Updated CDC Recommendation for Serologic Diagnosis of Lyme Disease.

Paul Mead,Alison Hinckley,Jeannine Petersen

doi:10.15585/mmwr.mm6832a4

Abstract

Lyme disease is a tickborne zoonosis for which serologic testing is the principal means of laboratory diagnosis. In 1994, the Association of State and Territorial Public Health Laboratory Directors, CDC, the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Council of State and Territorial Epidemiologists, and the National Committee for Clinical Laboratory Standards convened the Second National Conference on Serologic Diagnosis of Lyme Disease (1).

Highlights

Updated CDC Recommendation for Serologic Diagnosis of Lyme DiseaseLyme disease is a tickborne zoonosis for which serologic testing is the principal means of laboratory diagnosis
Serologic testing is the principal means of laboratory diagnosis of Lyme disease
On July 29, 2019, the Food and Drug Administration (FDA) cleared several Lyme disease serologic assays with new indications for use, allowing for an enzyme immunoassay (EIA) rather than western immunoblot assay as the second test in a Lyme disease testing algorithm

Summary

Updated CDC Recommendation for Serologic Diagnosis of Lyme Disease

Lyme disease is a tickborne zoonosis for which serologic testing is the principal means of laboratory diagnosis. To assist serologic test developers, CDC has made available, with support from NIH, a comprehensive panel of sera from patients with various stages of Lyme disease and other conditions, as well as healthy persons [3]. On July 29, 2019, FDA cleared several Lyme disease serologic assays with new indications for use based on a modified twotest methodology [4]. When cleared by FDA for this purpose, serologic assays that utilize EIA rather than western immunoblot assay in a two-test format are acceptable alternatives for the laboratory diagnosis of Lyme disease. Based on the criteria established at the 1994 Second National Conference on Serologic Diagnosis of Lyme Disease, clinicians and laboratories should consider serologic tests cleared by FDA as CDC-recommended procedures for Lyme disease serodiagnosis

What is already known about this topic?

What are the indications for public health practice?