Evidence map›Paper›PMID 35241679›Full record

ArticleScientific reports2022

Clinical validation of a multiplex PCR-based detection assay using saliva or nasopharyngeal samples for SARS-Cov-2, influenza A and B.

Nikhil S Sahajpal, Ashis K Mondal, Sudha Ananth, Allan Njau, Kimya Jones, Pankaj Ahluwalia, Eesha Oza, Ted M Ross, Vamsi Kota, Arvind Kothandaraman and 5 more

Open access · goldAbstract read
In one paragraph

Article in Scientific reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 11% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

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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

15 authors at 5 institutions in 2 countries.

Nikhil S SahajpalDepartment of Pathology, Medical College of Georgia, Augusta University, BAE 2576, 1120 15th Street, Augusta, GA, 30912, USA.
Ashis K MondalDepartment of Pathology, Medical College of Georgia, Augusta University, BAE 2576, 1120 15th Street, Augusta, GA, 30912, USA.
Sudha AnanthDepartment of Pathology, Medical College of Georgia, Augusta University, BAE 2576, 1120 15th Street, Augusta, GA, 30912, USA.
Allan NjauDepartment of Pathology, Aga Khan University Hospital, Nairobi, Kenya.
Kimya JonesDepartment of Pathology, Medical College of Georgia, Augusta University, BAE 2576, 1120 15th Street, Augusta, GA, 30912, USA.
Pankaj AhluwaliaDepartment of Pathology, Medical College of Georgia, Augusta University, BAE 2576, 1120 15th Street, Augusta, GA, 30912, USA.
Eesha OzaDepartment of Pathology, Medical College of Georgia, Augusta University, BAE 2576, 1120 15th Street, Augusta, GA, 30912, USA.
Ted M RossCenter for Vaccines and Immunology, University of Georgia, Athens, GA, USA.
Vamsi KotaDepartment of Medicine, Medical College of Georgia, Augusta University, Augusta, GA, USA.
Arvind KothandaramanGlobal Laboratory Services, Perkin Elmer, Waltham, USA.
Sadanand FulzeleCenter for Healthy Aging, Medical College of Georgia, Augusta University, Augusta, GA, USA.
Madhuri HegdeGlobal Laboratory Services, Perkin Elmer, Waltham, USA.
Alka ChaubeyDepartment of Pathology, Medical College of Georgia, Augusta University, BAE 2576, 1120 15th Street, Augusta, GA, 30912, USA.
Amyn M RojianiDepartment of Pathology, Penn State College of Medicine, Hershey, PA, USA.
Ravindra KolheDepartment of Pathology, Medical College of Georgia, Augusta University, BAE 2576, 1120 15th Street, Augusta, GA, 30912, USA. rkolhe@augusta.edu.
Augusta University · USPerkinElmer (United States) · USAga Khan University Hospital Nairobi · KEPenn State Milton S. Hershey Medical Center · USUniversity of Georgia · US

Funding

COVID Supplement - COMPONENT A OF THE COLLABORATIVE INFLUENZA VACCINE INNOVATION CENTERS (CIVICS) PROGRAM TO DESIGN AND EVALUATE INNOVATIVE INFLUENZA VACCINE APPROACHES,75N93019C00052 · NIAID · UNIVERSITY OF GEORGIA · PI ROSS, TED · 2019 to 2025
$74.6M
NIAID NIH HHS 75N93019C00052
6 · The paper itself

Abstract

The COVID-19 pandemic has resulted in significant diversion of human and material resources to COVID-19 diagnostics, to the extent that influenza viruses and co-infection in COVID-19 patients remains undocumented and pose serious public-health consequences. We optimized and validated a highly sensitive RT-PCR based multiplex-assay for the detection of SARS-CoV-2, influenza A and B viruses in a single-test. This study evaluated clinical specimens (n = 1411), 1019 saliva and 392 nasopharyngeal swab (NPS), tested using two-assays: FDA-EUA approved SARS-CoV-2 assay that targets N and ORF1ab gene, and the PKamp-RT-PCR based assay that targets SARS-CoV-2, influenza viruses A and B. Of the 1019 saliva samples, 17.0% (174/1019) tested positive for SARS-CoV-2 using either assay. The detection rate for SARS-CoV-2 was higher with the multiplex assay compared to SARS-specific assay [91.9% (160/174) vs. 87.9% (153/174)], respectively. Of the 392 NPS samples, 10.4% (41/392) tested positive for SARS-CoV-2 using either assay. The detection rate for SARS-CoV-2 was higher with the multiplex assay compared to SARS-specific assay [97.5% (40/41) vs. 92.1% (39/41)], respectively. This study presents clinical validation of a multiplex-PCR assay for testing SARS-CoV-2, influenza A and B viruses, using NPS and saliva samples, and demonstrates the feasibility of implementing the assay without disrupting the existing laboratory workflow.

Indexed as

HumansInfluenza A virusInfluenza B virusLimit of DetectionMultiplex Polymerase Chain ReactionNasopharynxReproducibility of ResultsSalivaSARS-CoV-2

Identifiers

PMID35241679
PMCPMC8894395
OpenAlexW4214880170

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.