FluChip-8G Influenza A+B Assay
Overview
The FluChip-8G Influenza A+B Assay by InDevR is an in vitro diagnostic (IVD) assay, not an AI tool for a physician directory. It is designed for the qualitative detection and differentiation of seasonal and non-seasonal influenza A viruses, as well as the genetic lineage of influenza B viruses (Yamagata or Victoria) from human nasal and nasopharyngeal swab specimens. The assay utilizes multiplexed reverse transcriptase polymerase chain reaction (RT-PCR) amplification of whole influenza gene segments, followed by detection on a low-density microarray. A key component of the system is its custom software, which employs artificial intelligence-based pattern recognition for automated interpretation of results, providing same-day turnaround. This technology aims to improve the nation’s preparedness to respond to influenza pandemics by offering a rapid and accurate method for characterizing influenza viruses, including those with pandemic potential like H7N9 and H5N1.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Qualitative detection and differentiation of influenza A and B viruses
- Distinguishes between seasonal and non-seasonal influenza A subtypes
- Identifies influenza B genetic lineages (Yamagata and Victoria)
- Multiplexed RT-PCR amplification
- Low-density microarray-based detection
- AI-based pattern recognition for automated interpretation
- Same-day results
- Aids in pandemic preparedness and surveillance
Use Cases
- Rapid influenza diagnosis in clinical laboratories
- Differentiation of influenza A subtypes for public health surveillance
- Early warning system for emerging influenza threats
- Enhanced surveillance of zoonotic influenza viruses
- Support for pandemic preparedness initiatives
What Physicians Need to Know
The FluChip-8G Influenza A+B Assay offers rapid, same-day results for influenza A and B, including the critical differentiation of seasonal versus non-seasonal influenza A subtypes with pandemic potential (e.g., H7N9, H5N1) and B lineage. This capability is crucial for timely patient management, infection control, and public health surveillance, enabling early antiviral treatment and mitigation strategies. The AI-assisted interpretation enhances accuracy and reduces the need for extensive expert analysis, making it a valuable tool for rapid characterization of emerging influenza threats. However, remember that 'non-seasonal' influenza A negative results do not entirely rule out infection and should be considered alongside clinical and epidemiological factors.
The FluChip-8G system's open platform and inclusion of an application programming interface (API) for its imaging system suggest a foundation for integration with existing laboratory information systems (LIS) and laboratory information management systems (LIMS). This facilitates automated data transfer and streamlined workflows, though specific pre-built integrations would need to be confirmed with the vendor.
Details
| Category | Lab & Diagnostics |
| Pricing | N/a (diagnostic assay, pricing typically handled through distributors or direct sales to laboratories) — N/A |
| Deployment | Laboratory setting (requires specific instrumentation and trained personnel) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The FluChip-8G Influenza A+B Assay received 510(k) market clearance (K182513) from the United States Food and Drug Administration (FDA) on April 22, 2019. This clearance signifies it is an FDA-cleared influenza diagnostic assay capable of distinguishing between seasonal and non-seasonal influenza A subtypes and characterizing seasonal viruses in a single multiplexed assay with same-day results. |
| Integrations | |
| EHR | Not specified |
| Specialties | Emergency Medicine, Infectious Disease, Laboratory Medicine |
What the Web Says
The FluChip-8G Influenza A+B Assay is a diagnostic tool designed for the rapid detection and characterization of seasonal and non-seasonal influenza A and B viruses. It utilizes a microarray-based system with AI-powered pattern recognition to provide same-day results, significantly reducing the time compared to traditional methods. The assay has received 510(k) market clearance and has been evaluated in various studies for its performance in identifying diverse influenza strains in human, animal, and environmental samples.
Overall: PositiveStrengths
- Rapid results (8-12 hours) compared to traditional methods (weeks).
- Capable of detecting and differentiating seasonal and non-seasonal influenza A viruses, including those with pandemic potential (e.g., H7N9, H5N1).
- Identifies genetic lineage of influenza B viruses (Victoria and Yamagata).
- Robust to antigenic shift and drift due to targeting conserved regions of the influenza genome.
- Utilizes AI-based pattern recognition for automated interpretation of complex data.
- High sensitivity and specificity for various target groups, including non-seasonal influenza A.
Limitations
- Had difficulty with some specific animal influenza strains (avian N6 types, swine H3 and N2).
- Showed some difficulty with samples containing multiple viral strains.
- Agreement with classical virologic techniques for influenza A-positive samples was 54.1% in one study.
- Primarily evaluated in research settings, with limited information on widespread clinical adoption or user reviews from physicians/healthcare IT outside of study contexts.
- No readily available reviews from platforms like Reddit, G2, or Capterra.
Based on reviews from: PubMed, InDevR (Press Release)
Last updated: 2026-07-18
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