The sensitivity and specificity of the OralCDx technique: evaluation of 103 cases Christian Scheifele * , Andrea-Maria Schmidt-Westhausen, Thomas Dietrich, Peter A. Reichart Department of Oral Surgery and Dental Radiology, Zentrum f€ ur Zahnmedizin, Campus Virchow, Charit  e––Universit € atsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany Received 6 January 2004; accepted 16 February 2004 Summary In this study, we compared 103 OralCDx results with the histological findings of 96 clinical sites in 80 patients (33 females; 64.3 ± 13.7 years and 47 males; 53.2 ± 11.5 years). The histological findings were classified as follows: compatible with oral leukoplakia (OL; n ¼ 60) or oral lichen planus (OLP; n ¼ 17), both without dysplasia; dysplasia in OL or OLP (n ¼ 9); and oral squamous cell carcinoma (OSCC; n ¼ 17). There were seven (6.8%) specimens with an inadequate cell count. Overall, the sensitivity of the OralCDx technique to detect dysplasia and OSCC was 92.3% (95% CI: 74.9–99.1%), and the specificity was 94.3% (95% CI: 86.0–98.4%). The positive likelihood ratio (LR+) was 16.2 (95% CI: 6.2–42.1) and the negative likelihood ratio (LR)) was 0.08 (95% CI: 0.02–0.31). In conclusion, these figures are in agreement with previously published data and support the use of OralCDx as a screening tool of oral lesions, but further trials are still necessary.  c 2004 Elsevier Ltd. All rights reserved. KEYWORDS Oral leukoplakia; Precancerous conditions; Mouth neoplasms; Biopsy; Computer-assisted diagnosis Introduction Standard exfoliative cytology of oral mucosal lesions, including oral precancer, has for years been criticised as not producing adequate and reliable results. 1 In recent years, new techniques, particularly the brush biopsy technique, have been developed. The computerised analysis of brush biopsies (OralCDx â , CDx Laboratories, Suffern, NY) has been introduced since 1999 for the evaluation of oral lesions that appear clinically benign and would otherwise not have received a scalpel biopsy. 2 Now, with more than 110,000 specimens tested, 3 it seems to represent a substantial pro- gress of exfoliative cytology techniques. The study by Sciubba 2 of 945 OralCDx biopsies reported a sensitivity of P 96% and a specificity of P 90% to detect cases of dysplasia or squamous cell carcinoma (OSCC). In a subsequent study 4 of 930 participants of a mass screening, 93 benign- appearing lesions not suspicious for oral precancer were identified by visual examination. OralCDx brush biopsies of these lesions were abnormal in seven cases. Out of these, six showed the OralCDx result “atypical”, i.e. atypical epithelial cells, and * Corresponding author. Tel.: +49-30-450-562-604; fax: +49- 30-450-562-901. E-mail address: christian.scheifele@charite.de (C. Schei- fele). 1368-8375/$ - see front matter  c 2004 Elsevier Ltd. All rights reserved. doi:10.1016/j.oraloncology.2004.02.004 Oral Oncology (2004) 40 824–828 http://intl.elsevierhealth.com/journals/oron/