iMS-LC Assay (intact M-protein Screening-Light Chain Assay) is a new technology based onmass spectrometry identification of intact clonal immunoglobulin light chains for thespecific detection of M-proteins in peripheral blood.The investigators propose to conduct a prospective, single-center observational study toscreen for M-proteins in the peripheral blood of individuals undergoing routine physicalexaminations using iMS-LC Assay technology. The goals of this observational study are :(1) to evaluate the diagnostic efficacy of detecting peripheral blood M-proteins usingthe iMS-LC Assay method; and (2) to determine the prevalence of MGUS in the populationundergoing routine physical examinations based on mass spectrometry screening.Initially, the investigators will collect clinical patient samples continuously andconduct a diagnostic trial of the iMS-LC Assay, using the clinical methods SPEP + SIFE +FLC as the gold standard. Based on the diagnostic performance of the iMS-LC Assay, theinvestigators will then screen for M-proteins in continuous samples from individualsundergoing routine physical examinations, to further determine the prevalence of MGUS inthis population based on mass spectrometry screening.
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Diagnostic Test: M protein detection by iMS-LC Assay
iMS-LC Assay (intact M-protein Screening-Light Chain Assay) technology is a new method
for the specific identification of M-proteins in peripheral blood, based on mass
spectrometry recognition of intact clonal immunoglobulin light chains. Combined with AI
algorithm models, M-proteins can be easily distinguished from the polyclonal background,
enabling automated identification and quantitative analysis of M-proteins.
Previous studies have shown that the detection limit of the iMS-LC Assay is several times
higher than that of IFE. Additionally, the iMS-LC Assay requires only 5 μL of peripheral
blood serum for detection, offering advantages over traditional methods in terms of
higher sensitivity, non-invasiveness, lower sample volume requirements, reduced detection
costs, and higher throughput.
Inclusion Criteria:
1. Clinical patients:
- ≥18 years old;
- have concurrent SPEP + SIFE + FLC test results.
2. Individuals undergoing routine physical examinations:
- ≥30 years old;
- have concurrent SPEP test results.
Exclusion Criteria:
- NA
Peking Union Medical College Hospital
Beijing 1816670, Beijing Municipality 2038349, China
Investigator: Jian Li, MD
Contact: +86-18610852525
lijian@pumch.cn
Jian Li
+86-18610852525
lijian@pumch.cn
Zihan Yang
+86-18800173196
yzh18800173196@163.com
Not Provided