Evidence map›Paper›PMID 34467100›Full record

ArticleDelaware journal of public health2020

Rapid Development and Validation of a Novel Laboratory-Derived Test for the Detection of SARS-CoV-2.

James Saylor, Vipsa Mehta, Leila H Choe, Jennifer Mantle, Alana Szkodny, Brewster Kingham, Leslie Taylor, Alaina Meadows, Cynthia Flynn, Kelvin H Lee and 1 more

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Delaware journal of public health, 2020. 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
0.0field-weighted citation impact, top 57% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. COVID-19 diagnostic methods in developing countries.Environmental science and pollution research international · 2022
    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

11 authors at 1 institution in 1 country.

James SaylorNational Institute for Innovation in Manufacturing Biopharmaceuticals, University of Delaware.
Vipsa MehtaChristianaCare Health System, Molecular Diagnostics Laboratory.
Leila H ChoeDepartment of Chemical and Biomolecular Engineering, University of Delaware.
Jennifer MantleNational Institute for Innovation in Manufacturing Biopharmaceuticals, University of Delaware.
Alana SzkodnyDepartment of Chemical and Biomolecular Engineering, University of Delaware.
Brewster KinghamDelaware Biotechnology Institute, University of Delaware.
Leslie TaylorChristianaCare Health System, Molecular Diagnostics Laboratory.
Alaina MeadowsChristianaCare Health System, Molecular Diagnostics Laboratory.
Cynthia FlynnChristianaCare Health System, Molecular Diagnostics Laboratory.
Kelvin H LeeNational Institute for Innovation in Manufacturing Biopharmaceuticals, University of Delaware; ChristianaCare Health System, Molecular Diagnostics Laboratory.
Abraham JosephChristianaCare Health System, Molecular Diagnostics Laboratory.
University of Delaware · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo increase testing capability for SARS-CoV-2 during a rapidly evolving public health emergency, we aimed to deploy a validated laboratory-developed real-time reverse transcription polymerase chain reaction (RT-PCR) diagnostic test for SARS-CoV-2 on an accelerated timeline and using reagent supply chains that were not constrained.

methodsA real-time RT-PCR assay that detects the structural envelope (

resultsA real-time RT-PCR assay for SARS-Cov-2 was developed and validated in just two weeks. For all oligonucleotides, 100% homology to the available SARS-CoV-2 sequences was observed. Greater than 80% homology between one or more oligonucleotides was observed for SARS-Cov (Urbani strain) and Influenza A, however risk of cross reactivity was deemed to be low. The limit of detection (LOD) of the assay was 250 copies/mL. The assay identified 100% of positive patient samples (30/30) and 100% of negative patient samples (29/29 patient negatives and 1/1 saline). Up to 92 samples can be run on a single plate and analysis takes approximately 3.5 hours.

conclusionsIn this work, we demonstrate the development and validation of a single target laboratory-developed test for SARS-CoV-2 in two weeks. Key considerations for complementary supply chains enabled development on an accelerated timeline and an increase in testing capability.

Identifiers

PMID34467100
PMCPMC8389818
OpenAlexW3112589709

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.