Qualitative screening and differentiation of 7 viral and bacterial respiratory pathogens across 2 oligo mixes from respiratory specimens: SARS-CoV-2, RSV, Influenza A/B, Rhinovirus/Enterovirus, Adenovirus and Streptococcus pyogenes.
Qualitative screening and differentiation of 7 common respiratory pathogen targets in nucleic acid extracts from nasopharyngeal swabs, 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 screening. Positive screening results should be confirmed by orthogonal testing when clinically indicated.
| Target genes | Influenza A (M1, PB2) · Influenza B (M1, NS2) · SARS-CoV-2 (ORF1ab, E) · RSV (M, N) · Rhinovirus/Enterovirus (VP1) · Adenovirus (L3) · S. pyogenes (Spy1258) |
| Internal control | Internal Control (HEX channel in both tubes) |
| Format | 2-mix mastermix · 5-channel readout (FAM, HEX, ROX, Cy5, Cy5.5) |
| 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 | SARS-CoV-2 | Internal Control | Respiratory Syncytial Virus | Influenza A | Influenza B |
| Mix 2 | Human Rhinovirus / Enterovirus | Internal Control | Adenovirus | Streptococcus pyogenes | — |
Rhinovirus / Enterovirus combined target (Mix 2 FAM): the VP1 primer set cross-reacts between rhinoviruses and enteroviruses; a positive result is reported as "Human Rhinovirus / Enterovirus detected" — discrimination requires sequencing or a type-specific test. Mix 2 Cy5.5: not used for any target — signals on this channel are artefactual and should be ignored.
| Oligo Mix 1 | 1 × 24 µL · SARS-CoV-2, RSV, Influenza A/B |
| Oligo Mix 2 | 1 × 24 µL · Rhinovirus/Enterovirus, Adenovirus, S. pyogenes |
| Uniqplex Enzyme Mix | 1 × 240 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. Cy5.5 is not included in the default dye calibration set; users must request a Cy5.5 calibration via an authorised service representative before using this kit.
Typical LoD is 100–500 copies/mL for RNA targets and 50–500 copies/mL for DNA targets. Target-based LoD values are documented in the performance evaluation report. Cross-reactivity has been tested against HIV-1, hepatitis viruses, the HHV series, parvovirus B19, dengue/yellow fever viruses, Aspergillus, Candida, Chlamydia, Cryptosporidium and Staphylococcus species; no cross-reactivity was observed.
Interpretation note: Rhinovirus/Enterovirus is reported on a combined channel; discrimination requires sequencing or a type-specific test. The Cy5.5 channel of Mix 2 is not used (artefact signals should be ignored).
| 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.