Dataset Information

Diagnostic accuracy of an app-guided, self-administered test for influenza among individuals presenting to general practice with influenza-like illness: study protocol.

ABSTRACT:

Introduction

Diagnostic tests for influenza in Australia are currently only authorised for use in clinical settings. At-home diagnostic testing for influenza could reduce the need for patient contact with healthcare services, which potentially could contribute to symptomatic improvement and reduced spread of influenza. We aim to determine the accuracy of an app-guided nasal self-swab combined with a lateral flow immunoassay for influenza conducted by individuals with influenza-like illness (ILI).

Methods and analysis

Adults (?18?years) presenting with ILI will be recruited by general practitioners (GP) participating in Australian Sentinel Practices Research Network. Eligible participants will have a nasal swab obtained by their GP for verification of influenza A/B status using reverse transcription polymerase chain reaction (RT-PCR) test at an accredited laboratory. Participants will receive an influenza test kit and will download an app that collects self-reported symptoms and influenza risk factors, then instructs them in obtaining a low-nasal self-swab, running a QuickVue influenza A+B lateral flow immunoassay (Quidel Corporation) and interpreting the results. Participants will also interpret an enhanced image of the test strip in the app. The primary outcome will be the accuracy of participants' test interpretation compared with the laboratory RT-PCR reference standard. Secondary analyses will include accuracy of the enhanced test strip image, accuracy of an automatic test strip reader algorithm and validation of prediction rules for influenza based on self-reported symptoms. A post-test survey will be used to obtain participant feedback on self-test procedures.

Ethics and dissemination

The study was approved by the Human Research and Ethic Committee (HREC) at the University of Adelaide (H-2019-116). Protocol details and any amendments will be reported to https://www.tga.gov.au/. Results will be published in the peer-reviewed literature, and shared with stakeholders in the primary care and diagnostics communities.

Trial registration number

Australia New Zealand Clinical Trial Registry (U1111-1237-0688).

SUBMITTER: Lyon V

PROVIDER: S-EPMC7678361 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Diagnostic accuracy of an app-guided, self-administered test for influenza among individuals presenting to general practice with influenza-like illness: study protocol.

Lyon Victoria V Zigman Suchsland Monica M Chilver Monique M Stocks Nigel N Lutz Barry B Su Philip P Cooper Shawna S Park Chunjong C Lavitt Libby Rose LR Mariakakis Alex A Patel Shwetak S Graham Chelsey C Rieder Mark M LeRouge Cynthia C Thompson Matthew M

BMJ open 20201119 11

<h4>Introduction</h4>Diagnostic tests for influenza in Australia are currently only authorised for use in clinical settings. At-home diagnostic testing for influenza could reduce the need for patient contact with healthcare services, which potentially could contribute to symptomatic improvement and reduced spread of influenza. We aim to determine the accuracy of an app-guided nasal self-swab combined with a lateral flow immunoassay for influenza conducted by individuals with influenza-like illne ...[more]

PMID: 33444172

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Project description:BackgroundPCR testing is considered the gold standard for SARS-CoV-2 diagnosis but its results are earliest available hours to days after testing. Rapid antigen tests represent a diagnostic tool enabling testing at the point of care. Rapid antigen tests have mostly been validated by the manufacturer or in controlled laboratory settings only. External validation at the point of care, particularly in general practice where the test is frequently used, is needed. Furthermore, it is unclear how well point of care tests are accepted by the practice staff.MethodsIn this prospective multicenter validation study in primary care, general practitioners included adult individuals presenting with symptoms suggesting COVID-19. Each patient was tested by the general practitioner, first with a nasopharyngeal swab for the point of care test (Roche SARS-CoV-2 Rapid Antigen Test) and then with a second swab for PCR testing. Using the RT-PCR result as a reference, we calculated specificity, sensitivity, positive predictive value and negative predictive value, with their 95% confidence intervals. General practitioners and medical assistants completed a survey to assess feasibility and usefulness of the point of care tests.ResultsIn 40 practices in Würzburg, Germany, 1518 patients were recruited between 12/2020 and 06/2021. The point of care test achieved a sensitivity of 78.3% and a specificity of 99.5% compared to RT-PCR. With a prevalence of 9.5%, the positive predictive value was 93.9% and the negative predictive value was 97.8%. General practitioners rated the point of care test as a helpful tool to support diagnostics in patients with signs and symptoms suggestive for infection, particularly in situations where decision on further care is needed at short notice.ConclusionThe point of care test used in this study showed a sensitivity below the manufacturer's specification (Sensitivity 96.25%) in the practice but high values for specificity and high positive predictive value and negative predictive value. Although widely accepted in the practice, measures for further patient management require a sensitive interpretation of the point of care test results.

Project description:ObjectivesTo investigate the epidemiology of influenza-like illness (ILI) by general practice and patient characteristics, and explore whether sociodemographic variables or comorbidities affect antiviral or antibiotic prescribing.DesignOpen cohort study.SettingA representative sample of 550 Australian general practices contributing data to the MedicineInsight programme.Participants4 228 149 patients of all age groups who had at least one consultation between 2015 and 2017. Median age was 37 years (Interquartile range: 21-57), 54.4% women, 16.4% aged ≥65 years, 2.2% Aboriginal or Torres Strait Islander, 17.6% had a chronic disease and 18.1% a mental health condition.Primary and secondary outcome measuresILI consultation rates (per 1000 consultations) were calculated using all ILI diagnoses for all clinical encounters with a general practitioner between 2015 and 2017. Antiviral and antibiotic prescribing for ILI cases were investigated and logistic regression models adjusted for practice and patient characteristics used to analyse associations.ResultsILI consultation rates in 2017 were higher than in previous years. Antiviral prescribing increased from 20.6% in 2015, to 23.7 in 2016 and 29.7% in 2017, while antibiotic prescribing decreased from 30.3% to 28.0% and 26.7%, respectively (p<0.05 in both cases). Practices located in high socioeconomic areas had higher ILI consultation rates (4.3 vs 2.5 per 1000 consultations, p<0.05), antibiotic (30.7% vs 23.4%, p<0.05) and antiviral (34.2% vs 13.5%, p<0.05) prescribing than those in lower socioeconomic areas. The coexistence of chronic or mental health conditions was associated with lower ILI consultation rates, higher antibiotic use, but not with antiviral prescribing. However, those with chronic respiratory conditions had a higher frequency of antibiotic and antiviral prescribing in 2017 than individuals with other comorbidities.ConclusionsAlthough the apparent decline in antibiotic prescribing for ILI is welcome, the increase in antiviral use may not be targeting those at high risk of complications from infection.

Project description:PURPOSE:To assess the utility of "influenza-like illness" (ILI) and whether it appropriately tests influenza vaccine effectiveness. PRINCIPAL RESULTS:The WHO and CDC definitions of "influenza-like illness" are similar. However many studies use other definitions, some not specifying a temperature and requiring specific respiratory and/or systemic symptoms, making many samples non-comparable. Most ILI studies find less than 25% of cases are RT-PCR-positive, those which test for other viruses and bacteria usually find multiple other pathogens, and most identify no pathogen in about 50% of cases. ILI symptom and symptom combinations do not have high sensitivity or specificity in identifying PCR-positive influenza cases. Rapid influenza diagnostic tests are increasingly used to screen ILI cases and they have low sensitivity and high specificity when compared to RT-PCR in identifying influenza. MAIN CONCLUSIONS:The working diagnosis of ILI presumes influenza may be involved until proven otherwise. Health care workers would benefit by renaming the WHO and CDC ILI symptoms and signs as "acute respiratory illness" and also using the WHO acute severe respiratory illness definition if the illness is severe and meets this criterion. This renaming would shift attention to identify the viral and bacterial pathogens in cases and epidemics, identify new pathogens, implement vaccination plans appropriate to the identified pathogens, and estimate workload during the viral season. Randomised controlled trials testing the effectiveness of influenza vaccine require all participants to be assessed by a gold standard (RT-PCR). ILI has no role in measuring influenza vaccine effectiveness. ILI is well established in the literature and in the operational definition of many surveillance databases and its imprecise definition may be inhibiting progress in research and treatment. The current ILI definition could with benefit be renamed "acute respiratory illness," with additional definitions for "severe acute respiratory illness" (SARI) with RT-PCR testing for pathogens to facilitate prevention and treatment.

Dataset Information

Diagnostic accuracy of an app-guided, self-administered test for influenza among individuals presenting to general practice with influenza-like illness: study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Diagnostic accuracy of an app-guided, self-administered test for influenza among individuals presenting to general practice with influenza-like illness: study protocol.

Similar Datasets

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