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FDA Grants Enforcement Discretion for Conjunctival Swabs Use in H5N1 Bird Flu Testing Amid Rising Cases

The Food and Drug Administration (FDA) has recently granted enforcement discretion for the use of conjunctival swabs in human testing for the H5N1 bird flu. This decision came on the heels of two human cases where conjunctivitis was the only symptom observed before the H5N1 infection was confirmed. 

The Centers for Disease Control and Prevention (CDC) has set epidemiologic and clinical or public health response criteria for H5N1 testing. For those patients satisfying these criteria, local laboratories have been directed to submit both nasal and conjunctival swabs to state laboratories. The collection and transportation of conjunctival swabs would require the same media as the companion nasal swabs currently used with the CDC-approved kits. 

The CDC announced a third confirmed instance of H5N1 bird flu in humans. The patient, a second dairy farm worker based in Michigan is unrelated to the first confirmed case from last week. Unlike the previous cases marked by conjunctivitis, the latest case also demonstrated upper respiratory tract symptoms, such as cough, sans fever. The patient is, thus, recorded as the first human case of H5 bird flu in the U.S. with symptoms typical of acute respiratory illness, a known feature of type A (H5N1) viruses. 


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