The objective of this study was to determine the performance characteristics of the Tush brush (TB) compared with a saline moistened Dacron swab (DS) as anal cytology sampling devices.
TB and DS anal cytology tests were randomly collected from 146 patients presenting for anal cytology. High-resolution anoscopy and biopsies were obtained as indicated. Sensitivity and specificity as well as rates of satisfactory specimens were determined for each method using the areas under the receiver operating characteristic curve (AUCROC) and McNemar's test, respectively. Perceived discomfort of each device was determined using a visual analog scale and compared using a paired t test.
The adjudicated AUCROC, sensitivity, and specificity were greater, but not significantly different, for the brush (0.63, 85.5, and 40.0, respectively) compared with the swab (0.50, 79.6, and 33.3, respectively) when the anal biopsy results were considered the criterion standard. In the 1 subject diagnosed with anal cancer, the swab cytology result was normal, but the brush result was abnormal. Specimen adequacy was 95.2% for the brush and 93.2% for the swab. Mean discomfort (visual analog scale) scores were swab 28.5 mm versus brush 35.6 mm (p = .0003) with both scores within the minimal to moderate discomfort range.
Anal cytology AUCROC, sensitivity, and specificity in detecting anal neoplasia were greater using the TB when compared with the DS. A novel anal cytology sampling device designed specifically to increase the detection of anal neoplasia would be clinically beneficial.
1Department of Obstetrics and Gynecology, Augusta University, Augusta, GA;
2Georgia Cancer Center, Augusta University, Augusta, GA;
3Department of Pathology, University of California San Francisco, San Francisco, CA;
4Department of Pathology, Augusta University, Augusta, GA; and
5Department of Population Health Sciences, Division of Biostatistics and Data Science, Augusta University, Augusta, GA
Correspondence to: Daron G. Ferris, MD, Department of Obstetrics and Gynecology, Medical College of Georgia, Georgia Cancer Center, HH-1013, Augusta University, Augusta, GA 30912. E-mail: firstname.lastname@example.org
D.G.F. is the inventor of the Tush Brush and Augusta University holds patent rights. The other authors have declared they have no conflicts of interest.
Supported by Georgia Research Alliance.
The IRB status was approved by Augusta University IRB.