21 February 2018. A group of medical lab companies, medical centers, and not-for-profit groups developed standardized testing protocols for chronic kidney disease, which participants expect will help more people diagnose the condition earlier. The collaboration is led by National Kidney Foundation in New York and American Society for Clinical Pathology in Chicago, joined by 5 medical testing labs, 5 professional organizations and lab industry groups, and 2 leading medical research centers.
Chronic kidney disease is the name given to the progressive loss of kidney function, allowing dangerous build-ups of electrolytes and wastes to occur. Early stages of the condition have few symptoms, but in more advanced cases can result in nausea, vomiting, appetite loss, fatigue, weakness, and changes in urination. While loss of kidney function is often gradual, it can lead to kidney failure, requiring dialysis or a transplant.
National Kidney Foundation says almost 75 million Americans are at risk for chronic kidney disease, as a result of their high blood pressure or diabetes. The organization says some 30 million people in the U.S. have chronic kidney disease, but only about 3.6 million are aware of it at any time. American Society for Clinical Pathology cites data showing nearly all (94%) of people with hypertension are not being tested for chronic kidney disease, nor are 6 in 10 of individuals (61%) with diabetes.
One of the reasons for the low testing rate, say the participants, is the need today for multiple lab tests to diagnose chronic kidney disease. The collaboration designed a standard, integrated approach, which combines 2 key lab tests into a single assessment called a Kidney Profile. One test, known as the estimated glomerular filtration rate, is based on the level of a chemical waste product known as creatinine in the blood. From the creatinine level, the test makes it possible to express a person’s degree of kidney functioning as a percentage from 0 to 100, with 90 or more considered normal function and less than 15 deemed kidney failure.
The second test is the albumin-creatinine ratio, which measures the protein albumin in urine, considered an indicator of kidney damage. Persistent elevated levels of albumin — 2 or more occurrences in 3 months — is an early and sensitive sign of kidney damage. Results from the two tests can also help predict cardiovascular as well as kidney problems.
The project participants say they’re implementing the Kidney Profile with a standard, combined request form, and an integrated entry in electronic health records. This correlation of tests includes linking their common standard medical billing codes, known as Current Procedural Terminology or CPT codes. The Kidney Profile also calls for standard naming conventions and common calculation methods to make it easier to compare results from different labs.
In addition to National Kidney Foundation and American Society for Clinical Pathology, taking part in the initiative are diagnostic lab companies ARUP Laboratories, BioReference Laboratories, LabCorp, Quest Diagnostics, and Sonic Healthcare USA. Also taking part are Mayo Clinic, Memorial Sloan Kettering Cancer Center, American Association of Bioanalysts, American Association for Clinical Chemistry, American Clinical Laboratory Association, Clinical Laboratory Management Association, and National Independent Laboratory Association.
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