CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Recommended Reading
Elise Venable, MBBS
January 2020—The Food and Drug Administration approved in 2001 the first testing modality for the detection of HPV in gynecological cytological specimens. To date, there are now five FDA-approved testing modalities, and molecular testing for high-risk HPV has become commonplace. Numerous studies have shown that high-risk HPV testing is more sensitive in detecting high-grade squamous intraepithelial lesion/cervical intraepithelial neoplasia grade two and above (HSIL/CIN2+) than cytology alone, but that cytology is more specific.
A fundamental understanding of each testing platform’s methodology is required in order to properly interpret results and to recognize the limitations of each platform. Salazar, et al., in a recent article review the five FDA-approved molecular testing platforms for high-risk HPV and provide a reference table that highlights the key characteristics of each platform (Table 1) (Salazar KL, et al. A review of the FDA-approved molecular testing platforms for human papillomavirus. J Am Soc Cytopathol. 2019;8[5]:284–292). The article describes the methodology and limitations of each testing platform and the approved specimen types. The different platforms are then compared with a focus on inter-platform concordance.
The authors write that “HPV tests are more automated and reproducible than cytology, but are by no means perfect,” adding that none of the platforms will identify every HSIL/CIN2+ or cancer. “This fact must be kept in mind,” they say, “when correlating the results of HPV testing with cytology or biopsy findings.”
Dr. Venable is a third-year resident at Mayo Clinic, Rochester, Minn., and a member of the CAP Cytopathology Committee.