Evidence map›Paper›PMID 34197468›Full record

ArticlePloS one2021

Development and validation of a quantitative, non-invasive, highly sensitive and specific, electrochemical assay for anti-SARS-CoV-2 IgG antibodies in saliva.

Samantha H Chiang, Michael Tu, Jordan Cheng, Fang Wei, Feng Li, David Chia, Omai Garner, Sukantha Chandrasekaran, Richard Bender, Charles M Strom and 1 more

Open access · goldAbstract readValidation Study
In one paragraph

Article in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.2field-weighted citation impact, top 17% 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

13 citing papers in PubMed, 20 citations in OpenAlex.

  1. Article
  2. Article
  3. Saliva diagnostics: Salivaomics, saliva exosomics, and saliva liquid biopsy.Journal of the American Dental Association (1939) · 2023
    Review
  4. Article
  5. Article
  6. Urine and Saliva: Relevant Specimens for Malaria Diagnosis?Diagnostics (Basel, Switzerland) · 2022
    Review
  7. Article
  8. Article
  9. Review
  10. The Kinetics of COVID-19 Vaccine Response in a Community-Vaccinated Population.Journal of immunology (Baltimore, Md. : 1950) · 2022
    Article
  11. Article
  12. Article
  13. The Kinetics of COVID-19 Vaccine Response in a Community Vaccinated Population.medRxiv : the preprint server for health sciences · 2021
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Samantha H ChiangSchool of Dentistry, University of California, Los Angeles, CA, United States of America.
Michael TuLiquid Diagnostics, LLC, San Clemente, CA, United States of America.
Jordan ChengSchool of Dentistry, University of California, Los Angeles, CA, United States of America.
Fang WeiSchool of Dentistry, University of California, Los Angeles, CA, United States of America.
Feng LiSchool of Dentistry, University of California, Los Angeles, CA, United States of America.
David ChiaDepartment of Pathology and Laboratory Medicine, University of California David Geffen School of Medicine, Los Angeles, CA, United States of America.
Omai GarnerDepartment of Pathology and Laboratory Medicine, University of California David Geffen School of Medicine, Los Angeles, CA, United States of America.
Sukantha ChandrasekaranDepartment of Pathology and Laboratory Medicine, University of California David Geffen School of Medicine, Los Angeles, CA, United States of America.
Richard BenderLiquid Diagnostics, LLC, San Clemente, CA, United States of America.
Charles M StromLiquid Diagnostics, LLC, San Clemente, CA, United States of America.ORCID 0000-0001-9709-0724
David T W WongSchool of Dentistry, University of California, Los Angeles, CA, United States of America.
University of California, Los Angeles · US

Funding

UC BRAID Center for Accelerated Innovation COVID-19 diagnostic project developmentU54HL119893 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI PALAZZOLO, MICHAEL J · 2013 to 2020
$18.3M
AFS/SERS Saliva-based SARS-CoV-2 Earliest Infection and Antibodies DetectionU18TR003778 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI HUANG, TONY JUN, KIM, YONG · 2021 to 2022
$1.8M
Oral-piRNAs Enhance Re-epithelialization in Oral Wound HealingF30DE027615 · NIDCR · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI CHIANG, SAMANTHA HSIN-YU · 2017 to 2020
$141k
NCATS NIH HHS U18 TR003778NHLBI NIH HHS U54 HL119893NIDCR NIH HHS F30 DE027615
6 · The paper itself

Abstract

Amperial™ is a novel assay platform that uses immobilized antigen in a conducting polymer gel followed by detection via electrochemical measurement of oxidation-reduction reaction between H2O2/Tetrametylbenzidine and peroxidase enzyme in a completed assay complex. A highly specific and sensitive assay was developed to quantify levels of IgG antibodies to SARS-CoV-2 in saliva. After establishing linearity and limit of detection we established a reference range of 5 standard deviations above the mean. There were no false positives in 667 consecutive saliva samples obtained prior to 2019. Saliva was obtained from 34 patients who had recovered from documented COVID-19 or had documented positive serologies. All of the patients with symptoms severe enough to seek medical attention had positive antibody tests and 88% overall had positive results. We obtained blinded paired saliva and plasma samples from 14 individuals. The plasma was analyzed using an EUA-FDA cleared ELISA kit and the saliva was analyzed by our Amperial™ assay. All 5 samples with negative plasma titers were negative in saliva testing. Eight of the 9 positive plasma samples were positive in saliva and 1 had borderline results. A CLIA validation was performed as a laboratory developed test in a high complexity laboratory. A quantitative non-invasive saliva based SARS-CoV-2 antibody test was developed and validated with sufficient specificity to be useful for population-based monitoring and monitoring of individuals following vaccination.

Indexed as

Antibodies, ViralCOVID-19COVID-19 Serological TestingElectrochemical TechniquesHumansImmunoglobulin GLimit of DetectionSalivaSARS-CoV-2Antibodies, ViralImmunoglobulin G

Identifiers

PMID34197468
PMCPMC8248704
OpenAlexW3175154911

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.