August 16, 2019
The Centers for Disease Control and Prevention (CDC) now recommends clinicians use serologic assays that utilize a second enzyme immunoassay (EIA) when testing for Lyme disease. This diagnostic method was just approved by the US Food and Drug Administration (FDA).
The CDC’s previous recommendation was for practitioners to use a sensitive EIA or immunofluorescence assay. If the specimen produced positive or equivocal results, the CDC recommended that practitioners utilize a western immunoblot assay.
Now, the CDC is updating the latter part of the recommendation by deeming a second EIA as an acceptable alternative to a western immunoblot assay for the serologic diagnosis of Lyme disease.
This update comes after the FDA approved several Lyme disease serologic assays with new indications for use on July 29, 2019.
“Clearance by FDA of the new Lyme disease assays indicates that test performance has been evaluated and is ‘substantially equivalent to or better than’ a legally marketed predicate test,” according to the CDC.
Mead P, Petersen J, Hinckley A. Updated CDC recommendation for serologic diagnosis of Lyme disease. MMWR Morb Mortal Wkly Rep. 2019;68(32):703. doi:10.15585/mmwr.mm6832a4.