Update – Guidelines for Adding Molecular Testing to Previous Pap
- Posted on: Mar 29 2016
January 14, 2016
As your partner in Women’s Health and Cytology, DPMG is committed to providing accurate results, ensuring the best possible patient care. DPMG offers both the ThinPrep and SurePath liquid based cytology media. Additional testing can be ordered out of the vial including, HPV, Chlamydia, Gonorrhea and Trichomonas. If your practice is requesting additional testing to be performed out of the vial, please note the following criteria:
ThinPrep: Additional testing may be ordered up to 21 days from the collection date.
SurePath: (note change). Additional testing may be ordered up to 14 days from the collection date.
Reason for the change:
As of January 1, the FDA as well as CAP and CLIA will be monitoring the use of Laboratory Developed Tests more closely. The chief concern is the length of time the specimen is still viable for Molecular testing of HPV. Recovery of DNA and RNA for molecular testing is dependent on the contents of the preservative. Whereas recovery of DNA and RNA is largely unaffected by long term storage in the ThinPrep preservative PerservCyt (30 days at room temperature), long term storage in the SurePath preservative has been shown to affect the recovery of both DNA and RNA due to the presence of formalin. Prolonged storage (>14 days at room temperature) of clinical samples in SurePath media may impact the detection of high-risk HPV by potentially masking a positive result, especially if the amount of nucleic acid present in the sample is initially at a low concentration. DPMG is adopting the recommendations of the Mayo clinic as they have done the appropriate studies for specificity and sensitivity.
We hope this does not cause any inconvenience for your practice.
If you have any questions, please contact your Client Liaison or call DPMG Customer Service at (800) 464-0424.
Posted in: Updates