ORAL HEALTH EVIDENCE-BASED PRACTICE PROGRAM
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Title Real time PCR is More Accurate Than Enzyme-linked Immunosorbent Assay (Evalusite Test™ Kit) at Detecting Known Periodontal Pathogens
Clinical Question In patients with suspected or unknown periodontitis, is the enzyme-linked immunosorbent assay (Evalusite Test™ kit) as accurate as real time PCR at detecting known periodontal pathogens to facilitate risk assessment and targeted treatment?     
Clinical Bottom Line For patients with suspected or unknown periodontal status, real time PCR is more accurate than enzyme-linked immunosorbent assay (Evalusite Test™ kit) at detecting known periodontal pathogens. However, both enzyme-linked immunosorbent assay (Evalusite Test™ kit) and real time PCR are more reliable than bacterial culture.
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) 8783055Boyer/19964 groups of patients- 26 (used both culture/ELISA) 59 (tested 2 deepest and shallowest sites/ELISA) 51 (1st-20; 2nd 31) (pooled samples).Cross-Sectional Study
Key resultsThe cutoff for culture counts was established (using the first group of patients) at 10(4) for disease vs. health determination. Paper point collection method; Enzyme linked immunosorbent assay (Evalusite Test™) chairside samples were processed within 1 hour of collection. Detected bacteria with 90% confidence in samples (second group of patients) retrieved from deeper pockets. The final assessment, based on the 3rd and 4th group of samples), deemed the Evalusite Test™ as an effective method to identify common periodontal pathogens, A. actinomycetemcomitans, P. intermedia and P. gingivalis.
#2) 18771361Atieh/2008A meta-analysis: Subjects were pooled from 5 studies.Meta-analysis
Key resultsPCR sensitivity for A.a ranged from 87-97%; specificity ranged from 67-77%. P. gingivalis sensitivity ranged from 94-99% and specificity ranged from 55-68%. PCR is accurate at diagnosis A.a and P.gingivalis and provides rapid detection of both viable or dead bacteria. Culture serves as the gold standard for identification of bacteria with the added advantage of antibiotic susceptibility testing.
#3) 7871359Aass/199420 patients-10 young “healthy” control sites, 10 adult periodontitis patients.Cross-Sectional Study
Key resultsReproducibility of culture, Evalusite Test™ (enzyme-linked immunoassay-ELISA), Omnigene (DNA probe analysis) and immunofluorescense were all low. However, culture and immunofluorescense faired better than the commercial products. Findings were only applicable to OmniGene not all DNA probe systems available. If utilized for longitudinal studies, the diagnostic tests would have low internal validity.
Evidence Search 1. Evalusite[All Fields] AND ("ethnology"[Subheading] OR "ethnology"[All Fields] OR "culture"[All Fields] OR "culture"[MeSH Terms]) AND periodontal[All Fields] AND ("sensitivity and specificity"[MeSH Terms] OR ("sensitivity"[All Fields] AND "specificity"[All Fields]) OR "sensitivity and specificity"[All Fields] OR "sensitivity"[All Fields]) 2. ("real-time polymerase chain reaction"[MeSH Terms] OR ("real-time"[All Fields] AND "polymerase"[All Fields] AND "chain"[All Fields] AND "reaction"[All Fields]) OR "real-time polymerase chain reaction"[All Fields] OR ("real"[All Fields] AND "time"[All Fields] AND "pcr"[All Fields]) OR "real time pcr"[All Fields]) AND ("ethnology"[Subheading] OR "ethnology"[All Fields] OR "culture"[All Fields] OR "culture"[MeSH Terms]) AND periodontal[All Fields] AND ("sensitivity and specificity"[MeSH Terms] OR ("sensitivity"[All Fields] AND "specificity"[All Fields]) OR "sensitivity and specificity"[All Fields] OR "sensitivity"[All Fields]) 3. ("enzyme-linked immunosorbent assay"[MeSH Terms] OR ("enzyme-linked"[All Fields] AND "immunosorbent"[All Fields] AND "assay"[All Fields]) OR "enzyme-linked immunosorbent assay"[All Fields] OR ("enzyme"[All Fields] AND "linked"[All Fields] AND "immunosorbent"[All Fields] AND "assay"[All Fields]) OR "enzyme linked immunosorbent assay"[All Fields]) AND periodontal[All Fields] AND reproducible[All Fields]
Comments on
The Evidence
Validity: Sensitivity and specificity of pathogen detection varies based on the microorganisms being evaluated. This meta-analysis provides the highest level of evidence on the validity of bacterial detection using real time PCR. Atieh study: Real time PCR was highly sensitive to detection in comparison with bacterial culture. The usefulness of the meta-analysis is "limited". "Real time PCR is a very promising microbiologic diagnostic method for the detection and quantification of A. actinomycetemcomitans and P.gingivalis." Boyer study: The collection methods were standardized but the environment (multiple private offices) was not controlled thereby increasing the likelihood of human error. There were also multiple sampling methods utilized. "A final determination of clinical utility will also require further study of the relationship between bacterial colonization, as detected by the Evalusite Test, and longitudinal measures of disease progression and/or treatment response." Perspective: The studies were not intended to assist with periodontal diagnosis directly but to assist with epidemiological evaluation. Enzyme linked immunosorbent assay (ELISA) has higher sensitivity and specificity in comparison to culture but is very limited in bacterial species detection. Current research in periodontics is directed towards identification of pathogens for the purpose of establishing causation of periodontal disease, patient risk assessment and exploring targeted treatment options.
Applicability Real time PCR may be utilized to detect common periodontal pathogens. Evalusite Test™ is no longer commercially available however enzyme linked immunosorbent assay (ELISA) technology remains applicable as a periodontal pathogen detection method. The studies demonstrate considerable heterogenicity therefore the true clinical applicability of chairside bacterial detection is uncertain. Additional studies are needed for a direct comparison between enzyme linked immunosorbent assay (ELISA), real time PCR and culture for detection and quantification of the most common periodontal pathogens.
Specialty/Discipline (Oral Medicine/Pathology/Radiology) (Periodontics)
Keywords Enzyme-linked immunosorbent assay, real time PCR
ID# 2535
Date of submission: 08/02/2013spacer
E-mail battlesiatit@uthscsa.edu
Author Shelrethia Battle-Siatita, DDS
Co-author(s) Sara Fayyazi, DDS
Co-author(s) e-mail sara_fayyazi58@yahoo.com; fayazi@uthscsa.edu
Faculty mentor/Co-author
Faculty mentor/Co-author e-mail
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