Quantitative detection and viral load monitoring of Parvovirus B19 DNA in peripheral blood, plasma and serum by real-time PCR.
Quantitative detection of Parvovirus B19 DNA in nucleic acid extracts from peripheral blood, plasma and serum samples. Designed for viral load monitoring in allogeneic haematopoietic stem cell transplant recipients, chronic anaemia follow-up, and in immunosuppressed patients. Also validated for additional sample types including bone marrow aspirate, amniotic fluid, CSF and FFPE tissue.
Quantitative reporting is performed in copies/mL. Trend analysis (serial samples) is clinically more meaningful than a single absolute value.
| Target gene | NS1 (Parvovirus B19) |
| Internal control | RPP-30 (co-amplification on HEX 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.
Typical LoD is in the range of 50–500 copies/mL in extracted samples. Linear amplification range extends approximately 5–6 log₁₀ above the LoD. Cross-reactivity has been tested against human bocaviruses 1–4, parvovirus 4 (PARV4), animal parvoviruses and other blood-borne viruses (CMV, EBV, HSV 1/2, Adenovirus, BK/JC viruses, HIV-1/2, HBV, HCV); no cross-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.