Data Quality
We ensure quality for every multiplex, every analyte, every sample, every time. Each analyte included in RBM's Multi-Analyte Profiles (MAPs) has its own set of calibrators and controls to provide reliable, high quality data.
Quality data is what sets RBM apart
Validation
All RBM assays are developed and validated to Clinical Laboratory Standards Institute (formerly NCCLS) guidelines based upon the principles of immunoassay. Each assay is first developed as a single test to achieve the sensitivity and dynamic range necessary for that analyte. It is then incorporated into a multiplex. Multiplexed calibrators (8 levels per analyte) and controls (3 levels per analyte) are developed. Validation of the multiplex is then performed using the assay parameters of least detectable dose, lower limit of quantification, precision, cross-reactivity, linearity, spike-recovery, dynamic range, matrix interference, freeze-thaw stability, and short-term sample stability. Once completed, no additional changes or additions are made to that multiplex without re-validation.
Native Controls
Native controls (native proteins produced in human cells) have been developed for most of the analytes in our Human MAP version 1.6. We have found that assay controls produced by spiking biological matrices with recombinant protein controls often do not produce the same results as with the native control. Using a native control to verify the performance of an assay ensures that the response of samples over time will be more consistent and apply more directly to your clinical samples.
Robust Curve Fitting
We have developed our own curve fitting routine that used weighted and unweighted 4 and 5 parameter curve fitting routines. Our curve fitting is based on a proprietary algorithm that accurately fits the difficult to fit points at the low and high end of the curve.
Precision
We monitor inter-assay imprecision using a Levy-Jennings methodology that utilizes the control values generated on each plate of samples. This means that each plate of samples is controlled individually and that lot-to-lot variability is minimized. Intra-assay imprecision is less than 10%.
Rugged and Robust
All testing is performed by strict standard operating procedure combining the analytical precisions of microsphere-based multiplexing with automated liquid handling.