Application of the CellDetect® staining technique in diagnosis of human cervical cancer

Gynecol Oncol. 2014 Feb;132(2):383-8. doi: 10.1016/j.ygyno.2013.12.016. Epub 2013 Dec 18.

Abstract

Background: CellDetect® staining technique is a newly invented technique for cancer diagnosis. It easily distinguishes between normal and neoplastic cells including pre-cancer and squamous cell carcinoma (SCC) cells, based on staining color and morphology. In this study, application of CellDetect® staining technique was assessed in diagnosis of human cervical cancer as compared with hematoxylin and eosin (H&E) staining in conventional slides and Thinprep cytologic test (TCT) smears.

Methods: The conventional slides and TCT smears of 600 patients were stained and observed while comparing with H&E staining to assess sensitivity and specificity of CellDetect® staining technique in diagnosis of cervical cancer. Conventional smear slides (440 cases) were fixed in 95% ethanol or with CYTOFIX® Spray. TCT smears (160 cases) were processed based on manual. The paraffin sections from cervical intraepithelium neoplasia (CIN) 2-3 and SCC cases were prepared by biopsy.

Results: CellDetect® staining exhibited well cell morphology, simultaneously, showed dual color discrimination, the stain targeted cytoplasm in normal cells in green and dysplastic cells or neoplastic cells in purple/red. Both cervical cell smears or both fixation methods in conventional slides did not affect CellDetect® staining diagnosis, especially in tissue biopsies CellDetect® staining exhibited well epithelium layers to benefit the diagnosis of CIN grade. The sensitivity and specificity of CellDetect® staining technology in diagnosing CIN and SCC were 94.34% and 88.73%, respectively.

Conclusions: CellDetect® staining technique provided a dual color discrimination and morphological analysis. It has the potential to become one of the most effective methods for cervical screening and early diagnosis.

Keywords: CellDetect® stain; Cervical exfoliated cells; Cervical neoplasia.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biomarkers, Tumor / analysis*
  • Carcinoma, Squamous Cell / diagnosis*
  • Carcinoma, Squamous Cell / pathology
  • Carcinoma, Squamous Cell / virology
  • Cervical Intraepithelial Neoplasia / blood
  • Cervical Intraepithelial Neoplasia / diagnosis*
  • Cervical Intraepithelial Neoplasia / pathology*
  • Cervical Intraepithelial Neoplasia / virology
  • Coloring Agents / chemistry
  • Eosine Yellowish-(YS) / chemistry
  • Erythrocytes / pathology
  • Female
  • Hematoxylin / chemistry
  • Humans
  • Papillomavirus Infections / blood
  • Papillomavirus Infections / pathology
  • Reagent Kits, Diagnostic
  • Sensitivity and Specificity
  • Staining and Labeling / methods*
  • Uterine Cervical Neoplasms / blood
  • Uterine Cervical Neoplasms / diagnosis*
  • Uterine Cervical Neoplasms / pathology*
  • Uterine Cervical Neoplasms / virology
  • Vaginal Smears / methods*

Substances

  • Biomarkers, Tumor
  • Coloring Agents
  • Reagent Kits, Diagnostic
  • Eosine Yellowish-(YS)
  • Hematoxylin