Qualitative multiplex species identification of Aspergillus fumigatus, A. flavus, A. terreus and A. nidulans from swabs, EDTA plasma, BAL and sputum samples.
Qualitative identification of the four clinically most relevant Aspergillus species (A. fumigatus, A. flavus, A. terreus, A. nidulans) in nucleic acid extracts from human swabs, EDTA plasma, BAL and sputum samples. Supports species-level differentiation in immunocompromised patients with clinical suspicion of invasive aspergillosis. Results must be interpreted in conjunction with clinical findings, patient history, imaging, culture and galactomannan/β-D-glucan biomarkers.
This test is designed for qualitative detection. Cq values must not be interpreted as quantitative or semi-quantitative fungal load results.
| Targets | A. fumigatus (rodA), A. flavus (CaM), A. terreus (benA), A. nidulans (CaM) · 4 targets · 1 mix |
| Internal control | β-Globin (co-amplification 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 real-time PCR |
| Mix | FAM | HEX | ROX | Cy5 | Cy5.5 |
| Mix 1 | Aspergillus fumigatus | Internal Control | Aspergillus flavus | Aspergillus terreus | Aspergillus nidulans |
| 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.
On QuantStudio 5, Cy5.5 dye calibration must be performed prior to first use (it is not included in the default dye calibration set).
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. Cross-reactivity has been tested against Candida albicans/glabrata/krusei/parapsilosis/tropicalis, Cryptococcus neoformans/gattii, Histoplasma capsulatum, Pneumocystis jirovecii, Fusarium spp., Mucor spp., Rhizopus spp., off-panel Aspergillus species (e.g. A. niger) and Penicillium spp.; no cross-reactivity was observed.
| 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.