Table 1 Novel assays
Test | Name | Target | Description |
|---|---|---|---|
Lateral Flow Assay (LFA) | PT Monitor® (Abviris GmbH, Germany) | HPV16-L1 Ab | Blood-based (serum) competitive immunoassay assessing the presence of epitope-specific antibodies against HPV16-L1. Elevated levels of these antibodies are associated with the presence of HPV16-induced cancer or pre-cancer. A quantitative readout is possible with an optical table-top reader (aLF reader by Qiagen, Germany). CE-marked IVD |
Rapid Lateral Flow Assay (rLFA) | Prevo-Check® (Abviris GmbH, Germany) | HPV16-L1 Ab | Qualitative (yes/no) output of LFA (PT Monitor®) in form of rapid capillary point-of-care test with a cut-off of HPV16-L1 Ab > 1000 ng/ml. CE-IVD-marked for the detection of HPV16-induced anal and oropharyngeal cancers |
Probe-based RNA Assay | HPV and dysplasia test – QuantiGene-Molecular-Profiling-Histology (QG-MPH) | mRNA of HPV oncogenes and cellular biomarkers | Cell-based. Quantitative detection of HPV16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82 and cellular biomarkers, correlating with severity of a dysplastic lesion. The emergence and strength of biomarkers define the lesion stage. The QuantiGene 2.0 platform (ThermoFisher) is used 2 Experimental molecular IVD, Charité-University Hospital Berlin, DE (WO2020/161285 A1) |