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Fast, Accurate Influenza A/B Antigen Detection

e of American Pathologists, but are not currently CLIA-waived and, thus, require specific laboratory certification for their use. These firms include:

Becton-Dickinson, Franklin Lakes, N.J., which produces the BD Directigen Flu A+B test kit, which the company says is the first rapid assay on the market that distinguishes influenza A viral antigens from those of influenza B. Specimen types that the kit can assess include nasopharyngeal wash, nasopharyngeal aspirate, nasopharyngeal swab, lower nasal swab, throat swab and bronchoalveolar lavage. The company reports influenza A sensitivity of 95.7 percent and specificity of 91.4 percent for nasopharyngeal aspirates. Influenza B sensitivity is 87.5 percent and specificity of 98.1 percent for nasopharyngeal aspirates. Test results time is 15 minutes.

Thermo Electron Corp., Waltham, Mass., produces the FLU OIA test, a high performance assay for the undifferentiated diagnosis of Influenza A and B in just over 15 minutes. Assay advantages include superior performance with mucoid samples, specimen flexibility and performance equivalent to 14-day viral culture, thus decreasing overall diagnostic costs by making additional ancillary testing unnecessary.

While these quick test products mark a significant advance in diagnostic options, the CDC notes that, The specificity and, in particular, the sensitivity of rapid tests are lower than for viral culture and vary by test. Because of the lower sensitivity of the rapid tests, physicians should consider confirming negative tests with viral culture or other means.
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