REF 1010241

Adenovirus Quantification Kit

Quantitative detection and viral load monitoring of human Adenovirus DNA (subtypes A, B1, B2, C, D, E, F, G) by real-time PCR.

IVD-D CE Quantitative UMS Compatible · Multiplex · 1-mix · 4-channel · 96-well · 24/48/96 reactions

Clinical Use

Quantitative detection of Adenovirus DNA in nucleic acid extracts from human clinical samples including nasopharyngeal and oropharyngeal swabs, bronchoalveolar lavage, stool and urine. Viral load monitoring in allogeneic haematopoietic stem cell transplant recipients and in surveillance following solid organ transplantation.

Quantitative reporting is performed in copies/mL. Trend analysis (serial samples) is clinically more meaningful than a single absolute value.

Test Design

Target geneHexon (conserved region, covers 8 subtypes)
Internal controlβ-Globin (co-amplification on HEX channel)
Format1-mix mastermix · 4-channel readout (FAM, HEX)
Reaction volume10 µL total
Cycle time~50 min
Standard curve4-point, 10³ – 10⁶ copies/µL

Kit Contents (24-reaction pack)

Oligo Mix1 × 24 µL · primer + probe
Uniqplex Enzyme Mix1 × 120 µL
NTC1 × 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.

Validated Instruments

  • Bio-Rad CFX96 Touch
  • HiMedia InstaQ96
  • Applied Biosystems QuantStudio 5
  • Qiagen Rotor-Gene Q 5plex

Performance

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. Kit-specific performance values and cross-reactivity data are documented in the performance evaluation report.

Storage

Before use−20 °C · until expiry date
After opening−20 °C · 4 months (including freeze-thaw)
Freeze-thaw cycleMaximum 3

Regulatory

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.