Evidence map›Paper›PMID 36066256›Full record

ArticleMicrobiology spectrum2022

A Multicenter Clinical Diagnostic Accuracy Study of SureStatus, an Affordable, WHO Emergency Use-Listed, Rapid, Point-Of-Care Antigen-Detecting Diagnostic Test for SARS-CoV-2.

Lisa J Krüger, Andreas K Lindner, Mary Gaeddert, Frank Tobian, Julian Klein, Salome Steinke, Federica Lainati, Paul Schnitzler, Olga Nikolai, Frank P Mockenhaupt and 18 more

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in Microbiology spectrum, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 33% 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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Comparison of a Commercial SARS-CoV-2 Rapid Antigen Test with Real-Time PCR.Infectious diseases & clinical microbiology · 2024
    Article
  3. Article
  4. 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

28 authors at 9 institutions in 5 countries.

Lisa J KrügerDivision of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
Andreas K LindnerCharité-Universitätsmedizin Berlin, Institute of Tropical Medicine and International Health, Berlin, Germany.ORCID 0000-0001-5768-5109
Mary GaeddertDivision of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
Frank TobianDivision of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
Julian KleinDivision of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
Salome SteinkeDivision of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
Federica LainatiDivision of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
Paul SchnitzlerVirology, Heidelberg University Hospital, Heidelberg, Germany.
Olga NikolaiCharité-Universitätsmedizin Berlin, Institute of Tropical Medicine and International Health, Berlin, Germany.
Frank P MockenhauptCharité-Universitätsmedizin Berlin, Institute of Tropical Medicine and International Health, Berlin, Germany.
Joachim SeyboldCharité-Universitätsmedizin Berlin, Medical Directorate, Berlin, Germany.
Victor M CormanCharité-Universitätsmedizin Berlin, Institute of Virology, Berlin, Germany.ORCID 0000-0002-3605-0136
Terry C JonesCharité-Universitätsmedizin Berlin, Institute of Virology, Berlin, Germany.
Nira R PollockDepartment of Laboratory Medicine, Boston Children's Hospital, Boston, Massachusetts, USA.ORCID 0000-0002-6396-2915
Britta KnorrDepartment of Public Health Rhein Neckar Region, Heidelberg, Germany.
Andreas WelkerDepartment of Public Health Rhein Neckar Region, Heidelberg, Germany.
Stephan WeberAcomed Statistik, Leipzig, Germany.
Nandini SethurarnanApollo Hospitalsgrid.413839.4, Chennai, India.
Jayanthi SwaminathanApollo Hospitalsgrid.413839.4, Chennai, India.
Hilda SolomonApollo Hospitalsgrid.413839.4, Chennai, India.
Ajay PadmanabanApollo Hospitalsgrid.413839.4, Chennai, India.
Ma ThirunarayanApollo Hospitalsgrid.413839.4, Chennai, India.
Prabakaran LFoundation of Innovative New Diagnostics (FIND), New Delhi, India.
Margaretha de VosFoundation of Innovative New Diagnostics (FIND), Campus Biotech, Geneva, Switzerland.ORCID 0000-0003-3059-2986
Stefano OngarelloFoundation of Innovative New Diagnostics (FIND), Campus Biotech, Geneva, Switzerland.
Jilian A SacksFoundation of Innovative New Diagnostics (FIND), Campus Biotech, Geneva, Switzerland.
Camille EscadafalFoundation of Innovative New Diagnostics (FIND), Campus Biotech, Geneva, Switzerland.
Claudia M DenkingerDivision of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.ORCID 0000-0002-7216-7067
Heidelberg University · DEApollo Hospitals · INFIND · CHBerlin Institute of Health at Charité - Universitätsmedizin Berlin · DEBoston Children's Hospital · USCharité - Universitätsmedizin Berlin · DEGerman Center for Infection Research · DEStatistisches Bundesamt · DEUniversity of Cambridge · GB

Funding

NIAID NIH HHS HHSN272201400008C
6 · The paper itself

Abstract

Access to reverse transcription-PCR (RT-PCR) testing, the gold standard for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection, is limited throughout the world, due to restricted resources, available infrastructure, and high costs. Antigen-detecting rapid diagnostic tests (Ag-RDTs) overcome some of these barriers, but independent clinical validations in settings of intended use are scarce. To inform the World Health Organization's (WHO) emergency use listing (EUL) procedure and ensure affordable, high-quality Ag-RDTs, we assessed the performance and ease of use of the SureStatus for SARS-CoV-2. For this prospective, multicenter diagnostic accuracy study, we recruited unvaccinated participants with presumed SARS-CoV-2 infection in India and Germany from December 2020 to March 2021, when the Alpha (B.1.1.7) variant was predominantly circulating. Paired swabs were performed for (i) routine clinical RT-PCR testing (sampling was either nasopharyngeal [NP] or combined NP and oropharyngeal [NP/OP]) and (ii) Ag-RDT (sampling was NP). Performance of the Ag-RDT was compared to RT-PCR overall and by predefined subgroups, e.g., cycle threshold (

Indexed as

COVID-19SARS-CoV-2Diagnostic Tests, RoutineHumansPoint-of-Care SystemsProspective StudiesSensitivity and SpecificityWorld Health Organizationantigen-detecting rapid diagnostic testsCOVID-19SARS-CoV-2sensitivityspecificity

Identifiers

PMID36066256
PMCPMC9604065
OpenAlexW4294755903

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.