PDx Test®

DNA Test for Periodontal Pathogens®

INSTRUCTIONS

The Bio-Tech USA PDx® Specimen Collection Kit contains all supplies you will need to col­lect subgingival plaque specimens for the PDx eight (8) Pathogen Analyses. The test must be administered by a licensed dental practitioner.

Please follow the instructions below.

1. COMPLETELY FILL OUT THE REQUESTED INFORMATION ON THE TEST REQUEST FORM OR ON YOUR ONLINE DATA FORM.

2. SELECT the sites to sample using the following clinical criteria: Select sites that are deepest, nonsuppurating sites. (Heavily bleeding sites are not acceptable)

DO NOT TEST:

·        If the patient has been treated with antibiotics within the last 4-5 weeks.

·        If the patient has had mechanical debridement in the past 4-5 weeks.

·        If the patient has rinsed with a chemotherapeutic mouthrinse within the past TWELVE (12) hours.

3. CLEAR supragingival plaque from the test sites with gauze prior to sampling and INSERT a paper point to the base of the pocket or until gentle resistance is felt (college pliers or cotton roll forceps can be used). Hold in place for 10 seconds. If necessary, a periodontal probe can be used to direct the point.

4. REMOVE the point(s) and place into the specimen collection plastic vial.

·        Close and wrap the vial with the bar-coded VIAL LABEL

·        Place the duplicate bar-coded FORM LABEL on the Test Request Form as indicated AND add to online data e-form.

5. PLACE the capped and barcode labeled vial into the zip-lock poly bag. (Only 1 vial in each poly bag)

6. COMPLETE the TEST REQUEST FORM with any COMMENTS or SPECIAL REQUESTS and sign and make a photocopy for your files. Delays are caused by failure to fully complete the Test Request Form (remember to include your FAX NUMBER and/or EMAIL ADDRESS).

7. PLACE THE ORIGINAL Test Request Form along with the specimen contained in the poly bag into the cardboard mailer tube. DO NOT SUBMIT IN ANY OTHER PACKAGE. Include PAYMENT information on the Test Request Form and mail payment in the cardboard mailer tube.

8. Use a separate tube for each patient.

9. PLACE the CAP over the tube and tape it shut. MAIL the tube and send the e-form online..

RESULTS will be returned to you in approximately 3 days of receipt of the Test at the Laboratory. If you would like the results telephoned to you from the laboratory, please check off the URGENT PRIORITY box on the Test Request Form. Otherwise, all results will be immediately faxed/emailed to you.

Comparing DNA Testing with Culture Testing

Culture reports are an indirect count of bacteria, which were successfully grown in the specific culture medium. The inherent discrepancy in growth rates between bacterial species increases the possibility of error.

-          The PDx Test® reports are more accurate.  This is especially important in pre and post therapy testing since a post treatment check will compare the levels of pathogens with the initial pre-treatment baseline levels.

-          The PDx Test® probe based test has been demonstrated to be highly sensitive. Sensitivity threshold levels for DNA probes are 103 cells versus culture sensitivity of 105 cells.

-          The PDx Test® does not require live bacteria.

-          Since the bacteria in the pocket are fastidious, many pathogens are not easily detected by culture.

-          The PDx Test® DNA probe-based test provides information on the key bacteria, which are implicated in the periodontal disease. The test report is not laden with confusing information on other bacteria, which have not been demonstrated to be important in periodontal disease.

-          Susceptibility testing is generally not recommended for the following reasons:
- Anaerobic infections are generally treated empirically because certain antibodies are almost always active against anaerobes;
- Susceptibility testing for anaerobic infections is not always accurate; results may vary depending on the procedure used.
- Susceptibility tests do not predict a patient's response.
- The National Committee for Clinical Laboratory Standards (NCCLS) recommends testing isolates only when unusual antibiotic regiments have failed or when unusual organisms are present.
- The NCCLS recommends susceptibility testing only for serious infections (e.g. brain abscess, encarditis, asteomyelistis, bacteria, and infections of in-dwelling protheses or vascular grans).
- The NCCLS does not mention susceptibility testing for periodontal disease