname: Belinson
mesh_terms: D000328:Adult; D002681:China / Q000453:epidemiology; D016001:Confidence Intervals; D003430:Cross-Sectional Studies; D003584:Cytological Techniques / Q000379:methods*; D015344:DNA Probes, HPV; D004279:DNA, Viral / Q000032:analysis*; D005260:Female; D052162:Human papillomavirus 16 / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D015994:Incidence; D008403:Mass Screening; D008875:Middle Aged; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000453:epidemiology; D011446:Prospective Studies; D018570:Risk Assessment; D002583:Uterine Cervical Neoplasms / Q000453:epidemiology / Q000473:pathology / Q000821:virology*; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000453:epidemiology / Q000473:pathology / Q000821:virology*
chemical_list: D015344:DNA Probes, HPV; D004279:DNA, Viral