Qualitative detection of 26 viral, bacterial and parasitic gastrointestinal pathogens from stool, rectal swab and endoscopic wash samples using a pre-loaded Uniqplex plate.
Qualitative detection of 26 viral, bacterial and parasitic gastrointestinal pathogen targets in nucleic acid extracts from fresh stool, rectal swab or endoscopic wash specimens. Designed for use in acute gastroenteritis, chronic diarrhoea, foodborne outbreak investigation, diarrhoea aetiology in immunocompromised patients and nosocomial GI infection investigations.
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 | 26 pathogens · 7 multiplex wells (A–G) |
| Internal control | RPP-30 (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 × 7 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) | Adenovirus F40/41 | Internal Control | Bacillus cereus | Norovirus GI/GII | — |
| Mix 2 (B) | Rotavirus A | Internal Control | Campylobacter | Astrovirus | Helicobacter pylori |
| Mix 3 (C) | Cryptosporidium | Internal Control | Cyclospora cayetanensis | Entamoeba histolytica | Giardia lamblia |
| Mix 4 (D) | Vibrio cholerae | Internal Control | Vibrio (parahaemolyticus / vulnificus) | Salmonella | Yersinia enterocolitica |
| Mix 5 (E) | STEC stx1 / stx2 | Internal Control | EAEC | EPEC | Plesiomonas shigelloides |
| Mix 6 (F) | Sapovirus (I, II, IV, V) | Internal Control | Shigella / EIEC | ETEC lt / st | — |
| Mix 7 (G) | C. difficile toxin A | Internal Control | C. difficile toxin B | C. difficile binary toxin A | C. difficile binary toxin B |
C. difficile interpretation (Mix 7): tcdA / tcdB positivity is consistent with toxigenic C. difficile; cdtA / cdtB positivity indicates binary toxin-producing strains (e.g. NAP1/B1/027) and may be associated with more severe disease. STEC (Mix 5 FAM): stx1 and stx2 are read on a combined channel; subtype or serotype discrimination may require an orthogonal test. Sapovirus (Mix 6 FAM): covers genogroups I, II, IV, and V; genogroup III (bovine) is not detected. Vibrio mix (Mix 4 ROX): V. parahaemolyticus and V. vulnificus share a channel; a type-specific test should be considered if discrimination is required. Mix 1 and Mix 6 Cy5.5: not used for any target.
| Uniqplex Plate | 2 plates · 7 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, Spin 800 RPM × 10 s + Mix 400 RPM × 30 s, 2 cycles).
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.
Interpretation notes: Four C. difficile targets are read in parallel (tcdA, tcdB, cdtA, cdtB); binary toxin positivity indicates high-severity strains such as NAP1/B1/027. STEC stx1/stx2 is reported on a combined FAM channel; subtyping requires additional testing. The Sapovirus target covers genogroups I/II/IV/V (genogroup III is bovine and not detected). V. parahaemolyticus and V. vulnificus are co-read on the ROX channel; type-specific testing is required for discrimination.
| 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.