Evidence map›Paper›PMID 34134647›Full record

ArticleBMC infectious diseases2021

Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2.

Bianca A Trombetta, Savannah E Kandigian, Robert R Kitchen, Korneel Grauwet, Pia Kivisäkk Webb, Glenn A Miller, Charles G Jennings, Sejal Jain, Samara Miller, Yikai Kuo and 48 more

Erratum issuedOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.8field-weighted citation impact, top 13% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 30 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Lateral Flow Immunoassays for SARS-CoV-2.Diagnostics (Basel, Switzerland) · 2022
    Review
  5. Article
  6. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

58 authors at 9 institutions in 1 country.

Bianca A Trombetta *Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
Savannah E Kandigian *Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
Robert R Kitchen *Department of Medicine, Harvard Medical School, Boston, MA, USA.
Korneel Grauwet *Cardiology Division, Massachusetts General Hospital, Charlestown, MA, USA.
Pia Kivisäkk WebbDepartment of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
Glenn A MillerMass General Brigham Innovation, Boston, MA, USA.
Charles G JenningsCardiology Division, Massachusetts General Hospital, Charlestown, MA, USA.
Sejal JainDepartment of Medical Oncology and Center for Cancer-Genome Discovery, Dana-Farber Cancer Institute, Boston, MA, USA.
Samara MillerDepartment of Medicine, Harvard Medical School, Boston, MA, USA.
Yikai KuoDepartment of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
Thadryan SweeneyCardiology Division, Massachusetts General Hospital, Charlestown, MA, USA.
Tal GilboaWyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA, USA.
Maia NormanWyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA, USA.
Daimon P SimmonsDivision of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
Christopher E RamirezDepartment of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
Melissa BedardDivision of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
Catherine FinkMedical Diagnostic Technology Evaluation, LLC, Carlisle, MA, USA.
Jina KoWyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA, USA.
Esmarline J De León PeraltaDepartment of Pathology, Massachusetts General Hospital, Boston, MA, USA.
Gerald WattsDivision of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
Emma Gomez-RivasDivision of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
Vannessa DavisDepartment of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Rocky M BarillaEvergrande Center for Immunologic Diseases, Brigham and Women's Hospital, Boston, MA, USA.
Jianing WangCardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
Pierre CuninDivision of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
Samuel BatesFunctional Genomics Laboratory, Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, MA, USA.
Chevaun Morrison-SmithDepartment of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Benjamin NicholsonCenter for Cancer Research, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.
Edmond WongCenter for Cancer Research, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.
Leena El-MuftiDepartment of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
Michael KannCenter for Cancer Research, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.
Anna BollingDepartment of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
Brooke FortinDepartment of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
Hayden VentrescaCardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
Wen ZhouDivision of Nephrology and Endocrine Unit Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.
Santiago PardoDepartment of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
Megan KwockCancer Center Protocol Office, Massachusetts General Hospital, Boston, MA, USA.
Aditi HazraDepartment of Medicine, Harvard Medical School, Boston, MA, USA.
Leo ChengRadiology and pathology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Q Rushdy AhmadWyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA, USA.
James A ToombsBrigham Research Institute, Brigham and Women's Hospital, Boston, MA, USA.
Rebecca LarsonImmunology Program, Harvard Medical School, Boston, MA, USA.
Haley PleskowCenter for Cancer Research, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.
Nell Meosky LuoFolia Health, Inc., Cambridge, MA, USA.
Christina SamahaFolia Health, Inc., Cambridge, MA, USA.
Unnati M PandyaDepartment of Medicine, Harvard Medical School, Boston, MA, USA.
Pushpamali De SilvaWellman Center for Photomedicine, Massachusetts General Research Institute, Boston, MA, USA.
Sally ZhouDepartment of Biology, Northeastern University, Boston, MA, USA.
Zakary GanhadeiroDepartment of Biology, Northeastern University, Boston, MA, USA.
Sara YohannesBrigham Research Institute, Brigham and Women's Hospital, Boston, MA, USA.
Rakiesha GayBrigham Research Institute, Brigham and Women's Hospital, Boston, MA, USA.
Jacqueline SlavikBrigham Research Institute, Brigham and Women's Hospital, Boston, MA, USA.
Shibani S MukerjiDepartment of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
Petr JarolimDepartment of Pathology, Harvard Medical School, Boston, MA, USA.
David R WaltWyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA, USA.
Becky C CarlyleDepartment of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
Lauren L Ritterhouse *Department of Pathology, Massachusetts General Hospital, Boston, MA, USA.
Sara Suliman *Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, MA, USA. ssuliman1@bwh.harvard.edu.
Brigham and Women's Hospital · USMassachusetts General Hospital · USHarvard University · USCenter for Cancer Research · USNortheastern University · USAccelerated Medical Diagnostics (United States) · USMass General Brigham · USReproductive Science Center · USTufts University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCOVID-19 has resulted in significant morbidity and mortality worldwide. Lateral flow assays can detect anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) antibodies to monitor transmission. However, standardized evaluation of their accuracy and tools to aid in interpreting results are needed.

methodsWe evaluated 20 IgG and IgM assays selected from available tests in April 2020. We evaluated the assays' performance using 56 pre-pandemic negative and 56 SARS-CoV-2-positive plasma samples, collected 10-40 days after symptom onset, confirmed by a molecular test and analyzed by an ultra-sensitive immunoassay. Finally, we developed a user-friendly web app to extrapolate the positive predictive values based on their accuracy and local prevalence.

resultsCombined IgG + IgM sensitivities ranged from 33.9 to 94.6%, while combined specificities ranged from 92.6 to 100%. The highest sensitivities were detected in Lumiquick for IgG (98.2%), BioHit for both IgM (96.4%), and combined IgG + IgM sensitivity (94.6%). Furthermore, 11 LFAs and 8 LFAs showed perfect specificity for IgG and IgM, respectively, with 15 LFAs showing perfect combined IgG + IgM specificity. Lumiquick had the lowest estimated limit-of-detection (LOD) (0.1 μg/mL), followed by a similar LOD of 1.5 μg/mL for CareHealth, Cellex, KHB, and Vivachek.

conclusionWe provide a public resource of the accuracy of select lateral flow assays with potential for home testing. The cost-effectiveness, scalable manufacturing process, and suitability for self-testing makes LFAs an attractive option for monitoring disease prevalence and assessing vaccine responsiveness. Our web tool provides an easy-to-use interface to demonstrate the impact of prevalence and test accuracy on the positive predictive values.

Indexed as

AdultAgedAntibodies, ViralCOVID-19COVID-19 Serological TestingFemaleHumansImmunoglobulin GImmunoglobulin MLimit of DetectionMaleMiddle AgedPredictive Value of TestsPrevalenceSARS-CoV-2Sensitivity and SpecificityAntibodies, ViralImmunoglobulin GImmunoglobulin MAntibodiesCoronavirusCOVID-19Lateral flow assaysSARS-CoV-2

Identifiers

PMID34134647
PMCPMC8206878
OpenAlexW3168136285

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LicenceCC BY
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Registered trials

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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.