Diagnostic Accuracy of Self-sampling Versus Healthcare Sampling for Coronavirus-Disease-2019 Detection.

NCT05209178 | Completed DMC

• 1 other identifier: CVB2022 - CoV2 selftest
• Study Type: interventional
• Target: 3,070
• Locations: 1 country
• Sites: 1

Brief Summary

The current Coronavirus Disease 2019 (COVID-19) pandemic continues to be a worldwide health emergency. To contain the spread of disease, high demands on testing availability and capacity are observed. Although polymerase chain reaction (PRC) is the golden standard method in detecting infection with COVID-19, the procedure is time consuming and requires healthcare personnel and laboratories. Rapid antigen tests, however, have several potential benefits including greater scalability and results are provided much quicker. So far, sampling for rapid antigen tests is predominantly performed by health care personnel. Though, the testing and analyzing procedure of an antigen test seems manageable by laymen but the validity of a self-performed rapid antigen test is sparsely examined. Thus, the investigators wish to conduct a study evaluating the diagnostic accuracy of self-performed rapid antigen test for detecting COVID-19 infection by comparing self-performed and healthcare-performed rapid antigen tests on the same individual while using a PCR tests as a control.

Conditions

COVID-19 Pandemic

Keywords

COVID-19 Serological Testing; Rapid Antigen Test; Self-collected specimen

Outcome Measures

Primary Outcomes (1)

• Sensitivity of the self-collected rapid antigen test compared to healthcare collected test

  This applies to both specimen from the anterior part of the nose and from the oropharynx

  48 hours from sampling to results of RT-PCR analysis

Secondary Outcomes (1)

• Diagnostic accuracy including sensitivity and specificity of self-collected and healthcare collected rapid antigen test to RT-PCR tests collected by health care personnel

  30 minutes from sampling to results of the two rapid antigen tests

Study Arms (2)

Self-collection of specimen

EXPERIMENTAL

Participants allocated to this arm will perform specimen collection for the antigen tests independently using written instructions and access to a video. Sampling is performed as two individual procedures from the anterior part of the nose and the oropharynx respectively.

Diagnostic Test: Collection of nasal and oropharyngeal specimen for COVID19 antigen test

Healthcare-collection of specimen

ACTIVE COMPARATOR

Participants allocated to this arm will initially have specimen collection for the antigen tests done by a healthcare personnel. Sampling is performed as two individual procedures from the anterior part of the nose and the oropharynx respectively.

Diagnostic Test: Collection of nasal and oropharyngeal specimen for COVID19 antigen test

Interventions

Collection of nasal and oropharyngeal specimen for COVID19 antigen test DIAGNOSTIC_TEST

Regarding two independent sampling procedures from the anterior part of the nose and the oropharynx, participants are randomized to either perform the sampling by themselves with written instructions or having the procedure performed by trained personnel. The specimen is meant for a rapid antigen test for COVID-19 infection.

Also known as: Standard Q COVID-19 Ag-test, SD Biosensor INC

Healthcare-collection of specimen; Self-collection of specimen

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 16 years
• Having a scheduled appointment for a COVID-19 test at one of the test centers run by Testcenter Danmark in the Capital Region

You may not qualify if:

• Non-fluent in Danish
• Impaired citizen i.e. not capable of an independent self-testing
• Neck breathers (Tracheostomy/laryngectomy patients)
• Nasopharyngeal or oropharyngeal anomalies disallowing sampling using swabs

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Emergency Medical Services, Capital Region, Denmark: collaborator
• Technical University of Denmark: collaborator
• Copenhagen Medical A/S: collaborator

Study Sites (1)

Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet-Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Related Publications (11)

• Jakobsen KK, Jensen JS, Todsen T, Tolsgaard MG, Kirkby N, Lippert F, Vangsted AM, Martel CJ, Klokker M, von Buchwald C. Accuracy and cost description of rapid antigen test compared with reverse transcriptase-polymerase chain reaction for SARS-CoV-2 detection. Dan Med J. 2021 Jun 14;68(7):A03210217.

  PMID: 34169830 BACKGROUND

• Bundgaard JS, Raaschou-Pedersen DT, Todsen T, Ringgaard A, Torp-Pedersen C, Von Buchwald C, Iversen K, Bundgaard H. Danish citizens' preferences for at-home oropharyngeal/nasal SARS-CoV-2 specimen collection. Int J Infect Dis. 2021 Aug;109:195-198. doi: 10.1016/j.ijid.2021.06.060. Epub 2021 Jul 1.

  PMID: 34216732 BACKGROUND

• McCulloch DJ, Kim AE, Wilcox NC, Logue JK, Greninger AL, Englund JA, Chu HY. Comparison of Unsupervised Home Self-collected Midnasal Swabs With Clinician-Collected Nasopharyngeal Swabs for Detection of SARS-CoV-2 Infection. JAMA Netw Open. 2020 Jul 1;3(7):e2016382. doi: 10.1001/jamanetworkopen.2020.16382.

  PMID: 32697321 BACKGROUND

• Lindner AK, Nikolai O, Kausch F, Wintel M, Hommes F, Gertler M, Kruger LJ, Gaeddert M, Tobian F, Lainati F, Koppel L, Seybold J, Corman VM, Drosten C, Hofmann J, Sacks JA, Mockenhaupt FP, Denkinger CM. Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with self-collected nasal swab versus professional-collected nasopharyngeal swab. Eur Respir J. 2021 Apr 15;57(4):2003961. doi: 10.1183/13993003.03961-2020. Print 2021 Apr.

  PMID: 33303544 BACKGROUND

• Wurstle S, Spinner CD, Voit F, Hoffmann D, Hering S, Weidlich S, Schneider J, Zink A, Treiber M, Iakoubov R, Schmid RM, Protzer U, Erber J. Self-sampling versus health care professional-guided swab collection for SARS-CoV-2 testing. Infection. 2021 Oct;49(5):927-934. doi: 10.1007/s15010-021-01614-9. Epub 2021 May 10.

  PMID: 33970430 BACKGROUND

• Tonen-Wolyec S, Dupont R, Awaida N, Batina-Agasa S, Hayette MP, Belec L. Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France. Diagnostics (Basel). 2021 Nov 27;11(12):2217. doi: 10.3390/diagnostics11122217.

  PMID: 34943454 BACKGROUND

• Harmon A, Chang C, Salcedo N, Sena B, Herrera BB, Bosch I, Holberger LE. Validation of an At-Home Direct Antigen Rapid Test for COVID-19. JAMA Netw Open. 2021 Aug 2;4(8):e2126931. doi: 10.1001/jamanetworkopen.2021.26931.

  PMID: 34448871 BACKGROUND

• Bundgaard H, Bundgaard JS, Raaschou-Pedersen DET, von Buchwald C, Todsen T, Norsk JB, Pries-Heje MM, Vissing CR, Nielsen PB, Winslow UC, Fogh K, Hasselbalch R, Kristensen JH, Ringgaard A, Porsborg Andersen M, Goecke NB, Trebbien R, Skovgaard K, Benfield T, Ullum H, Torp-Pedersen C, Iversen K. Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers : A Randomized Controlled Trial. Ann Intern Med. 2021 Mar;174(3):335-343. doi: 10.7326/M20-6817. Epub 2020 Nov 18.

  PMID: 33205991 BACKGROUND

• Therchilsen JH, von Buchwald C, Koch A, Dam Nielsen S, Rasmussen DB, Thudium RF, Kirkby NS, Raaschou-Pedersen DET, Bundgaard JS, Iversen K, Bundgaard H, Todsen T. Self-Collected versus Healthcare Worker-Collected Swabs in the Diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2. Diagnostics (Basel). 2020 Sep 9;10(9):678. doi: 10.3390/diagnostics10090678.

  PMID: 32916801 BACKGROUND

• Jakobsen KK, Schmidt Jensen J, Todsen T, Lippert F, Cyril ;, Martel J-M, et al. Detection of SARS-CoV-2 infection by rapid antigen test in comparison with RT-PCR in a public setting. medRxiv [Internet]. 2021 Jan 25 [cited 2021 Feb 25];2021.01.22.21250042. Available from: https://doi.org/10.1101/2021.01.22.21250042

  BACKGROUND

• Todsen T, Jakobsen KK, Gronlund MP, Callesen RE, Folke F, Larsen H, Ersboll AK, Benfield T, Gredal T, Klokker M, Kirkby N, von Buchwald C. COVID-19 Rapid Antigen Tests With Self-Collected vs Health Care Worker-Collected Nasal and Throat Swab Specimens: A Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2344295. doi: 10.1001/jamanetworkopen.2023.44295.

  PMID: 38055280 DERIVED

Related Links

• Analyses of the COVID19 pandemic by Statens Serum Institut
• Weekly reports of surveillance data, Denmark
• Weekly updates on the COVID19 pandemic by WHO
• Collecting Upper Respiratory Specimens for COVID-19 Testing

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kathrine K Jakobsen, MD

  Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 26, 2022
• Study Start: February 4, 2022
• Primary Completion: March 25, 2022
• Study Completion: May 6, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)