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Quality Assurance01:19

Quality Assurance

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Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
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Related Experiment Video

Updated: Mar 29, 2026

An HS-MRM Assay for the Quantification of Host-cell Proteins in Protein Biopharmaceuticals by Liquid Chromatography Ion Mobility QTOF Mass Spectrometry
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MRMPlus: an open source quality control and assessment tool for SRM/MRM assay development.

Paul Aiyetan1, Stefani N Thomas2, Zhen Zhang3

  • 1Department of Pathology, The Johns Hopkins University School of Medicine, Robert H and Clarice Smith Building, Room 4000C, 400 North Broadway, Baltimore, MD, 21287, USA. paul.aytton@gmail.com.

BMC Bioinformatics
|December 15, 2015
PubMed
Summary

MRMPlus is a new open-source software tool that simplifies the validation of targeted mass spectrometry assays. It provides essential analytical measures to ensure accurate and reproducible quantification of peptides and proteins.

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Area of Science:

  • Proteomics
  • Analytical Chemistry
  • Biotechnology

Background:

  • Selected and multiple reaction monitoring (SMRM) is crucial for quantifying proteins via proteotypic peptides in mass spectrometry.
  • Robust validation is needed to ensure peptide and transition measurements are stable, quantifiable, and reproducible.
  • Current analytical tools and validation methods for SMRM assays are often inadequate, leading to errors and inconsistencies.

Purpose of the Study:

  • To develop and introduce MRMPlus, a freely available, open-source software tool.
  • To streamline the analytical workflow for targeted mass spectrometry assay development.
  • To provide standardized analytical measures for assay validation.

Main Methods:

  • MRMPlus was implemented as a platform-independent Java program.
  • The software computes key analytical measures recommended by the Clinical Proteomics Tumor Analysis Consortium (CPTAC) for non-clinical assays.
  • Computed measures include limit of detection, lower limit of quantification, linearity, carry-over, partial specificity validation, and upper limit of quantification.

Main Results:

  • MRMPlus successfully computes critical analytical measures for targeted assays.
  • The tool supports the validation of 'Tier 2' assays, suitable for measuring biological and experimental perturbations.
  • The software is freely available, promoting wider adoption and standardization.

Conclusions:

  • MRMPlus significantly streamlines the assay development workflow, minimizing error predisposition.
  • The tool enhances the reliability and reproducibility of targeted mass spectrometry assays.
  • MRMPlus can be used for performance estimation of various targeted assays, including those not explicitly covered by CPTAC guidelines.