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Of the 14 candidate genes selected for laboratory validation, Xi et al. already validated differential splicing of CEACAM1 in AdCa of NSCLC [ 34].
Although a formal inter laboratory validation was not undertaken, both methods have been independently validated according to FDA guidelines.
Biomarkers are validated using a process that typically includes three stages: laboratory validation, clinical trials and clinical application.
From the laboratory validation, the proposed technique successfully captures the presence of delamination.
For laboratory validation, nine samples were fabricated and IDT strength test was performed on them.
Additionally, allele-specific EMSA and luciferase reporter assays are commonly used in laboratory validation of candidate regulatory SNPs27,28,29,30,31,32.
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The above method was validated according to AOAC International guidelines for conducting single-laboratory validation [ 26].
The method was first validated in-house according to the IUPAC harmonised guideline for single-laboratory validation.
Finally, inter-laboratory validation verified robustness and reproducibility.
A detailed procedure for single-laboratory validation of qualitative methods is proposed.
The intra-laboratory validation was performed with sterilized milk samples artificially spiked with gentamicin at concentrations less than, equal to, and greater than the cut-off level.
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