Quantitative detection of Epstein-Barr virus (EBV) DNA in peripheral blood, plasma, serum, throat swab, CSF and FFPE tissue specimens by real-time PCR.
Quantitative detection of Epstein-Barr virus (EBV) DNA in nucleic acid extracts from peripheral blood, plasma, serum, throat swab, lymph node biopsy, CSF, urine and FFPE tissue specimens. Surveillance for post-transplant lymphoproliferative disorder (PTLD) following allogeneic haematopoietic stem cell transplantation, monitoring after solid organ transplantation and viral load follow-up in immunosuppressed patients.
Quantitative reporting is performed in copies/mL. Trend analysis (serial samples) is clinically more meaningful than a single absolute value.
| Target gene | EBNA-1 (conserved region) |
| Internal control | RPP-30 (co-amplification on HEX/VIC channel) |
| Format | 1-mix mastermix · 2-channel readout (FAM, HEX) |
| Reaction volume | 10 µL total |
| Cycle time | ~50 min |
| Standard curve | 4-point, 10³ – 10⁶ copies/µL |
| Oligo Mix | 1 × 24 µL · primer + probe |
| Uniqplex Enzyme Mix | 1 × 120 µL |
| NTC | 1 × 1000 µL · negative control |
| Standards (4 points) | 4 × 50 µL · 10³ – 10⁶ copies/µL |
48- and 96-reaction packs are also available — see IFU §3.
The typical LoD is in the range of 50–500 copies/mL in extracted samples. The linear amplification range extends approximately 5–6 log₁₀ above the LoD. Cross-reactivity was tested against CMV, HSV 1/2, VZV, HHV-6/7/8 (including Kaposi-sarcoma HHV-8), BK virus, JC virus, Adenovirus, Parvovirus B19, HIV-1/2, Hepatitis B/C viruses and Toxoplasma gondii; no reactivity was observed. Kit-specific performance values are documented in the performance evaluation report.
| Before use | −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.