Evidence map›Paper›PMID 35054373›Full record

ArticleDiagnostics (Basel, Switzerland)2022

Preclinical Validation of a Novel Injection-Molded Swab for the Molecular Assay Detection of SARS-CoV-2.

Chiara E Ghezzi, Devon R Hartigan, Justin P Hardick, Rebecca Gore, Miryam Adelfio, Anyelo R Diaz, Pamela D McGuinness, Matthew L Robinson, Bryan O Buchholz, Yukari C Manabe

Open access · goldAbstract 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.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.5field-weighted citation impact, top 38% 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

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. A Targeted LC-MRMMolecular & cellular proteomics : MCP · 2024
    Article
  3. Article
  4. Article
  5. ACS omega · 2022
    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

10 authors at 2 institutions in 1 country.

Chiara E GhezziBiomedical Engineering Department, University of Massachusetts Lowell, Lowell, MA 01854, USA.ORCID 0000-0002-9800-4397
Devon R HartiganBiomedical Engineering Department, University of Massachusetts Lowell, Lowell, MA 01854, USA.
Justin P HardickDivision of Infectious Diseases, Department of Medicine, John Hopkins University School of Medicine, Baltimore, MD 21287, USA.
Rebecca GoreBiomedical Engineering Department, University of Massachusetts Lowell, Lowell, MA 01854, USA.
Miryam AdelfioBiomedical Engineering Department, University of Massachusetts Lowell, Lowell, MA 01854, USA.
Anyelo R DiazBiomedical Engineering Department, University of Massachusetts Lowell, Lowell, MA 01854, USA.
Pamela D McGuinnessBiomedical Engineering Department, University of Massachusetts Lowell, Lowell, MA 01854, USA.
Matthew L RobinsonDivision of Infectious Diseases, Department of Medicine, John Hopkins University School of Medicine, Baltimore, MD 21287, USA.
Bryan O BuchholzBiomedical Engineering Department, University of Massachusetts Lowell, Lowell, MA 01854, USA.
Yukari C ManabeDivision of Infectious Diseases, Department of Medicine, John Hopkins University School of Medicine, Baltimore, MD 21287, USA.
University of Massachusetts Lowell · USJohns Hopkins University · US

Funding

The Center for Advancing Point of Care in Heart, Lung, Blood and Sleep DiseasesU54HL143541 · NHLBI · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI Nathaniel Scott Hafer · 2018 to 2026
$141.0M
TrainingU54EB007958 · NIBIB · JOHNS HOPKINS UNIVERSITY · PI Yukari C Manabe, Susan Anne Tuddenham · 2007 to 2026
$34.6M
NHLBI NIH HHS U54 HL143541NIH HHS 3U54HL143541NIH HHS U54EB007958
6 · The paper itself

Abstract

During the COVID-19 public health emergency, many actions have been undertaken to help ensure that patients and health care providers have timely and continued access to high-quality medical devices to respond effectively. The development and validation of new testing supplies and equipment, including collection swabs, has helped to expand the availability and capability for various diagnostic, therapeutic, and protective medical devices in high demand during the COVID-19 emergency. Here, we report the initial validation of a new injection-molded anterior nasal swab, ClearTip™, that was experimentally validated in a laboratory setting as well as in independent clinical studies in comparison to gold standard flocked swabs. We have also developed an in vitro anterior nasal tissue model which offers a novel, efficient, and clinically relevant validation tool to replicate the clinical swabbing workflow with high fidelity, while being accessible, safe, reproducible, and time- and cost-effective. ClearTip™ displayed greater inactivated virus release in the benchtop model, confirmed by its greater ability to report positive samples in a small clinical study in comparison to flocked swabs. We also quantified the detection of biological materials, as a proxy for viral material, in multi-center pre-clinical and clinical studies which showed a statistically significant difference in one study and a reduction in performance in comparison to flocked swabs. Taken together, these results emphasize the compelling benefits of non-absorbent injection-molded anterior nasal swabs for COVID-19 detection, comparable to standard flocked swabs. Injection-molded swabs, as ClearTip™, could have the potential to support future swab shortages, due to its manufacturing advantages, while offering benefits in comparison to highly absorbent swabs in terms of comfort, limited volume collection, and potential multiple usage.

Indexed as

COVID-19diagnostic testingSARS-CoV-2swabtissue modelvirological testing

Identifiers

PMID35054373
PMCPMC8775180
OpenAlexW4206438210

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.