CLN Daily 2024

Redefining reference intervals for health equity

Jen A. Miller

Male and female laboratorians sitting at a table in a discussion.

Addressing health disparities is an important consideration for the clinical laboratory, particularly establishing reference intervals. During ADLM 2024, Katie Troike, PhD, clinical chemistry fellow at Cleveland Clinic, will host a round table discussion, Health Equity in the Laboratory: Re-evaluating the Role of Sex and Race in Reference Interval Determinations, to provide an overview of health equity in the context of laboratory medicine and identify areas for improvement. Through concrete examples, Troike hopes to help participants understand how sex- and race-based cutoffs may impact patient outcomes and encourage discussion about the utility of these criteria when establishing reference intervals in the future.

“We want to have equity in our field, and we want to be able to treat everyone equitably and provide the best patient care we possibly can,” Troike said. “A lot of that starts with the way we are establishing reference intervals and running tests in our laboratories.”

Troike has long been interested in diversity, equity, and inclusion (DEI), but didn’t know that inequities also existed in laboratory interval testing. “I thought ‘The lab is the lab, and we test samples equally,’” she said. Then she came across a paper about sex-based testing intervals in hematology, which was eye-opening — and alarming. “The more I started digging, the more I uncovered potential problems that could be corrected,” she said.

In her roundtable session, which will be held on Monday, July 29, Troike will facilitate a discussion about what health equity looks like in the laboratory, and how to combat health inequities in the field.

Discussions will focus on race-based adjustments in testing, including for eGFR; alpha-fetoprotein tests; and sex- and race- based reference intervals in hematology.

The need for such discussions and changes is critical to ensure that reference intervals best serve patients. For example, ferritin and hemoglobin reference intervals are sex-based, yet 40% of U.S. females ages 12-21 have an iron deficiency, while an estimated 30% of women under the age of 50 are anemic, according to the World Health Organization. In 2019 alone, anemia caused 50 million years of healthy life lost due to disability, with the largest culprits being a dietary iron deficiency, thalassemia and sickle cell trait, and malaria.

Addressing disparities in reference intervals, particularly for anemia in pregnancy/alpha-fetoprotein and eGFR, is also critical given the emergency of maternal mortality rates for Black, pregnant people, which are 2.6 times higher than for white individuals. Research shows that Black infants are also than two times more likely to die compared to white infants.

How do reference intervals fit in? A 2020 study published in the Journal of General Internal Medicine found that the removal of race-based adjustments would hypothetically have reassigned 33% of Black patients to a more advanced stage of chronic kidney disease, and 3% of those would meet criteria for kidney transplant priority.

“There’s been some action in the elimination of race-based adjustments in some forms of testing, but there’s a lot more work to be done,” Troike said.

The roundtable will also address reference intervals for transgender patients, and the impact of gender affirming hormones on tests in the laboratory. “It isn’t talked about enough in the diagnostic testing space.” She said. “ADLM 2024 is a perfect platform to do that.”

Troike hopes the roundtable will “inspire more people to question the way that things are being done in the lab, and more specifically why they’re being done rather than just accepting the precedent that’s been set,” with the end goal of creating more equality in the field of laboratory medicine, she said.

Jen A. Miller is a freelance journalist who lives in Audubon, New Jersey. +X: @byJenAMiller.