NeuMoDx HPV Test Strip
For high volume screening applications, the HPV Risk/ QIAscreen assay is also available on a fully automated system as the NeuMoDx HPV Test Strip. The automated workflow on the NeuMoDx™ 96 and 288 Molecular Systems include DNA extraction, PCR amplification, fluorescent detection and result calculation.
The assay – designed on the E7 gene region to avoid false negative results due to integration events of L1 regions – and report HPV16 and HPV18 separately and all 13 other high risk types at clinically relevant infection levels. It performs equally well on cervical screening specimens collected in PreservCyt and SurePath samples.
The NeuMoDx HPV Test strip fulfils the requirements to be used for primary cervical screening.
The analytical and clinical validations are performed according to the International “Meijer” HPV DNA Test Guidelines.
Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening
Key features
Key features of the NeuMoDx HPV DNA Test Strip on the NeuMoDx Molecular Systems.
Assay and Instrument characteristics
- Walk away principle, once samples are loaded and the assay is started, there is no manual intervention, results are generated fully automatic.
- Automatic liquid handling of multiple specimen types, reagents, and buffers
- Assay runs with dried reagents in microfluid cartridge, which can be stored at room temperature – allowing one month on deck reagent storage
- Possibility to run different PCR assays simultaneously, there is independent nucleic acid extraction and PCR modules across all available locations of the instrument
- No batching required – continuous random access: flexibility to add additional samples at any time for any assay
- Time to first result: 60 minutes
- Test volume: 18 tests per hour, max 144 tests per 8 hour for the 96 system and 36 tests per hour and max 288 per 8 hours for the 288 system
- Identification of all consumables and specimen tubes by barcode reader, ensuring complete traceability
- Inventory management to automatically remove empty consumables and replace with new, when applicable
- Integration with LIS and automated test order verification by NeuMoDx Software
- Multi-language support for English, French, Italian, German, and Spanish
NeuMoDx HPV Assay literature and studies
- Heideman e.a., Viruses 2022 – Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening
- Heideman e.a., J Clin Virology 2024 – Validation of the Clinical Performance and Reproducibility of the NeuMoDx HPV Assay Self-sampling Workflow
- Webinar recording – Development and validation of the high-throughput, fully-automated NeuMoDx Assay for HPV detection
For ordering and pricing information, please contact us at order@self-screen.nl
