A Clinical Evaluation of COVID-19 Rapid Point of Care Antigen Tests

SARS CoV-2 Clinical Trial

Official title:

A Clinical Performance Evaluation of the SARS-COV-2 Direct Antigen Rapid Test "DART"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04568356
• Other study ID #: E25001_NEU2012
• Status: Completed
• Phase: N/A
• Start date: April 24, 2020
• Est. completion date: September 24, 2020

Study information

• Verified date: October 2020
• Source: E25Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current standard of care for diagnosis of Severe Acute Respiratory Syndrome associated Coronavirus -2 (SARS-CoV-2 ) infection involves sample collection to be prepared and measured via real time-polymerase chain reaction (RT-PCR). This process is often time consuming depending on the level of automation within the laboratory processing the samples. In many cases, sample turn-around times can take hours to several days. A rapid assay that does not require the sophisticated laboratory equipment and techniques could provide a significant advantage to the way practitioners screen and ultimately treat patients. Moreover, the collection of samples from the nasal nares should prove useful and less invasive. The study aims to validate the use of nasal swabs and also to validate the antigen test using nasal swabs.

Description:

A rapid point of care bioassay for the detection of virus proteins will be compared to the hospital validated RT-PCR detection standard. Nasopharyngeal, nasal and saliva samples will be collected along with hospital standard of care collection. Nasal and saliva will be self-administered collection. Samples will be collected in an Emergency Room setting from up to 100 subjects who entered the hospital over concerns about SARS-CoV-2. The goal is to collect a minimum of N=30 confirmed Covid-19 positive subjects and N=30 confirmed Covid-19 negative subjects of comparable ages, genders and races. The SARS-CoV-2 Direct Antigen Rapid Test ("DART") is an immunoassay for point-of-care, qualitative detection of SARS-CoV-2 viral particles/secreted protein in nasopharyngeal swabs from suspected patients with Coronavirus Disease 2019 or COVID-19 infection. Dipsticks are printed with a monoclonal antibody that binds the signature SARS-CoV-2 viral particles/protein (Test line) and a control antibody (Control line) for quality control. A second monoclonal antibody is attached to gold nanoparticles (conjugate) and quencher buffer, and mixed with the patient samples, though in the near future the final format will contain the dry conjugate. The SARS-CoV-2 viral particles/Spike protein attach to both antibodies resulting in a visual line on the test strip within 15 minutes. Prior experience for detection virus and viral proteins via antibody binding using lateral flow are E25Bio portfolio platform for dengue, Zika and Chikungunya viruses among others.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 24, 2020
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provision of verbal informed consent form

• Subject is suspected case of COVID-19 by clinical criteria a patient with acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia)

• No other etiology that fully explains the clinical presentation

• With or without a history of close contact with a confirmed or probable COVID-19 case in the last 14 days prior to onset of symptoms.

• Subject is an appropriate candidate for Nasopharyngeal sample collection

• Subject is willing to provide nasopharyngeal swab and saliva samples

Exclusion Criteria:

• Individuals who present to ER with 10 or greater days of COVID-19 Related Symptoms, (Fever, Cough, Fatigue, Decreased Appetite, Shortness of Breath, Myalgia) or post-defervescence and/or convalescence

Related Conditions & MeSH terms

• SARS CoV-2

Intervention

Diagnostic Test:
• Direct Antigen Tests for COVID-19
Rapid Antigen diagnostic device performance comparative to RT-PCR

Locations

Country	Name	City	State
United States	Aventura Hospital and Medical Center	Miami	Florida
United States	JFK Medical Center	Miami	Florida
United States	Kendall Regional	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
E25Bio, Inc.	SCRI Development Innovations, LLC

Country where clinical trial is conducted

United States, 

References & Publications (17)

Arnaout R, Lee RA, Lee GR, Callahan C, Yen CF, Smith KP, Arora R, Kirby JE. SARS-CoV2 Testing: The Limit of Detection Matters. bioRxiv. 2020 Jun 4. pii: 2020.06.02.131144. doi: 10.1101/2020.06.02.131144. — View Citation

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. E — View Citation

Bosch I, de Puig H, Hiley M, Carré-Camps M, Perdomo-Celis F, Narváez CF, Salgado DM, Senthoor D, O'Grady M, Phillips E, Durbin A, Fandos D, Miyazaki H, Yen CW, Gélvez-Ramírez M, Warke RV, Ribeiro LS, Teixeira MM, Almeida RP, Muñóz-Medina JE, Ludert JE, No — View Citation

Buitrago-Garcia D, Egli-Gany D, Counotte MJ, Hossmann S, Imeri H, Ipekci AM, Salanti G, Low N. Occurrence and transmission potential of asymptomatic and presymptomatic SARS-CoV-2 infections: A living systematic review and meta-analysis. PLoS Med. 2020 Sep — View Citation

Carpenter CR, Mudd PA, West CP, Wilber E, Wilber ST. Diagnosing COVID-19 in the Emergency Department: A Scoping Review of Clinical Examinations, Laboratory Tests, Imaging Accuracy, and Biases. Acad Emerg Med. 2020 Jun 16. doi: 10.1111/acem.14048. [Epub ah — View Citation

Cui Z, Chang H, Wang H, Lim B, Hsu CC, Yu Y, Jia H, Wang Y, Zeng Y, Ji M, Liu W, Inverarity C, Huang WE. Development of a rapid test kit for SARS-CoV-2: an example of product design. Biodes Manuf. 2020 May 11:1-4. doi: 10.1007/s42242-020-00075-7. [Epub ah — View Citation

Dinnes J, Deeks JJ, Adriano A, Berhane S, Davenport C, Dittrich S, Emperador D, Takwoingi Y, Cunningham J, Beese S, Dretzke J, Ferrante di Ruffano L, Harris IM, Price MJ, Taylor-Phillips S, Hooft L, Leeflang MM, Spijker R, Van den Bruel A; Cochrane COVID- — View Citation

Hirotsu Y, Maejima M, Shibusawa M, Nagakubo Y, Hosaka K, Amemiya K, Sueki H, Hayakawa M, Mochizuki H, Tsutsui T, Kakizaki Y, Miyashita Y, Yagi S, Kojima S, Omata M. Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative R — View Citation

Kucirka LM, Lauer SA, Laeyendecker O, Boon D, Lessler J. Variation in False-Negative Rate of Reverse Transcriptase Polymerase Chain Reaction-Based SARS-CoV-2 Tests by Time Since Exposure. Ann Intern Med. 2020 Aug 18;173(4):262-267. doi: 10.7326/M20-1495. — View Citation

Kyosei Y, Namba M, Yamura S, Takeuchi R, Aoki N, Nakaishi K, Watabe S, Ito E. Proposal of De Novo Antigen Test for COVID-19: Ultrasensitive Detection of Spike Proteins of SARS-CoV-2. Diagnostics (Basel). 2020 Aug 14;10(8). pii: E594. doi: 10.3390/diagnost — 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). — 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

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, R — View Citation

Pondaven-Letourmy S, Alvin F, Boumghit Y, Simon F. How to perform a nasopharyngeal swab in adults and children in the COVID-19 era. Eur Ann Otorhinolaryngol Head Neck Dis. 2020 Sep;137(4):325-327. doi: 10.1016/j.anorl.2020.06.001. Epub 2020 Jun 5. — 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. — 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 2 — View Citation

Wang X, Tan L, Wang X, Liu W, Lu Y, Cheng L, Sun Z. Comparison of nasopharyngeal and oropharyngeal swabs for SARS-CoV-2 detection in 353 patients received tests with both specimens simultaneously. Int J Infect Dis. 2020 May;94:107-109. doi: 10.1016/j.ijid — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Positive Agreement and Negative Percent Agreement	Calculate the performance of the antigen test compared to PCR using nasopharyngeal swab samples	90 days