Guiding laboratories through the validation processes
for every panel.

Limit of detection (LoD) is established using quantified plasmids and reference organisms for each target across all panels.

Intra-assay and inter-assay studies are performed to demonstrate consistent performance across runs.

All oligonucleotides are rigorously assessed using BLAST and complementary bioinformatics tools to ensure target specificity. Documentation is provided for inclusion in validation records.

Specificity is confirmed using both in-panel and out-of-panel organisms with commercial certifications, demonstrating accurate target discrimination.

Panels are evaluated using characterized clinical samples benchmarked against established comparator methods to demonstrate clinical accuracy.

Potential interfering substances are systematically evaluated, with studies tailored to each panel to assess robustness under real-world conditions.

Sample stability is assessed across multiple time points and storage conditions to verify consistent performance during handling and processing.

Axis Bio can support additional validation and performance studies based on your laboratory's specific needs, including: expanded organism panels, high/low concentration, carryover, matrix-specific validation, workflow optimization studies, and more.