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CDC Warns Against Use of Unapproved Lyme Disease Test — Physician’s First Watch

Medical News |
April 18, 2014

CDC Warns Against Use of Unapproved Lyme Disease Test

By Cara Adler

An unapproved test that uses a new culture method for Borrelia burgdorferi could misdiagnose Lyme disease, CDC and FDA researchers warn in MMWR.

The test involves immunostaining enriched culture specimens, with or without polymerase chain reaction analysis. Specimens are considered positive when either immunostaining or PCR is positive. A CDC review of research describing the test raised "serious concerns" that lab contamination could cause false-positive results and misdiagnosis.

The CDC recommends two-tier serologic testing for Lyme disease, with FDA-cleared tests. Under that scheme, an enzyme immunoassay, if positive or equivocal, is followed by a Western blot. Testing is considered positive only when both results are positive.

A list of FDA-approved tests is available online from the link provided below.

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