Evidence map›Paper›PMID 35262001›Full record

ArticleJournal of clinical virology plus2021

Field performance evaluation of the PanBio rapid SARS-CoV-2 antigen assay in an epidemic driven by the B.1.351 variant in the Eastern Cape, South Africa.

Oluwakemi Laguda Akingba, Kaitlin Sprong, Gert Marais, Diana Ruth Hardie

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical virology plus, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 6 pooled it
2.0field-weighted citation impact, top 11% 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

19 citing papers in PubMed, 6 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.The Cochrane database of systematic reviews · 2022
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  15. Detection of SARS-CoV-2 variants by Abbott molecular, antigen, and serological tests.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2022
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  18. Novel SARS-CoV-2 variants: the pandemics within the pandemic.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2021
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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

4 authors at 1 institution in 1 country.

Oluwakemi Laguda AkingbaNational Health Laboratory Service, South Africa.
Kaitlin SprongNational Health Laboratory Service, South Africa.
Gert MaraisNational Health Laboratory Service, South Africa.
Diana Ruth HardieNational Health Laboratory Service, South Africa.
National Health Laboratory Service · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: South Africa was the African country with the most recorded cases of SARS-CoV-2 during 2020, experiencing 2 waves of infection. During the first wave, diagnostics were largely based on reverse transcription-linked PCR (RT-PCR). The Abbott PanBio antigen test was deployed during the 2nd wave which may have been driven by emergence of the B.1.351 variant. At the time of evaluation in mid-November 2020, B.1.351 was the dominant circulating virus in Nelson Mandela Bay, in the Eastern Cape Province. Methods: Used PanBio antigen swabs (collected from patients with genetically characterised virus) were first validated as suitable for PCR. A prospective study was then undertaken to evaluate assay performance in the field. Testing was conducted at mobile community testing centres on 677 ambulant patients. Used swabs were kept and tested by RT-PCR. Results: During initial validation, used swabs in proprietary lysis buffer were found to be suitable for PCR and secondly, the PB assay reliably detected patients infected with B.1.351. In the field study, of 146 RT-PCR positive individuals, 101 were RTD positive in the clinic. The RTD had a sensitivity of 69.2% (95%CI 61.4, 75.8) and specificity of 99.0% (95%CI 98.8, 99.3). Sensitivity was dependent on the amount of viral RNA in clinical samples, as reflected by the PCR cycle threshold (CT) value. Conclusions: The assay reliably detected B.1.351 infections in ambulatory ill patients during initial validation and in field testing. In the field, assay sensitivity was >90% in patients with high viral loads who are expected to be most infectious. Negative and positive predictive values were also >90%.

Indexed as

501Y.v2501Y.v2, 501Y variant 2B.1.351COVID-19COVID-19, Coronavirus disease 2019CT, cycle thresholdGISAID, global initiative for sharing all influenza dataIQR, interquartile rangeNP, nasopharyngealPCR, polymerase chain reactionPoint of careRapid antigen testRTD, rapid test deviceRT-PCR, reverse transcription polymerase chain reactionSARS-CoV-2SARS-CoV-2, severe acute respiratory syndrome coronavirus 2WHO, world health organisation

Identifiers

PMID35262001
PMCPMC8025602
OpenAlexW3146540684

What OpenQuestion holds

Textmetadata
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.