Influenza Testing Guidelines - Guidelines

DHI_EduWeb_FluSeason

WORLD HEALTH ORGANIZATION

WHO recommendation on the use of rapid testing for influenza diagnosis.  WHO.  July, 2005.  Available here.

  •  “The accuracy of an influenza diagnostic test is determined by the sensitivity and specificity of the test to detect an influenza virus infection compared with a ‘gold’ standard (usually culture)...In general, the sensitivity of rapid tests is variable...and lower than that of cell culture”
  • “Because of low sensitivity, false negative results are major concerns with these tests.”
  • “Viral culture: Considered the ‘gold standard’”

CENTERS FOR DISEASE CONTROL AND PREVENTION

Prevention and Control of Influenza: Role of Laboratory Diagnosis.  CDC:MMWR.  July, 2005. Available here.

  • “Because of the lower sensitivity of rapid tests, physicians should consider confirming negative tests with viral  culture.”
  • “Despite the availability of rapid diagnostic tests, collecting clinical specimens for viral culture is critical, because only culture isolates can provide specific information regarding circulating strains and subtypes of influenza virus.”

U.S. FOOD AND DRUG ADMINISTRATION

Cautions in Using Rapid Tests for Detecting Influenza A viruses.  FDA, Office of In Vitro Diagnostic Device Evaluation and Safety.  November, 2005.  Available here.

  • “Culture and methods other than rapid testing are essential for detecting influenza infection missed by rapid testing...”
  • “Although rapid influenza tests cleared for use in the U.S. generally demonstrate a sensitivity of >60%, false negatives are likely, and may vary by age and type of specimen.” 
  • “Confirmatory testing using immunofluorescence, viral culture, or PCR must always be considered because a negative test may not rule out influenza viral infection.”

U.S. HEALTH AND HUMAN SERVICES

HHS Pandemic Influenza Plan: SUPPLEMENT 2,  Laboratory Diagnostics, 2005. Available here.
  • “Physicians should be reminded that a negative [Rapid] test result might not rule out influenza and should not affect patient management or infection control decisions.”