Qualitative detection of SARS-CoV-2, RSV, Influenza A and Influenza B from respiratory specimens — four targets in a single multiplex mix.
Qualitative detection of SARS-CoV-2, RSV (Respiratory Syncytial Virus), Influenza A and Influenza B viral nucleic acids in nucleic acid extracts from nasopharyngeal swabs, oropharyngeal swabs, nasopharyngeal aspirate/lavage, bronchoalveolar lavage and sputum specimens. Designed for differential diagnosis of seasonal respiratory viral infections (between COVID-19, influenza and RSV) in a single reaction — for surveillance and diagnostic use.
This test is designed for qualitative detection. Cq values should not be interpreted as quantitative or semi-quantitative viral-load results.
| Targets | SARS-CoV-2, RSV, Influenza A, Influenza B (4 targets · 1 mix) |
| Internal control | RPP-30 (co-amplified on HEX channel) |
| Format | 1-mix plate · pre-loaded oligo + enzyme · pierceable foil seal |
| Reaction volume | 10 µL total (oligo+enzyme pre-loaded + 4 µL template) |
| Cycle time | ~50 min |
| Test type | Qualitative multiplex RT-PCR · plate columns are snap-apart |
| Mix | FAM | HEX | ROX | Cy5 | Cy5.5 |
| Mix 1 | SARS-CoV-2 | Internal Control | RSV | Influenza A | Influenza B |
| SARS-CoV-2 | ORF1ab & E |
| RSV (Respiratory Syncytial Virus) | M & N |
| Influenza A | M1 |
| Influenza B | NS2 |
| Uniqplex Plate | 2 plates · 1 mix × 12 columns, oligo+enzyme pre-loaded, pierceable foil-sealed 96-well |
| NTC | 1 × 1000 µL · negative control |
| PC (Positive Control) | 1 × 120 µL · reagent stability control |
| Pierceable adhesive seal | 2 sheets · transparent PCR seal |
On QuantStudio 5 the HEX channel is reported as VIC (same internal-control fluorophore). Cy5.5 dye calibration must be performed on QuantStudio 5 before first use. Recommended plate-preparation device: Biosan CVP-2 (SMS — Spin-Mix-Spin program).
Typical LoD values by target type: RNA targets in the range of 100–500 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 seasonal coronavirus variants, off-panel influenza subtypes and respiratory tract commensal/pathogen organisms — none observed.
| Before use (foil intact) | −20 °C · until expiry date |
| After opening | −20 °C · 4 months (including freeze-thaw) |
| Freeze-thaw cycles | 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.