False Positive Results with a Commercially Available West Nile Virus Immunoglobulin M Assay
MedSun: Newsletter #38, July 2009

CDC MMWR

In September 2008, CDC, the Food and Drug Administration (FDA), and state health departments began a nationwide investigation into an increase in false-positive test results obtained with a commercially available West Nile virus (WNV) immunoglobulin M (IgM) capture enzyme-linked immunosorbent assay (ELISA). The investigation revealed that, in the United States, one lot of the commercially available test kits was the source of the false-positive results. That lot was recalled, and a second lot distributed outside the United States also was recalled.

Additional Information:

False Positive Results with a Commercially Available West Nile Virus Immunoglobulin M Assay. CDC MMWR. May 8, 2009.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5817a2.htm?s_cid=mm5817a2_e


MedSun Newsletters are available at www.fda.gov/cdrh/medsun