Evidence map›Paper›PMID 34643409›Full record

ArticleMicrobiology spectrum2021

Comparative Performance of a New SARS-CoV-2 Rapid Detection System.

Gianni Gori Savellini, Gabriele Anichini, Chiara Terrosi, Shibily Prathyumnan, Claudia Gandolfo, Stefano Marini, Maria Grazia Cusi

Abstract readComparative Study
In one paragraph

Article in Microbiology spectrum, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. 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

7 authors.

Gianni Gori SavelliniDepartment of Medical Biotechnologies, University of Sienagrid.9024.f, Siena, Italy.
Gabriele AnichiniDepartment of Medical Biotechnologies, University of Sienagrid.9024.f, Siena, Italy.
Chiara TerrosiDepartment of Medical Biotechnologies, University of Sienagrid.9024.f, Siena, Italy.
Shibily PrathyumnanDepartment of Medical Biotechnologies, University of Sienagrid.9024.f, Siena, Italy.
Claudia GandolfoDepartment of Medical Biotechnologies, University of Sienagrid.9024.f, Siena, Italy.
Stefano MariniDati & Ricerca S.r.l., Rome, Italy.
Maria Grazia CusiDepartment of Medical Biotechnologies, University of Sienagrid.9024.f, Siena, Italy.ORCID 0000-0001-8869-8164

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The extraordinary global demand for reagents and diagnostic instruments needed for timely detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has rapidly affected their availability. In order to meet diagnostic needs, it has been necessary to develop new diagnostic procedures. To date, molecular diagnostic tools have represented the gold standard for diagnosis of SARS-CoV-2 infection, and thus an alternative and real-time PCR system was required. To this aim, a molecular rapid test which works with direct real-time RT-PCR may be a relevant aid. In the present work, the accuracy, sensitivity, and specificity of the bKIT Virus Finder COVID-19 rapid molecular test by Hyris Ltd. was evaluated. Moreover, the influence of a different swab storage medium composition was examined relative to that of a routinely used comparator assay. The Hyris Ltd. assay showed an overall agreement of 100% with the comparator based on a panel consisting of 74 retrospective positive nasopharyngeal swabs (NPSs), collected either in universal transport medium (UTM) or using ESwab. No false-positive result was achieved on samples that previously tested negative. Cross-reactivity screening on microorganisms that commonly colonize the human upper respiratory tract was not detected, excluding the risk of false-positive results. Simultaneously, drugs frequently administered to cure respiratory diseases did not interfere with the analytical performance of the assay. Our results showed that the Hyris Ltd. bKIT Virus Finder COVID-19 is a reliable assay for rapid qualitative detection of SARS-CoV-2, providing the advantage of less complex and unambiguous interpretation of results. Indeed, skilled technicians are not required, and thus the Hyris system is suitable as a rapid and easy system for SARS-CoV-2 diagnosis.

Indexed as

COVID-19COVID-19 Nucleic Acid TestingHumansLimit of DetectionMolecular Diagnostic TechniquesNasopharynxReal-Time Polymerase Chain ReactionSARS-CoV-2Specimen Handlingdiagnostic platformmolecular diagnosisSARS-CoV-2

Identifiers

PMID34643409
PMCPMC8515926

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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.