by Influenza, commonly known as the flu, is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and lungs. It can cause mild to severe illness and, at times, can lead to death. The best way to prevent the flu is by getting a seasonal flu vaccine each year. However, rapid and accurate diagnosis is also important for proper clinical management of patients and timely administration of antiviral drugs which can lessen the severity and duration of the illness.
Need for Rapid Influenza Diagnostic Tests
Traditional Influenza Diagnostic Tests like viral culture and reverse transcription polymerase chain reaction (RT-PCR) tests are considered the gold standard but they require specialized equipment and skilled personnel, take several hours to days to provide results. This leads to delays in starting appropriate treatment. Rapid influenza diagnostic tests (RIDTs) have emerged as a reliable point-of-care option to diagnose influenza infections within 15-30 minutes. They can be performed in settings like physician offices, urgent care clinics and emergency departments where timely diagnosis and treatment initiation is crucial.Global Rapid Influenza Diagnostic Tests
How RIDTs Work
Most commonly used RIDTs are immunoassays that use monoclonal antibodies to detect influenza viral nucleoprotein antigens in respiratory samples like nasal or throat swabs. The tests work on similar principles as over-the-counter home pregnancy tests where positive results are visualized via color change within the test strip area. Newer technologies like optical immunoassays, microfluidics platforms and CRISPR-based tests also provide rapid results. While RIDTs are less sensitive than molecular assays, they provide a quick answer at the point-of-care to guide initial clinical management.
Usage Trends
According to a recent report by Global Market Insights, the global rapid influenza diagnostic tests market size was valued at USD 625 million in 2019 and is projected to witness 8% CAGR during 2020-2026 due to growing awareness and rising disease prevalence. North America currently dominates the market due to supportive reimbursement scenarios and presence of major players. The Asia Pacific region is also growing at a noteworthy rate with improving healthcare infrastructure and diagnostic capabilities in various countries.
Types of RIDTs Available
Major products available in the global RIDTs market include:
– Influenza A/B Rapid Test: Tests for both influenza A and B viruses in one assay providing results within 15 minutes. Popular brand names include Sofia Influenza A+B, BD Veritor System Flu A+B.
– Influenza A Rapid Test: Specific tests to detect only influenza A virus strains like those from Alere, Quidel, and Becton Dickinson.
– Influenza B Rapid Test: Tests that identify only influenza B viruses from vendors like Quidel and Coris BioConcept.
– Multi-Test Panels: Kits that identify multiple respiratory pathogens like influenza A/B plus RSV in one device for broad differential diagnosis. Examples are BD Veritor Plus System, GenBody America Influenza A&B/RSV.
– PCR-based Tests: Molecular assays providing sensitive detection of influenza virus in under 30 minutes like Cepheid Xpert Xpress Flu/RSV.
– Professional Point-of-Care Tests: Benchtop systems for clinical labs and large hospitals that run multiple patient samples simultaneously like Luminex RespirVir Panel.
Most tests require nasal or nasopharyngeal swabs as samples and take 15-30 minutes to provide visible line results. Continuous technological advancements are further enhancing performance and user-friendliness of RIDTs.
Clinical Utility and Limitations
Some key advantages of RIDTs in clinical practice include rapid results to guide immediate therapy decisions, ability to triage patients appropriately, lessen unnecessary antibiotic usage, and curb unnecessary admissions or readmissions. However, RIDTs have moderate sensitivity compared to PCR, ranging from 50-70% depending on the viral load and strains. Co-infections may also be missed. Positive predictive value remains high but false negatives require confirmation with alternate tests. Proper technique for specimen collection and handling is important for reliable results. Overall, RIDTs are suitable for point-of-care decisions but cannot fully replace reference laboratory assays.
Future Outlook
Experts project the COVID-19 pandemic will further increase demand for rapid diagnostics as clinicians become more aware of their benefits in respiratory infection management. Emerging applications include screening programs for early detection, guided treatment and surveillance to curb outbreaks. Home-based self-testing kits are another area of active research. Multiplex panels with integrated digital readouts will likely replace individual mono-analyte tests in future. Continuous performance enhancements through improved antibodies, labelling techniques and automated reader technologies will expand the utility of RIDTs across diverse populations and settings worldwide. Wider availability and reimbursement coverage especially in developing countries will also determine future growth prospects.
Rapid influenza diagnostic tests have revolutionized influenza diagnosis from a service available only via reference laboratories to a rapid point-of-care modality. Their clinical value in facilitating timely clinical decisions and case management through same-day reliable results makes them an attractive option. While limitations exist, ongoing advancements are enhancing performance to address current challenges. Future applications in screening, home testing and digital connectivity also hold promise as disease diagnosis moves towards greater portability, affordability and accessibility on a global scale.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
