Evidence map›Paper›PMID 34043631›Full record

Trial reportPloS one2021

The Abbott PanBio WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test for SARS-CoV-2-Evaluation of the accuracy and ease-of-use.

Lisa J Krüger, Mary Gaeddert, Frank Tobian, Federica Lainati, Claudius Gottschalk, Julian A F Klein, Paul Schnitzler, Hans-Georg Kräusslich, Olga Nikolai, Andreas K Lindner and 11 more

Open access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 7 pooled it
3.2field-weighted citation impact, top 6% 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

35 citing papers in PubMed, 7 syntheses or guidelines pooled it, 55 citations in OpenAlex.

  1. Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Antigen Testing (January 2023).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Guideline
  3. Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.The Cochrane database of systematic reviews · 2022
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Trial
  9. Review
  10. Article
  11. The New Normal: Delayed Peak SARS-CoV-2 Viral Loads Relative to Symptom Onset and Implications for COVID-19 Testing Programs.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Article
  12. Article
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  17. Review
  18. ESCMID COVID-19 guidelines: diagnostic testing for SARS-CoV-2.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2022
    Article
  19. Article
  20. Article
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

21 authors at 4 institutions in 3 countries.

Lisa J KrügerDivision of Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
Mary GaeddertDivision of Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.ORCID 0000-0002-6713-3495
Frank TobianDivision of Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
Federica LainatiDivision of Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
Claudius GottschalkDivision of Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
Julian A F KleinDivision of Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
Paul SchnitzlerVirology, Heidelberg University Hospital, Heidelberg, Germany.
Hans-Georg KräusslichVirology, Heidelberg University Hospital, Heidelberg, Germany.
Olga NikolaiCharité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Tropical Medicine and International Health, Berlin, Germany.
Andreas K LindnerCharité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Tropical Medicine and International Health, Berlin, Germany.
Frank P MockenhauptCharité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Tropical Medicine and International Health, Berlin, Germany.
Joachim SeyboldCharité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Medical Directorate, Berlin, Germany.
Victor M CormanCharité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Virology, Berlin, Germany.
Christian DrostenCharité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Virology, Berlin, Germany.
Nira R PollockDepartment of Laboratory Medicine, Boston Children's Hospital, Boston, Massachusetts, United States of America.
Britta KnorrDepartment of Public Health Rhein Neckar Region, Heidelberg, Germany.
Andreas WelkerDepartment of Public Health Rhein Neckar Region, Heidelberg, Germany.
Margaretha de VosFoundation for Innovative New Diagnostics, Geneva, Switzerland.ORCID 0000-0003-3059-2986
Jilian A SacksFoundation for Innovative New Diagnostics, Geneva, Switzerland.
Claudia M DenkingerDivision of Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.ORCID 0000-0002-7216-7067
study team
Heidelberg University · DEHumboldt-Universität zu Berlin · DEFIND · CHBoston Children's Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesDiagnostics are essential for controlling the pandemic. Identifying a reliable and fast diagnostic device is needed for effective testing. We assessed performance and ease-of-use of the Abbott PanBio antigen-detecting rapid diagnostic test (Ag-RDT).

methodsThis prospective, multi-centre diagnostic accuracy study enrolled at two sites in Germany. Following routine testing with reverse-transcriptase polymerase chain reaction (RT-PCR), a second study-exclusive swab was performed for Ag-RDT testing. Routine swabs were nasopharyngeal (NP) or combined NP/oropharyngeal (OP) whereas the study-exclusive swabs were NP. To evaluate performance, sensitivity and specificity were assessed overall and in predefined sub-analyses accordingly to cycle-threshold values, days after symptom onset, disease severity and study site. Additionally, an ease-of-use assessment (EoU) and System Usability Scale (SUS) were performed.

results1108 participants were enrolled between Sept 28 and Oct 30, 2020. Of these, 106 (9.6%) were PCR-positive. The Abbott PanBio detected 92/106 PCR-positive participants with a sensitivity of 86.8% (95% CI: 79.0% - 92.0%) and a specificity of 99.9% (95% CI: 99.4%-100%). The sub-analyses indicated that sensitivity was 95.8% in Ct-values <25 and within the first seven days from symptom onset. The test was characterized as easy to use (SUS: 86/100) and considered suitable for point-of-care settings.

conclusionThe Abbott PanBio Ag-RDT performs well for SARS-CoV-2 testing in this large manufacturer independent study, confirming its WHO recommendation for Emergency Use in settings with limited resources.

Indexed as

COVID-19COVID-19 Serological TestingPoint-of-Care TestingAdultFemaleGermanyHumansMaleMiddle AgedSARS-CoV-2Sensitivity and SpecificityWorld Health Organization

Identifiers

PMID34043631
PMCPMC8158996
OpenAlexW3164851792

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.