Automation and validation of a MALDI-TOF MS (Mass-Fix) replacement of immunofixation electrophoresis in the clinical lab
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Mindy Kohlhagen
Abstract
Objectives
A matrix assisted laser desorption ionization time of flight mass spectrometry (MALDI-TOF MS) method (Mass-Fix) as a replacement for gel-based immunofixation (IFE) has been recently described. To utilize Mass-Fix clinically, a validated automated method was required. Our aim was to automate the pre-analytical processing, improve positive specimen identification and ergonomics, reduce paper data storage and increase resource utilization without increasing turnaround time.
Methods
Serum samples were batched and loaded onto a liquid handler along with reagents and a barcoded sample plate. The pre-analytical steps included: (1) Plating immunopurification beads. (2) Adding 10 μl of serum. (3) Bead washing. (4) Eluting the immunoglobulins (Igs), and reducing to separate the heavy and light Ig chains. The resulting plate was transferred to a second low-volume liquid handler for MALDI plate spotting. MALDI-TOF mass spectra were collected. Integrated in-house developed software was utilized for sample tracking, driving data acquisition, data analysis, history tracking, and result reporting. A total of 1,029 residual serum samples were run using the automated system and results were compared to prior electrophoretic results.
Results
The automated Mass-Fix method was capable of meeting the validation requirements of concordance with IFE, limit of detection (LOD), sample stability and reproducibility with a low repeat rate. Automation and integrated software allowed a single user to process 320 samples in an 8 h shift. Software display facilitated identification of monoclonal proteins. Additionally, the process maintains positive specimen identification, reduces manual pipetting, allows for paper free tracking, and does not significantly impact turnaround time (TAT).
Conclusions
Mass-Fix is ready for implementation in a high-throughput clinical laboratory.
Research funding: None declared.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: DLM and SD have intellectual property rights encompassing the Mass-Fix process which have been licensed to The Binding Site. All other authors state no conflict of interest.
Ethical approval: The local Institutional Review Board deemed the study exempt from review.
References
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© 2020 Walter de Gruyter GmbH, Berlin/Boston
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- Editorial
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- The emerging role of cell senescence in atherosclerosis
- Mini Review
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- Opinion Paper
- Cardiotoxic effects and myocardial injury: the search for a more precise definition of drug cardiotoxicity
- EFLM Papers
- The CRESS checklist for reporting stability studies: on behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PRE)
- Thoughts and expectations of young professionals about the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)
- Guidelines and Recommendations
- Evidence on clinical relevance of cardiovascular risk evaluation in the general population using cardio-specific biomarkers
- Genetics and Molecular Diagnostics
- A systematic evaluation of stool DNA preparation protocols for colorectal cancer screening via analysis of DNA methylation biomarkers
- General Clinical Chemistry and Laboratory Medicine
- The new IVD Regulation 2017/746: a case study at a large university hospital laboratory in Belgium demonstrates the need for clarification on the degrees of freedom laboratories have to use lab-developed tests to improve patient care
- Evaluation of serum electrolytes measurement through the 6-year trueness verification program in China
- Feasibility for aggregation of commutable external quality assessment results to evaluate metrological traceability and agreement among results
- Sample size and rejection limits for detecting reagent lot variability: analysis of the applicability of the Clinical and Laboratory Standards Institute (CLSI) EP26-A protocol to real-world clinical chemistry data
- Effects of calcium dobesilate (CaD) interference on serum creatinine measurements: a national External Quality Assessment (EQA)-based educational survey of drug-laboratory test interactions
- Mass spectrometric sample identification with indicator compounds introduced via labeled sample tubes
- Automation and validation of a MALDI-TOF MS (Mass-Fix) replacement of immunofixation electrophoresis in the clinical lab
- A new strategy implementing mass spectrometry in the diagnosis of congenital disorders of N-glycosylation (CDG)
- Analytical evaluation of four faecal immunochemistry tests for haemoglobin
- Reference Values and Biological Variations
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- Appropriate thresholds for accurate screening for β-thalassemias in the newborn period: results from a French center for newborn screening
- Cardiovascular Diseases
- Analysis of B-type natriuretic peptide impurities using label-free data-independent acquisition mass spectrometry technology
- Diabetes
- Hemoglobin variants in southern China: results obtained during the measurement of glycated hemoglobin in a large population
- Potential of MALDI-TOF mass spectrometry to overcome the interference of hemoglobin variants on HbA1c measurement
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- Letter to the Editors
- Measurement uncertainty estimation for derived biological quantities
- Non-reproducible cardiac troponin results occurring with a particular reagent lot
- Successfully meeting analytical expectations for the fast 0/1-h algorithm for NSTEMI by internal control procedures for cardiac troponin T
- Performance of perpendicular drop versus tangent skimming gating of M-protein in proficiency testing challenges
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