NCT04610489

Brief Summary

A comparison of a direct antigen test for SARS-CoV-2 obtained by mid-turbinate swab with the reference standard rt-PCR test obtained by nasopharyngeal swab in outpatients with symptoms compatible with COVID-19.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

November 13, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2021

Completed
5 months until next milestone

Results Posted

Study results publicly available

August 17, 2021

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

October 27, 2020

Results QC Date

June 28, 2021

Last Update Submit

August 15, 2021

Conditions

Covid-19

Keywords

diagnostic testantigen testPCR testsymptomatic

Outcome Measures

Primary Outcomes (2)

  • Proportion of True Positives

    Of all Disease (rtPCR) Positive subjects, the proportion who were Test (antigen) Positive (sensitivity).

    1 day

  • Proportion of True Negatives

    Of all Disease (rtPCR) Negative subjects, the proportion who were Test (antigen) Negative (specificity).

    1 day

Study Arms (1)

Study Population

OTHER

All subjects will undergo bilateral mid-turbinate swabs for COVID Antigen (Quidel Sofia SARS Antigen Fluorescent Immunoassay (FIA)) as well as bilateral rt-PCR testing (Quest SARS-CoV-2 rRT-PCR).

Diagnostic Test: Quidel Sofia SARS Antigen FIA

Interventions

Quidel Sofia SARS Antigen FIADIAGNOSTIC_TEST

Obtained via bilateral mid-turbinate swab.

Study Population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acutely ill with one or more COVID-19 symptoms

You may not qualify if:

  • Unable to speak English
  • Unable to provide written informed consent
  • Symptoms have lasted longer than 5 days
  • Currently hospitalized

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24016, United States

Location

Related Publications (11)

  • Lambert-Niclot S, Cuffel A, Le Pape S, Vauloup-Fellous C, Morand-Joubert L, Roque-Afonso AM, Le Goff J, Delaugerre C. Evaluation of a Rapid Diagnostic Assay for Detection of SARS-CoV-2 Antigen in Nasopharyngeal Swabs. J Clin Microbiol. 2020 Jul 23;58(8):e00977-20. doi: 10.1128/JCM.00977-20. Print 2020 Jul 23. No abstract available.

    PMID: 32404480BACKGROUND

  • Nagura-Ikeda M, Imai K, Tabata S, Miyoshi K, Murahara N, Mizuno T, Horiuchi M, Kato K, Imoto Y, Iwata M, Mimura S, Ito T, Tamura K, Kato Y. Clinical Evaluation of Self-Collected Saliva by Quantitative Reverse Transcription-PCR (RT-qPCR), Direct RT-qPCR, Reverse Transcription-Loop-Mediated Isothermal Amplification, and a Rapid Antigen Test To Diagnose COVID-19. J Clin Microbiol. 2020 Aug 24;58(9):e01438-20. doi: 10.1128/JCM.01438-20. Print 2020 Aug 24.

    PMID: 32636214BACKGROUND

  • Castro R, Luz PM, Wakimoto MD, Veloso VG, Grinsztejn B, Perazzo H. COVID-19: a meta-analysis of diagnostic test accuracy of commercial assays registered in Brazil. Braz J Infect Dis. 2020 Mar-Apr;24(2):180-187. doi: 10.1016/j.bjid.2020.04.003. Epub 2020 Apr 18.

    PMID: 32330437BACKGROUND

  • Mertens P, De Vos N, Martiny D, Jassoy C, Mirazimi A, Cuypers L, Van den Wijngaert S, Monteil V, Melin P, Stoffels K, Yin N, Mileto D, Delaunoy S, Magein H, Lagrou K, Bouzet J, Serrano G, Wautier M, Leclipteux T, Van Ranst M, Vandenberg O; LHUB-ULB SARS-CoV-2 Working Diagnostic Group. Development and Potential Usefulness of the COVID-19 Ag Respi-Strip Diagnostic Assay in a Pandemic Context. Front Med (Lausanne). 2020 May 8;7:225. doi: 10.3389/fmed.2020.00225. eCollection 2020.

    PMID: 32574326BACKGROUND

  • Takeuchi Y, Akashi Y, Kato D, Kuwahara M, Muramatsu S, Ueda A, Notake S, Nakamura K, Ishikawa H, Suzuki H. Diagnostic performance and characteristics of anterior nasal collection for the SARS-CoV-2 antigen test: a prospective study. Sci Rep. 2021 May 18;11(1):10519. doi: 10.1038/s41598-021-90026-8.

    PMID: 34006975BACKGROUND

  • Porte L, Legarraga P, Vollrath V, Aguilera X, Munita JM, Araos R, Pizarro G, Vial P, Iruretagoyena M, Dittrich S, Weitzel T. Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples. Int J Infect Dis. 2020 Oct;99:328-333. doi: 10.1016/j.ijid.2020.05.098. Epub 2020 Jun 1.

    PMID: 32497809BACKGROUND

  • Mak GC, Cheng PK, Lau SS, Wong KK, Lau CS, Lam ET, Chan RC, Tsang DN. Evaluation of rapid antigen test for detection of SARS-CoV-2 virus. J Clin Virol. 2020 Aug;129:104500. doi: 10.1016/j.jcv.2020.104500. Epub 2020 Jun 8.

    PMID: 32585619BACKGROUND

  • Blairon L, Wilmet A, Beukinga I, Tre-Hardy M. Implementation of rapid SARS-CoV-2 antigenic testing in a laboratory without access to molecular methods: Experiences of a general hospital. J Clin Virol. 2020 Aug;129:104472. doi: 10.1016/j.jcv.2020.104472. Epub 2020 May 30.

    PMID: 32504944BACKGROUND

  • Scohy A, Anantharajah A, Bodeus M, Kabamba-Mukadi B, Verroken A, Rodriguez-Villalobos H. Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis. J Clin Virol. 2020 Aug;129:104455. doi: 10.1016/j.jcv.2020.104455. Epub 2020 May 21.

    PMID: 32485618BACKGROUND

  • Soleimani R, Deckers C, Huang TD, Bogaerts P, Evrard S, Wallemme I, Habib B, Rouze P, Denis O. Rapid COVID-19 antigenic tests: Usefulness of a modified method for diagnosis. J Med Virol. 2021 Sep;93(9):5655-5659. doi: 10.1002/jmv.27094. Epub 2021 May 31.

    PMID: 34009649BACKGROUND

  • La Marca A, Capuzzo M, Paglia T, Roli L, Trenti T, Nelson SM. Testing for SARS-CoV-2 (COVID-19): a systematic review and clinical guide to molecular and serological in-vitro diagnostic assays. Reprod Biomed Online. 2020 Sep;41(3):483-499. doi: 10.1016/j.rbmo.2020.06.001. Epub 2020 Jun 14.

    PMID: 32651106BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
John Epling, MD, MSEd
Organization
Carilion Clinic
jwepling@carilionclinic.org
540-581-0123

Study Officials

  • John W Epling, MD

    Carilion Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
simultaneous acquisition of both test of interest and reference standard without contingency
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director of Research, Department of Family Medicine

Study Record Dates

First Submitted

October 27, 2020

First Posted

October 30, 2020

Study Start

November 13, 2020

Primary Completion

March 10, 2021

Study Completion

March 10, 2021

Last Updated

August 17, 2021

Results First Posted

August 17, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)