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{{Monoclonal gammopathy of undetermined significance}}
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== Overview ==
== Overview ==
There is no single gold standard test for the diagnosis of monoclonal gammopathy of undetermined significance. Bone marrow aspiration and biopsy is done in all patients having M-protein level ≥1.5 g/dL. Diagnostic criteria depends on the type of monoclonal gammopathy like non-IgM, [[IgM]], or [[light chain]] gammopathy. The criteria includes serum monoclonal proteins, [[Plasma cell|plasma cells]] in the marrow and absence of systemic signs.


== Diagnostic Study of Choice ==
==Study of choice ==
 
There is no single gold standard test for the diagnosis of monoclonal gammopathy of undetermined significance. [[Bone marrow]] aspiration and [[biopsy]] is done in all patients having M-protein level ≥1.5 g/dL.
=== Study of choice ===
[Name of the investigation] is the gold standard test for the diagnosis of [disease name].
 
OR
 
The following result of [gold standard test] is confirmatory of [disease name]:
* [Result 1]
* [Result 2]
OR
 
[Name of the investigation] must be performed when:
* The patient presents with [symptom/sign 1], [symptom/sign 2], and [symptom/sign 3].
* A [name of test] is positive for [sign 1], [sign 2], and [sign 3] in the patient.
OR
 
[Name of the investigation] is the gold standard test for the diagnosis of [disease name].
 
OR
 
The diagnostic study of choice for [disease name] is [name of the investigation].
 
OR
 
There is no single diagnostic study of choice for the diagnosis of [disease name].
 
OR
 
There is no single diagnostic study of choice for the diagnosis of [disease name], but [disease name] can be diagnosed based on [name of the investigation 1] and [name of the investigation 2].
 
OR
 
[Disease name] is primarily diagnosed based on the clinical presentation.
 
OR
 
Investigations:
* Among the patients who present with clinical signs of [disease name], the [investigation name] is the most specific test for the diagnosis.
* Among the patients who present with clinical signs of [disease name], the [investigation name] is the most sensitive test for diagnosis.
* Among the patients who present with clinical signs of [disease name], the [investigation name] is the most efficient test for diagnosis.
 
==== The comparison of various diagnostic studies for [disease name] ====
{| class="wikitable"
!Test
!Sensitivity
!Specificity
|-
!Test 1
|...%
|...%
|-
!Test 2
|...%
|...%
|}
<small>[Name of test with higher sensitivity and specificity] is the preferred investigation based on the sensitivity and specificity</small>
 
===== Diagnostic results =====
The following finding(s) on performing [investigation name] is(are) confirmatory for [disease name]:
* [Finding 1]
* [Finding 2]
 
===== Sequence of Diagnostic Studies =====
The [name of investigation] must be performed when:
* The patient presented with symptoms/signs 1, 2, and 3 as the first step of diagnosis.
* A positive [test] is detected in the patient, to confirm the diagnosis.
OR
 
The various investigations must be performed in the following order:
* [Initial investigation]
* [2nd investigation]
 
=== Name of Diagnostic Criteria ===
'''It is recommended that you include the criteria in a table. Make sure you always cite the source of the content and whether the table has been adapted from another source.'''
 
[Disease name] is primarily diagnosed based on clinical presentation. There are no established criteria for the diagnosis of [disease name].
 
OR
 
There is no single diagnostic study of choice for [disease name], though [disease name] may be diagnosed based on [name of criteria] established by [...].
 
OR
 
The diagnosis of [disease name] is made when at least [number] of the following [number] diagnostic criteria are met: [criterion 1], [criterion 2], [criterion 3], and [criterion 4].
 
OR
 
The diagnosis of [disease name] is based on the [criteria name] criteria, which includes [criterion 1], [criterion 2], and [criterion 3].
 
OR
 
[Disease name] may be diagnosed at any time if one or more of the following criteria are met:
* Criteria 1
* Criteria 2
* Criteria 3
OR
 
'''IF there are clear, established diagnostic criteria'''
 
The diagnosis of [disease name] is made when at least [number] of the following [number] diagnostic criteria are met: [criterion 1], [criterion 2], [criterion 3], and [criterion 4].
 
OR


The diagnosis of [disease name] is based on the [criteria name] criteria, which include [criterion 1], [criterion 2], and [criterion 3].
== Diagnostic Criteria ==


OR
Non-IgM MGUS (IgG, IgA, or IgD MGUS) is diagnosed on the basis of the following three criteria


The diagnosis of [disease name] is based on the [definition name] definition, which includes [criterion 1], [criterion 2], and [criterion 3].
* Serum monoclonal protein (M-protein, whether [[IgA]], [[IgG]], or [[IgD]]) level <3 g/dL.
* Less than 10 percent clonal [[Plasma cell|plasma cells]] in marrow.
* Absence of lytic bone lesions, [[anemia]], hypercalcemia, and renal insufficiency related to the plasma cell disorder.


OR
IgM MGUS is diagnosed on the basis of the following three criteria<ref name="pmid12780789">{{cite journal |vauthors= |title=Criteria for the classification of monoclonal gammopathies, multiple myeloma and related disorders: a report of the International Myeloma Working Group |journal=Br. J. Haematol. |volume=121 |issue=5 |pages=749–57 |date=June 2003 |pmid=12780789 |doi= |url=}}</ref><ref name="pmid25439696">{{cite journal |vauthors=Rajkumar SV, Dimopoulos MA, Palumbo A, Blade J, Merlini G, Mateos MV, Kumar S, Hillengass J, Kastritis E, Richardson P, Landgren O, Paiva B, Dispenzieri A, Weiss B, LeLeu X, Zweegman S, Lonial S, Rosinol L, Zamagni E, Jagannath S, Sezer O, Kristinsson SY, Caers J, Usmani SZ, Lahuerta JJ, Johnsen HE, Beksac M, Cavo M, Goldschmidt H, Terpos E, Kyle RA, Anderson KC, Durie BG, Miguel JF |title=International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma |journal=Lancet Oncol. |volume=15 |issue=12 |pages=e538–48 |date=November 2014 |pmid=25439696 |doi=10.1016/S1470-2045(14)70442-5 |url=}}</ref><ref name="pmid645746">{{cite journal |vauthors=Kyle RA |title=Monoclonal gammopathy of undetermined significance. Natural history in 241 cases |journal=Am. J. Med. |volume=64 |issue=5 |pages=814–26 |date=May 1978 |pmid=645746 |doi= |url=}}</ref>


'''IF there are no established diagnostic criteria'''
* Serum monoclonal protein (M-protein, whether [[IgA]], [[IgG]], or [[IgD]]) levels <3 g/dL.<ref name="pmid7955402">{{cite journal |vauthors=Kyle RA |title=The monoclonal gammopathies |journal=Clin. Chem. |volume=40 |issue=11 Pt 2 |pages=2154–61 |date=November 1994 |pmid=7955402 |doi= |url=}}</ref>
* Fewer than 10 percent clonal lymphoplasmacytic/[[Plasma cell|plasma cells]] in the marrow.
* Absence of end-organ damage such as anemia, constitutional symptoms, [[hyperviscosity]], [[lymphadenopathy]], or [[hepatosplenomegaly]] related to the [[plasma cell]] disorder


There are no established criteria for the diagnosis of [disease name].
Light chain MGUS (LC-MGUS) is diagnosed on the basis of the following three criteria<ref name="pmid25439696">{{cite journal |vauthors=Rajkumar SV, Dimopoulos MA, Palumbo A, Blade J, Merlini G, Mateos MV, Kumar S, Hillengass J, Kastritis E, Richardson P, Landgren O, Paiva B, Dispenzieri A, Weiss B, LeLeu X, Zweegman S, Lonial S, Rosinol L, Zamagni E, Jagannath S, Sezer O, Kristinsson SY, Caers J, Usmani SZ, Lahuerta JJ, Johnsen HE, Beksac M, Cavo M, Goldschmidt H, Terpos E, Kyle RA, Anderson KC, Durie BG, Miguel JF |title=International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma |journal=Lancet Oncol. |volume=15 |issue=12 |pages=e538–48 |date=November 2014 |pmid=25439696 |doi=10.1016/S1470-2045(14)70442-5 |url=}}</ref>


== References ==
* Abnormal FLC ratio (ie, ratio of [[Kappa-chain immunoglobulin|kappa]] to lambda FLCs <0.26 or >1.65)
* Increased level of light chain (eg, increased [[Kappa-chain immunoglobulin|kappa]] FLC with a ratio >1.65 and increased lambda FLC with a ratio <0.26)
* No monoclonal [[immunoglobulin]] heavy chain (IgG, IgA, IgD, or IgM)
* Fewer than 10 percent clonal lymphoplasmacytic cells in the marrow
* Absence of lytic bone lesions, anemia, [[hypercalcemia]], and renal insufficiency related to the [[plasma cell]] disorders
==References==
{{Reflist|2}}
[[Category:Hematology]]
[[Category:Disease]]
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Latest revision as of 03:16, 3 January 2019

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omer Kamal, M.D.[2]

Overview

There is no single gold standard test for the diagnosis of monoclonal gammopathy of undetermined significance. Bone marrow aspiration and biopsy is done in all patients having M-protein level ≥1.5 g/dL. Diagnostic criteria depends on the type of monoclonal gammopathy like non-IgM, IgM, or light chain gammopathy. The criteria includes serum monoclonal proteins, plasma cells in the marrow and absence of systemic signs.

Study of choice

There is no single gold standard test for the diagnosis of monoclonal gammopathy of undetermined significance. Bone marrow aspiration and biopsy is done in all patients having M-protein level ≥1.5 g/dL.

Diagnostic Criteria

Non-IgM MGUS (IgG, IgA, or IgD MGUS) is diagnosed on the basis of the following three criteria

  • Serum monoclonal protein (M-protein, whether IgA, IgG, or IgD) level <3 g/dL.
  • Less than 10 percent clonal plasma cells in marrow.
  • Absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the plasma cell disorder.

IgM MGUS is diagnosed on the basis of the following three criteria[1][2][3]

Light chain MGUS (LC-MGUS) is diagnosed on the basis of the following three criteria[2]

  • Abnormal FLC ratio (ie, ratio of kappa to lambda FLCs <0.26 or >1.65)
  • Increased level of light chain (eg, increased kappa FLC with a ratio >1.65 and increased lambda FLC with a ratio <0.26)
  • No monoclonal immunoglobulin heavy chain (IgG, IgA, IgD, or IgM)
  • Fewer than 10 percent clonal lymphoplasmacytic cells in the marrow
  • Absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the plasma cell disorders

References

  1. ↑ "Criteria for the classification of monoclonal gammopathies, multiple myeloma and related disorders: a report of the International Myeloma Working Group". Br. J. Haematol. 121 (5): 749–57. June 2003. PMID 12780789.
  2. ↑ 2.0 2.1 Rajkumar SV, Dimopoulos MA, Palumbo A, Blade J, Merlini G, Mateos MV, Kumar S, Hillengass J, Kastritis E, Richardson P, Landgren O, Paiva B, Dispenzieri A, Weiss B, LeLeu X, Zweegman S, Lonial S, Rosinol L, Zamagni E, Jagannath S, Sezer O, Kristinsson SY, Caers J, Usmani SZ, Lahuerta JJ, Johnsen HE, Beksac M, Cavo M, Goldschmidt H, Terpos E, Kyle RA, Anderson KC, Durie BG, Miguel JF (November 2014). "International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma". Lancet Oncol. 15 (12): e538–48. doi:10.1016/S1470-2045(14)70442-5. PMID 25439696.
  3. ↑ Kyle RA (May 1978). "Monoclonal gammopathy of undetermined significance. Natural history in 241 cases". Am. J. Med. 64 (5): 814–26. PMID 645746.
  4. ↑ Kyle RA (November 1994). "The monoclonal gammopathies". Clin. Chem. 40 (11 Pt 2): 2154–61. PMID 7955402.

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