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Accula™ Flu A/Flu B Test
The Thermo Fisher Scientific™ Accula™ Flu A/Flu B Test is a rapid diagnostic test that combines the accuracy1 of RT-PCR with the simplicity, convenience, and procedural familiarity of traditional rapid immunoassays. The Accula Flu A/Flu B Test has received 510(k) clearance from the US Food And Drug Administration (FDA) for the qualitative and differential detection of influenza A and influenza B viral RNA in Clinical Laboratory Improvement Amendments (CLIA) waived environments. Designed for use with the palm-sized Thermo Fisher Scientific™ Accula™ Dock, the Accula Flu A/Flu B Test provides reliable results in approximately 30 minutes.
97% sensitivity and 94% specificity for Flu A; 94% sensitivity and 99% specificity for Flu B
Simple sample collection
prepare and load nasal swab samples in seconds
qualitative, rapid PCR-based test provides visual results in approximately 30 minutes
reagents stored at room temperature (15°C to 30°C, 59°F to 86°F); eluted samples in Thermo Fisher Scientific™ Accula™ Buffer may be kept at room temperature for up to 2 hours
dock fits in the palm of your hand; ideal size for clinical settings
The Accula Flu A/Flu B Test is performed in a portable, palm-sized dock with a required plug-in power cord that plugs into a standard outlet, with a 10-second dock initiation/ start-up and no data entry required. Because the test can be administered, run, and interpreted in one place, time-to-results is reduced to ~30 minutes—often while the subject waits.
This is stark contrast to a standard lab-based qPCR which relies on specialized materials and instruments, highly trained personnel, and transportation of specimens to a centralized laboratory. Samples are batched (many are run at the same time on a highthroughput instrument), and time-to-results can vary from several hours to several days.
The rapid results of PCR virus detection are achieved by using our proprietary Oscillating Amplification Reaction (Oscar) PCR technology that enables shortened thermocycling times and faster PCR completion without the need for costly thermal cycler hardware and optical detection systems used in laboratory-based qPCR.
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), simple, low-risk tests can be waived and performed with no routine regulatory oversight in physicians' offices and various other locations like ambulances, hospital rooms, physicians' offices, pharmacies, etc4.
The small size, ease of use, and inclusion of all necessary reagents and consumables in the kit will enable smooth integration of the Accula Flu A/Flu B system at many different point of care locations including doctors’ offices, urgent care centers, pharmacies, and hospitals.
The Accula Flu A/Flu B Test has received 510(k) clearance from the FDA.