Qualitative detection of 12 sexually transmitted viral, bacterial and fungal pathogens from cervical, penile and other urogenital specimens using a pre-loaded Uniqplex plate.
Qualitative detection of 12 sexually transmitted pathogen targets in nucleic acid extracts from cervical, penile, self-collected vaginal, anal, oropharyngeal swabs and urine or tissue samples. Designed for use by trained professional users in the clinical laboratory environment.
This test is designed for qualitative detection. Cq values may be reported as supplementary information but must not be interpreted as a quantitative load.
| Targets | 12 pathogens · 4 multiplex wells (A–D) |
| Internal control | Internal Control (HEX channel in every well) |
| Format | Pre-loaded plate · 5-channel readout (FAM, HEX, ROX, Cy5, Cy5.5) |
| Reaction volume | 10 µL total · 4 µL template per well × 4 wells per sample |
| Cycle time | ~50 min |
| Cut-off | Cq < 38, sigmoidal · 200 RFU threshold |
| Mix (well) | FAM | HEX | ROX | Cy5 | Cy5.5 |
| Mix 1 (A) | Neisseria gonorrhoeae | Internal Control | Gardnerella vaginalis | Ureaplasma parvum / Ureaplasma urealyticum | Trichomonas vaginalis |
| Mix 2 (B) | Mycoplasma hominis | Internal Control | Mycoplasma genitalium | Treponema pallidum | Haemophilus ducreyi |
| Mix 3 (C) | — | Internal Control | Candida albicans | Streptococcus agalactiae | — |
| Mix 4 (D) | HSV1 | Internal Control | HSV2 | — | — |
Ureaplasma combined target (Mix 1 Cy5): Ureaplasma parvum and Ureaplasma urealyticum are read on a shared channel via the ureC primer set; species discrimination may require an orthogonal test. HSV (Mix 4): HSV1 (US3 & US4) is detected on FAM and HSV2 (UL36 & UL37) on ROX with separate type-specific probe sets. Mix 3 FAM and Cy5.5, Mix 4 Cy5 and Cy5.5: not used for any target — signals on these channels are artefactual.
| Uniqplex Plate | 1 plate · 4 mixes × 12 columns · pre-loaded with oligo and enzyme mix, pierceable foil-sealed |
| NTC | 1 × 1000 µL · negative template control |
| PC | 1 × 120 µL · reagent stability positive control |
| Pierceable adhesive seal | 2 sheets · applied after sample loading |
Break off only the column(s) you need; return the remainder to −20 °C with the foil intact. Recommended plate mixing: Biosan CVP-2 (SMS program).
Plate preparation workflow differs depending on instrument optics (bottom- vs top-read); see IFU §7.1.
Typical LoD is 100–500 copies/mL for RNA targets and 50–500 copies/mL for DNA targets. Target-based LoD values and cross-reactivity data are documented in the performance evaluation report. Cross-reactivity has been tested against Lactobacillus crispatus/gasseri/iners/jensenii (vaginal flora), Atopobium vaginae, Prevotella bivia, Mobiluncus spp., Bacteroides fragilis, Escherichia coli and other urogenital commensal flora; no cross-reactivity was observed.
Interpretation note: Ureaplasma parvum and Ureaplasma urealyticum are co-read on the Cy5 channel. Positivity of multiple targets in the same sample is interpreted as co-infection and should be assessed together with clinical findings.
| 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.