[The role of serological (rapid) tests for the early detection of HPV-related cancers]

Oncogenic human papillomaviruses (HPV), such as HPV16, can cause anogenital and oropharyngeal cancer (OPC). Unlike anogenital cancers, there are no known premalignant precursor lesions for HPV-induced OPC (HPV-OPC). While cytology-based and HPV-DNA/mRNA-based screening programs are recommended for anogenital cancers in the general population (cervical cancer) or for high-risk groups (anal cancer), this is not the case for HPV-OPC. This article summarizes the role of HPV serology for the early detection of HPV-OPC. The detection of antibodies against the HPV16 oncoprotein E6 has been investigated in many studies. In a systematic review with meta-analysis, a pooled sensitivity of 83.1% and a specificity of 94.6% were calculated for the detection of HPV-OPC with HPV16-E6 serology. The HPV16-E6 antibodies can be detected in serum many years before an OPC diagnosis. At present, however, there is still no validated management approach for individuals who test positive for HPV16-E6 antibodies but are clinically tumor-free. In contrast to HPV-E6 antibodies, antibodies against the HPV capsid protein L1 are detectable following HPV vaccination and also following natural HPV infection in individuals without cancer. In Germany and other countries, a CE in vitro diagnostics (IVD)-labelled rapid test for the detection of HPV16-L1 antibodies (Prevo-Check®) is marketed for the early detection of HPV16-induced cancer. In a recent study, the HPV16-L1 rapid test yielded a positive result in only one quarter of patients with HPV16-OPC. Nearly all HPV vaccinated individuals, as well as more than one third of young people who had experienced a natural HPV16 infection, also tested positive with the HPV16-L1 rapid test. Due to its low sensitivity (12.5-25%) and a high rate of false positive test results, the HPV16-L1 rapid test is not suitable for screening for HPV-OPC.