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Test Update

Recommendations for Human Papillomavirus (HPV) Testing



September 2010

#80171, Human Papillomavirus (HPV) Detection
#83344, Human Papillomavirus (HPV) Detection, High-Risk Types

The human papillomavirus (HPV) types that are associated with cervical cancer are called high-risk viral types. There are numerous high-risk viral types but the most common are 16, 18, 31, 33, 35, and 39. A number of HPV viral types are low risk (types 6, 11, 42, 43, and 44) and have not been detected in any cervical cancers. These HPV types carry no significant risk of developing cervical neoplasia.

While identification of high-risk HPV types is considered an important component of cervical cancer screening protocols, current recommendations by the American Cancer Society (ACS), American Society for Colposcopy and Cervical Pathology (ASCCP), and American College of Obstetricians and Gynecologists (ACOG) state that identification of low-risk HPV types does not have a role in routine cervical cancer screening and provides limited clinical value in this setting.

Mayo Medical Laboratories test #80171, Human Papillomavirus (HPV) Detection detected both high- low risk types of HPV from female cervical and vaginal specimens. So, in keeping with the current recommendations, we have discontinued the use of this assay. All specimens submitted for detection of HPV are now tested utilizing #83344, Human Papillomavirus (HPV) Detection, High Risk Types, which provides a more economical and medically useful option for clients wishing to test for HPV from cervical and vaginal specimens.

Michael Henry, MD, director of the Cytology Laboratory in the Division of Anatomic Pathology at Mayo Clinic, presents a review of the current guidelines for the appropriate use of HPV tests in a Hot Topic video presentation (Cervical Cytology and HPV Testing) available at www.mayomedicallaboratories.com.

ASCO and CAP Guidelines for Estrogen and Progesterone Receptor Immunohistochemical Testing in Breast Cancer

Effective January 1, 2011, new guidelines for immunohistochemical testing (IHC) of estrogen receptor (ER) and progesterone receptor (PR) in breast cancer from the American Society of Clinical Oncology (ASCO) and College of American Pathologists (CAP) will be instituted at Mayo Clinic. These new guidelines are available online at the following Web sites:

www.asco.org
www.cap.org

The primary goal of the guidelines is to reduce assay variability and improve accuracy and utility of ER/PR testing as predictive markers for breast cancers by offering strategies to optimize assay performance, result interpretation, and result reporting. Among other recommendations, the new guidelines highlight the critical nature of the specimen-handling requirements. Preanalytic treatment of the specimen greatly impacts the quality of the specimen and, therefore, the quality of the test result. Specifically, the time from biopsy or resection of the breast tumor to fixation in 10% neutral buffered formalin fixative should be as short as possible and certainly within 1 hour. Additionally, the breast needle/core biopsy and excisional specimens must be fixed in 10% neutral buffered formalin for 6 to 72 hours before processing. Any deviation from this handling can potentially impact the final test results. The new guidelines also require documentation of time to fixation and the total fixation time. Mayo Medical Laboratories will continue to monitor the recommendations of ASCO and CAP so that we can rapidly respond to process and testing improvements. Meanwhile, it is important to adhere to all specimen collection, preparation, and handling instructions. Delay to fixation, underfixation, or overfixation fall outside of ASCO/CAP guidelines and may affect results.

Following these instructions will optimize your test results:

  • Acquire specimen
  • Within 1 hour of collection, section surgical specimens at 5mm intervals and fix specimen in 10% neutral buffered formalin
  • Fix specimen for no less than 6 hours and no more than 72 hours before processing
  • Embed tissue in paraffin

* Submit only nondecalcified specimens.

Mayo Medical Laboratories would like to take this opportunity to reassure our clients that we routinely participate in proficiency testing surveys and maintain in-house proficiency testing and quality control.

Reference
Hammond ME, Hayes DF, Dowsett M, et al: American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer (unabridged version). Arch Pathol Lab Med 2010 Jul;134(7):e48-72


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