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NCT04610489 Clinical Trial

Diagnostic Performance of an Antigen Test for SARS-CoV-2 Infection (COVID-19)

Covid-19 Clinical Trial

Official title:
Diagnostic Performance of an Antigen Test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04610489
Other study ID # IRB-20-1088
Secondary ID Epling-533
Status Terminated
Phase N/A
First received
Last updated
Start date November 13, 2020
Est. completion date March 10, 2021

Study information
Verified date August 2021
Source Carilion Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

This study plans to compare a direct antigen test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) obtained by mid-turbinate nasal swab with a reverse transcription polymerase chain reaction (rt-PCR) test obtained by nasopharyngeal swab (the current reference standard) in a population of patients with symptoms suggestive of COVID-19 for fewer than 5 days. Subjects whose physicians have already ordered an rt-PCR test at a Carilion testing center will be screened and recruited by phone during a required scheduling call. The study coordinator will describe the study by phone, and the subject will be consented when they arrive at the testing center. After consenting, a mid-turbinate swab direct antigen test will be obtained just prior to the ordered nasopharyngeal swab and any other ordered tests. The subjects will receive their rt-PCR test results through the usual channels of clinical notification. The subjects will not receive their nasal antigen results. The antigen test results will be analyzed in a batch process and the results entered into RedCap by the study staff. The rt-PCR results will be extracted from the Epic electronic health record using patient identifiers and paired with the corresponding antigen result for statistical analysis.

Recruitment information / eligibility
Status Terminated
Enrollment 117
Est. completion date March 10, 2021
Est. primary completion date March 10, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Acutely ill with one or more COVID-19 symptoms Exclusion Criteria: - Unable to speak English - Unable to provide written informed consent - Symptoms have lasted longer than 5 days - Currently hospitalized

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Quidel Sofia SARS Antigen FIA
Obtained via bilateral mid-turbinate swab.

Locations
Country Name City State
United States Carilion Clinic Roanoke Virginia

Sponsors (1)
Lead Sponsor Collaborator
Carilion Clinic

Country where clinical trial is conducted

United States, 

References & Publications (11)

Blairon L, Wilmet A, Beukinga I, Tré-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. — View Citation

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. — View Citation

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. — View Citation

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). pii: e00977-20. doi: 10.1128/JCM.00977-20. Print 2020 Jul 23. — View Citation

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. — View Citation

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. — View Citation

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). pii: e01438-20. doi: 10.1128/JCM.01438-20. Print 2020 Aug 24. — View Citation

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. — View Citation

Scohy A, Anantharajah A, Bodéus 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. — View Citation

Soleimani R, Deckers C, Huang TD, Bogaerts P, Evrard S, Wallemme I, Habib B, Rouzé 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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of True Positives Of all Disease (rtPCR) Positive subjects, the proportion who were Test (antigen) Positive (sensitivity). 1 day
Primary Proportion of True Negatives Of all Disease (rtPCR) Negative subjects, the proportion who were Test (antigen) Negative (specificity). 1 day
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