scholarly journals Utility of Reflexing Suspicious Beta Region Findings on Capillary Serum Protein Electrophoresis to Immunofixation for Detecting Monoclonal Gammopathies

2018 ◽  
Vol 150 (suppl_1) ◽  
pp. S74-S74
Author(s):  
Amanda Kitson ◽  
Donald Giacherio ◽  
David Keren
Keyword(s):  
Serum Protein ◽  
Protein Electrophoresis ◽  
Serum Protein Electrophoresis ◽  
Monoclonal Gammopathies

The Biologic and Analytic Variability of Serum Protein Electrophoresis M-Spike, Nephelometric Ig Quantitation, Serum FLC Quantitation, and Urine M-Spike in Monoclonal Gammopathies.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1803-1803
Author(s):  
Melissa Snyder ◽  
Angela Dispenzieri ◽  
S.Vincent Rajkumar ◽  
Robert Kyle ◽  
Joanne Benson ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Serum Protein ◽  
Protein Electrophoresis ◽  
Serum Protein Electrophoresis ◽  
Monoclonal Gammopathies ◽  
Number Of Patients ◽  
Measurable Disease ◽  
M Spike ◽  
Serial Samples ◽  
Serum And Urine

Abstract Abstract 1803 Poster Board I-829 Background Plasma cell proliferative disorders are monitored by a variety of methods. Serum protein electrophoresis (SPEP) and/or urine PEP M-spike quantitation are commonly assessed in patients with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), and multiple myeloma (MM) to determine disease progression, response, or relapse. Serum immunoglobin (Ig) concentrations can be quantitated when the M-spike is large or if the migration is obscured within the SPEP beta fraction. Serum FLC quantitation provides a rapid indicator of response, will detect the rare occurrence of FLC escape, and will allow disease monitoring in the absence of a measurable serum or urine M-spike. The International Myeloma Working Group (IMWG) has recommended that the serum and urine M-spike should be used to monitor disease, and that FLC quantitation should be used only if there is no measurable disease by electrophoresis and if the monoclonal FLC concentration is greater than 10 mg/dL in the context of an abnormal FLC K/L ratio. We have studied serial samples in clinically stable patients in order to assess the total variability (analytic and biologic) of these assays and to confirm the IMWG recent recommendations. Methods Serial data from stable MGUS patients (n=35) were identified by the availability of all 3 serum test results (M-spike, Ig, FLC) in at least 4 serial samples that were obtained 9 months to 5 years apart and whose serum M-spikes varied by less than 25%. For MM (n=60) and SMM (n=48) the samples were within 9-15 months and serum M-spikes varied by less than 0.5 g/dL. Among the 60 MM, 48 SMM, and 35 MGUS patients, there were 23, 41, and 18 patients with measurable disease by serum M-spike (i.e. M-spike >1 g/dL); 19, 10, and 10 patients with an evaluable FLC (i.e. monoclonal FLC > 10 mg/dL and an abnormal FLC ratio); and 5, 5, and 1 patient with an evaluable urine (i.e. M-spike > 200mg/24 hr). The FLC data was analyzed as the involved FLC concentration (iFLC), the difference between the involved and uninvolved FLC concentration (dFLC), and the FLC K/L ratio (rFLC). The coefficients of variability (CV) were determined for each methodology in each patient sample set, and the average CVs were determined. Igs were quantitated by immunonephelometry using a Siemens BNII and Siemens reagent sets; kappa and lambda FLC were quantitated using a Siemens BNII and Freelite reagent sets from The Binding Site; M-spikes were quantitated using Helena SPIFE SPE and reagent sets. Results The CVs for the Ig quantitation, SPEP M-spike, FLC quantitation, and urine M-spike in each of the patient groups are listed in the table: Our laboratory's interassay analytic CV for replicate samples are 4-5% for Ig quantitation, 6-8% for SPEP M-spikes, 6-7% for FLC quantitation, and 5-7% for urine M-spikes. The analytic CVs of the methods are similar, but the total (analytic + biologic) CVs are very different. The samples have been selected by restricting the variability of serum M-spike values; when we apply the same criteria to the IgG quantitation, the IgG total CV comes closer to the serum M-spike CVs. The remaining differences, however, may be due to biologic variability contributed by polyclonal Ig. The total CV for iFLC is similar to the urine M-spike CV and suggests a previously unrecognized large biologic CV for serum FLC. The iFLC and dFLC CVs were comparable but were smaller than the rFLC CV. Conclusion The variability of the serum and urine M-spike, Ig, and FLC measurements confirm the IMWG recommendations for patient monitoring. If a patient has a measurable M-spike >1 g/dL, then the serum M-spike should be followed. If there is no measurable disease, then the iFLC can be monitored, provided that the rFLC is abnormal and the iFLC concentration is >10 mg/dL. Although the number of patients with evaluable urine M-spikes in this study is small, larger studies may confirm the utility of serum FLC compared to urine M-spike for monitoring patients with monoclonal gammopathies. Disclosures No relevant conflicts of interest to declare.

scholarly journals Usefulness of serum globulin levels for discriminating patients with monoclonal gammopathies/ paraproteinemias

Biomedicine ◽  
2021 ◽  
Vol 41 (1) ◽  
pp. 31-35
Author(s):  
Neelam M Pawar ◽  
Anupama Hegde
Keyword(s):  
Serum Protein ◽  
Total Protein ◽  
Monoclonal Gammopathy ◽  
Protein Electrophoresis ◽  
Serum Protein Electrophoresis ◽  
Serum Globulin ◽  
Protein Ratio ◽  
Monoclonal Gammopathies ◽  
Median Serum ◽  
Control Study

Introduction and Aim: The confirmatory step in diagnosis of monoclonal gammopathies is bone marrow biopsy and presence of M-protein in serum protein electrophoresis. These tests are relatively expensive & invasive for screening and unavailable in low resource settings. Increased levels of serum globulin are clue to the diagnosis of monoclonal gammopathy. The aim of this study was to assess the relevance of serum globulin levels in discriminating between patients with & without monoclonal gammopathies/ paraproteinemia. Materials and Methods: We retrospectively reviewed serum protein electrophoresis (SPE) and related investigations of patients suspected of monoclonal gammopathy. Reports with an M-band were considered as paraproteinemias, and those without as controls. ROC for sensitivities & specificities for serum globulin levels were computed. Results: For the case-control study, median serum globulin values in cases were 4.4 (3.5-6.3) g/dL in males and 3.65 (3.33-5.0) g/dL in females. They were significantly higher than those with normal SPE pattern, with a p <0.001. A cut-off value of 3.25 g/dL of globulin could distinguish between paraproteinemias and controls with a sensitivity of 82.1% and specificity of 85.4% in males; a sensitivity of 79.2%, a specificity of 76.7% for females. At a cut-off value of 3.4 g/dL, sensitivity was 77% and specificity 92.7% for males; sensitivity was 75% and specificity 83.7% for females. Alternatively, a cut-off value of 0.458 of globulin/total protein ratio could distinguish at a best sensitivity & specificity of 80% and 89% in males; 83.3% and 83.7% in females. Conclusion: Serum globulin values and globulin/total protein ratio can reliably differentiate patients with paraproteinemias.

A comparison between high resolution serum protein electrophoresis and screening immunofixation for the detection of monoclonal gammopathies in serum

2018 ◽  
Vol 56 (2) ◽  
pp. 256-263 ◽  
Author(s):  
Joel Smith ◽  
Geoffrey Raines ◽  
Hans-Gerhard Schneider
Keyword(s):  
High Resolution ◽  
Sensitivity And Specificity ◽  
Serum Protein ◽  
Light Chain ◽  
Monoclonal Gammopathy ◽  
Protein Electrophoresis ◽  
Serum Protein Electrophoresis ◽  
Agarose Gel ◽  
Serum Free ◽  
Monoclonal Gammopathies

Abstract Background: There are a variety of initial laboratory tests or combinations of tests that can be performed when a monoclonal gammopathy is suspected including serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), serum immunofixation (IFE) and serum free light chain assays. Some groups have recently used simplified “screening” IFE methods for the detection of monoclonal gammopathies leveraging the greater sensitivity of IFE over SPEP alone to improve the detection of monoclonal gammopathies. These screening techniques have been predominantly evaluated against lower resolution agarose gel electrophoresis techniques. Methods: In this study we evaluated the diagnostic performance of the combined κ and λ light chain screening immunofixation (CLIF) in comparison to serum protein electrophoresis on a high-resolution (Sebia Hydragel 15 HR) agarose gel system. Each gel was interpreted by three adjudicators. A total of 156 patient samples were analysed. Adjudicated diagnoses based on the screening techniques were compared against the results of high resolution serum protein electrophoresis and high resolution standard immunofixation performed during routine laboratory operation. Where standard immunofixation was not performed a combination of a review of medical records, serum free light chains, UPEP and bone marrow aspirate and trephine and subsequent standard immunofixation and protein electrophoresis results where available were used to confirm the absence of a monoclonal gammopathy. Results: In this cohort a total of 65 (41%) patients had a paraprotein confirmed by standard immunofixation. HR SPEP had a sensitivity and specificity of 95% and 85%, respectively, while CLIF had a sensitivity and specificity of 88% and 97%, respectively. Conclusions: Overall we found that high-resolution gel serum protein electrophoresis using a Sebia Hydragel 15 HR system was more sensitive than a screening immunofixation method (CLIF) for the detection of paraproteins in patient serum in this patient cohort. The drawback of the greater sensitivity of HR SPEP was a higher false positive rate requiring an increased utilisation of follow up immunofixation electrophoresis.

Should routine laboratories stop doing screening serum protein electrophoresis and replace it with screening immune-fixation electrophoresis? No quick fixes: Counterpoint

2016 ◽  
Vol 54 (6) ◽  
Author(s):  
Joel D. Smith ◽  
Geoffrey Raines ◽  
Hans G. Schneider
Keyword(s):  
Serum Protein ◽  
Cell Clone ◽  
Protein Electrophoresis ◽  
Serum Protein Electrophoresis ◽  
Patient Anxiety ◽  
Transient Phenomena ◽  
Monoclonal Gammopathies ◽  
Immunofixation Electrophoresis ◽  
Chain Type

AbstractMonoclonal gammopathies are characterised by the production of a monoclonal immunoglobulin or free light chains by an abnormal plasma cell or B-cell clone and may indicate malignancy or a precursor (MGUS). There is currently no consensus on the initial test or combination of tests to be performed in suspected monoclonal gammopathies but serum protein electrophoresis and urine protein electrophoresis are commonly requested as initial investigations. If abnormal, immunofixation electrophoresis is then performed to confirm the presence of paraprotein and to determine its heavy and light chain type. Recently, some groups have developed simplified “screening” IFE methods for use in parallel to SPEP for the detection monoclonal gammopathies. We argue here that screening IFE may be of benefit in clinical laboratories using SPEP with poor resolution in the β-region, assisting in the detection of mainly IgA paraprotein, but may be of less benefit in laboratories utilising higher resolution gels. Further it may increase the detection of trace bands of questionable clinical significance, representing transient phenomena in infectious and auto-immune conditions or very low risk MGUS. The increased detection of these bands using screening IFE would require further patient follow up, possibly causing unnecessary patient anxiety and additional follow up healthcare costs.

scholarly journals Immunoglobulin Pattern in Monoclonal Gammopathy Disorders

2020 ◽  
Vol 14 (2) ◽  
pp. 160-163
Author(s):  
Monwar Tarek ◽  
Latifa Rahman ◽  
Susane Giti ◽  
Md Abdul Wahab
Keyword(s):  
Serum Protein ◽  
Monoclonal Gammopathy ◽  
Armed Forces ◽  
Bone Marrow Examination ◽  
Protein Electrophoresis ◽  
Serum Protein Electrophoresis ◽  
Cross Sectional ◽  
Monoclonal Gammopathies ◽  
Medical College ◽  
Monoclonal Proteins

Introduction: The presence of abnormal monoclonal proteins, the M band, is a frequent characteristic feature of plasma cell dyscrasias and is usually detected as a discrete band in the γ or β region in serum or urine protein electrophoresis. It is characterized and confirmed by immunofixation electrophoresis (IFE). Accurate detection and quantification of monoclonal immunoglobulins are important for the diagnosis and management of monoclonal gammopathies. Objectives: To find out the pattern of immunoglobulin in monoclonal gammopathy cases and evaluate the role of IFE in the detection of them. Materials and Methods: This cross-sectional descriptive study was conducted in the Department of Haematology, Armed Forces Institute of Pathology (AFIP), Dhaka from July 2015 to December 2015. Thirty diagnosed cases of monoclonal gammopathies of both sexes were selected. Bone marrow examination, serum protein electrophoresis, skeletal survey, relevant biochemical test and IFE were performed for all the cases. Results: Out of 30 monoclonal gammopathy cases, M band was identified in 24(80%) cases by serum protein electrophoresis but by the IFE M band was found in all 30(100%) cases. Among the M band pattern of immunoglobulin was characterized by IFE and the result was; 15(50%) cases IgG Kappa, 09(30%) cases IgG Lambda, 02(6.7%) cases IgA Kappa, 02(6.7%) cases IgM Kappa and 02(6.7%) cases light chain kappa monoclonal protein. Conclusion: Though the number of the patient was limited, it is evident that in 20% gammopathy cases M band was missing by conventional serum protein electrophoresis but IFE could identify M band in all the cases. It is recommended that IFE should be carried out in all monoclonal gammopathy patients. Journal of Armed Forces Medical College Bangladesh Vol.14 (2) 2018: 160-163

scholarly journals Comparison of Kappa & Lambda Freelite to Total Kappa & Lambda Immunoassays for the Detection of Monoclonal Gammopathies, Both As Standalone Tests and Alongside Serum Protein Electrophoresis

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 5705-5705 ◽  
Author(s):  
Vania T M Hungria ◽  
Petros Kampanis ◽  
Mark T Drayson ◽  
Tim Plant ◽  
Edvan de Queiroz Crusoe ◽  
...  
Keyword(s):  
B Cell ◽  
Serum Protein ◽  
Light Chain ◽  
Protein Electrophoresis ◽  
Immunoglobulin M ◽  
Serum Protein Electrophoresis ◽  
Monoclonal Protein ◽  
Monoclonal Gammopathies ◽  
Total Light ◽  
Age Range

Abstract Introduction Monoclonal gammopathies are a disparate group of diseases from benign to malignant which are characterised by the proliferation of a single B cell clone that produces a homogeneous monoclonal immunoglobulin (M-Ig). The method of detection and quantification of the M-Ig will depend upon whether it is an intact immunoglobulin or present as serum free light chain only. Historically serum (SPEP) and urine (UPEP) electrophoresis were considered the gold standard for identifying intact M-Ig and FLC respectively. In 2001 the introduction of the Freelite test changed the diagnostic and monitoring paradigm. The assay is now recommended as a tool to diagnose and monitor patients with B cell disorders. However, the assay is sometimes confused with monospecific immunoassays for measuring total kappa and total lambda. Here we compare kappa & lambda Freelite with total kappa & lambda immunoassays alongside SPEP as tools to identify patients with monoclonal gammopathies. Materials and Methods Sera from 102 blood donors (55 males and 47 females, age range 18-67 years) and 103 patients with light chain associated gammopathies (44 males and 59 females, age range 38 to 88 years, 60 kappa / 43 lambda)taken during the course of their treatment were available. The sera was analysed retrospectively with FreeliteTM (The Binding Site Ltd, Birmingham, UK) on a SPAPLUSand Total Kappa &Lambda nephelometricassays (Beckman Coulter, USA) on an Immage.Monoclonality was identified by results falling outside of manufacturers normal ratio ranges (Freelite 0.256-1.65, Total light chain 1.53-3.29). Serum protein electrophoresis was performed and unexpectedly positive or negative results were assessed using immunofixation on the Hydrasys electrophoretic system (Sebia, France). Results Monoclonal production was identified in 80/103 light chain associated gammopathiesby Freelite, negative IFE confirmed the absence of monoclonal protein in 22/23 patients with normal FLC kappa/lambda ratios and 1/23 patients had an IgG lambda intact immunoglobulin. SPEP was positive in 30/103 patients, with total kappa/lambda immunoassays detecting monoclonal protein in just 26/103 samples. Freelite was positive in 6/102, SPEP in 2/102 and total kappa/lambda in 8/102 normal blood donor sera. Interestingly, in 1 patient with an abnormal FLC ratio and total kappa/lambda result had a lambda light chain identified using IFE.Comparisons between the performances of Freelite, Freelite + SPEP, Total kappa/lambda and total kappa/lambda + SPEP are shown in table 1). Conclusion In keeping with Kyle et al (1999) our study confirms the limitations of total kappa / lambda assays as tools to identify M-Igs. This is the first study looking to apply the recommended algorithm of Freelite + SPEP to the total kappa/lambda assays. The addition of SPEP to total kappa/lambda assays improved the performance to detect abnormalities, but even combined they were neither as sensitive, specific or accurate as the Freelite assay. Given the limitations of the total light chain assays identified in our study, it is important that physicians are aware of which assay is being utilised; one easy method to discriminate would be to look at the normal range of the assay being reported. Table 1: Comparison of Freelite, Freelite + SPEP, Total kappa/lambda, Total kappa/lambda + SPEP Freelite Freelite + SPEP Total Total + SPEP Sensitivity 77.67 81.55 25.24 43.69 Specificity 94.12 92.16 92.16 91.18 PPV 93.02 91.30 76.47 83.33 NPV 80.67 83.19 54.97 61.59 Accuracy 85.85 86.83 58.54 67.32 Disclosures No relevant conflicts of interest to declare.

Sequence of Testing for Monoclonal Gammopathies

1999 ◽  
Vol 123 (2) ◽  
pp. 114-118 ◽  
Author(s):  
Robert A. Kyle
Keyword(s):  
Multiple Myeloma ◽  
Serum Protein ◽  
Protein Electrophoresis ◽  
Serum Protein Electrophoresis ◽  
Primary Amyloidosis ◽  
Waldenström’S Macroglobulinemia ◽  
Related Disorder ◽  
Monoclonal Gammopathies ◽  
Waldenstrom's Macroglobulinemia ◽  
Waldenström's Macroglobulinemia

Abstract The first test for recognition of monoclonal gammopathies should be serum protein electrophoresis with high-resolution agarose gel. Serum protein electrophoresis should be performed whenever multiple myeloma, Waldenström’s macroglobulinemia, primary amyloidosis, or a related disorder is suspected. Immunofixation is critical for the differentiation of a monoclonal from a polyclonal increase in immunoglobulins. Quantitation of immunoglobulins should be performed with a rate nephelometer. The viscosity of serum should be measured if the patient has signs or symptoms of hyperviscosity syndrome. A 24-hour urine specimen should be obtained for determination of the total amount of protein excreted each day. Immunofixation of the urine should be performed on every patient who has an M-protein level greater than 1.5 g/dL (15 g/L) in the serum or in whom multiple myeloma, Waldenström’s macroglobulinemia, primary amyloidosis, or a related disorder is suspected.

scholarly journals Diagnosing Paraproteinemic Keratopathy: A Case Report

2021 ◽  
pp. 337-343
Author(s):  
Eugenie Mok ◽  
Ka Wai Kam ◽  
Anthony J. Aldave ◽  
Alvin L. Young
Keyword(s):  
Optical Coherence Tomography ◽  
Genetic Testing ◽  
Serum Protein ◽  
Molecular Genetic ◽  
Anterior Segment ◽  
Protein Electrophoresis ◽  
Serum Protein Electrophoresis ◽  
Optical Coherence ◽  
Molecular Genetic Testing ◽  
Corneal Opacities

A 65-year-old man presented with bilateral, painless, progressive blurring of vision over 9 years. Slit-lamp examination revealed bilateral subepithelial corneal opacities in clusters located at the mid-periphery. Anterior segment optical coherence tomography, in vivo confocal microscopy (IVCM), serum protein electrophoresis, and molecular genetic testing were performed to evaluate the cause of corneal opacities. Anterior segment optical coherence tomography revealed a band-like, hyperreflective lesion in the Bowman layer and anterior stroma of both corneas. IVCM revealed hyperreflective deposits in the epithelium, anterior stroma, and endothelium. Serum protein electrophoresis identified the presence of paraproteins (immunoglobulin kappa), and molecular genetic testing revealed absence of mutations in the transforming growth factor beta-induced gene (<i>TGFBI</i>) and collagen type XVII alpha 1 gene (<i>COL17A1</i>). The ocular diagnosis of paraproteinemic keratopathy eventually led to a systemic diagnosis of monoclonal gammopathy of undetermined significance by our hematologist/oncologist. Paraproteinemic keratopathy is a rare differential diagnosis in patients with bilateral corneal opacities and therefore may be misdiagnosed as corneal dystrophy or neglected as scars. In patients with bilateral corneal opacities of unknown cause, serological examination, adjunct anterior segment imaging, and molecular genetic testing play a role in establishing the diagnosis.

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