TABLE 1.

Commercially available rapid test kits for detection of influenza virus

Test name (manufacturer)Test methodInfluenza virus type detectedDistinguishes A from BTime (min)CLIA waivedaCost per test ($)b
Directigen Flu A (Becton Dickinson)Membrane immunoassayA only15No20.50
Directigen Flu A + B (Becton Dickinson)Membrane immunoassayA, BYes15No20.50
Flu OIA (Thermo BioStar)Optical immunoassayA, BNo15No16.50
QuickVue (Quidel)Lateral-flow immunoassayA, BNo10Yes13.80
NOW FluA and NOW FluB (Binax)Lateral-flow immunoassayA, BYes15No18.00
Xpect FluA&BLateral-flow immunoassayA, BYes15No24.75
ZstatFlu (Zyme Tx)Enzyme-based color-metric assayA, BNo30Yes14.50
  • a CLIA waived: diagnostic tests may be granted a Clinical Laboratory Improvement Amendments (CLIA) waiver from regulatory oversight if they meet certain requirements established by the statute. The section of the statute specifying the criteria for categorizing a test as waived was excerpted without elaboration in the regulations at 42 CFR 493.15(b) and 493.15(c).

  • b Cost is the estimated cost of materials only, to perform testing on one sample, and was obtained by calling manufacturers. Material costs may vary with region. Costs for quality control assurance and improvement, and also cost for technical time to perform testing, were not included.