Qualitative detection of 14 meningitis/encephalitis pathogens from CSF and blood samples using 4 multiplex mixes in a pre-loaded Uniqplex Plate format.
Qualitative detection of 14 viral and bacterial pathogens involved in the aetiology of acute meningitis and encephalitis in nucleic acid extracts from CSF and blood samples. The primary sample is CSF obtained by lumbar puncture; blood, pleural fluid and other body fluids may be tested at the discretion of the responsible physician depending on clinical context. Results must be interpreted in conjunction with clinical findings, patient history, epidemiological information and other laboratory results.
This test is designed for qualitative detection. Cq values must not be interpreted as quantitative or semi-quantitative viral/bacterial load results.
| Targets | 14 pathogens · 4 multiplex mixes (A–D) |
| Internal control | Internal Control (co-amplification on HEX channel in every well) |
| Format | Pre-loaded Uniqplex Plate · 4 mixes × 12 columns · 5-channel readout (FAM, HEX, ROX, Cy5, Cy5.5) |
| Reaction volume | 10 µL total · 4 µL template added |
| Cycle time | ~50 min |
| Per sample | 4 PCR reactions (wells A, B, C, D) |
| Mix | FAM | HEX | ROX | Cy5 | Cy5.5 |
| Mix 1 | E. coli K1 | Internal Control | Cryptococcus neoformans/gattii | Listeria monocytogenes | — |
| Mix 2 | Neisseria meningitidis | Internal Control | Varicella zoster virus | Streptococcus agalactiae | Streptococcus pneumoniae |
| Mix 3 | Enterovirus | Internal Control | — | Human parechovirus | Haemophilus influenzae |
| Mix 4 | Herpes simplex virus 1 | Internal Control | Herpes simplex virus 2 | Human herpesvirus 6A | Human herpesvirus 6B |
| Uniqplex Plate | 1 plate · 4 mixes × 12 columns · pierceable foil-sealed |
| NTC | 1 × 1000 µL · negative control |
| PC (Positive Control) | 1 × 120 µL · reagent stability control |
| Pierceable adhesive seal | 2 sheets · applied to the plate after sample loading |
The plate format allows the user to break off only the column(s) needed; the remaining columns are returned to storage with the foil intact.
On QuantStudio 5, Cy5.5 dye calibration must be performed prior to first use (it is not included in the default dye calibration set).
Typical LoD values for RNA targets are in the range of 100–500 copies/mL and 50–500 copies/mL for DNA targets in extracted samples; 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 Streptococcus oralis/mitis/sanguinis, Staphylococcus aureus/epidermidis, Enterococcus faecalis/faecium, Pseudomonas aeruginosa, Klebsiella pneumoniae, Mycobacterium tuberculosis, off-panel Neisseria species and cytomegalovirus; no cross-reactivity was observed.
| Before use (sealed) | −20 °C · until expiry date |
| After opening | −20 °C · 4 months (including freeze-thaw) |
| Freeze-thaw cycle | 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.