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Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies


The CAP assembled a team of experts to develop an evidence-based clinical practice guideline that aims to reduce variability, identify optimal testing, and improve the accurate diagnosis of patients with monoclonal gammopathies (MGs). The “Laboratory Work-up and Initial Diagnosis of MGs” draft summary of 13 recommendations will be available for public comment from January 30 to February 22, 2019.

The process for the detection of MGs is highly complex. To obtain an accurate diagnosis, diagnostic data must be compiled from several areas of the laboratory (eg, total protein, immunoglobulin levels, gel or capillary electrophoreses patterns).


A primary goal of this guideline would be evidence-based recommendations for the laboratory detection and initial diagnosis of MGs. The scope includes testing modalities in peripheral blood and urine, and excludes testing on bone marrow. The scope will also include the reinforcement of the International Myeloma Working Group “Criteria for Diagnosis of Multiple Myeloma” for testing and reporting.

Key Questions

  • What specimens are useful to detect MGs?
  • What are the appropriate tests needed to accurately detect and quantify MGs?
  • What information should be included in the laboratory order? And which laboratory tests are best used in which patients? What appropriate ancillary testing should be recommended?

Open Comment Period Information

All stakeholders—including pathologists, hematologists, oncologists, hospital or laboratory administrators, and patient advocacy group representatives—are encouraged to review and submit feedback on these draft recommendations from January 30 to February 22, 2019.

Download the informative packet which includes the project scope, study selection criteria, references included in the data extraction, draft recommendations, grades for strength of recommendations, expert panel conflicts of interest disclosure report, to be reviewed in context with the draft recommendations.


American Association for Clinical Chemistry

American Society for Clinical Pathology 

American Society of Hematology

International Myeloma Working Group 

Panel Members

David Keren, MD, FCAP, Co-chair

M. Qasim Ansari, MD, FCAP, Co-chair

Gregary Bocsi, DO, FCAP

Joan Etzell, MD, FCAP 

James Faix, MD, FCAP

Shaji Kumar, MD

Brea Lipe, MD

Christopher McCudden, PhD

Roberta Montgomery, MLS(ASCP)cmSI(ASCP)

David Murray, MD, PhD

Alex Rai, PhD

Teresita Redondo, MD, FCAP

Lesley Souter, PhD

Brooke Billman, MLIS

Christina B. Ventura, MPH, MT(ASCP) 

Additional Information

Prospero listing

The information, data, and draft recommendations provided by the College of American Pathologists are presented for informational and public feedback purposes only.
The draft recommendations and supporting documents will be removed on March 1, 2019.
The draft recommendations along with the public comments received and completed evidence review will be reassessed by the expert panel in order to formulate the final recommendations. These draft materials should not be stored, adapted, or redistributed in any manner.

Please note: comments are not posted automatically. All comments will be posted on a weekly basis beginning February 4 through March 4, 2019.
Following the open comment period, the guideline authors will consider all feedback to finalize the recommendations. The final recommendations will be formally published as a guideline in Archives of Pathology & Laboratory Medicine.
The CAP Pathology and Laboratory Quality Center for Evidence-based Guidelines develops recommendations related to the practice of pathology and laboratory medicine. Through this work, we and our members continually improve the quality of diagnostic medicine and patient outcomes. For questions, please contact CENTER@CAP.ORG.

Review more upcoming CAP evidence-based guidelines by the Center.

Public Comment Period

Share your voice by 2/22/19 on draft recommendations for monoclonal gammopathies 

Submit Your Comments Right Arrow