Qualitative multiplex detection of Clostridioides difficile toxin A, toxin B, binary toxin A and binary toxin B from fresh stool, rectal swab and endoscopic lavage specimens.
Qualitative detection of Clostridioides difficile toxin A (tcdA), toxin B (tcdB), binary toxin A (cdtA) and binary toxin B (cdtB) in nucleic acid extracts from fresh stool, rectal swabs or endoscopic lavage specimens. Designed for screening toxigenic strains in suspected C. difficile-associated diarrhoea and pseudomembranous colitis.
This test is designed for qualitative detection. Cq values should not be interpreted as quantitative or semi-quantitative bacterial-load results.
| Targets | tcdA, tcdB, cdtA, cdtB (4 targets · 1 mix) |
| Internal control | Internal Control (co-amplified on HEX channel) |
| Format | 1-mix mastermix · 5-channel readout (FAM, HEX, ROX, Cy5, Cy5.5) |
| Reaction volume | 10 µL total (1 µL oligo mix + 5 µL enzyme + 4 µL template) |
| Cycle time | ~50 min |
| Test type | Qualitative multiplex RT-PCR |
| Mix | FAM | HEX | ROX | Cy5 | Cy5.5 |
| Mix 1 | C. difficile toxin A | Internal Control | C. difficile toxin B | C. difficile binary toxin A | C. difficile binary toxin B |
| Oligo Mix | 1 × 24 µL · primer + probe |
| Uniqplex Enzyme Mix | 1 × 120 µL |
| NTC | 1 × 1000 µL · negative control |
| PC (Positive Control) | 1 × 120 µL · reagent stability control |
48- and 96-reaction packs are also available — see IFU §3.
Cy5.5 dye calibration must be performed before first use on QuantStudio 5 (not included in the default dye set).
Typical LoD for DNA targets is in the range of 50–500 copies/mL in extracted specimens; target-specific LoD values are documented in the performance evaluation report. The linear amplification range extends approximately 5–6 log₁₀ above the LoD. Cross-reactivity has been tested against Staphylococcus spp., Chlamydia trachomatis, Cryptosporidium parvum, Candida albicans, Aspergillus brasiliensis and a broad viral panel — no cross-reactivity was observed.
| Before use (sealed) | −20 °C · until expiry date |
| After opening | −20 °C · 4 months (including freeze-thaw) |
| Freeze-thaw cycles | 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.