Rules-Based Medicine

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DATA QUALITY

Commitment to Quality

RBM is committed to delivering the highest quality service to its customers in compliance with all applicable federal, state, and local laws and regulations. We maintain quality systems, policies, processes and procedures to help ensure that we consistently deliver the high-quality results that we’ve built our reputation on. Through continuous quality improvement, RBM ensures that customers are satisfied with the products and service they receive.

Lab Quality

RBM is a CLIA-licensed laboratory with accreditation from the Commission on Office Laboratory Accreditation (COLA). We participate in external proficiency testing programs from the College of American Pathologists (CAP), and our lab can support Good Laboratory Practice (GLP) studies. Standardized procedures, instrumentation and quality controls are used to ensure quality throughout all aspects of the laboratory from sample receipt to results reporting.
Our policies comply with the applicable portions of the following regulations:
  • Good Laboratory Practices (21 CFR Part 58)
  • Quality System Regulation (21 CFR Part 820)
  • Electronic Signatures and Records (21 CFR Part 11)
  • Clinical Laboratory Improvement Amendments CLIA (42 CFR Part 493)
  • Good Clinical Practice (ICH E6)

Data Quality / Assay Validation

Data Quality

A rigorous set of criteria guides every stage of our work, from the development, validation, and manufacturing of our assays to the testing, quality controlling, and reporting of the data.


Validation

RBM’s assay validation is guided by Clinical Laboratory Standards based upon the principles of immunoassay.

  1. Each assay is developed as a single test to establish the sensitivity and dynamic range necessary.
  2. Once the assay is optimized, it can be incorporated into a multiplex.
  3. Multiplexed calibrators (8 levels per analyte) and controls (3 levels per analyte) monitor assay performance.
  4. Key performance parameters are established for every assay include:
    1. Lower limit of quantification
    2. Precision
    3. Cross-reactivity
    4. Linearity
    5. Spike-recovery
    6. Dynamic range
    7. Matrix interference
    8. Freeze-thaw stability
    9. Short-term sample stability

 

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 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

robust-curve-fitting

 

Precision

The output of every run is monitored closely. These records provide us with extensive knowledge of our assay 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 on 189 analytes x 3 control levels over 15 runs.

Coefficient of Variation for Controls from DiscoveryMAP (n=568)

precision

 

Rugged and Robust

The RBM platform combines the sensitivity and dynamic range of microsphere-based immunoassay testing 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.


For additional information, reach out to Client Services or download our Quality Systems White Paper. To see an up-to-date list of changes made to our assays, please visit our Assay Change Log.