Evidence map›Paper›PMID 35626434›Full record

ArticleDiagnostics (Basel, Switzerland)2022

Assessment of the Diagnostic Performance of a Novel SARS-CoV-2 Antigen Sealing Tube Test Strip (Colloidal Gold) as Point-of-Care Surveillance Test.

Alessandro Medoro, Sergio Davinelli, Serena Voccola, Gaetano Cardinale, Daniela Passarella, Nicola Marziliano, Mariano Intrieri

Abstract read
In one paragraph

Article in Diagnostics (Basel, Switzerland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

5 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. 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

7 authors.

Alessandro MedoroDepartment of Medicine and Health Sciences "V. Tiberio", University of Molise, 86100 Campobasso, Italy.ORCID 0000-0002-6285-607X
Sergio DavinelliDepartment of Medicine and Health Sciences "V. Tiberio", University of Molise, 86100 Campobasso, Italy.ORCID 0000-0003-2578-7199
Serena VoccolaCentro Diagnostico Delta S.r.l., Consorzio Sannio Tech, Apollosa, 82030 Benevento, Italy.
Gaetano CardinaleCentro Diagnostico Delta S.r.l., Consorzio Sannio Tech, Apollosa, 82030 Benevento, Italy.
Daniela PassarellaDepartment of Medicine and Health Sciences "V. Tiberio", University of Molise, 86100 Campobasso, Italy.
Nicola MarzilianoDepartment of Medicine and Health Sciences "V. Tiberio", University of Molise, 86100 Campobasso, Italy.ORCID 0000-0001-6800-089X
Mariano IntrieriDepartment of Medicine and Health Sciences "V. Tiberio", University of Molise, 86100 Campobasso, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant outbreaks have highlighted the need of antigen-detecting rapid diagnostic tests (Ag-RDTs) that can be used at the point-of-care (POC). Although many Ag-RDTs have been approved for SARS-CoV-2 detection, studies demonstrating the clinical performance of Ag-RDTs against variants of concern, especially the new Omicron variant, are limited. The aim of this study was to evaluate the diagnostic sensitivity and specificity of the AMAZING COVID-19 Antigen Sealing Tube Test Strip (Colloidal Gold) in 584 early symptomatic and asymptomatic participants (age range 0-90 years). The performance of this Ag-RDT was assessed by comparing its results with reverse transcription RT-PCR (rRT-PCR). One hundred twenty positive samples were also analyzed with rRT-PCR to discriminate Omicron and Delta/Kappa variants (72.50% Omicron; 27.50% Delta/Kappa). Overall, the Ag-RDT showed high positive and negative percent values of 92.52% (95% CI, 86.61-95.95%) and 98.05% (95% CI, 96.41-98.95%), respectively, as well as an overall diagnostic accuracy of 96.92% (95% CI, 95.17-98.16%). Taken together, these data indicate that this inexpensive and simple-to-use Ag-RDT presents excellent analytical performance and can reliably detect Omicron and Delta/Kappa variants.

Indexed as

antigen testclinical validationCOVID-19lateral flow assaynasal swabnasopharyngeal swabnucleocapsidRT-PCRSARS-CoV-2

Identifiers

PMID35626434
PMCPMC9141887

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.