ENZD-QM02 was evaluated for residual host DNA contamination using no-template control (NTC) amplification assays in Escherichia coli and Pseudomonas aeruginosa systems, in comparison with a conventional commercial reagent (Reagent A).
The results showed no detectable amplification in all NTC reactions (48 replicates), indicating extremely low levels of residual host DNA background and ensuring high assay reliability. These findings are based on internal validation studies assessing residual host DNA background in bacterial detection systems.
The premix stability of ENZD-QM02 was assessed after primer–probe pre-mixing under multiple stress conditions, including incubation at 37°C for 28 days and 50 freeze–thaw cycles.
Compared with the -20°C control group, no significant differences in amplification performance were observed, demonstrating strong stability of the premix system under long-term thermal stress and repeated handling conditions. These findings are based on internal validation studies assessing premix stability under thermal stress and freeze–thaw conditions.
ENZD-QM02 was evaluated using a serial dilution of SD1–SD5 templates (10–105 copies/μL) to assess amplification efficiency and dynamic range performance.
The results demonstrated an amplification efficiency close to 100% across different systems, with a wide linear dynamic range, indicating robust quantification performance and strong assay linearity. These results are derived from internal validation studies of amplification efficiency and linear dynamic range performance.