Qualitative detection and differentiation of Influenza A H1, H3 and H1N1pdm09 subtypes from respiratory specimens by multiplex real-time RT-PCR.
Qualitative detection and differentiation of Influenza A H1, Influenza A H3 and Influenza A H1N1pdm09 targets in nucleic acid extracts from nasopharyngeal and oropharyngeal swabs, nasopharyngeal aspirate/lavage, bronchoalveolar lavage and sputum 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 viral load.
| Target genes | Influenza A H1 (HA), H3 (HA), H1N1pdm09 (HA) |
| Internal control | RPP-30 (co-amplification on HEX channel) |
| Format | 1-mix mastermix · 4-channel readout (FAM, HEX, ROX, Cy5) |
| Reaction volume | 10 µL total |
| Cycle time | ~50 min |
| Cut-off | Cq < 38, sigmoidal · 200 RFU threshold |
| Mix | FAM | HEX | ROX | Cy5 | Cy5.5 |
| Mix 1 | Influenza A H1N1pdm09 | Internal Control | Influenza A H3 | Influenza A H1 | — |
Influenza A subtyping: Mix 1 reports H1N1pdm09 (FAM), seasonal H3 (ROX) and seasonal H1 (Cy5) subtypes on separate channels. Cy5.5: not used in this kit.
| Oligo Mix | 1 × 24 µL · primer + probe (Mix 1) |
| Uniqplex Enzyme Mix | 1 × 120 µL |
| NTC | 1 × 1000 µL · negative template control |
| PC | 1 × 120 µL · reagent stability positive control |
48- and 96-reaction packs are also available — see IFU §3.
On QuantStudio 5 the HEX channel is reported as VIC — both labels refer to the same internal control fluorophore.
Typical LoD is in the range of 100–500 copies/mL in extracted samples. Target-based LoD values are documented in the performance evaluation report. Cross-reactivity has been tested against Influenza B, RSV, SARS-CoV-2, seasonal coronaviruses, hMPV, Adenovirus, Parainfluenza 1–4, Rhinovirus, Enterovirus, M. pneumoniae, S. pneumoniae and other off-panel Influenza A subtypes; no cross-reactivity was observed.
| Before use | −20 °C · until expiry date |
| After opening | −20 °C · 4 months (including freeze-thaw) |
| Freeze-thaw cycle | Maximum 3 |
Class B 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.