Developing a new option for molecular point-of-care influenza testing
COVID-19 Increases the Need for Molecular Point-of-Care Influenza Testing
Before the COVID-19 pandemic, molecular point-of-care tests for influenza were just starting to become available.1–5 These tests generally possess higher sensitivity and lower false negative rates compared to the rapid influenza antigen diagnostic tests that were already in point-of-care settings.2–5 However, despite their superior performance, the higher per-test cost of molecular point-of-care tests likely slowed their uptake.5
With the emergence of SARS-CoV-2, we believe that the cost-benefit equation for molecular point-of-care influenza testing has changed. Now, when a patient presents with respiratory symptoms, the clinician needs to very quickly determine if the causative agent is influenza, SARS-CoV-2, a different pathogen like respiratory syncytial virus (RSV), or co-infection of multiple viruses because the: (a) disease course, public health needs, and treatment options are very different6–8 and (b) consequences of a false negative for any of these viruses include the potential for further transmission, as well as poor health outcomes due to ineffective treatment decisions.7,9
For these reasons, the Talis team believes that now, more than ever, is the right time for healthcare teams to consider a molecular point-of-care influenza test.
CDC Recommends a Rapid Influenza Nucleic Acid Detection Assay when SARS-CoV-2 and Influenza are Co-circulating6
The importance of prioritizing the more sensitive molecular point-of-care influenza tests over rapid influenza antigen assays when both influenza and SARS-CoV-2 are co-circulating is also recognized by the Centers for Disease Control and Prevention (CDC, United States).6 Its guidance provides recommendations on how to manage individuals with respiratory symptoms in outpatient clinics and emergency departments, and specifically recommends that patients who are not admitted to the hospital get both a SARS-CoV-2 test—preferably a nucleic acid detection test—and to: […test for influenza if results will change clinical management or for infection control decisions (e.g. long-term care facility resident returning to a facility, or a person of any age returning to a congregate setting): order rapid influenza nucleic acid detection assay; if rapid influenza nucleic acid detection assay is not available on-site, order rapid influenza antigen assay; prescribe antiviral treatment if positive.6] with an alternative of prescribing antiviral treatment without testing.6
What’s the difference between a rapid influenza diagnostic test and a molecular point-of-care influenza test?
Both rapid influenza diagnostic tests and molecular point-of-care influenza tests can be used in an outpatient setting to inform clinical decision making. However, both the CDC and the Infectious Diseases Society of America (IDSA) recommend molecular point-of-care tests over rapid influenza diagnostic tests due to the increased sensitivity of the molecular tests.6,10,11
Rapid Influenza Diagnostic Test
- Near-patient setting10
- Detects influenza antigens10
- Low to moderate sensitivity10 (the potential for false negatives often leads to the need for additional testing)9
- Sensitivity varies by patient age and virus subtype and strain9
Molecular Point-of-Care Influenza Test
- Near-patient setting10
- Detects influenza nucleic acid (nucleic acid amplification technology, NAAT)10
- High sensitivity regardless of patient age, virus subtype and strain9,10
- Preferred type of test for outpatient settings10
The Expected Benefits of Molecular Point-of-Care Influenza Testing
A number of studies have reported on the sensitivity and specificity of different types of point-of-care influenza tests (see the meta-analysis by Merckx, et al.2), with rapid nucleic acid amplification tests showing much higher sensitivity, as a group, than the rapid influenza antigen detection tests,2 leading to ~40% improved detection of influenza.2 The benefits of improved detection affect outcomes at multiple levels:
- Patients experience better health through quick administration of antiviral treatment2,12,13
Because influenza antivirals are most effective when administered within 48 hours of symptom onset,14 quck and accurate diagnosis of influenza can help ensure patients get the right antiviral when it can have the most impact.
- Reduce inappropriate antibiotic use2,12,13
Quick and accurate identification of the causative agent of a patient’s symptoms not only ensures more effective patient treatment but can support antibiotic stewardship by ruling-out the use of antibiotics when the causative agent is a virus.2,12,13
- Fewer diagnostic tests are needed2,15,16
A quick positive diagnosis leads to ordering fewer overall tests as an effective treatment plan can be formed immediately.2,15,16
- Transmission can be reduced2,4
Because respiratory viruses differ in the timing of when an infected individual can transmit the disease to others, a rapid positive identification can lead to the most effective transmission control procedures.
Note that multiplex tests are expected to accelerate the efficiency of achieving the correct diagnosis.
Point-of-Care Influenza Testing
Designed to maximize health outcomes in the face of infectious diseases like influenza, the Talis One™ system enables fast, accurate, lab-quality molecular diagnostic testing in a variety of care settings.
We have already developed a Talis One COVID-19 Test System that is available through an Emergency Use Authorization (EUA), and are developing a multiplex Talis One SARS-CoV-2/Influenza Test to meet the new complexities the COVID-19 pandemic has brought to diagnosing respiratory infections.
Talis One Point-of-care Instrument
The Talis One point-of-care instrument delivers rapid, reliable, and accurate, lab-quality diagnostic testing results across a variety of CLIA-waived care settings.
Talis One Consumables
The Talis One Nasal Mid-Turbinate Collection Kit stabilizes viral RNA and inactivates viruses.1 Each single-use cartridge contains a highly sensitive, solid-phase nucleic acid amplification test (NAAT).
Dedicated Talis One Customer Support
Our Customer Service support team is happy to help answer your questions.
The Talis One infectious disease system is designed to help you meet your community’s needs during influenza season. Tell us what capabilities you’d like to see in a point-of-care influenza assay.
- CDC: Information for Healthcare Practitioners
- Summary: ‘Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP)—United States, 2021-22’
- Clinical Practice Guidelines by the Infectious Diseases Society of America: 2018 Update on Diagnosis, Treatment, Chemoprophylaxis, and Institutional Outbreak Management of Seasonal Influenza
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The GenBody COVID-19 Ag Test and the Talis One COVID-19 Test System are for use under Emergency Use Authorization (EUA) only. For In Vitro Diagnostic (IVD) use. For prescription use only. Talis is an authorized distributor of the GenBody COVID-19 Ag test.
*Additional testing solutions are currently in development and not available for sale.
- Benirschke RC, McElvania E, Thomson RB, Kaul KL, Das S. Clinical Impact of Rapid Point-of-Care PCR Influenza Testing in an Urgent Care Setting: a Single-Center Study. J Clin Microbiol. 57(3):e01281-18. doi:10.1128/JCM.01281-18
- Merckx J, Wali R, Schiller I, et al. Diagnostic Accuracy of Novel and Traditional Rapid Tests for Influenza Infection Compared With Reverse Transcriptase Polymerase Chain Reaction: A Systematic Review and Meta-analysis. Ann Intern Med. 2017;167(6):394-409. doi:10.7326/M17-0848
- Anselem O, Baraud C, L’Honneur A-S, Gobeaux C, Rozenberg F, Goffinet F. Improving care for pregnant women with suspected influenza: A retrospective study before and after introduction of a rapid molecular assay. PLOS ONE. 2019;14(6):e0217651. doi:10.1371/journal.pone.0217651
- Allen AJ, O’Leary RA, Davis S, et al. Cost implications for the NHS of using the AlereTM i Influenza A & B near patient test with nasal swabs. Diagn Progn Res. 2018;2(1):15. doi:10.1186/s41512-018-0031-8
- Svoboda E. A sticking point for rapid flu tests? Scientific American. Accessed September 29, 2021.
- Testing Guidance for Clinicians When SARS-CoV-2 and Influenza Viruses are Co-circulating. Published October 26, 2020. Accessed September 29, 2021.
- Solomon DA, Sherman AC, Kanjilal S. Influenza in the COVID-19 Era. JAMA. 2020;324(13):1342-1343. doi:10.1001/jama.2020.14661
- CDC. Similarities and Differences between Flu and COVID-19?. Centers for Disease Control and Prevention. Published June 7, 2021. Accessed September 29, 2021.
- Trombetta VK, Chan YL, Bankowski MJ. Are Rapid Influenza Antigen Tests Still Clinically Useful in Today’s Molecular Diagnostics World? Hawaii J Med Public Health. 2018;77(9):226-230.
- Uyeki TM, Bernstein HH, Bradley JS, et al. Clinical Practice Guidelines by the Infectious Diseases Society of America: 2018 Update on Diagnosis, Treatment, Chemoprophylaxis, and Institutional Outbreak Management of Seasonal Influenzaa. Clin Infect Dis. 2019;68(6):e1-e47. doi:10.1093/cid/ciy866
- Information on Rapid Molecular Assays, RT-PCR, and other Molecular Assays for Diagnosis of Influenza Virus Infection | CDC. Published October 21, 2019. Accessed September 29, 2021.
- Benito-Fernández J, Vázquez-Ronco MA, Morteruel-Aizkuren E, Mintegui-Raso S, Sánchez-Etxaniz J, Fernández-Landaluce A. Impact of Rapid Viral Testing for Influenza A and B Viruses on Management of Febrile Infants Without Signs of Focal Infection. Pediatr Infect Dis J. 2006;25(12):1153-1157. doi:10.1097/01.inf.0000246826.93142.b0
- Blaschke AJ, Shapiro DJ, Pavia AT, et al. A National Study of the Impact of Rapid Influenza Testing on Clinical Care in the Emergency Department. J Pediatr Infect Dis Soc. 2014;3(2):112-118. doi:10.1093/jpids/pit071
- CDC. Influenza Antiviral Medications: Clinician Summary. Centers for Disease Control and Prevention. Published September 22, 2021. Accessed October 4, 2021.
- Esposito S, Marchisio P, Morelli P, Crovari P, Principi N. Effect of a rapid influenza diagnosis. Arch Dis Child. 2003;88(6):525-526. doi:10.1136/adc.88.6.525
- Iyer SB, Gerber MA, Pomerantz WJ, Mortensen JE, Ruddy RM. Effect of Point-of-care Influenza Testing on Management of Febrile Children. Acad Emerg Med. 2006;13(12):1259-1268. doi:10.1197/j.aem.2006.07.026