Qualitative multiplex real-time RT-PCR panel for the detection, differentiation and monitoring of 28 respiratory viral and bacterial pathogens from human nasopharyngeal and oropharyngeal swab specimens.
Qualitative, multiplex real-time RT-PCR test for the detection, differentiation and monitoring of selected respiratory viral and bacterial pathogen nucleic acids in nucleic acid extracts from human nasopharyngeal and oropharyngeal swab specimens. Intended for symptomatic individuals of all age groups with clinical suspicion of respiratory tract infection — acute respiratory tract infection, influenza-like illness (ILI), suspected pneumonia, chronic cough aetiology, surveillance of immunocompromised patients and investigation of hospital-acquired infection.
This test is designed for qualitative detection. Semi-quantitative monitoring is supported only when interpreted via UMS software through Cq values anchored to the test detection limit.
| Number of targets | 28 pathogens distributed across 8 multiplex wells (Mix 1-8) |
| Internal control | RPP-30 (co-amplified on HEX channel, in every mix) |
| Format | Plate format · 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 |
The design allows the entire panel to be screened from a single extract of one patient specimen — 8 PCR reactions per sample (Mix 1-8). Plate columns are snap-apart: only the columns required for the run are detached; remaining columns are stored sealed with intact foil for later use.
| Mix | FAM | HEX | ROX | Cy5 | Cy5.5 |
| Mix 1 | SARS-CoV-2 | Internal Control | RSV | Influenza A | Influenza B |
| Mix 2 | Parainfluenza Virus 1 | Internal Control | Parainfluenza Virus 2 | Parainfluenza Virus 3 | Parainfluenza Virus 4 |
| Mix 3 | Coronavirus 229E | Internal Control | Coronavirus HKU1 | Coronavirus NL63 | Coronavirus OC43 |
| Mix 4 | Legionella pneumophila | Internal Control | Chlamydia pneumoniae | Mycoplasma pneumoniae | Human Metapneumovirus |
| Mix 5 | Human Rhinovirus / Enterovirus | Internal Control | Human Bocavirus | Human Parechovirus | Haemophilus influenzae |
| Mix 6 | Adenovirus | Internal Control | Bordetella parapertussis | Bordetella pertussis | Streptococcus pneumoniae |
| Mix 7 | Influenza A H1N1pdm09 | Internal Control | Influenza A H3 | Influenza A H1 | — |
| Mix 8 | — | Internal Control | — | Streptococcus pyogenes | — |
Influenza A subtyping: Mix 1 detects Influenza A on the Cy5 channel as a screening target; Mix 7 differentiates the subtype as H1N1pdm09, H3 or seasonal H1. Rhinovirus / Enterovirus combined target (Mix 5 FAM): the 5'UTR primer set cross-reacts between rhinoviruses and enteroviruses; a positive result is reported as "Human Rhinovirus / Enterovirus detected". Mix 6 and Mix 7 Cy5.5: not used for any target — signals on these channels are artefactual and should be ignored.
| SARS-CoV-2 | ORF1ab & E |
| RSV (Respiratory Syncytial Virus) | M & N |
| Influenza A · A H1N1pdm09 · A H3 · A H1 | M1 & PB2 · HA · HA · HA |
| Influenza B | M1 & NS2 |
| Parainfluenza Virus 1-4 | HN |
| Coronavirus 229E / HKU1 / NL63 / OC43 | N |
| Adenovirus | hexon |
| Human Metapneumovirus | N |
| Human Rhinovirus / Enterovirus | 5'UTR |
| Human Bocavirus | NS1 |
| Human Parechovirus | 5'UTR + polyprotein |
| Legionella pneumophila | mip |
| Chlamydia pneumoniae | ompA |
| Mycoplasma pneumoniae | P1 |
| Bordetella parapertussis · Bordetella pertussis | IS1001 · ptxP |
| Haemophilus influenzae | pal |
| Streptococcus pneumoniae · Streptococcus pyogenes | lytA · Spy1258 (TetR/AcrR) |
| Uniqplex Plate | 2 plates · 8 mixes × 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 (contains 8-mix targets) |
| 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; DNA targets in the range of 50–500 copies/mL. 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 the Streptococcus mitis/oralis/salivarius group, Moraxella catarrhalis, Neisseria spp., Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, non-pneumophila Legionella species, Bordetella holmesii/bronchiseptica, Haemophilus parainfluenzae, seasonal coronavirus variants, off-panel influenza subtypes and off-panel rhinovirus/enterovirus representatives — 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.