June 2023—For Lyme disease testing, immunoblots became optional in 2019 when the FDA cleared enzyme immunoassays for use as part of a modified two-tiered testing algorithm. “It was a historic event in the world of Lyme diagnostics,” says Elitza Theel, PhD, D(ABMM).
January 2020—“You can eliminate blots altogether!” may sound like a pitch for a cleaning product. But it’s a line from a webpage of Zeus Scientific touting the new algorithm for Lyme disease testing that ditches Western immunoblot in favor of a two-enzyme immunoassay test sequence. The new algorithm, which the CDC recommended last year, is the first approved alternative to the standard algorithm in 25 years.
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CAP TODAY Pathology/Laboratory Medicine/Laboratory Management