MSI Reference Standards

Clinical Validation of MSI Assay Performance

Labs implementing MSI testing need well‑characterized controls to verify sensitivity (correctly identifying MSI‑H samples), specificity (correctly identifying MSS samples), and accuracy (concordance with expected instability percentages). Our MSS and MSI‑H standards allow systematic evaluation of your PCR or NGS workflow before running patient samples, ensuring reliable results for research‑based MSI assessment.

IVD Kit Development & Research‑Use Kit Optimization

For developers creating MSI detection kits for research use, our standards provide essential validation tools. Use the MSI gradient (MSS, low‑percentage MSI‑H, high‑percentage MSI‑H) to determine optimal locus panels, amplification conditions, and bioinformatics cutoffs. The standards are compatible with both the classic NCI panel and the Promega five‑mononucleotide panel, helping you demonstrate robust performance across different assay designs – all for research purposes only.

Daily Quality Assurance & Translational Research

Integrate our MSI reference standards into routine NGS or PCR runs for intra‑lab QC to monitor batch‑to‑batch reproducibility and instrument stability. For translational researchers, the well‑defined MSI/MSS panel facilitates studies on MSI‑driven tumorigenesis, therapy resistance mechanisms, and co‑biomarker analysis (e.g., correlation with TMB or PD‑L1 expression). The matrix controls also help troubleshoot assay drift and contamination.