Children are particularly vulnerable to lead exposure due to the effect on their developing brains and organ systems. The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States. FDA is now warning that M age llan Dia gn ostics’ Le adC are® ana l yzer s (LeadCare, LeadCare II, LeadCare Ultra and LeadCare Plus) should no longer be used with venous blood samples due to the potential for falsely low test results.
Archives for May 2017
The U.S. Food and Drug Administration (FDA) has issued a safety communication warning about the use of Magellan Diagnostics’ LeadCare® analyzers (LeadCare, LeadCare II, LeadCare Ultra and LeadCare Plus) with venous blood samples because they might result in falsely low test results. FDA is now advising that Magellan Diagnostics’ LeadCare® analyzers should no longer be used with venous blood samples. The safety alert does not apply to capillary blood lead test results collected by fingerstick or heelstick. The purpose of this Health Advisory is to notify state and local health departments, healthcare providers, and laboratories about CDC’s re-testing guidance in light of the safety alert.
Mosquito-borne diseases occur annually in West Virginia beginning in early spring and peaking in August and September, coinciding with mosquito activity. Arboviral infections, particularly La Crosse encephalitis (LAC) and West Nile virus (WNV), are endemic mosquito-borne diseases identified in West Virginia. In 2016, eight LAC cases and one WNV case were reported in West Virginia. Persons with severe arboviral infections will often have symptoms of encephalitis. Please be vigilant in identifying such cases, and ensure that all hospitalized patients with encephalitis undergo appropriate arboviral disease testing during mosquito season.
In July 2016, CDC issued Interim Guidance for Health Care Providers Caring for Pregnant Women with Possible Zika Virus Exposure – United States, July 2016 (https://www.cdc.gov/mmwr/volumes/65/wr/mm6529e1.htm) that includes Zika virus immunoglobulin M (IgM) testing of pregnant women. However, some flavivirus infections can result in prolonged IgM responses (>12 weeks) that make it difficult to determine the timing of infection, especially in testing of asymptomatic people. Emerging epidemiologic and laboratory data indicate that Zika virus IgM can persist beyond 12 weeks in a subset of infected people. Therefore, detection of IgM may not always indicate a recent infection. Although IgM persistence could affect IgM test interpretation for all infected people, it would have the greatest effect on clinical management of pregnant women with a history of living in or traveling to areas with Zika virus transmission. Pregnant women who test positive for IgM antibody may have been infected with Zika virus and developed an IgM response before conception.
Tickborne diseases occur annually in West Virginia with most cases developing symptoms between April and September. Lyme disease is the most commonly reported tickborne disease in West Virginia. In 2016, West Virginia recorded 368 Lyme disease cases, the most ever in a single year. Counties in the northwestern and southwestern parts of the state have had increasing case counts in recent years. In 2016, 43 counties reported at least one confirmed or probable Lyme disease case. Based on new national reporting standards, West Virginia is considered a high incidence Lyme disease state.