Qualitative genotyping of 16 high-risk HPV types (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 67, 68) in cervical, penile, anal and other swab samples by real-time PCR.
Qualitative detection and discrimination of 16 high-risk HPV genotypes in nucleic acid extracts from cervical, penile, anal, vaginal self-collected, oropharyngeal swab, urine and tissue samples. Designed for reflex genotyping in cervical cancer screening programs, colposcopy triage and post-treatment follow-up. Cervical swabs are validated in ThinPrep PreservCyt and BD SurePath LBC media.
Qualitative test — Cq values must not be interpreted as quantitative viral load. Clinical management is recommended in line with the 2019 ASCCP risk-based management guidelines.
| Target gene | E6/E7 oncogene regions for all 16 HPV genotypes |
| Internal control | RPP-30 (co-amplification on HEX channel in every well) |
| Format | 4-mix plate (pre-loaded), 4 PCR reactions per sample |
| Reaction volume | 10 µL total (including 4 µL template) |
| Cycle time | ~50 min |
| Plate capacity | 24 samples × 4 wells = 96 reactions / plate |
| Mix | FAM | HEX | ROX | Cy5 | Cy5.5 |
| Mix 1 | HPV-16 | Internal Control | HPV-18 | HPV-31 | HPV-33 |
| Mix 2 | HPV-35 | Internal Control | HPV-39 | HPV-45 | HPV-51 |
| Mix 3 | HPV-52 | Internal Control | HPV-53 | HPV-56 | HPV-58 |
| Mix 4 | HPV-59 | Internal Control | HPV-66 | HPV-67 | HPV-68 |
| Uniqplex Plate | 2 plates · oligo and enzyme mix preloaded, pierceable foil-sealed |
| NTC | 1 × 1000 µL · negative control |
| PC | 1 × 120 µL · reagent stability positive control |
| Pierceable seal | 2 sheets · transparent PCR seal applied after loading |
The plate is supplied in a column-based format: the user breaks off only the column(s) to be run; the remaining columns are kept with foil intact in storage.
Recommended plate preparation device: Biosan CVP-2 (Centrifuge/Vortex for PCR Plates), SMS program.
Typical LoD is in the range of 50–500 copies/mL in extracted samples. Cross-reactivity has been tested against low-risk HPV genotypes (HPV 6, 11, 42, 43, 44), other high-risk genotypes, animal papillomaviruses, HSV 1/2, CMV, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium, Lactobacillus spp., Gardnerella vaginalis and Candida albicans; no cross-reactivity was observed. Kit-specific performance values are documented in the performance evaluation report.
| Before use | −20 °C · until expiry date |
| After opening | −20 °C · 4 months (including freeze-thaw) |
| Freeze-thaw cycle | Maximum 3 |
Class C IVD device. CE marked under the transitional provisions of Regulation (EU) 2017/746. The conformity assessment process under (EU) 2017/746 (IVDR) is ongoing. TİTCK registered. For in vitro diagnostic use only — for laboratory and professional use.