Evidence map›Paper›PMID 36152227›Full record

ArticleInfectious diseases and therapy2022

Performance Evaluation of the Microfluidic Antigen LumiraDx SARS-CoV-2 and Flu A/B Test in Diagnosing COVID-19 and Influenza in Patients with Respiratory Symptoms.

Jayne E Ellis, Poppy Guest, Vicki Lawson, Julia Loecherbach, Nigel Lindner, Andrew McCulloch

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Infectious diseases and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.0field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04288921 completednot on this map

A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx Influenza A/B + RSV Test at Point of Care Testing Sites

TypeobservationalSponsorLumiraDx UK LimitedRan2020 to 2020Enrolled525ConditionsInfluenza, Human, Respiratory Syncytial Virus InfectionsArmsSwab
NCT04557046 completednot on this map

A Multicenter COVID-19 Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 Ag Test at Point of Care Testing Sites

TypeobservationalSponsorLumiraDx UK LimitedRan2020 to 2020Enrolled1,134ConditionsCovid19ArmsNasal Swab, Nasopharyngeal swab, Throat swab, Fingerstick, Saliva specimen
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 10 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 2 countries.

Jayne E EllisLumiraDx Ltd, Stirling, UK. jayne.ellis@lumiradx.com.
Poppy GuestLumiraDx Ltd, Stirling, UK.
Vicki LawsonLumiraDx Ltd, Stirling, UK.
Julia LoecherbachLumiraDx Ltd, Stirling, UK.
Nigel LindnerLumiraDx Ltd, Stirling, UK.
Andrew McCullochLumiraDx Ltd, Stirling, UK.
University of Stirling · GBLuminex (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCoronavirus disease 2019 (COVID-19) and influenza share similar symptoms, which hampers diagnosis. Given that they require different containment and treatment strategies, fast and accurate distinction between the two infections is needed. This study evaluates the sensitivity and specificity of the microfluidic antigen LumiraDx SARS-CoV-2 and Flu A/B Test for simultaneous detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza A/B from a single nasal swab.

methodsNasal samples were collected from patients as part of the ASPIRE (NCT04557046) and INSPIRE (NCT04288921) studies at point-of-care testing sites in the USA. ASPIRE study participants were included after developing COVID-19 symptoms in the last 14 days or following a positive SARS-CoV-2 test in the last 48 h. INSPIRE study participants were included after developing influenza symptoms in the last 4 days. Samples were extracted into proprietary buffer and analysed using the LumiraDx SARS-CoV-2 and Flu A/B Test. A reference sample was taken from each subject, placed into universal transport medium and tested using reference SARS-CoV-2 and influenza reverse transcription polymerase chain reaction (RT-PCR) tests. The test and reference samples were compared using the positive percent agreement (PPA) and negative percent agreement (NPA), together with their 95% confidence intervals (CIs).

resultsAnalysis of the data from the ASPIRE (N = 124) and INSPIRE (N = 159) studies revealed high levels of agreement between the LumiraDx SARS-CoV-2 and Flu A/B Test and the reference tests in detecting SARS-CoV-2 (PPA = 95.5% [95% CI 84.9%, 98.7%]; NPA = 96.0% [95% CI 90.9%, 98.3%]), influenza A (PPA = 83.3% [95% CI 66.4%, 92.7%]; NPA = 97.7% [95% CI 93.4%, 99.2%]) and influenza B (PPA = 80.0% [95% CI 62.7%, 90.5%]; NPA = 95.3% [95% CI 90.2%, 97.9%]).

conclusionsThe LumiraDx SARS-CoV-2 and Flu A/B Test shows a high agreement with the reference RT-PCR tests while simultaneously detecting and differentiating between SARS-CoV-2 and influenza A/B.

trial registrationClinicalTrials.gov identifiers NCT04557046 and NCT04288921.

Indexed as

CoinfectionCOVID-19Influenza testPoint-of-careSARS-CoV-2 test

Identifiers

PMID36152227
PMCPMC9510530
OpenAlexW4297175676

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.