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Screening Method for M-Proteins in Serum Using Nanobody Enrichment Coupled to MALDI-TOF Mass Spectrometry.
Mindy C Kohlhagen1, David R Barnidge1, John R Mills1
1Department of Laboratory Medicine and Pathology.
Clinical Chemistry
|August 13, 2016
Summary
A new assay, MASS-SCREEN, shows promise for screening monoclonal gammopathies by detecting M-proteins. Combined with free light chain (FLC) measurements, it may offer an alternative to current methods like serum protein electrophoresis (PEL).
Area of Science:
- Clinical chemistry
- Mass spectrometry
- Immunology
Background:
- Current monoclonal gammopathy screening relies on serum protein electrophoresis (PEL), immunofixation electrophoresis (IFE), and free light chain (FLC) ratios.
- An M-protein is a key indicator for diagnosing and monitoring monoclonal gammopathies.
Purpose of the Study:
- To evaluate the feasibility of a novel assay, MASS-SCREEN, for qualitatively screening M-proteins.
- MASS-SCREEN utilizes immunoenrichment and MALDI-TOF-MS (Matrix-Assisted Laser Desorption/Ionization–Time of Flight Mass Spectrometry).
Main Methods:
- Serum samples from 556 patients previously tested by PEL and IFE were used.
- Samples underwent immunopurification using κ/λ-specific nanobody beads.
- Light chains (LC) were released, and MALDI-TOF analysis was performed to detect M-proteins.
Main Results:
- Unblinded MASS-SCREEN analysis detected 100% of PEL-positive samples, with 96% sensitivity and 81% specificity against IFE.
- Blinded analysis by 6 personnel achieved 92% consensus, with overall sensitivity of 92% and specificity of 80%.
- Abnormal FLC ratios were noted in 28% of MASS-SCREEN-negative samples.
Conclusions:
- MASS-SCREEN shows potential to replace PEL in screening panels, especially when combined with FLC measurements.
- Further research is needed to validate clinical sensitivity and specificity and confirm its suitability as a general monoclonal protein screen.
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