Quantitative detection of BK virus (BKV) DNA in EDTA plasma and urine specimens by real-time PCR, and viral load monitoring in kidney transplant recipients.
Quantitative detection of BK virus (BKV) DNA in nucleic acid extracts from EDTA plasma and urine specimens. Viral load monitoring for BKV-associated nephropathy (BKVAN) surveillance in kidney transplant recipients and for haemorrhagic cystitis following allogeneic haematopoietic stem cell transplantation.
Quantitative reporting is performed in copies/mL. Trend analysis (serial samples) is clinically more meaningful than a single absolute value.
| Target gene | LT-antigen (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 JCV, SV40, CMV, EBV, HSV 1/2, VZV, Adenovirus, Parvovirus B19, HHV-6/7/8, HIV-1/2 and Hepatitis B/C viruses; 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.