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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 accuracy 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.
PCR Technology
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
Fast Results
Qualitative, rapid PCR-based test provides visual results in approximately 30 minutes
Easy Storage
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
Compact Design
Dock fits in the palm of your hand; ideal size for clinical settings
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Intended Use
The Accula™ Flu A/B Test performed on the Accula™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula™ Flu A/Flu B Test uses a nasal swab specimen collected from patient with signs and symptoms of respiratory infection. Accula™ Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza viruses are emerging, performance characteristics may vary.
If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL-3+ facility is available to receive and culture specimens.