Evidence map›Paper›PMID 34259914›Full record

ArticleArchives of virology2021

Clinical evaluation of a multiplex real-time RT-PCR assay for detection of SARS-CoV-2 in individual and pooled upper respiratory tract samples.

Melissa Laverack, Rebecca L Tallmadge, Roopa Venugopalan, Brittany Cronk, XiuLin Zhang, Rolf Rauh, Amy Saunders, William M Nelson, Elizabeth Plocharczyk, Diego G Diel

Open access · bronzeAbstract read
In one paragraph

Article in Archives of virology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 15% 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

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

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  8. White-tailed deer (Proceedings of the National Academy of Sciences of the United States of America · 2023
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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

10 authors at 3 institutions in 1 country.

Melissa LaverackDepartment of Population Medicine and Diagnostic Sciences, College of Veterinary Medicine, Cornell COVID-19 Testing Laboratory, Animal Health Diagnostic Center, Cornell University, Ithaca, NY, USA.
Rebecca L TallmadgeDepartment of Population Medicine and Diagnostic Sciences, College of Veterinary Medicine, Cornell COVID-19 Testing Laboratory, Animal Health Diagnostic Center, Cornell University, Ithaca, NY, USA.
Roopa VenugopalanDepartment of Population Medicine and Diagnostic Sciences, College of Veterinary Medicine, Cornell COVID-19 Testing Laboratory, Animal Health Diagnostic Center, Cornell University, Ithaca, NY, USA.
Brittany CronkDepartment of Population Medicine and Diagnostic Sciences, College of Veterinary Medicine, Cornell COVID-19 Testing Laboratory, Animal Health Diagnostic Center, Cornell University, Ithaca, NY, USA.
XiuLin ZhangDepartment of Population Medicine and Diagnostic Sciences, College of Veterinary Medicine, Cornell COVID-19 Testing Laboratory, Animal Health Diagnostic Center, Cornell University, Ithaca, NY, USA.
Rolf RauhTetracore Inc., Rockville, MD, USA.
Amy SaundersTetracore Inc., Rockville, MD, USA.
William M NelsonTetracore Inc., Rockville, MD, USA.
Elizabeth PlocharczykCayuga Medical Center, Cayuga Health System, Ithaca, NY, USA.
Diego G DielDepartment of Population Medicine and Diagnostic Sciences, College of Veterinary Medicine, Cornell COVID-19 Testing Laboratory, Animal Health Diagnostic Center, Cornell University, Ithaca, NY, USA. dgdiel@cornell.edu.ORCID http://orcid.org/0000-0003-3237-8940
Cornell University · USTetracore (United States) · USCayuga Community College · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of this study was to identify and validate a sensitive, high-throughput, and cost-effective SARS-CoV-2 real-time RT-PCR assay to be used as a surveillance and diagnostic tool for SARS-CoV-2 in a university surveillance program. We conducted a side-by-side clinical evaluation of a newly developed SARS-CoV-2 multiplex assay (EZ-SARS-CoV-2 Real-Time RT-PCR) with the commercial TaqPath COVID-19 Combo Kit, which has an Emergency Use Authorization from the FDA. The EZ-SARS-CoV-2 RT-PCR incorporates two assays targeting the SARS-CoV-2 N gene, an internal control targeting the human RNase P gene, and a PCR inhibition control in a single reaction. Nasopharyngeal (NP) and anterior nares (AN) swabs were tested as individuals and pools with both assays and in the ABI 7500 Fast and the QuantStudio 5 detection platforms. The analytical sensitivity of the EZ-SARS-CoV-2 RT-PCR assay was 250 copies/ml or approximately 1.75 genome copy equivalents per reaction. The clinical performance of the EZ-SARS-CoV-2 assay was evaluated using NP and AN samples tested in other laboratories. The diagnostic sensitivity of the assay ranged between 94 and 96% across the detection platforms, and the diagnostic specificity was 94.06%. The positive predictive value was 94%, and the negative predictive value ranged from 94 to 96%. Pooling five NP or AN specimens yielded 93% diagnostic sensitivity. The overall agreement between these SARS-CoV-2 RT-PCR assays was high, supported by a Cohen's kappa value of 0.93. The EZ-SARS-CoV-2 RT-PCR assay performance attributes of high sensitivity and specificity with AN sample matrix and pooled upper respiratory samples support its use in a high-throughput surveillance testing program.

Indexed as

Coronavirus Nucleocapsid ProteinsCOVID-19COVID-19 Nucleic Acid TestingEpidemiological MonitoringGene ExpressionHumansMultiplex Polymerase Chain ReactionNasal CavityNasopharynxPhosphoproteinsReproducibility of ResultsRNA, ViralSARS-CoV-2Sensitivity and SpecificitySpecimen HandlingViral LoadCoronavirus Nucleocapsid Proteinsnucleocapsid phosphoprotein, SARS-CoV-2PhosphoproteinsRNA, Viral

Identifiers

PMID34259914
PMCPMC8278812
OpenAlexW3135675801

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.