title: Application of the CellDetect® staining technique in diagnosis of human cervical cancer.
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.
authors.affiliation: Department of Pathology, Affiliated Tumor Hospital, Nantong University, Nantong, China.
authors.forename: Song
authors.initials: S
authors.lastname: He
authors.affiliation: Department of Pathological Anatomy, Nantong University, Nantong, China.
authors.forename: Gui-lan
authors.initials: GL
authors.lastname: Wang
authors.affiliation: Biomics Biotechnologies Co., Ltd, Nantong, China.
authors.forename: Yuan-yuan
authors.initials: YY
authors.lastname: Zhu
authors.affiliation: Biomics Biotechnologies Co., Ltd, Nantong, China.
authors.forename: Mei-hua
authors.initials: MH
authors.lastname: Wu
authors.affiliation: Department of Pathology, Affiliated Tumor Hospital, Nantong University, Nantong, China.
authors.forename: Zhi-guo
authors.initials: ZG
authors.lastname: Ji
authors.affiliation: Department of Pathological Anatomy, Nantong University, Nantong, China.
authors.forename: Juan
authors.initials: J
authors.lastname: Seng
authors.affiliation: Biomics Biotechnologies Co., Ltd, Nantong, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Ji
authors.affiliation: Department of Pathological Anatomy, Nantong University, Nantong, China.
authors.forename: Jia-ming
authors.initials: JM
authors.lastname: Zhou
authors.affiliation: Department of Pathology, Affiliated Tumor Hospital, Nantong University, Nantong, China; Department of Pathological Anatomy, Nantong University, Nantong, China. Electronic address: bl1@ntu.edu.cn.
authors.forename: Li
authors.initials: L
authors.lastname: Chen
mesh_terms: D014408:Biomarkers, Tumor / Q000032:analysis*; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis* / Q000473:pathology / Q000821:virology; D004396:Coloring Agents / Q000737:chemistry; D004801:Eosine Yellowish-(YS) / Q000737:chemistry; D004912:Erythrocytes / Q000473:pathology; D005260:Female; D006416:Hematoxylin / Q000737:chemistry; D006801:Humans; D030361:Papillomavirus Infections / Q000097:blood / Q000473:pathology; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013194:Staining and Labeling / Q000379:methods*; D002583:Uterine Cervical Neoplasms / Q000097:blood / Q000175:diagnosis* / Q000473:pathology* / Q000821:virology; D014626:Vaginal Smears / Q000379:methods*; D002578:Uterine Cervical Dysplasia / Q000097:blood / Q000175:diagnosis* / Q000473:pathology* / Q000821:virology
chemical_list: D014408:Biomarkers, Tumor; D004396:Coloring Agents; D011933:Reagent Kits, Diagnostic; D004801:Eosine Yellowish-(YS); D006416:Hematoxylin
keywords: CellDetect® stain; Cervical exfoliated cells; Cervical neoplasia