Monoclonal gammopathy of undetermined significance diagnostic study of choice: Difference between revisions

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=== Study of choice ===
=== Study of choice ===
bone marrow aspiration and biopsy is the gold standard test for the diagnosis of Monoclonal gammopathy of undetermined significance<ref name="pmid23859528">{{cite journal |vauthors=Mangiacavalli S, Cocito F, Pochintesta L, Pascutto C, Ferretti V, Varettoni M, Zappasodi P, Pompa A, Landini B, Cazzola M, Corso A |title=Monoclonal gammopathy of undetermined significance: a new proposal of workup |journal=Eur. J. Haematol. |volume=91 |issue=4 |pages=356–60 |date=October 2013 |pmid=23859528 |doi=10.1111/ejh.12172 |url=}}</ref>.
There is no single gold standard test for the diagnosis of Monoclonal gammopathy of undetermined significance. bone marrow aspiration and biopsy is indicated in all patients with an M-protein ≥1.5 g/dL<ref name="pmid23859528">{{cite journal |vauthors=Mangiacavalli S, Cocito F, Pochintesta L, Pascutto C, Ferretti V, Varettoni M, Zappasodi P, Pompa A, Landini B, Cazzola M, Corso A |title=Monoclonal gammopathy of undetermined significance: a new proposal of workup |journal=Eur. J. Haematol. |volume=91 |issue=4 |pages=356–60 |date=October 2013 |pmid=23859528 |doi=10.1111/ejh.12172 |url=}}</ref>.


OR
=== Diagnostic Criteria ===


The following result of [gold standard test] is confirmatory of [disease name]:
Non-IgM MGUS — Non-IgM MGUS (IgG, IgA, or IgD MGUS) is diagnosed by meeting 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>
* [Result 1]
* [Result 2]
OR


[Name of the investigation] must be performed when:
* Presence of a serum monoclonal protein (M-protein, whether IgA, IgG, or IgD), at a concentration <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>
* The patient presents with [symptom/sign 1], [symptom/sign 2], and [symptom/sign 3].
* Fewer than 10 percent clonal plasma cells in the bone marrow.
* A [name of test] is positive for [sign 1], [sign 2], and [sign 3] in the patient.
* The absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the plasma cell proliferative process.
OR


[Name of the investigation] is the gold standard test for the diagnosis of [disease name].


OR
IgM MGUS — IgM MGUS is diagnosed by meeting 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>


The diagnostic study of choice for [disease name] is [name of the investigation].
* Presence of a serum monoclonal protein (M-protein, whether IgA, IgG, or IgD), at a concentration <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 cells in the bone marrow.
* The absence of end-organ damage such as anemia, constitutional symptoms, hyperviscosity, lymphadenopathy, or hepatosplenomegaly related to the plasma cell proliferative process<ref name="pmid12881316">{{cite journal |vauthors=Kyle RA, Therneau TM, Rajkumar SV, Remstein ED, Offord JR, Larson DR, Plevak MF, Melton LJ |title=Long-term follow-up of IgM monoclonal gammopathy of undetermined significance |journal=Blood |volume=102 |issue=10 |pages=3759–64 |date=November 2003 |pmid=12881316 |doi=10.1182/blood-2003-03-0801 |url=}}</ref>


OR
Light chain MGUS — Light chain MGUS (LC-MGUS) is diagnosed by meeting 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><ref name="pmid20472173">{{cite journal |vauthors=Dispenzieri A, Katzmann JA, Kyle RA, Larson DR, Melton LJ, Colby CL, Therneau TM, Clark R, Kumar SK, Bradwell A, Fonseca R, Jelinek DF, Rajkumar SV |title=Prevalence and risk of progression of light-chain monoclonal gammopathy of undetermined significance: a retrospective population-based cohort study |journal=Lancet |volume=375 |issue=9727 |pages=1721–8 |date=May 2010 |pmid=20472173 |pmc=2904571 |doi=10.1016/S0140-6736(10)60482-5 |url=}}</ref>


There is no single diagnostic study of choice for the diagnosis of [disease name].
* The presence of an abnormal FLC ratio (ie, ratio of kappa to lambda FLCs <0.26 or >1.65)
 
* Increased level of the appropriate involved light chain (eg, increased kappa FLC in patients with a ratio >1.65 and increased lambda FLC in patients with a ratio <0.26)
OR
* No monoclonal immunoglobulin heavy chain (IgG, IgA, IgD, or IgM)
 
* Fewer than 10 percent clonal lymphoplasmacytic cells in the bone marrow
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].
* The absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the plasma cell proliferative process.
 
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].
 
OR
 
The diagnosis of [disease name] is based on the [definition name] definition, which includes [criterion 1], [criterion 2], and [criterion 3].
 
OR
 
'''IF there are no established diagnostic criteria'''
 
There are no established criteria for the diagnosis of [disease name].


== References ==
== References ==

Revision as of 15:57, 13 August 2018

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

Overview

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 indicated in all patients with an M-protein ≥1.5 g/dL[1].

Diagnostic Criteria

Non-IgM MGUS — Non-IgM MGUS (IgG, IgA, or IgD MGUS) is diagnosed by meeting the following three criteria[2][3][4]

  • Presence of a serum monoclonal protein (M-protein, whether IgA, IgG, or IgD), at a concentration <3 g/dL.[5]
  • Fewer than 10 percent clonal plasma cells in the bone marrow.
  • The absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the plasma cell proliferative process.


IgM MGUS — IgM MGUS is diagnosed by meeting the following three criteria[2][3][4]

  • Presence of a serum monoclonal protein (M-protein, whether IgA, IgG, or IgD), at a concentration <3 g/dL.[5]
  • Fewer than 10 percent clonal lymphoplasmacytic/plasma cells in the bone marrow.
  • The absence of end-organ damage such as anemia, constitutional symptoms, hyperviscosity, lymphadenopathy, or hepatosplenomegaly related to the plasma cell proliferative process[6]

Light chain MGUS — Light chain MGUS (LC-MGUS) is diagnosed by meeting the following three criteria[3][7]

  • The presence of an abnormal FLC ratio (ie, ratio of kappa to lambda FLCs <0.26 or >1.65)
  • Increased level of the appropriate involved light chain (eg, increased kappa FLC in patients with a ratio >1.65 and increased lambda FLC in patients with a ratio <0.26)
  • No monoclonal immunoglobulin heavy chain (IgG, IgA, IgD, or IgM)
  • Fewer than 10 percent clonal lymphoplasmacytic cells in the bone marrow
  • The absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the plasma cell proliferative process.

References

  1. ↑ Mangiacavalli S, Cocito F, Pochintesta L, Pascutto C, Ferretti V, Varettoni M, Zappasodi P, Pompa A, Landini B, Cazzola M, Corso A (October 2013). "Monoclonal gammopathy of undetermined significance: a new proposal of workup". Eur. J. Haematol. 91 (4): 356–60. doi:10.1111/ejh.12172. PMID 23859528.
  2. ↑ 2.0 2.1 "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.
  3. ↑ 3.0 3.1 3.2 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.
  4. ↑ 4.0 4.1 Kyle RA (May 1978). "Monoclonal gammopathy of undetermined significance. Natural history in 241 cases". Am. J. Med. 64 (5): 814–26. PMID 645746.
  5. ↑ 5.0 5.1 Kyle RA (November 1994). "The monoclonal gammopathies". Clin. Chem. 40 (11 Pt 2): 2154–61. PMID 7955402.
  6. ↑ Kyle RA, Therneau TM, Rajkumar SV, Remstein ED, Offord JR, Larson DR, Plevak MF, Melton LJ (November 2003). "Long-term follow-up of IgM monoclonal gammopathy of undetermined significance". Blood. 102 (10): 3759–64. doi:10.1182/blood-2003-03-0801. PMID 12881316.
  7. ↑ Dispenzieri A, Katzmann JA, Kyle RA, Larson DR, Melton LJ, Colby CL, Therneau TM, Clark R, Kumar SK, Bradwell A, Fonseca R, Jelinek DF, Rajkumar SV (May 2010). "Prevalence and risk of progression of light-chain monoclonal gammopathy of undetermined significance: a retrospective population-based cohort study". Lancet. 375 (9727): 1721–8. doi:10.1016/S0140-6736(10)60482-5. PMC 2904571. PMID 20472173.
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