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Analytical Performance

Fujirebio Diagnostics, Inc., completed validation and performance evaluations of MESOMARK®. This section will provide some of the analytical performance data that resulted from the evaluations. Please contact Fujirebio Diagnostics at 1-800-342-9225 or mesomark@fdi.com if you have any additional questions. 

            Distribution of SMRP Levels
            Precision
            Analytical Sensitivity

Reference: 1. MESOMARK Assay Product Insert (1/2007)

Distribution of SMRP levels
SMRP values were determined on 1086 specimens; the sample distribution is shown below. 

Distribution

In our studies, 99% of the healthy subjects had SMRP levels at or below 1.5 nM. It is recommended that each laboratory establish its own reference value for the population of interest. 

Precision

The MESOMARK assay precision is <15% total CV. A precision study was performed in which 3 panels were assayed, using 2 kit lots, in replicates of 2 at 2 separate times per day for 20 days at two sites. Below is a summary of the data collected from this study.

Precision

 

Analytical Sensitivity

The sensitivity of the MESOMARK assay is 0.3 nM. Analytical sensitivity corresponds to the upper limit of the 95% confidence interval of the zero calibrator and represents the lowest concentration of antigen that can be distinguished from zero.