Retiring an Aging Test Can Be Harder Than it Seems

Lab directors "should engage in a dialogue" with ordering physicians to determine whether certain "antiquated" assays should be "eliminated from the test menu," according to results of a recent study.

The retrospective study, which appears in the current issue of the American Journal of Managed Care, also found that lab directors "should create testing pathways based on evidence-based medicine that will streamline testing and incorporate the most appropriate tests for the diagnosis or management of the specific disease state."

And while the paper concedes that "not every physician … is likely to agree" with its findings, such collaborations "could help lab medicine grow" while avoiding "unnecessary services simply because of tradition."

The study also underscores the age-old friction that lab managers occasionally encounter with physicians who are reluctant to shelve older assays in favor of "newer technologies … [that] have been shown to have superior clinical value or are recommended in contemporary clinical guidelines."

It could also, if taken seriously by physicians, spur an increase in new testing technologies, which could benefit traditional clinical labs as well as those that develop and market their own LDTs and IVDs.

'Limited Clinical Utility'

According to the study, "given the current economic climate for medical practices, it is the responsibility of clinical laboratory directors … to review their test menu and … remove tests that do not provide clinical value to a particular medical practice, whether such testing is conducted in-house or sent to a reference laboratory."

The study focused on 10 assays, introduced between the 1960s and the 1980s, that "no longer provide value." In fact one test, erythrocyte sedimentation rate, was first used when Woodrow Wilson occupied the White House.

The tests include creatine kinase-MB and myoglobin assays, serum folate and red blood cell folate tests, amylase and lecithin/sphingomyelin ratio testing, qualitative serum human chorionic gonadotropin testing, prostatic acid phosphatase, bleeding time, and ESR.

According to the paper, newer analytes such as troponin, prostate-specific antigen, and C-reactive protein "have replaced creatine kinase-MB, myoglobin, and lactate dehydrogenase; prostatic acid phosphatase; and the erythrocyte sedimentation rate, respectively." The study authors concluded that these assays have "limited diagnostic and clinical utility."

In addition, the need for folate testing "has been dramatically reduced with dietary folic acid." And as for lecithin/sphingomyelin ratio and amylase testing, new technologies have made the assays "redundant or unnecessary."

And presumably economically wasteful, which could be why the study appears in a managed-care journal.

The paper also notes there "may be many other tests that can be eliminated after a systematic review."

In fact, a recent paper in the American Journal of Obstetrics & Gynecology found that many US labs are using outdated genital herpes tests that often yield false-positive results.

"Commercially available herpes simplex virus antibody assays that were not glycoprotein-G based demonstrated high false-positive rates (14 percent-88 percent) for herpes simplex virus type-2 antibodies in sera that were positive for herpes simplex virus type-1 antibodies but negative for herpes simplex virus type-2 antibodies," according to the paper. "Herpes simplex virus serologic testing should be performed with only glycoprotein-G–based tests."

Despite the potential advantages of using newer and better diagnostic technologies — not to mention the potential legal implications that could accompany clinical calamities resulting from the use of outdated assays — the AJMC paper notes that convincing physicians to consider replacing older tests with newer ones, and the concomitant step of changing test menus, "can be a difficult process."

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