Maximizing the adequacy of Hologic(®) Cervista(®) HPV HR results on ThinPrep(®) Pap samples treated with glacial acetic acid

Diagn Cytopathol. 2016 Mar;44(3):215-9. doi: 10.1002/dc.23426. Epub 2016 Jan 18.

Abstract

Background: Although glacial acetic acid (GAA) treatment of bloody cervical samples has reduced the rate of unsatisfactory Pap Tests, recent studies suggest that it may negatively impact high-risk (hr)-HPV test results. The objectives of this study were to compare the levels of genomic DNA between GAA treated and nontreated ThinPrep(®) samples using the Hologic(®) Cervista(®) HPV-HR assay and to compare the adequacy of the ThinPrep(®) Pap Test between aliquoted and nonaliquoted samples.

Methods: Prior to GAA treatment, 2.5 ml of the cervical sample was prealiquoted from 102 bloody ThinPrep(®) vials. Both GAA treated and nontreated samples were analyzed for hr-HPV using the Cervista(®) HPV HR assay. The levels of genomic DNA were measured and compared between these samples. In addition, ThinPrep(®) Pap Test adequacy rates were calculated and compared on aliquoted and nonaliquoted cervical samples.

Results: Of the 102 cervical samples, 95 (93%) nontreated aliquots contained satisfactory levels of genomic DNA as compared to 36 (35%) GAA-treated samples (p < 0.00001). Ninety-nine (97%) aliquoted cervical samples were satisfactory for cytologic evaluation as compared to 1,326 (96%) GAA treated samples from 2013 (nonaliquoted); not statistically significant (p = 0.7968).

Conclusion: The levels of genomic DNA were significantly decreased in GAA treated vs non-treated TP samples. Aliquoting from the TP sample prior to treatment with GAA enables accurate measurement of DNA without affecting the adequacy of the TP cytology slide.

Keywords: Hologic® Cervista® HPV HR test; ThinPrep® Pap test; adequacy rates; cervical cytology; glacial acetic acid.

MeSH terms

  • Acetic Acid
  • Human Papillomavirus DNA Tests / instrumentation
  • Human Papillomavirus DNA Tests / methods*
  • Human Papillomavirus DNA Tests / standards
  • Papanicolaou Test / instrumentation
  • Papanicolaou Test / methods*
  • Papanicolaou Test / standards
  • Sensitivity and Specificity

Substances

  • Acetic Acid