scholarly journals Use of the FebriDx point-of-care assay as part of a triage algorithm for medical admissions with possible COVID-19

Author(s):  
Hamish Houston ◽  
Ankur Gupta-Wright ◽  
Gavin Deas ◽  
Shivam Naik ◽  
Kamal Shah ◽  
...  

AbstractBackgroundPatients admitted to hospital with COVID-19 must be rapidly identified and isolated to prevent nosocomial transmission. However, isolation facilities are often limited, and SARS-CoV-2 RT-PCR results are too slow to inform emergency department triage. We evaluated a pragmatic triage algorithm to isolate patients with suspected COVID-19 using simple clinical criteria and the FebriDx assay.MethodsAll medical admissions in a large UK hospital were triaged as likely, possible or unlikely COVID-19 based on clinical criteria. Patients triaged as possible COVID-19 underwent FebriDx lateral flow assay on capillary blood, and those who tested MxA positive were isolated. We evaluated the accuracy of the algorithm and the FebriDx assay compared to SARS-CoV-2 RT-PCR from nasopharyngeal swabs as the reference standard.ResultsBetween 10th August 2020 and 4th November 2020, 136/3,443 medical admissions (4.0%) were diagnosed with RT-PCR confirmed COVID-19. Prevalence of COVID-19 was 45.7% (80/175) in those triaged as likely, 4.1% (50/1,225) in possible and 6/2,033 (0.3%) in unlikely COVID-19. Compared to SARS-CoV-2 RT-PCR, clinical triage had sensitivity of 95.6% (130/136) and specificity of 61.5% (2027/3297), whilst the triage algorithm including FebriDx had sensitivity of 92.6% (126/136) and specificity of 86.4% (2849/3297). The triage algorithm reduced the need for 2,859 patients to be admitted to isolation rooms. The patients missed by the algorithm had mild or asymptomatic COVID-19.ConclusionsA simple triage algorithm including FebriDx assay had good sensitivity and is a useful ‘rule-out’ for COVID-19. The algorithm is useful for managing medical admissions from the emergency department.SummaryWe studied a COVID-19 triage algorithm for hospital medical admissions using clinical parameters and the FebriDx assay. The algorithm had good sensitivity and negative-predictive value compared to SARS-CoV-2 PCR. FebriDx improved triage specificity allowing fewer isolation rooms to be used.

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e049179
Author(s):  
Hamish Houston ◽  
Gavin Deas ◽  
Shivam Naik ◽  
Kamal Shah ◽  
Shiras Patel ◽  
...  

ObjectiveTo evaluate a triage algorithm used to identify and isolate patients with suspected COVID-19 among medical patients needing admission to hospital using simple clinical criteria and the FebriDx assay.DesignRetrospective observational cohort.SettingLarge acute National Health Service hospital in London, UK.ParticipantsAll medical admissions from the emergency department between 10 August 2020 and 4 November 2020 with a valid SARS-CoV-2 RT-PCR result.InterventionsMedical admissions were triaged as likely, possible or unlikely COVID-19 based on clinical criteria. Patients triaged as possible COVID-19 underwent FebriDx lateral flow assay on capillary blood, and those positive for myxovirus resistance protein A (a host response protein) were managed as likely COVID-19.Primary outcome measuresDiagnostic accuracy (sensitivity, specificity and predictive values) of the algorithm and the FebriDx assay using SARS-CoV-2 RT-PCR from nasopharyngeal swabs as the reference standard.Results4.0% (136) of 3443 medical admissions had RT-PCR confirmed COVID-19. Prevalence of COVID-19 was 46% (80/175) in those triaged as likely, 4.1% (50/1225) in possible and 0.3% (6/2033) in unlikely COVID-19. Using a SARS-CoV-2 RT-PCR reference standard, clinical triage had sensitivity of 96% (95% CI 91% to 98%) and specificity of 61.5% (95% CI 59.8% to 63.1%), while the triage algorithm including FebriDx had sensitivity of 93% (95% CI 87% to 96%) and specificity of 86.4% (95% CI 85.2% to 87.5%). While 2033 patients were deemed not to require isolation using clinical criteria alone, the addition of FebriDx to clinical triage allowed a further 826 patients to be released from isolation, reducing the need for isolation rooms by 9.5 per day, 95% CI 8.9 to 10.2. Ten patients missed by the algorithm had mild or asymptomatic COVID-19.ConclusionsA triage algorithm including the FebriDx assay had good sensitivity and was useful to ‘rule-out’ COVID-19 among medical admissions to hospital.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Aldous ◽  
J Pickering ◽  
J Young ◽  
P George ◽  
A Watson ◽  
...  

Abstract Background High sensitivity troponin assays were developed to improve analytical sensitivity and precision at the decision cut-points for the diagnosis and rule out of acute myocardial infarction (AMI). Central laboratory assays have achieved this but point of care assays, which have the ability to accelerate decision making due to much shorter turnaround times, have remained lacking. Purpose To ascertain the threshold for decision making and subsequent clinical utility for ruling out AMI on presentation in patients attending the emergency department acutely with chest pain, using a high precision point of care troponin assay (TnI Nx), (i-STAT, Abbott). Methods We measured arrival TnI-Nx concentrations in stored plasma samples in adults presenting acutely to the emergency department with chest pain. The primary outcome was an AMI or cardiac death on index admission or within 30 days. We used 2000 bootstrapped data sets to derive and validate a suitable threshold for TnI-Nx before calculating diagnostic test performance. We pre-specified this threshold must have a <1% false negative rate for the primary outcome. We compared this with a core laboratory high sensitivity troponin I (hs-TnI) (Abbott Architect) using the early rule-out cut-point (European Society of Cardiology) at the limit of detection (2 ng/L). Results We recruited 1320 patients of whom 192 (14.1%) had the primary outcome. The TnI-Nx threshold was determined to be 8 ng/L with subsequent sensitivity of 99.0% (95% confidence interval: 97.3% to 100%), negative predictive value of 99.7% (99.2% to 100%) and specificity of 59.0% (56.0% to 62.0%). The hs-TnI had a sensitivity of 99.5% (98.2% to 100%), negative predictive value of 99.7% (99.0% to 100%), and specificity of 28.4% (25.8% to 31.2%) at 2ng/L. Conclusion A high precision point of care assay, TnI-Nx, with a decision threshold of 8ng/L, has comparable rule out performance compared with a core laboratory high sensitivity assay and therefore could potentially be used for early decision making in the assessment of acute chest pain. Acknowledgement/Funding Research grant from Abbott Point of Care. Senior Research Fellowship from ECF, CMRF and CDHB. Clinical Research Fellowship from NZ HRC


2020 ◽  
Vol 9 (6) ◽  
pp. 576-585
Author(s):  
Òscar Miró ◽  
Pedro Lopez-Ayala ◽  
Gemma Martínez-Nadal ◽  
Valentina Troester ◽  
Ivo Strebel ◽  
...  

Background We aimed to externally validate an emergency department triage algorithm including five hierarchical clinical variables developed to identify chest pain patients at low risk of having an acute coronary syndrome justifying delayed rather than immediate evaluation. Methods In a single-centre cohort enrolling 29,269 consecutive patients presenting with chest pain, the performance of the algorithm was compared against the emergency department discharge diagnosis. In an international multicentre study enrolling 4069 patients, central adjudication by two independent cardiologists using all data derived from cardiac work-up including follow-up served as the reference. Triage towards ‘low-risk’ required absence of all five clinical ‘high-risk’ variables: history of coronary artery disease, diabetes, pressure-like chest pain, retrosternal chest pain and age above 40 years. Safety (sensitivity and negative predictive value (NPV)) and efficacy (percentage of patients classified as low risk) was tested in this initial proposal (Model A) and in two additional models: omitting age criteria (Model B) and allowing up to one (any) of the five high-risk variables (Model C). Results The prevalence of acute coronary syndrome was 9.4% in the single-centre and 28.4% in the multicentre study. The triage algorithm had very high sensitivity/NPV in both cohorts (99.4%/99.1% and 99.9%/99.1%, respectively), but very low efficacy (6.2% and 2.7%, respectively). Model B resulted in sensitivity/NPV of 97.5%/98.3% and 96.1%/89.4%, while efficacy increased to 14.2% and 10.4%, respectively. Model C resulted in sensitivity/NPV of 96.7%/98.6% and 95.2%/91.3%, with a further increase in efficacy to 23.1% and 15.5%, respectively. Conclusion A triage algorithm for the identification of low-risk chest pain patients exclusively based on simple clinical variables provided reasonable performance characteristics possibly justifying delayed rather than immediate evaluation in the emergency department.


2017 ◽  
Vol 39 (2) ◽  
pp. 152-158 ◽  
Author(s):  
Jesse M. Pines ◽  
Mark S. Zocchi ◽  
Mary Elizabeth Buchanan ◽  
Manish N. Shah ◽  
Debbie Travers

2020 ◽  
Author(s):  
Asimina Safarika ◽  
James W. Wacker ◽  
Konstantinos Katsaros ◽  
Nicky Solomonidi ◽  
George Giannikopoulos ◽  
...  

AbstractStudy designWhether or not to administer antibiotics is a common and challenging clinical decision in patients with suspected infections presenting to the emergency department (ED). We prospectively validate InSep, a 29-mRNA blood-based host response test for the prediction of bacterial and viral infections.MethodsThe PROMPT trial is a prospective, non-interventional, multi-center randomized, controlled clinical trial that enrolled 397 adult patients presenting to the ED with signs of acute infection and at least one vital sign change. The infection status was adjudicated using chart review (including a syndromic molecular respiratory panel, procalcitonin and C-reactive protein) by three infectious disease physicians blinded to InSep results. InSep (version BVN-2) was performed using PAXgene Blood RNA processed and quantified on NanoString nCounter SPRINT. InSep results (likelihood of bacterial and viral infection) were compared to the adjudicated infection status.ResultsSubject mean age was 64 years, comorbidities were significant for diabetes (17.1%), chronic obstructive pulmonary disease (13.6%), and severe neurological disease (6.8%); 16.9% of subjects were immunocompromised. Infections were adjudicated as bacterial (14.1%), viral (11.3%) and noninfected (0.25%): 74.1% of subjects were adjudicated as indeterminate. InSep distinguished bacterial vs. viral/noninfected patients and viral vs. bacterial/noninfected patients using consensus adjudication with AUROCs of 0.94 (95% CI 0.90-0.99) and 0.90 (95% CI 0.83-0.96), respectively. AUROCs for bacterial vs. viral/noninfected patients were 0.88 (95%CI 0.79-0.96) for PCT, 0.80 (95% CI 0.72-89) for CRP and 0.78 (95% CI 0.69-0.87) for white blood cell counts (of note, the latter biomarkers were provided as part of clinical adjudication). To enable clinical actionability, InSep incorporates score cutoffs to allocate patients into interpretation bands. The Very Likely (rule in) InSep bacterial band showed a specificity of 98% compared to 94% for the corresponding PCT band (>0.5 ug/L); the Very Unlikely (rule-out) band showed a sensitivity of 95% for InSep compared to 86% for PCT. For the detection of viral infections, InSep demonstrated a specificity of 93% for the Very Likely band (rule in) and a sensitivity of 96% for the Very Unlikely band (rule out).ConclusionInSep demonstrated high accuracy for predicting the presence of both bacterial and viral infections in ED patients with suspected acute infections or suspected sepsis. When translated into a rapid, point-of-care test, InSep will provide ED physicians with actionable results supporting early informed treatment decisions to improve patient outcomes while upholding antimicrobial stewardship.Take-home messageInSep host response test is a point-of-care test providing with accuracy the likelihood for bacterial or viral infection for patients admitted at the emergencies InSep provided information on the likelihood of bacterial co-infection among patients with COVID-19.


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