Qualitative screening for HPV-16, HPV-18 and high-risk HPV group signal in cervical, penile and vaginal swab samples by real-time PCR — in a fast 1-mix screening format.
Qualitative screening for HPV-16, HPV-18 and high-risk HPV group signal in nucleic acid extracts from cervical, penile and vaginal swab samples. Designed as a first-line screening test in cervical cancer screening programs: HPV-16 and HPV-18 are reported separately, while other high-risk types (HPV-31 and others) are reported as a combined "high-risk group" signal. In case of a positive result, reflex testing with the 16-type genotyping kit (REF 1070241) or the 32-type kit (REF 1180241) is recommended for specific genotyping. Cervical swabs are validated in ThinPrep PreservCyt and BD SurePath LBC media.
Qualitative test — Cq values must not be interpreted as quantitative viral load. The combined high-risk group channel does not differentiate the listed types individually. IFU-specified LoD: 1,000 HPV copies/reaction.
| Targets | HPV-16 (FAM), HPV-18 (ROX), HPV high-risk group (Cy5) |
| Target gene | E6/E7 oncogene regions |
| Internal control | RPP-30 (co-amplification on HEX channel) |
| Format | 1-mix mastermix · 4-channel readout |
| Reaction volume | 10 µL total (including 4 µL template) |
| Cycle time | ~50 min |
| Mix | FAM | HEX | ROX | Cy5 | Cy5.5 |
| Mix 1 | HPV-16 | Internal Control | HPV-18 | HPV high-risk group | — |
High-risk group (Cy5): HPV-31 and other high-risk types are reported as a combined signal; this channel does not differentiate the listed types individually. For positive results, reflex testing with P-1-17 (16 types) or P-1-19 (32 types) is recommended. Cy5.5: not used in this kit.
| Oligo Mix | 1 × 24 µL · primer + probe |
| Uniqplex Enzyme Mix | 1 × 120 µL |
| NTC | 1 × 1000 µL · negative control |
| PC | 1 × 120 µL · reagent stability positive control |
48- and 96-reaction packs are also available — see IFU §3.
Typical LoD is in the range of 50–500 copies/mL in extracted samples; IFU-specified kit-specific LoD is 1,000 HPV copies/reaction. 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.