Evidence map›Paper›PMID 36735683›Full record

ArticlePloS one2023

Real-world performance of SARS-Cov-2 serology tests in the United States, 2020.

Carla V Rodriguez-Watson, Anthony M Louder, Carly Kabelac, Christopher M Frederick, Natalie E Sheils, Elizabeth H Eldridge, Nancy D Lin, Benjamin D Pollock, Jennifer L Gatz, Shaun J Grannis and 17 more

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 43% 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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Article
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

27 authors at 12 institutions in 1 country.

Carla V Rodriguez-WatsonReagan-Udall Foundation for the FDA, Washington, District of Columbia, United States of America.ORCID 0000-0003-4898-1613
Anthony M LouderAetion, New York, New York, United States of America.
Carly KabelacAetion, New York, New York, United States of America.
Christopher M FrederickRegenstrief Institute, Indianapolis, Indiana, United States of America.ORCID 0000-0002-8979-1616
Natalie E SheilsOptum Labs, Minnetonka, Minnesota, United States of America.ORCID 0000-0002-0631-5834
Elizabeth H EldridgeHealth Catalyst, Salt Lake City, Utah, United States of America.
Nancy D LinHealth Catalyst, Salt Lake City, Utah, United States of America.
Benjamin D PollockMayo Clinic, Rochester, Minnesota, United States of America.
Jennifer L GatzRegenstrief Institute, Indianapolis, Indiana, United States of America.
Shaun J GrannisRegenstrief Institute, Indianapolis, Indiana, United States of America.ORCID 0000-0002-8093-6639
Rohit VashishtBakar Computational Health Sciences Institute, University of California, San Francisco, San Francisco, California, United States of America.
Kanwal GhauriReagan-Udall Foundation for the FDA, Washington, District of Columbia, United States of America.
Camille KnepperMayo Clinic, Rochester, Minnesota, United States of America.
Sandy LeonardHealthVerity, Philadelphia, Pennsylvania, United States of America.ORCID 0000-0002-9876-3596
Peter J EmbiVanderbilt University Medical Center, Nashville, Tennessee, United States of America.
Garrett JenkinsonMayo Clinic, Rochester, Minnesota, United States of America.
Reyna KleshHealthVerity, Philadelphia, Pennsylvania, United States of America.ORCID 0000-0003-2095-3661
Omai B GarnerDepartment of Pathology and Laboratory Medicine, UCLA Medical Center, Los Angeles, California, United States of America.
Ayan PatelCenter for Data-Driven Insights and Innovation, University of California Health, Oakland, California, United States of America.
Lisa DahmCenter for Data-Driven Insights and Innovation, University of California Health, Oakland, California, United States of America.
Aiden BarinCenter for Data-Driven Insights and Innovation, University of California Health, Oakland, California, United States of America.
Dan M CooperCenter for Data-Driven Insights and Innovation, University of California Health, Oakland, California, United States of America.
Tom AndriolaCenter for Data-Driven Insights and Innovation, University of California Health, Oakland, California, United States of America.
Carrie L ByingtonCenter for Data-Driven Insights and Innovation, University of California Health, Oakland, California, United States of America.ORCID 0000-0002-7350-9495
Bridgit O CrewsDepartment of Pathology and Laboratory Medicine, University of California, Irvine, Irvine, California, United States of America.
Atul J ButteBakar Computational Health Sciences Institute, University of California, San Francisco, San Francisco, California, United States of America.ORCID 0000-0002-7433-2740
Jeff AllenFriends of Cancer Research, Washington, District of Columbia, United States of America.ORCID 0000-0002-0586-3054
University of California System · USMayo Clinic · USRegenstrief Institute · USUniversity of California, Irvine · USAetion (United States) · USCommunity Catalyst · USReagan-Udall Foundation · USUniversity of California, San Francisco · USFriends of Cancer Research · USOptum (United States) · USUCLA Medical Center · USVanderbilt University Medical Center · US

Funding

UCSF-Stanford Center of Excellence in Regulatory Science and InnovationU01FD005978 · FDA · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ALTMAN, RUSS BIAGIO, GIACOMINI, KATHLEEN M · 2016 to 2025
$34.5M
Yale-Mayo FDA Center for Excellence in Regulatory Science and InnovationU01FD005938 · FDA · YALE UNIVERSITY · PI Joseph Solomon Ross · 2016 to 2026
$25.4M
Understanding the Personal Impact of Substance Use Disorders (including Opioid Use Disorder) U01FD007223 · FDA · REAGAN-UDALL FOUNDATION/FOOD/DRUG/ADMIN · PI BHAT, AMARNATH · 2020 to 2025
$11.2M
FDA HHS U01 FD005938FDA HHS U01 FD005978FDA HHS U01 FD007223
6 · The paper itself

Abstract

backgroundReal-world performance of COVID-19 diagnostic tests under Emergency Use Authorization (EUA) must be assessed. We describe overall trends in the performance of serology tests in the context of real-world implementation.

methodsSix health systems estimated the odds of seropositivity and positive percent agreement (PPA) of serology test among people with confirmed SARS-CoV-2 infection by molecular test. In each dataset, we present the odds ratio and PPA, overall and by key clinical, demographic, and practice parameters.

resultsA total of 15,615 people were observed to have at least one serology test 14-90 days after a positive molecular test for SARS-CoV-2. We observed higher PPA in Hispanic (PPA range: 79-96%) compared to non-Hispanic (60-89%) patients; in those presenting with at least one COVID-19 related symptom (69-93%) as compared to no such symptoms (63-91%); and in inpatient (70-97%) and emergency department (93-99%) compared to outpatient (63-92%) settings across datasets. PPA was highest in those with diabetes (75-94%) and kidney disease (83-95%); and lowest in those with auto-immune conditions or who are immunocompromised (56-93%). The odds ratios (OR) for seropositivity were higher in Hispanics compared to non-Hispanics (OR range: 2.59-3.86), patients with diabetes (1.49-1.56), and obesity (1.63-2.23); and lower in those with immunocompromised or autoimmune conditions (0.25-0.70), as compared to those without those comorbidities. In a subset of three datasets with robust information on serology test name, seven tests were used, two of which were used in multiple settings and met the EUA requirement of PPA ≥87%. Tests performed similarly across datasets.

conclusionAlthough the EUA requirement was not consistently met, more investigation is needed to understand how serology and molecular tests are used, including indication and protocol fidelity. Improved data interoperability of test and clinical/demographic data are needed to enable rapid assessment of the real-world performance of in vitro diagnostic tests.

Indexed as

COVID-19SARS-CoV-2Clinical Laboratory TechniquesCOVID-19 TestingHumansSerologic TestsUnited States

Identifiers

PMID36735683
PMCPMC9897562
OpenAlexW4319059956

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.