Tuesday, October 14, 2008, 15:40 EDT (3:40 PM EDT)

CDCHAN-00278-2008-10-14-ADV-N

The Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and state health departments are investigating an increase in false-positive test results obtained with a commercially-available West Nile virus immunoglobulin M capture enzyme-linked immunosorbent assay (WNV IgM capture ELISA). On October 8, 2008, Inverness Medical (Princeton, NJ), the manufacturer of the implicated assays, voluntarily recalled two lots of their PanBio WNV IgM capture ELISA kit. One lot (#07262) was only distributed in Canada. The other lot (#08118) was distributed from July-September 2008 to four laboratories in the United States. The laboratories that used the recalled test kit include ViroMed (Minnetonka, MN), Meritcare Health System (Fargo, ND), Pennsylvania Department of Health (Exton, PA), and Baylor University Medical Center (Dallas, TX). Based on the investigation to date, this increase in false-positive results appears to be limited to these two lots of the PanBio kit. CDC and FDA will continue to monitor and evaluate any additional reports of false-positive tests that may have resulted from previous lots.

False-positive test results that occurred between July and September 2008 may have led to an incorrect diagnosis in some patients. If the patient is still experiencing symptoms, additional evaluation and alternative diagnoses should be considered. State health departments can help healthcare providers decide if a new serum specimen should be obtained to test for WNV or another etiology.

Health Alert Network (HAN)

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