Testing for H5N1 in Humans

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• Overview
• Tests
• Testing Guidance

Overview

Quick and accurate diagnosis for the H5N1 avian influenza in humans is essential to early treatment.  Currently, the available tests have require specially-equipped laboratories, and take as long as one or two weeks to obtain test results.  Recent progress has been made in creating tests that are inexpensive, do not require special laboratories, and can test large numbers of flu samples.

Tests

• Inexpensive Test Detects H5N1 Infections Quickly and Accurately (National Institute of Allergy and Infectious Diseases)
  This new test, MChip, is based on a single gene segment that mutates less often than the flu genes typically used in diagnostic tests. Unlike current tests, it creates a way to simultaneously screen large numbers of flu samples to learn both the type and subtype of virus.
• Quick Diagnosis of Flu Strains Possible with New Microchip Test (National Institute of Allergy and Infectious Diseases) 
  Scientists have developed the FluChip, a microchip-based test that may allow more labs to diagnose influenza infections - including the H5N1 avian influenza strain - and to learn more about the viruses causing illness.
• FDA Approves New Laboratory Test To Detect Human Infections With Avian Influenza A/H5 Viruses (Food and Drug Administration)
  New test developed to diagnose H5 strains of influenza in patients suspected to be infected with the virus.
• HHS Awards Contracts for the Development of Faster Influenza Diagnostic Tests (U.S. Department of Health and Human Services)
  The $12.9 million is for the development of low-cost flu tests that can detect and differentiate seasonal human flu viruses from avian flu within three hours.

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Testing Guidance

• CDC Health Update: Updated Interim Guidance for Laboratory Testing of Persons with Suspected Infection with Avian Influenza A (H5N1) Virus in the United States (Centers for Disease Control and Prevention)
  The interim testing guidance is based on current knowledge of human infection with H5N1 viruses.
• Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path; Availability  (PDF - 50 KB) (Food and Drug Administration)
  Read guidance from the FDA on steps needed to ensure the safe and effective use of in vitro diagnostic devices intended for use in the detection of influenza A virus from human specimens.

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