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Performance of the Roche cobas 4800 high-risk human papillomavirus test in cytologic preparations of squamous cell carcinoma of the head and neck.
Cancer Cytopathol. 2014 Mar; 122(3):167-74.CC

Abstract

BACKGROUND

Determining high-risk human papillomavirus (HR-HPV) status of head and neck squamous cell carcinoma (HNSCC) defines a tumor subset with important clinical implications. Cytologic sampling often provides the sentinel or sole diagnostic specimen. The authors assessed the performance characteristics for the Roche cobas 4800 HPV real-time polymerase chain reaction (PCR)-based system (cobas) on cytologic specimens of HNSCC compared with standard methods of in situ hybridization (ISH) for HR-HPV and immunohistochemistry (IHC) for p16 on formalin-fixed, paraffin-embedded (FFPE) tissue.

METHODS

Samples of HNSCC were collected by fine-needle aspiration and from surgical biopsies or resections, fixed, and processed with the cobas system. Available corresponding FFPE samples were synchronously evaluated for HR-HPV using ISH and IHC. Discrepant cases underwent additional PCR studies for adjudication.

RESULTS

Thirty-six samples from 33 patients were analyzed. Forty-two percent (n = 15) of tumors were positive for HR-HPV according to cobas. Corresponding histology with ISH (n = 30) was concordant in 91% of samples. Compared with the adjudication PCR standard, there were 3 false-positive cases according to cobas. Ninety-two percent (n = 12) of cases were the HPV16 subtype. The overall sensitivity for the cobas system was 100%, and the specificity was 86%.

CONCLUSIONS

Concordance in HNSCC HR-HPV status between cobas and ISH/IHC was > 90%, and cobas demonstrated a sensitivity of 100% and a specificity of 86%, broadening options for HR-HPV testing of fine-needle aspiration samples. Advantages for this system include subtyping of HR-HPV and the ability to discern HR-HPV status earlier in a patient's treatment course.

Authors+Show Affiliations

Department of Pathology, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article

Language

eng

PubMed ID

24259368

Citation

Kerr, Darcy A., et al. "Performance of the Roche Cobas 4800 High-risk Human Papillomavirus Test in Cytologic Preparations of Squamous Cell Carcinoma of the Head and Neck." Cancer Cytopathology, vol. 122, no. 3, 2014, pp. 167-74.
Kerr DA, Pitman MB, Sweeney B, et al. Performance of the Roche cobas 4800 high-risk human papillomavirus test in cytologic preparations of squamous cell carcinoma of the head and neck. Cancer Cytopathol. 2014;122(3):167-74.
Kerr, D. A., Pitman, M. B., Sweeney, B., Arpin, R. N., Wilbur, D. C., & Faquin, W. C. (2014). Performance of the Roche cobas 4800 high-risk human papillomavirus test in cytologic preparations of squamous cell carcinoma of the head and neck. Cancer Cytopathology, 122(3), 167-74. https://doi.org/10.1002/cncy.21372
Kerr DA, et al. Performance of the Roche Cobas 4800 High-risk Human Papillomavirus Test in Cytologic Preparations of Squamous Cell Carcinoma of the Head and Neck. Cancer Cytopathol. 2014;122(3):167-74. PubMed PMID: 24259368.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Performance of the Roche cobas 4800 high-risk human papillomavirus test in cytologic preparations of squamous cell carcinoma of the head and neck. AU - Kerr,Darcy A, AU - Pitman,Martha B, AU - Sweeney,Brenda, AU - Arpin,Ronald N,3rd AU - Wilbur,David C, AU - Faquin,William C, Y1 - 2013/11/20/ PY - 2013/09/30/received PY - 2013/10/03/revised PY - 2013/10/21/accepted PY - 2013/11/22/entrez PY - 2013/11/22/pubmed PY - 2014/5/13/medline KW - cobas KW - cytology KW - fine-needle aspiration KW - head and neck KW - human papillomavirus KW - polymerase chain reaction KW - squamous cell carcinoma SP - 167 EP - 74 JF - Cancer cytopathology JO - Cancer Cytopathol VL - 122 IS - 3 N2 - BACKGROUND: Determining high-risk human papillomavirus (HR-HPV) status of head and neck squamous cell carcinoma (HNSCC) defines a tumor subset with important clinical implications. Cytologic sampling often provides the sentinel or sole diagnostic specimen. The authors assessed the performance characteristics for the Roche cobas 4800 HPV real-time polymerase chain reaction (PCR)-based system (cobas) on cytologic specimens of HNSCC compared with standard methods of in situ hybridization (ISH) for HR-HPV and immunohistochemistry (IHC) for p16 on formalin-fixed, paraffin-embedded (FFPE) tissue. METHODS: Samples of HNSCC were collected by fine-needle aspiration and from surgical biopsies or resections, fixed, and processed with the cobas system. Available corresponding FFPE samples were synchronously evaluated for HR-HPV using ISH and IHC. Discrepant cases underwent additional PCR studies for adjudication. RESULTS: Thirty-six samples from 33 patients were analyzed. Forty-two percent (n = 15) of tumors were positive for HR-HPV according to cobas. Corresponding histology with ISH (n = 30) was concordant in 91% of samples. Compared with the adjudication PCR standard, there were 3 false-positive cases according to cobas. Ninety-two percent (n = 12) of cases were the HPV16 subtype. The overall sensitivity for the cobas system was 100%, and the specificity was 86%. CONCLUSIONS: Concordance in HNSCC HR-HPV status between cobas and ISH/IHC was > 90%, and cobas demonstrated a sensitivity of 100% and a specificity of 86%, broadening options for HR-HPV testing of fine-needle aspiration samples. Advantages for this system include subtyping of HR-HPV and the ability to discern HR-HPV status earlier in a patient's treatment course. SN - 1934-6638 UR - https://www.unboundmedicine.com/medline/citation/24259368/Performance_of_the_Roche_cobas_4800_high_risk_human_papillomavirus_test_in_cytologic_preparations_of_squamous_cell_carcinoma_of_the_head_and_neck_ L2 - https://doi.org/10.1002/cncy.21372 DB - PRIME DP - Unbound Medicine ER -