Delta Pathology introduces Cobas HPV testing beginning September 8, 2015
The HPV test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies (types) HPV 16 and HPV 18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) at clinically relevant infection levels. The Cobas HPV Test is the only clinically validated, FDA-approved assay that simultaneously provides pooled results on high-risk genotypes and individual results on the highest-risk genotypes, HPV 16 and HPV 18. This allows clinicians to focus on the few women who need aggressive treatment and allows them to reassure the vast majority of women that they are at very low risk.
Very little will change for the clinicians. Because HPV testing can be performed using a cervical cytology specimen (ThinPrep vial), there will be no need to collect additional samples. The requisitions used for testing will be slightly different as will the results. The HPV order check boxes on the new requisition will now read “High Risk HPV with 16/18”. Results for HPV 16 and HPV 18 genotyping will appear in the report for every patient who tests positive for High Risk HPV, and it will no longer be necessary to order this separately. There will no longer be a check box on the requisition for low risk HPV testing. Current guidelines recommend against testing for low risk HPV stating it should have no role in cervical cancer screening/prevention. Consequently, most laboratories are no longer offering this testing. However, if you still feel that low risk HPV testing is necessary for your patient, you may write this in under “other” on the requisition. Be aware that low risk HPV testing is a send out test and the results may be delayed a week or more.
The new HPV testing will go into effect September 8th and new requisitions will be distributed. We hope that everyone will have received the new requisitions prior to September 8th; however, if you have not received the new requisitions by then, you may continue to use the old ones until the new ones are received. Standing orders for HPV will also need to be updated. Please do not hesitate to contact us with any questions or concerns you may have.
BEST PRACTICES SPECIMEN LABELING AND REQUISITIONING
Specimen labeling and specimen collection information are two critical pieces needed for anatomic pathology and clinical pathology testing. The patient is not personally seen for pathological testing; however that does not diminish the desire to provide excellent service. The specimens received are regarded as representatives of the physical bodies which are actually seen in the client’s office. The requisition and the appropriate specimen container ensure that the necessary information is provided and that specimen integrity is maintained. Information that should be included on the requisition is:
- Date of birth
- Social security number
- Specimen source
- Collection date
- Collection time
- Physician name
- Diagnosis if insurance is to be billed
Complete information and maintenance of specimen integrity are essential to timely and accurate reporting of test results. Please help to ensure the requisitions are completely filled out and the specimens are labeled correctly.