Merck
HomeSingle Molecule Counting (SMC®) TechnologyWhy Rigorous Verification is Important for High-Sensitivity Immunoassays

Why Rigorous Verification is Important for High-Sensitivity Immunoassays

Rigorous verification of high-sensitivity immunoassays is critical for accurate sensitivity and optimal performance. Learn how the verification criteria of ultrasensitive Single Molecule Counting (SMC®) immunoassays help deliver results researchers can trust.


Why is Verification Important in High-Sensitivity Immunoassays?

Verification of high-sensitivity immunoassays is important to ensure the precision of the sensitivity is accurate and the results are reliable. This involves using a variety of verification criteria including LLOQ, Spike Recovery, and more.

The SMC® high sensitivity detection system addresses the needs of researchers who require highly quantitative, accurate, and robust biomarker assays. These assays are rigorously developed and tested in matrix by multiple operators over multiple days. A comprehensive set of criteria evaluating ultimate quantitative performance are used to verify each immunoassay.

Verification Criteria

Below describes the verification criteria that are used to qualify SMC® assays.

Lower Limit of Quantification

The lower limit of quantification (LLOQ) is the lowest point on the standard curve where CV is <20% and accuracy is within 20% of expected values.

Inter- and Intra- Assay Precision

Inter-assay and intra-assay precision involve the same samples run on multiple plates over multiple days to ensure reproducibility. The spiked and un-spiked samples must report values within 20% across experiments.

Spike Recovery

Spike recovery is when the analyte is added at the lower end of the standard curve to ensure accurate measurements for real samples. A minimum of 10 samples are spiked with an acceptable recovery between 80-120%.

Dilutional Linearity

Dilutional linearity involves spiked samples diluted through at least 3 dilutions. A minimum of 10 samples are spiked and diluted with an acceptable recovery between 80-120%.

Dynamic Range

The dynamic range of the assays targets a quantifiable range of 3-4 logs.

Endogenous Range

A minimum of 10 samples from individual donors are assessed for the ability to quantify baseline biomarker levels.

For Research Use Only. Not For Use In Diagnostic Procedures.