Single-mix real-time RT-PCR for qualitative detection of SARS-CoV-2 RNA (ORF1ab and E regions) from respiratory specimens.
Qualitative detection of SARS-CoV-2 RNA in nucleic acid extracts from nasopharyngeal aspirate/lavage, bronchoalveolar lavage, nasopharyngeal swab, oropharyngeal swab and sputum samples. Designed for use by trained professional users in the clinical laboratory environment; results must be interpreted together with clinical findings, patient history, epidemiological information and other laboratory results.
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 regions | SARS-CoV-2 ORF1ab & E (genome-specific primer-probe set) |
| Internal control | RNase P (co-amplification on HEX channel) |
| Format | 1-mix mastermix · 2-channel readout (FAM, HEX) |
| Reaction volume | 10 µL total |
| Cycle time | ~50 min |
| LoD (manual) | 250 SARS-CoV-2 copies/mL · 200 RFU threshold |
| Mix | FAM | HEX | ROX | Cy5 | Cy5.5 |
| Mix 1 | SARS-CoV-2 | Internal Control | — | — | — |
SARS-CoV-2 is detected on the FAM channel using a combined primer-probe set targeting the ORF1ab and E regions; the RNase P internal control is co-amplified on the HEX channel in every reaction. The single-mix design is compatible with all validated instruments calibrated for 2-channel (FAM, HEX) readout.
| 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.
The LoD declared in the IFU for all kit versions is 250 SARS-CoV-2 copies/mL. Cross-reactivity has been tested against seasonal coronaviruses (229E, HKU1, NL63, OC43), MERS-CoV, SARS-CoV (2003), Influenza A and B, RSV, hMPV, Parainfluenza 1–4, Adenovirus, Rhinovirus, Enterovirus, M. pneumoniae, C. pneumoniae and S. pneumoniae; no cross-reactivity was observed. In-silico testing shows cross-reactivity with some bat-associated SARS-CoV strains (not clinically relevant).
| 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.