Candida species identification — 6 clinically critical species (auris, albicans, krusei, glabrata, parapsilosis, tropicalis) in a single panel. Species-level diagnosis in candidaemia and invasive candidiasis suspicion.
Qualitative species-level identification of 6 clinically critical Candida species — C. auris, C. albicans, C. krusei, C. glabrata, C. parapsilosis, C. tropicalis — in nucleic acid extracts from blood, swab, body fluid, BAL and sputum samples. Used as a supportive diagnostic test in clinical suspicion of candidaemia, invasive candidiasis and fungaemia, particularly in intensive care, haematological malignancy and neutropenic patient populations. Species-level resolution guides antifungal selection and resistance expectations. Results must be interpreted in conjunction with clinical findings, blood culture, patient history and other laboratory results.
This test is designed for qualitative species identification. Cq values must not be interpreted as quantitative or semi-quantitative fungal load results.
| Targets | 6 Candida species (auris, albicans, krusei, glabrata, parapsilosis, tropicalis) |
| Internal control | β-Globin (co-amplification on HEX channel in each mix) |
| Format | 2-mix mastermix · 4-channel readout (FAM, HEX, Cy5, Cy5.5) |
| Reaction volume | 10 µL total (1 µL oligo mix + 5 µL master mix + 4 µL template) |
| Cycle time | ~50 min |
| Test type | Qualitative multiplex species identification real-time PCR |
| Mix | FAM | HEX | Cy5 | Cy5.5 |
| Mix 1 | C. auris | Internal Control | C. albicans | C. krusei |
| Mix 2 | C. glabrata | Internal Control | C. parapsilosis | C. tropicalis |
ROX channel is not used in this kit. HEX carries the internal control (β-Globin) in both mixes.
| Oligo Mix 1 | 1 × 24 µL · auris/albicans/krusei + IC primers + probes |
| Oligo Mix 2 | 1 × 24 µL · glabrata/parapsilosis/tropicalis + IC primers + probes |
| Uniqplex Enzyme Mix | 1 × 240 µL (2 mix × 120 µL) |
| NTC | 1 × 1000 µL · negative control |
| PC (Positive Control) | 1 × 120 µL · synthetic 6-species mix |
48- and 96-reaction packs are also available — see IFU §3.
Typical LoD values for DNA targets are in the range of 50–500 copies/mL in extracted samples; target-specific LoD values are documented in the performance evaluation report. The linear amplification range extends approximately 5–6 log₁₀ above the LoD. Analytical specificity and cross-reactivity data are documented in the performance evaluation report.
| Before use (sealed) | −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.