To ensure the highest caliber data, RBM has established a rigorous set of criteria that serve as a guide through every stage of our work, from the development, validation, and manufacturing of our assays; to the testing, quality controlling, and reporting of the data. This page briefly summarizes our commitment to quality that sets our assays apart from the competition. For a more detailed description of our assay processes and quality measures please refer to the QC white paper An Overview of Assay Quality Systems at RBM®. To see an up-to-date list of changes made to our assays, please visit our Assay Change Log.
RBM’s assay validation is guided by Clinical Laboratory Standards based upon the principles of immunoassay. Each assay is developed as a single test to establish the sensitivity and dynamic range necessary for that analyte. Once the assay is optimized, it is ready to be incorporated into a multiplex. Multiplexed calibrators (8 levels per analyte) and controls (3 levels per analyte) are developed to monitor the assays’ performance. Key performance parameters such as lower limit of quantification, precision, cross-reactivity, linearity, spike-recovery, dynamic range, matrix interference, freeze-thaw stability, and short-term sample stability are established for every assay.
Robust Curve Fitting
We have developed our own curve fitting routine that uses weighted and unweighted, 4- and 5- parameter equations. This routine is based on a proprietary algorithm that is specifically designed to accommodate the difficult to fit points at the low end and high end of the curve, providing a more accurate readout of the data.
Fitting the Standard Curve and Measuring the Three-Level Controls
The output of every run is closely monitored and these records provide us with extensive knowledge of our assays’ performance. Each plate of samples is controlled individually, reducing intra-assay imprecision to less than 10% in most cases. We also track our inter-assay variability by recording the control values generated on each plate of samples over time using the Levy-Jennings methodology. The figure below shows the % CV of all the controls (189 analytes x 3 control levels) for the Human DiscoveryMAP® over 15 runs.
Coefficient of Variation for Controls from DiscoveryMAP (n=568)
Rugged and Robust
The RBM platform combines the sensitivity and dynamic range of microsphere-based immuno-multiplexing with the precision and dependability of automated liquid handling. Together these features distinguish RBM from other biomarker testing labs by offering high quality, cost-effective immunoassay measurements that are guided by strict standard operating procedures.