Real-time PCR for qualitative detection of Pneumocystis jirovecii DNA from BAL and sputum samples.
Qualitative detection of Pneumocystis jirovecii DNA in nucleic acid extracts from BAL and sputum samples. Used as a supportive diagnostic test in immunocompromised patients (HIV, haematological malignancy, solid organ and haematopoietic stem cell transplant recipients, long-term corticosteroid users) with clinical suspicion of Pneumocystis pneumonia (PJP/PCP). Results must be interpreted in conjunction with clinical findings, patient history, imaging and other laboratory results.
This test is designed for qualitative detection. Cq values must not be interpreted as quantitative or semi-quantitative fungal load results.
| Target | Pneumocystis jirovecii (RNL gene) |
| Internal control | β-Globin (co-amplification on HEX channel) |
| Format | 1-mix mastermix · 2-channel readout (FAM, HEX) |
| Reaction volume | 10 µL total (1 µL oligo mix + 5 µL enzyme + 4 µL template) |
| Cycle time | ~50 min |
| Test type | Qualitative single-target real-time PCR |
| Mix | FAM | HEX |
| Mix 1 | Pneumocystis jirovecii | Internal Control (β-Globin) |
| 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 values for DNA targets are in the range of 50–500 copies/mL 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 Aspergillus fumigatus/flavus/niger/terreus, Candida albicans/glabrata/krusei, Cryptococcus neoformans, Histoplasma capsulatum, Mycobacterium tuberculosis/avium, Streptococcus pneumoniae, Haemophilus influenzae, Pseudomonas aeruginosa, Klebsiella pneumoniae, Cytomegalovirus, EBV, HSV-1/2 and human saprophytic mycobacterial species; 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.