FluChip-8G® : IP Available for License or Acquisition
FluChip-8G Influenza A+B Assay
510(k) Market Clearance Obtained April 22, 2019.
The FluChip-8G Influenza A+B Assay is a high-information content molecular assay for qualitative detection and differentiation of influenza viruses. The multiplexed system capitalizes on proprietary universal amplification technology, a high information content DNA microarray, and a powerful machine learning algorithm for automated data analysis to identify influenza A and B viruses in human clinical samples through an intuitive, easy to use interface. With cost-effective same day turnaround time, automated interpretation that eliminates the need for expert-driven data analysis, the FluChip-8G assay is poised to enhance influenza detection, surveillance, and pandemic preparedness.
FluChip-8G blends many of the benefits of sequencing information with the ease of use of RT-PCR and the simplicity of data interpretation of rapid immunoassays.
InDevR’s FluChip-8G Influenza A+B Assay represents a progressive shift away from the ‘single bit’ information offered by typical real-time RT-PCR-based assays by providing a highly multiplexed molecular assay with automated data interpretation. Unlike next generation sequencing technologies that often require significant bioinformatics expertise to analyze sequence data, the FluChip-8G assay provides immediate, clearly defined results to the user.
The heart of the FluChip-8G Influenza A+B assay is a high information content DNA microarray. The assay uses highly conserved primers to amplify whole gene segments for HA, NA, M, NS, and NP of influenza A viruses as well as the HA and NA gene segments of influenza B viruses. Amplified material is then hybridized to a DNA microarray designed to detect and discriminate influenza A and B viruses, after which the microarray is labeled, imaged, and analyzed by a machine learning algorithm trained to identify the signal pattern of specific target virus groups, namely seasonal influenza A/H1N1pdm2009, A/H3N2, B/Yamagata, B/Victoria, as well as “non-seasonal” influenza A (defined as influenza A subtypes other than A/H1N1pdm2009 and A/H3N2). The end user is provided with the results in a simple report.
In a single test, FluChip-8G provides the end user with positive identification of both seasonal viruses as well as a wide range of influenza A viruses other than the typical circulating annual strains. A single user can process up to 48 assays at a time in a single workday.
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The FluChip-8G Influenza A+B Assay software consists of an intuitive user interface on the front end, and seamless control of the accompanying fluorescence imaging system combined with a powerful microarray data analysis algorithm behind the scenes.
Either manually or using a barcode scanner, the user first enters names and chooses sample types for each sample to be analyzed. The user then clicks to scan the microarray, and waits a few minutes until the scan is complete and the software automatically identifies the location of the spots on each array, analyzes the fluorescence intensities of all controls and microarray capture sequences, and displays the result obtained for each sample analyzed in the form of a straightforward printable PDF report. Importantly, the software also produces an audit trail of important software events and allows electronic signatures to enable adherence to 21 CFR part 11 and Annex 11.