Point of Care Testing using rapid automated Antigen Testing for SARS-COV-2 in Care Homes; an exploratory safety, usability and diagnostic agreement evaluation

IntroductionSuccessful adoption of POCTs (Point-of-Care tests) for COVID-19 in care homes requires the identification of ideal use cases and a full understanding of contextual and usability factors that affect test results and minimise biosafety risks. This paper presents findings from a scoping-usability and test performance study of a microfluidic immunofluorescence assay for COVID-19 in care homes. MethodsA mixed-methods evaluation was conducted in four UK care homes to scope usability and to assess the agreement with qRT-PCR. A dry run with luminescent dye was carried out to explore biosafety issues. ResultsThe agreement analysis was carried out on 227 asymptomatic participants (159 staff and 68 residents) and 14 symptomatic participants (5 staff and 9 residents). Asymptomatic specimens showed 50% (95% CI: 1.3%-98.7%) positive agreement and 96% (95% CI: 92.5%-98.1%) negative agreement with overall prevalence and bias-adjusted Kappa (PABAK) of 0.911 (95% CI: 0.857-0.965). Symptomatic specimens showed 83.3% (95% CI: 35.9%-99.6%) positive agreement and 100% (95% CI: 63.1%-100%) negative agreement with overall prevalence and bias-adjusted Kappa (PABAK) of 0.857 (95% CI: 0.549-1). The dry run showed four main sources of contamination that led to the modification of the standard operating procedures. Simulation after modification showed no further evidence of contamination. ConclusionCareful consideration of biosafety issues and contextual factors associated with care home are mandatory for safe use the POCT. Whilst POCT may have some utility for ruling out COVID-19, further diagnostic accuracy evaluations are needed to promote effective adoption.

Primary care and point-of-care testing during a pandemic: Clinician's perspectives on integrating rapid testing for COVID-19 into the primary care pathway

BackgroundReal-world evidence to support the adoption of SARS-CoV-2 point-of-care (POC) tests in primary care is limited. As the first point of contact of the health system for most patients, POC testing can potentially support general practitioners (GPs) quickly identify infectious and non-infectious individuals to rapidly inform patient triaging, clinical management, and safely restore more in-person services. ObjectivesTo explore the potential role of SARS-CoV-2 point-of-care testing in primary care services. DesignA qualitative study using an inductive thematic analysis. Setting21 general practices located across three regions in England. ResultsThree major themes were identified related to POC test implementation in primary care: (1) Insights into SARS-CoV-2 POC tests; (2) System and organisational factors; and (3) Practice-level service delivery strategies. Thematic subcategories included involvement in rapid testing, knowledge and perception of the current POC testing landscape, capacity for testing, economic concerns, resource necessities, perception of personal risk and safety, responsibility for administering the test, and targeted testing strategies. ConclusionGPs knowledge of POC tests influences their degree of trust, uncertainty, and their perception of risk of POC test use. Concerns around funding, occupational exposure, and workload play a crucial role in GPs hesitation to provide POC testing services. These concerns could potentially be addressed with government funding, the use of targeted testing, and improved triaging strategies to limit testing to essential patient cohorts.

FebriDx point-of-care test in patients with suspected COVID-19: a pooled diagnostic accuracy study

BackgroundWe conducted a systematic review and individual patient data (IPD) meta-analysis to evaluate the diagnostic accuracy of a commercial point-of-care test, the FebriDx lateral flow device (LFD), in adult patients with suspected COVID-19. The FebriDx LFD is designed to distinguish between viral and bacterial respiratory infection. MethodsWe searched MEDLINE, EMBASE, PubMed, Google Scholar, LitCovid, ClinicalTrials.gov and preprint servers on the 13th of January 2021 to identify studies reporting diagnostic accuracy of FebriDx (myxovirus resistance protein A component) versus real time reverse transcriptase polymerase chain reaction (RT-PCR) testing for SARS-CoV-2 in adult patients suspected of COVID-19. IPD were sought from studies meeting the eligibility criteria. Studies were screened for risk of bias using the QUADAS-2 tool. A bivariate linear mixed model was fitted to the data to obtain a pooled estimate of sensitivity and specificity with 95% confidence intervals (95% CIs). A summary receiver operating characteristic (SROC) curve of the model was constructed. A sub-group analysis was performed by meta-regression using the same modelling approach to compare pooled estimates of sensitivity and specificity between patients with a symptom duration of 0 to 7 days and >7 days, and patients aged between 16 to 73 years and >73 years. ResultsTen studies were screened, and three studies with a total of 1481 patients receiving hospital care were included. FebriDx produced an estimated pooled sensitivity of 0.911 (95% CI: 0.855-0.946) and specificity of 0.868 (95% CI: 0.802-0.915) compared to RT-PCR. There were no significant differences between the sub-groups of 0 to 7 days and >7 days in estimated pooled sensitivity (p = 0.473) or specificity (p = 0.853). There were also no significant differences between the sub-groups of 16 to 73 years of age and >73 years of age in estimated pooled sensitivity (p = 0.946) or specificity (p = 0.486). ConclusionsBased on the results of three studies, the FebriDx LFD had high diagnostic accuracy for COVID-19 in a hospital setting, however, the pooled estimates of sensitivity and specificity should be interpreted with caution due to the small number of studies included, risk of bias, and inconsistent reference standards. Further research is required to confirm these findings, and determine how FebriDx would perform in different healthcare settings and patient populations. Trial registrationThis study was conducted at pace as part of the COVID-19 National Diagnostic Research and Evaluation Platform (CONDOR) national test evaluation programme (https://www.condor-platform.org), and as a result, no protocol was developed, and the study was not registered. Lay summaryTests to diagnose COVID-19 are crucial to help control the spread of the disease and to guide treatment. Over the last few months, tests have been developed to diagnose COVID-19 either by detecting the presence of the virus or by detecting specific markers linked to the virus being active in the body. These tests use complex machines in laboratories accepting samples from large geographical areas. Sometimes it takes days for test results to come back. So, to reduce the wait for results, new portable tests are being developed. These point-of-care (POC) tests are designed to work close to where patients require assessment and care such as hospital emergency departments, GP surgeries or care homes. For these new POC tests to be useful, they should ideally be as good as standard laboratory tests. In this study we looked at published research into a new test called FebriDx. FebriDx is a POC test that detects the bodys response to infection, and is claimed to be able to detect the presence of any viral infection, including infections due to the SARS-CoV-2 virus which causes COVID-19, as well as bacterial infections which can have similar symptoms. The FebriDx result was compared with standard laboratory tests for COVID-19 performed on the same patients throat and nose swab sample. We were able to analyse data from three studies with a total of 1481 adult patients who were receiving hospital care with symptoms of COVID-19 during the UK pandemic. Approximately one fifth of the patients were diagnosed as positive for SARS-CoV-2 virus using standard laboratory tests for COVID-19. Our analysis demonstrated that FebriDx correctly identified 91 out of 100 patients who had COVID-19 according to the standard laboratory test. FebriDx also correctly identified 87 out of 100 patients who did not have COVID-19 according to the standard laboratory test. These results have important implications for how these tests could be used. As there were slightly fewer FebriDx false results when the results of the standard laboratory test were positive (9 out of 100) than when the results of the standard laboratory test were negative (13 out of 100), we can have slightly more confidence in a positive test result using FebriDx than a negative FebriDx result. Overall, we have shown that the FebriDx POC test performed well during the UK COVID-19 pandemic when compared with laboratory tests, especially when COVID-19 was indicated. For the future, this means that the FebriDx POC test might be helpful in making a quick clinical decision on whether to isolate a patient with COVID-19-like symptoms arriving in a busy emergency department. However, our results indicate it would not completely replace the need to conduct a laboratory test in certain cases to confirm COVID-19. There are limitations to our findings. For example, we do not know if FebriDx will work in a similar way with patients in different settings such as in the community or care homes. Similarly, we do not know whether other viral and bacterial infections which cause similar COVID-19 symptoms, and are more common in the autumn and winter months, could influence the FebriDx test accuracy. Our findings are also only based on three studies.