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Clinical Laboratory Improvement Advisory Committee

April 13, 2023

Dr. Patti Jones on behalf of the

American Association for Clinical Chemistry

My name is Dr. Patti Jones, and I am the Clinical Director of Clinical Chemistry at the Children’s Medical Center in Dallas, Texas. Today, however, I am speaking today on behalf of the American Association for Clinical Chemistry, which represents nearly 7,000 scientific and medical professionals worldwide dedicated to advancing clinical laboratory science and its application to healthcare.

AACC is committed to serving as a driving force for health equity. As such, AACC agrees with the recommendations of the National Kidney Foundation and the American Society of Nephrology outlined by Dr. Genzen and Ms. Lewis, namely that clinical laboratories should immediately adopt the CKD-EPI 2021 eGFR Equation without a race coefficient to diagnose and monitor kidney disease.

In 2021, an AACC eGFR and Race Equity Task Force performed a systematic review of the scientific literature to examine the performance of eGFR equations with and without the black race modifier (BRM) in diagnosing and staging chronic kidney disease, drug dosing, and safety assessments for radiologic and oncologic interventions.&

The Task Force published its findings in Clinical Chemistry in 2022 and concluded that “there is little evidence supporting the inclusion of a race modifier in eGFR calculations.” The Task Force further added that “pursuit of alternatives to BRM-inclusive eGFR calculations is therefore recommended to mitigate health disparities among marginalized populations and provide a more accurate assessment of renal function in adult populations, agnostic of social constructs of race and ethnicity.”

AACC has collaborated with the NKF on developing a guidance document to help laboratories to implement the CKD-EPI 2021 race-agnostic equation, which will be published this July. The document provides further recommendations that clinical laboratories can use to support the implementation of additional guidance issued by the National Kidney Foundation and the American Society of Nephrology. Thank you for your time and the opportunity to provide input on this key issue.