Laboratories worldwide use protein electrophoresis to diagnose monoclonal gammopathies. However, guidance is lacking on clinical reporting of serum (SPE), urine (UPE) protein electrophoresis and immunotyping. The Canadian Society of Clinical Chemists’ (CSCC) Monoclonal Gammopathy Working Group (MGWG) decided to take action, forming a working group and developing a series of candidate recommendations to standardize protein electrophoresis reporting, which have published in Clinical Biochemistry.

Members of CSCC’s MGWG noticed that there were variations in protein electrophoresis reporting practices, based on their own research and personal experiences. External quality assurance data “demonstrated striking differences in the length extent and content of interpretations. In addition to the text interpretation aspects, the literature is rife with differences in terminology and definitions,” study co-author Christopher McCudden, PhD, DABCC, FACB, FCACB, told CLN Stat.

Substantial differences also exist in practices for quantitative bands or monoclonal proteins that are either low concentration or migrate in the alpha or beta regions. “These differences are often amplified with the use of different technologies,” said McCudden, a clinical biochemist with the Ottawa Hospital’s Division of Biochemistry, and an associate professor of pathology and laboratory medicine at the University of Ottawa.

For the clinicians that receive these reports, standardizing reporting has huge advantages, McCudden said. At least in his region, patients often move between laboratories and sites and sometimes even between provinces. Under these scenarios, “variation in reports at best can cause confusion and at worst can affect patient care. For example, in the absence of clear actions, recommendations, or context for a given report, it is possible that a patient might be over- or undertreated,” he said.

The working group’s key recommendations cover three areas: what information should be used in reports; details on fraction reporting; and interferences.

In their reports, labs should use the same format to report the same quantity of information, and maintain consistency between interpreters. SPE reports that show the presence of monoclonal immunoglobulin should include its concentration and isotype. In any instances where confirmation testing isn’t available or possible, the report should state that an abnormality is present, and recommend further testing.

For fraction reporting, SPE reports should include protein fraction quantitation. If monoclonal proteins are present, labs should quantitate and report them independent of other fractions. In other measures, labs should report protein and monoclonal fractions in g/L and report normal protein fractions with a healthy population-based reference interval.

Interpreters should receive education about the various interference types and how to resolve interferences. “Clinicians receiving reports from samples with interferences should be explicitly informed in the interpretative comments about limitations” such as false positive bands and quantitation accuracy, according to a summary of the recommendations. For patients receiving monoclonal treatments, interpreters and clinicians should collaborate on methods for reporting results in these patients.

McCudden said his own lab has already begun using these guidelines as a basis for conducting protein electrophoresis reporting. Based on the consensus working group’s findings, it’s clear that practices among labs vary widely, he emphasized. A lab’s workflow and protocols will determine what changes it will need to make to comply with these guidelines. In some instances, this might mean a complete transformation of the workflow and interpretive comments and quantitative reporting practices.

“Some of these changes are relatively easy or may already be in line with good laboratory practice, such as understanding the effects of interferences. But in other cases there may be laboratory information system changes required as well as discussions with clinicians,” McCudden said.

The way in which interpreters provide their comments on gels, may be the most challenging thing to change, he offered. “As with most changes, modifying behavior is more difficult than modifying systems and processes.”

The working group will continue to refine its candidate recommendations, which have yet to achieve consensus in Canada.

“We are dividing into subgroups in order to tackle many of these different aspects over the course of the next year. In order to adopt the recommendations, individual laboratories will need to first agree that they want to adopt them,” according to McCudden. They’ll also have to prioritize the order in which they want to adopt the recommendations, and then as individual institutions, implement them either as concepts, or concrete changes.

Beyond its immediate goals, the working group is interested in working globally toward best practices and standards, McCudden said. “We are already in discussions with experts around the world to move towards this goal.”