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

TL;DR

This study evaluated a blood test called PrevoCheck for detecting HPV16-related head and neck cancers but found it had low sensitivity and is not suitable for screening.

Contribution

The study provides new empirical evidence on the diagnostic performance of the PrevoCheck test for HPV16-driven head and neck cancers.

Findings

PrevoCheck had a sensitivity of 12.5% and a specificity of 100% for detecting HPV16-related HNSCC.

14 false negatives were observed, indicating the test is not reliable for screening.

Interobserver agreement for test interpretation was perfect.

Abstract

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).

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.

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.

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.

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