Change to New FDA-approved DNA Methodology
Beginning May 1, 2009 MuirLab changed its method of high risk HPV to a newly FDA-approved molecular methodology from Hologic, Inc. While we have been very satisfied with the performance of our previous assay, market forces have eliminated that manufacturer from the HPV cytology product line at this time. After careful review of all available replacements we selected the Hologic Cervista™ HR HPV test. Requisition ordering protocols and our reporting format will not change.
Clinical Significance: The regular use of the Pap test (cervical cytology) in conjunction with a physician assessment of cytology history, other risk factors (e.g. sexual and smoking history), and professional treatment guidelines has been credited with a marked reduction in the incidence of cervical cancer from its high in the 1950s. In more recent years, the advent of liquid based cervical cytology and computer image guided screening have improved upon the traditional Pap test. Having recognized that HPV is the cause of most cervical cancers, and it is the most common sexually transmitted disease (STD) in the United States, organizations such as the American College of Obstetrics and Gynecology (ACOG), American Society for Colposcopy and Cervical Pathology (ASCCP), and the American Cancer Society (ACS) have recommended including "high risk" HPV testing in specific groups of women based on evidence based medicine principles.
Appropriate Use of Test: Current ASCCP guidelines suggest consideration of high risk HPV testing as a triage for Pap test results of ASC-US (atypical squamous cells of undetermined significance) OR in conjunction with a Pap test for women age 30 or older at least every three years. The results are used to determine the need for colposcopy, which in turn may lead to biopsy and treatment if indicated.
Methodology: The Hologic Cervista™ HPV HR test detects the presence of the 14 HPV types that are designated as "high risk" for the development of cervical cancer by the International Agency for Research on Cancer. It is based on DNA hybridization that employs isothermal signal amplification. It is optimized to our Thin Prep™ liquid based cytology collection specimen, as Hologic is its parent company as well, and needs the industry minimum of 2 mL specimen volume. Another benefit is the inclusion of an internal control that detects the presence of adequate amounts of human DNA. This feature assures us that there is sufficient cellularity in the specimen, thus preventing false negatives and verifying that no inhibitory substances are present interfering with the results. In addition, the assay demonstrates a low indeterminate rate of <1% and no cross reactivity with commonly reported low risk HPV types, thus reducing false positives and the subsequent potential unnecessary clinical management and patient concerns.
Specimen Requirement: Collect: Thin Prep vial (Minimum volume: 2 mL fluid); Transport: Refrigerated / Routine; Storage: ThinPrep vial is stable at room temperature for 1 month; Unacceptable Conditions: Inadequate cellularity; HSV-HR CPT Code: 87621