NeuMoDx HPV Assay Fulfills the International Guidelines for HPV screening
HPV assays to be used in screening setting need to fulfill clinical sensitivity and clinical specificity specifications as defined in the International Guidelines. The NeuMoDx HPV assay is a novel fully automated, real-time PCR-based assay for the qualitative detection of high-risk HPV DNA in cervical specimens.
The assay is designed on the E7 gene region and specifically reports HPV16 and HPV18 separately and all 13 other high-risk HPV types at clinically relevant infection levels. Following the international guidelines, the clinical performance of the NeuMoDx HPV assay for CIN2+ detection were assessed against the reference standard Hybrid Capture 2, as well as intra- and inter-laboratory reproducibility on PreservCyt samples. The clinical accuracy was additionally evaluated against the clinically validated Alinity m HR HPV and COBAS 4800 HPV Test on PreservCyt samples, and against the clinically validated HPV-Risk assay on SurePath samples. The NeuMoDx HPV assay performance for CIN2+ was non-inferior to the reference methods on both sample types, and showed excellent intra- and inter-laboratory reproducibility. In conclusion, the NeuMoDx HPV assay meets international guideline criteria for cross-sectional accuracy and reproducibility, and performs equally well on cervical screening specimens collected in PreservCyt and SurePath samples. With that, the NeuMoDx HPV assay fulfils the requirements to be used for primary cervical screening.
publication: Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening