Abstract
Annual influenza epidemics cause substantial morbidity and mortality, and the majority of patients with influenza-like illness present to primary care. Point-of-care influenza tests could support treatment decisions. It is critical to establish analytic performance of these platforms in real-life patient samples before uptake can be considered. We aimed to assess the analytical performance and ease of use of the cobas® Liat® PCR POCT in detecting influenza A/B and RSV in samples collected from patients with influenza-like illness in primary care. Sensitivity and specificity of the cobas® Liat® POCT are calculated in comparison with a commercial laboratory-based PCR test (Fast-Track Respiratory Pathogens 21 Plus kit (Fast-Track Diagnostics)). Samples with discordant results were analysed additionally by the RespiFinder 2Smart (PathoFinder) using an Extended Gold Standard (EGS). Acceptability was scored on a five-point Likert scale as well as a failure mode analysis of the cobas® Liat® POCT was performed. Nasal and oropharyngeal swabs were obtained from 140 children and nasopharyngeal swabs from 604 adults (744 patients). The cobas® Liat® POCT had a sensitivity and specificity of 100% (95% CI 99–100%) and 98.1% (95%CI 96.3–99%) for influenza A, 100% (95% CI 97.7–100%) and 99.7% (95%CI 98.7–99.9%) for influenza B and 100% (95% CI 87.1–100%) and 99.4% (95%CI 98.6–99.8%) for RSV, respectively. According to trained lab technicians, the cobas® Liat® POCT was considered easy-to-use, with a fast turn-around-time. Cobas® Liat® POCT is a promising decentralised test platform for influenza A/B and RSV in primary care as it provides fairly rapid results with excellent analytic performance. Point-of-care influenza tests could support treatment decisions in primary care. Cobas® Liat® POCT is a promising decentralised test platform for influenza A/B and RSV in primary care as it provides fairly rapid results with excellent analytic performance.
Highlights
Several new POCTS for common respiratory infections in primary care are merging onto the market. [10, 11] We aimed to use the opportunity of an existing trial, the “Antivirals for influenza-Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE (ALIC4E)” trial, [12, 13] to evaluate the cobas® Liat® point-of-care tests (POCTs), selected as it is easy to use and has excellent proof-of-principle supporting data. [14,15,16,17,18] before uptake into routine care, it is critical that analytic performance be established using samples obtained from real patients in the setting in which the test might be marketed
Our primary objective was to assess the analytical performance of the cobas® Liat® POCT in detecting influenza A/B and RSV in samples collected from patients consulting with influenza-like illness (ILI) in primary care
We included a selection of swabs taken from patients presenting to primary care with symptoms of ILI, willing to participate in the ALIC4E trial, who met the inclusion criteria and gave informed consent. [12, 13] There were no additional exclusion criteria
Summary
Annual influenza epidemics cause substantial morbidity and mortality and the 2009 H1N1 influenza outbreak was defined as a pandemic by the World Health Organisation (WHO). [1, 2]About 50% of patients presenting to primary care with influenza-like illness (ILI) during a period of high influenza incidence, with some variation by country, usually have laboratory-confirmed influenza infection. [3] Unlike in Japan for example, [4] in European primary care, point-of-care testing for influenza is not routine practice, making it difficult for clinicians to distinguish influenza from other viral infections that cause ILI at the point of care with a high degree of certainty. [5] It is common practice throughout Europe to base treatment or advice to patients with ILI on signs and symptoms alone, given that point-of-care tests (POCTs) may neither be feasible nor perform adequately, and that antiviralEur J Clin Microbiol Infect Dis (2020) 39:1453–1460 treatment is hardly ever prescribed in primary care. [6] guidelines recommend use of antiviral drugs during the influenza season for high-risk groups. [7, 8] POCTs for routine use in primary care and (cost) effective treatment and willingness to prescribe would have major implications for care delivery. [5] It is common practice throughout Europe to base treatment or advice to patients with ILI on signs and symptoms alone, given that point-of-care tests (POCTs) may neither be feasible nor perform adequately, and that antiviral. [9] A valid, rapid test to detect influenza in primary care patients could help target antiviral treatment and informing patients about avoidance of risk for transmission and likely clinical course. [14,15,16,17,18] before uptake into routine care, it is critical that analytic performance be established using samples obtained from real patients in the setting in which the test might be marketed. Our primary objective was to assess the analytical performance of the cobas® Liat® POCT in detecting influenza A/B and RSV in samples collected from patients consulting with ILI in primary care.
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