Diagnostic Performance of the PrevoCheck for the Detection of Human Papillomavirus 16-Driven Head and Neck Squamous Cell Carcinoma

Background: Human papillomavirus (HPV)-16 is the most commonly found HPV-type in HPV-induced oropharyngeal squamous cell carcinomas (OPSCC). The serological response to HPV oncoproteins could be a way to detect HPV-driven OPSCC early. A rapid test for the detection of HPV16 L1 antibodies in blood was developed in 2015 (PrevoCheck). Methods: Prospectively, we included 42 patients with newly diagnosed head and neck squamous cell carcinomas (HNSCC). Pretreatment venous blood samples were collected and analyzed with PrevoCheck. The results were interpreted by 2 reviewers. Immunohistochemistry with p16 and HPV DNA-PCR testing served as a reference standard. Results: Sixteen patients had HPV-positive tumors (38.1%). PrevoCheck showed 2 true positives, 26 true negatives, 0 false positives, and 14 false negatives, which resulted in a sensitivity of 12.5% (95% CI: 1.6%-38.4%) at a specificity of 100% (95% CI: 86.8-100). Interobserver agreement showed perfect agreement. Conclusion: A negative result in a test with a high sensitivity can be used to rule out disease, that is, HPV16-related HNSCC. We found 14 false negative results, resulting in low sensitivity for PrevoCheck. This test does not seem suitable to screen for HPV16-related head and neck cancers.