Evidence map›Paper›PMID 33957320›Full record

ArticleThe Journal of molecular diagnostics : JMD2021

Clinical Validation of a Sensitive Test for Saliva Collected in Healthcare and Community Settings with Pooling Utility for Severe Acute Respiratory Syndrome Coronavirus 2 Mass Surveillance.

Nikhil S Sahajpal, Ashis K Mondal, Sudha Ananth, Allan Njau, Pankaj Ahluwalia, Vamsi Kota, Kevin Caspary, Ted M Ross, Michael Farrell, Michael P Shannon and 5 more

Open access · bronzeAbstract readValidation Study
In one paragraph

Article in The Journal of molecular diagnostics : JMD, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 4 pooled it
1.7field-weighted citation impact, top 13% 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

20 citing papers in PubMed, 4 syntheses or guidelines pooled it, 27 citations in OpenAlex.

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  18. Mouth Washing Impaired SARS-CoV-2 Detection in Saliva.Diagnostics (Basel, Switzerland) · 2021
    Article
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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, Augusta, Georgia.
Ashis K MondalDepartment of Pathology, Medical College of Georgia, Augusta University, Augusta, Georgia.
Sudha AnanthDepartment of Pathology, Medical College of Georgia, Augusta University, Augusta, Georgia.
Allan NjauDepartment of Pathology, Aga Khan University Hospital, Nairobi, Kenya.
Pankaj AhluwaliaDepartment of Pathology, Medical College of Georgia, Augusta University, Augusta, Georgia.
Vamsi KotaDepartment of Medicine, Medical College of Georgia, Augusta University, Augusta, Georgia.
Kevin Caspary4th Weapons of Mass Destruction Civil Support Team, Georgia Army National Guard, Marietta, Georgia.
Ted M RossCenter for Vaccines and Immunology, University of Georgia, Athens, Georgia.
Michael FarrellInstitute for Internet Security and Privacy, Georgia Institute of Technology, Atlanta, Georgia.
Michael P ShannonAdvanced Warfighting Technologies Division, Georgia Tech Research Institute, Georgia Institute of Technology, Atlanta, Georgia.
Sadanand FulzeleCenter for Healthy Aging, Medical College of Georgia, Augusta University, Augusta, Georgia.
Alka ChaubeyDepartment of Pathology, Medical College of Georgia, Augusta University, Augusta, Georgia.
Madhuri HegdeGlobal Laboratory Services, PerkinElmer Inc., Waltham, Massachusetts.
Amyn M RojianiDepartment of Pathology, Medical College of Georgia, Augusta University, Augusta, Georgia.
Ravindra KolheDepartment of Pathology, Medical College of Georgia, Augusta University, Augusta, Georgia. Electronic address: rkolhe@augusta.edu.
Augusta University · USGeorgia Institute of Technology · USAga Khan University Hospital Nairobi · KEPerkinElmer (United States) · 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 clinical performance of saliva compared with nasopharyngeal swabs (NPSs) has shown conflicting results in healthcare and community settings. In the present study, a total of 429 matched NPS and saliva sample pairs, collected in either healthcare or community setting, were evaluated. Phase-1 (protocol U) tested 240 matched NPS and saliva sample pairs; phase 2 (SalivaAll protocol) tested 189 matched NPS and saliva sample pairs, with an additional sample homogenization step before RNA extraction. A total of 85 saliva samples were evaluated with both protocols. In phase-1, 28.3% (68/240) samples tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from saliva, NPS, or both. The detection rate from saliva was lower compared with that from NPS samples (50.0% versus 89.7%). In phase-2, 50.2% (95/189) samples tested positive for SARS-CoV-2 from saliva, NPS, or both. The detection rate from saliva was higher compared with that from NPS samples (97.8% versus 78.9%). Of the 85 saliva samples evaluated with both protocols, the detection rate was 100% for samples tested with SalivaAll, and 36.7% with protocol U. The limit of detection with SalivaAll protocol was 20 to 60 copies/mL. The pooled testing approach demonstrated a 95% positive and 100% negative percentage agreement. This protocol for saliva samples results in higher sensitivity compared with NPS samples and breaks the barrier to using pooled saliva for SARS-CoV-2 testing.

Indexed as

Delivery of Health CareResidence CharacteristicsCOVID-19COVID-19 Nucleic Acid TestingDiagnostic Tests, RoutineGeorgiaHumansLimit of DetectionMass ScreeningPopulation SurveillanceReal-Time Polymerase Chain ReactionRNA, ViralSalivaSARS-CoV-2Sensitivity and SpecificityRNA, Viral

Identifiers

PMID33957320
PMCPMC8129802
OpenAlexW3158392340

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.