Quantitative detection of JC virus (JCV) DNA in EDTA plasma, CSF and urine specimens by real-time PCR — for PML investigation and viral load monitoring in immunosuppressed patients.
Quantitative detection of JC virus (JCV) DNA in nucleic acid extracts from EDTA plasma, cerebrospinal fluid (CSF) and urine specimens. Investigation of progressive multifocal leukoencephalopathy (PML), monitoring of JCV reactivation in at-risk patients treated with natalizumab and other immunomodulatory therapies, and viral load follow-up in transplant recipients.
Quantitative reporting is performed in copies/mL. Trend analysis (serial samples) is clinically more meaningful than a single absolute value.
| Target gene | VP1 (capsid protein 1) |
| 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 BK virus (closely related polyomavirus), 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.