Qualitative real-time PCR detection of Streptococcus pyogenes (Group A Streptococcus) DNA in nucleic acid extracts from validated respiratory specimens.
Qualitative detection of Streptococcus pyogenes DNA in nucleic acid extracts from nasopharyngeal swabs, oropharyngeal swabs, nasopharyngeal aspirate/lavage, bronchoalveolar lavage and sputum specimens. Intended to aid the clinical diagnosis of suspected acute pharyngitis/tonsillitis (Group A Streptococcal disease) and the investigation of invasive GAS infection.
This test is designed for qualitative detection. Cq values should not be interpreted as quantitative or semi-quantitative bacterial-load results.
| Target gene | Spy1258 (TetR/AcrR family) |
| Internal control | Internal Control (co-amplified on HEX channel) |
| Format | 1-mix mastermix · 2-channel readout (HEX, Cy5) |
| Reaction volume | 10 µL total (1 µL oligo mix + 5 µL enzyme + 4 µL template) |
| Cycle time | ~50 min |
| Test type | Qualitative multiplex RT-PCR |
The channel mapping matches the Streptococcus pyogenes channel on Mix 8 of the Respiratory Pathogen Panel (Cy5).
| Mix | FAM | HEX | ROX | Cy5 | Cy5.5 |
| Mix 1 | — | Internal Control | — | Streptococcus pyogenes | — |
| 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.
Typical LoD for DNA targets is in the range of 50–500 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 common upper-respiratory-tract commensals and pathogens (S. pneumoniae, S. agalactiae, S. mitis/oralis/salivarius group, S. dysgalactiae, Staphylococcus aureus, Moraxella catarrhalis, Haemophilus influenzae).
| Before use (sealed) | −20 °C · until expiry date |
| After opening | −20 °C · 4 months (including freeze-thaw) |
| Freeze-thaw cycles | 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.