title: The false negative rate in cervical cytology. Comparison of monolayers to conventional smears.
abstract: OBJECTIVE
  To compare cervical monolayers prepared by a density gradient technique to conventional smears.
  
  
  METHODS
  The study evaluated 2,863 patient samples. After conventional smears were prepared, the residual samples (collected in preservative fluid) were processed by the monolayer preparation system, which disaggregates the cells, removes nonclinical debris and layers the diagnostic material onto a microscopic slide. Slides were screened in Germany and the United States in masked studies.
  
  
  RESULTS
  In the U.S. study, the false negative rate for the conventional smears was 9.4% when endocervical components were present and 16.7% when absent. The false negative rate for the monolayer preparation was 4.0% when endocervical components were present and 5.7% when absent. A comparison of the diagnostic results showed that the monolayer made possible the detection of 48 cases of low grade disease or higher that were not found on the conventional smear. The German study was independent but used the same samples. The results, although based upon the Papanicolaou classification, were similar.
  
  
  CONCLUSIONS
  Cervical samples that are preserved in a liquid suspension and prepared using the density gradient monolayer technology have many advantages over conventional cervical cytologic smear preparations. The quality of cell preservation and presentation is superior. Elimination of obscuring material, homogeneity of the sample and standardized quality work together to produce preparations that can be effectively and reliably screened by cytotechnologists. These preparations should greatly enhance the reliability of machine-based screening in the future.
authors.affiliation: Institute for Cytopathology, Clinics of the University of Kiel, Germany.
authors.forename: E
authors.initials: E
authors.lastname: Sprenger
authors.forename: P
authors.initials: P
authors.lastname: Schwarzmann
authors.forename: M
authors.initials: M
authors.lastname: Kirkpatrick
authors.forename: W
authors.initials: W
authors.lastname: Fox
authors.forename: R H
authors.initials: RH
authors.lastname: Heinzerling
authors.forename: J W
authors.initials: JW
authors.lastname: Geyer
authors.forename: E A
authors.initials: EA
authors.lastname: Knesel
mesh_terms: D005188:False Negative Reactions; D005260:Female; D006801:Humans; D065006:Papanicolaou Test; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000517:prevention & control; D014626:Vaginal Smears / Q000379:methods* / Q000592:standards*