Concerns about a new laboratory test for Lyme disease prompted the Centers for Disease Control and Prevention (CDC) to caution against using diagnostic tests that aren’t cleared or approved by the US Food and Drug Administration (FDA).
The test is known as “home brew” because it’s manufactured and used in a single laboratory without FDA oversight. It has a 2-step pre-enrichment process for patient specimens followed by immunostaining with or without polymerase chain reaction (PCR) analysis. Positive results by immunostaining or PCR are considered “culture positive” (Nelson C et al. MMWR Morb Mortal Wkly Rep. 2014;63:333).
Lyme Disease Test Raises Concern. JAMA. 2014;311(23):2374. doi:10.1001/jama.2014.6266