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Title Insufficient Evidence Available to Support the Use of OraRisk HPV Salivary Diagnostic Test
Clinical Question In adult patients, how effective is OraRisk HPV salivary diagnostic test in detecting HPV as compared to biopsy?
Clinical Bottom Line There are currently no published studies evaluating the OraRisk HPV salivary diagnostic test.
Best Evidence (you may view more info by clicking on the PubMed ID link)
PubMed ID Author / Year Patient Group Study type
(level of evidence)
#1) 18558666Termine/2008Adult HumansMeta-Analysis
Key resultsSixty two studies were included in the meta-analysis. HPV DNA was present in 38.1% of oral squammous cell carcinomas. Some studies used PCR (polymerase chain reaction) detection while others used in situ hybridization. Studies using PCR reported a higher prevalence of HPV DNA. All samples were taken of tissues, no samples used saliva. This meta-analysis does not directly apply to the OraRisk HPV test because there were no articles or trails using this specific test.
#2) 19680210SahebJamee/2009Adult HumansCohort
Key resultsTwenty two patients positive for oral squammous cell carcinoma were age-sex matched with 20 healthy controls. Saliva samples were taken and the presence of HPV was evaluated by PCR. There were no significant differences found in the detection rates of HPV in saliva between the patient and control groups. The results of this study are "unable to support the detection of HPV in saliva rinses as a diagnostic method for OSCC." This study did not use the OraRisk HPV test, but it did use PCR, the same method of detection used by the OraRisk HPV test.
Evidence Search HPV[All Fields] AND salivary[All Fields] AND ("diagnosis"[MeSH Terms] OR "diagnosis"[All Fields] OR "diagnostic"[All Fields]), OraRisk, ("saliva"[MeSH Terms] OR "saliva"[All Fields]) AND hpv[All Fields] AND ("research design"[MeSH Terms] OR ("research"[All Fields] AND "design"[All Fields]) OR "research design"[All Fields] OR "test"[All Fields])
Comments on
The Evidence
No studies were found evaluating the OraRisk HPV test. Oral cancer has been linked to HPV infection. The SahebJamee study did find that PCR can detect HPV in saliva, but no difference was found between patient and control groups. The lack of statistical significance could be due to the small sample size. High specificity rates have been reported for HPV detection by PCR, but they are expensive and have high false positive rates. If the OraRisk test is able to detect HPV in saliva, it may be of limited value based on the results of the SahebJamee study. Without testing of the OraRisk HPV test, the sensitivity, specificity and diagnostic value of the test remain unknown. If accurate, a saliva test would be a simple, noninvasive screening tool to diagnose high risk HPV, but may be cost prohibitive. Scientific studies are needed to test the diagnostic value of OraRisk HPV salivary diagnostic test.
Applicability There currently is no FDA-approved HPV test for oral HPV, and no HPV test for men. A saliva based test would be non-invasive, fast and convenient for patients and clinicians.
Specialty/Discipline (Oral Medicine/Pathology/Radiology) (Endodontics) (General Dentistry) (Oral Surgery) (Periodontics)
Keywords OraRisk, HPV, Saliva Test, PCR
ID# 2525
Date of submission: 08/20/2013spacer
E-mail hosking@uthscsa.edu
Author Michael Hosking, DDS
Co-author(s) Jane Chadwick, DDS
Co-author(s) e-mail Chadwick@uthscsa.edu
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