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Disease/health condition -
Cancer
Protein electrophoresis (PEP)
Assay format
Capillary electrophoresis
Information History
First added in 2024
Purpose type
Aid to diagnosis, Monitoring, Prognosis
Purpose
To aid in the diagnosis, monitoring and prognosis of monoclonal gammopathies.
Specimen types
Serum, Urine
WHO prequalified or recommended products
N/A
GMDN
53967
Protein electrophoresis IVD, kit, electrophoresis
A collection of reagents and other associated materials intended to be used for determining the qualitative and/or quantitative separation of proteins in a clinical specimen, using an electrophoresis method.
The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024WHO supporting publications
Haematolymphoid Tumours WHO Classification of Tumours, 5th Edition, Volume 11, 2024. https://publications.iarc.who.int/Book-And-Report-Series/Who-Classification-Of-Tumours/Haematolymphoid-Tumours-2024 ; World Health Organization. (2017). WHO list of priority medical devices for cancer management. World Health Organization. https://iris.who.int/handle/10665/255262 ; World Health Organization. (2019). Guide for establishing a pathology laboratory in the context of cancer control. World Health Organization. https://iris.who.int/handle/10665/330664
Technical specifications
N/A
SAGE IVD recommended listing the protein electrophoresis test category in EDL 5:
• as a disease-specific IVD for use in health care facilities with clinical laboratories (Section II.b Cancer);
• using capillary electrophoresis as assay format;
• using serum and urine as specimen types;
• to aid in the diagnosis, monitoring and prognosis of monoclonal gammopathies. SAGE IVD also recommended including a note to the EDL stating that this test is recommended for use in specialized health care settings/clinical laboratories.
• as a disease-specific IVD for use in health care facilities with clinical laboratories (Section II.b Cancer);
• using capillary electrophoresis as assay format;
• using serum and urine as specimen types;
• to aid in the diagnosis, monitoring and prognosis of monoclonal gammopathies. SAGE IVD also recommended including a note to the EDL stating that this test is recommended for use in specialized health care settings/clinical laboratories.
The application proposed the inclusion of a protein electrophoresis test using capillary electrophoresis as assay format to aid in the diagnosis, monitoring, and prognosis of monoclonal gammopathies.
It was acknowledged that this method offered similar diagnostic accuracy as the gel electrophoresis and the two tests were complementary rather than mutually exclusive.
The gel test may be more common, cost-effective and suitable for low-resource settings, although it requires skilled pipetting. The capillary electrophoresis is automated, and hence reduces labour intensity and pretest errors. However, equipment costs are higher and so the capillary method may not be feasible in low-resource settings without automation and more suited for well-equipped urban laboratories.
SAGE IVD members noted the lack of comprehensive data on cost–effectiveness for capillary electrophoresis.
The consensus of the SAGE IVD was to include capillary electrophoresis in EDL 5. Decisions on implementation depend on local resources and infrastructure. Further evaluation of cost–effectiveness for capillary electrophoresis would be useful.
No systematic reviews on diagnostic accuracy of protein tests (PEP, IFE, FLC) were provided by the applicant. Primary studies on (comparative) diagnostic accuracy in clinically relevant settings (in which suspected patients are included) are lacking. Only one reference (#28) provided relevant evidence, but the sample is small and the reference standard may be at high risk of introducing bias. There were no systematic reviews on clinical utility. Although the current evidence does not support clinical utility, the iStopMM study (reference #36) implies that trial results are underway, which would allow for an excellent comparison of the value of PEP (gel+ capillary) + FLC on clinical outcomes. Currently there are no cost-effectiveness studies available, and thus insufficient evidence for cost-effectiveness of protein tests.
Current evidence on diagnostic accuracy is lacking for protein tests. More studies on comparative diagnostic accuracy of these tests compared to contemporary alternative tests are warranted to make an informed evidence based decision. Downstream consequences on clinical utility and cost-effectiveness are unknown, and depend greatly on clinical consequences, and availability and effectiveness of treatment.
The selection and use of essential in vitro diagnostics: report of the fifth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2024. World Health Organization. (To be published)