Title OralCDx Brush Test Should Not Replace Surgical Biopsy in Oral Cancer Examinations
Clinical Question For a patient with a small white innocuous looking oral lesion, would the OralCDx brush test be as effective as a surgical biopsy in detecting the presence of dysplasia within the lesion?
Clinical Bottom Line The OralCDx brush test may have the ability to detect dysplasia in innocuous looking oral lesions, but recently published reports continue to have contrasting results pertaining to its overall clinical applicability. Surgical biopsy is still considered the gold standard and should be used to achieve the correct detection and diagnosis.
Best Evidence  
PubMed ID Author / Year Patient Group Study type
(level of evidence)
21864339Mehrotra/201179 patients with minimally suspicious oral lesionsCross-Sectional
Key resultsThe sensitivity and specificity of the brush test are 96.3% (95%CI:87%-100%) and 90.4% (95%CI:82%-97%), respectively. The PPV and NPV for the brush test are 84% and 98%, respectively.
19165806Bhoopathi/2009152 patients with a positive or atypical OralCDx test result were referred to a surgeon for a scalpel biopsyCross-Sectional
Key resultsSince only positive OralCDx lesions were surgically biopsied, sensitivity, specificity, and NPV were not given.T he PPV for the brush test is 7.9% (95%CI:4.2%-13.4%)The proportion of false-positive biopsy results were 92.1% (95%CI:86.6%-95.9%)
Evidence Search ("Mouth Neoplasms"[Mesh]) AND "Biopsy"[Mesh]AND "Oral brush biopsy"
Comments on
The Evidence
Mehrota Study: Surgical biopsy was considered as the gold standard and was used on every lesion tested, and the OralCDx test was measured blind to the surgical biopsy. The lesions tested were defined as “minimally suspicious.” There were no competing interests in the study. Some limitations to this study include, but not limited to: 1. The study population is one that has a higher tobacco use and higher prevalence of oral cancer compared to the United States. 2. The definition “minimally suspicious” is open to interpretation. 3. The location of just under half the lesions was the buccal mucosa, which is considered a low risk area. Bhoopathi Study: Surgical biopsy was considered as the gold standard and was only used to evaluate lesions that had previously tested positive with the OralCDx test. The spectrum of lesion severity was not disclosed. There were no competing interests in the study.Some limitations to this study include, but not limited to: 1. The “suspiciousness” of the lesions evaluated was not mentioned. 2. The time frame between OralCDx brush test and scalpel biopsy was not defined. 3. They were only able to calculate the PPV.
Applicability Since there is a drastic difference between the two reported PPV’s, more clinical studies need to be conducted to determine the overall applicability and accuracy of the OralCDx brush test in detecting dysplastic lesions. Some situations where the OralCDx test may be beneficial: a patient with history of noncompliance that has a suspicious lesion and you feel that the patient will not return for a biopsy and further treatment; a patient with multiple lesions in multiple sites who is unwilling to undergo multiple biopsies.
Specialty (Oral Medicine/Pathology/Radiology) (General Dentistry) (Oral Surgery) (Periodontics) (Dental Hygiene)
Keywords Brush biopsy, Biopsy, OralCDx, Oral cancer
ID# 2194
Date of submission 04/05/2012
E-mail juber@livemail.uthscsa.edu
Author Shane Juber
Co-author(s) e-mail
Faculty mentor Michaell Huber, DDS
Faculty mentor e-mail huberM@uthscsa.edu
Basic Science Rationale
(Mechanisms that may account for and/or explain the clinical question, i.e. is the answer to the clinical question consistent with basic biological, physical and/or behavioral science principles, laws and research?)
None available
Comments and Evidence-Based Updates on the CAT
None available