Performance and ease of use of a molecular point-of-care test for influenza A/B and RSV in patients presenting to primary care

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 turnaround 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. Keywords Influenza. Point-of-care. Primary care. Ease-of-use. PCR BACKGROUND 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 antiviral Electronic supplementary material The online version of this article (

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“…Liat SARS-CoV-2 Manuscript JCM submission 19NOV2020 performance for influenza A/B detection as well as overall assay workflow and field usability were established in previous studies (10)(11)(12) (10,11,13,14).…”

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“…According to current studies, a POC test performing a RT-PCR is a promising method with high sensitivity and specificity to enable a faster availability of test results directly in the ED. [16][17][18][19] Previous studies mainly focused on TAT and have shown strong effects on the length of stay (LOS). [20][21][22][23] The effects on frequency of antibiotic or antiviral therapy with NAI varied from study to study.…”

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