Qualitative single-plate genotyping of 32 HPV types (16 high-risk + 16 low-risk) by real-time PCR — a comprehensive HPV profile from a single sample with a single extract.
Qualitative detection and discrimination of 32 HPV genotypes in nucleic acid extracts from cervical, penile, anal, vaginal self-collected, oropharyngeal swab, urine and tissue samples — high-risk: 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 67, 68; low-risk: 6, 11, 26, 40, 42, 43, 44, 54, 61, 69, 70, 72, 73, 81, 82, 83. A comprehensive solution that allows both cervical cancer screening and differential diagnosis of genital warts to be performed on a single plate. 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 32 HPV genotypes |
| Internal control | RPP-30 (co-amplification on HEX channel in every well) |
| Format | 8-mix plate (pre-loaded), 8 PCR reactions per sample |
| Reaction volume | 10 µL total (including 4 µL template) |
| Cycle time | ~50 min |
| Plate capacity | 24 samples × 8 wells = 192 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 |
| Mix 5 | HPV-6 | Internal Control | HPV-11 | HPV-26 | HPV-40 |
| Mix 6 | HPV-42 | Internal Control | HPV-43 | HPV-44 | HPV-54 |
| Mix 7 | HPV-61 | Internal Control | HPV-69 | HPV-70 | HPV-72 |
| Mix 8 | HPV-73 | Internal Control | HPV-81 | HPV-82 | HPV-83 |
| Uniqplex Plate | 2 plates · 8 mixes × 12 columns, 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 HIV-1, hepatitis A/B viruses, HHV-1/2/3/5/6A/6B/8, HTLV-1/2, parvovirus B19, dengue virus, yellow fever virus, Aspergillus brasiliensis, Candida albicans, Chlamydia trachomatis, Cryptosporidium parvum and Staphylococcus spp.; 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.