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Detection of SARS-CoV-2 RNA and Antibodies in Diverse Samples: Protocol to Validate the Sufficiency of Provider-Observed, Home-Collected Blood, Saliva, and Oropharyngeal Samples.
JMIR Public Health Surveill. 2020 04 24; 6(2):e19054.JP

Abstract

BACKGROUND

The response in the United States to the coronavirus disease (COVID-19) pandemic has been hampered by a lack of aggressive testing for the infection. Testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cornerstone of an effective public health response. However, efforts to test have been hampered by limited reagents, limitations in the availability of swabs used for the collection of nasopharyngeal swab (NPS) specimens, limitations in personal protective equipment (PPE) for health care providers collecting the NPS specimens, and limitations in viral transport media for transporting the specimens. Therefore, more flexible options for screening for SARS-CoV-2 RNA and serologic responses are critical to inform clinical and public health responses.

OBJECTIVE

We aim to document the ability of patients to self-collect sufficient specimens for SARS-CoV-2 viral detection and serology.

METHODS

Patient self-collection of samples will be done with observation by a health care provider during a telemedicine session. Participants will be mailed a specimen collection kit, engage in a telehealth session with a provider through a HIPPA (Health Insurance Portability and Accountability Act of 1996)-compliant video meeting, and collect specimens while being observed by the provider. Providers will record whether they are confident in the suitability of the specimen for laboratory testing that would inform clinical decision making. We will objectively assess the sufficiency of biological material in the mailed-in specimens.

RESULTS

The protocol was approved by the Emory University Institutional Review Board (IRB) on March 30, 2020 (Protocol number 371). To date, we have enrolled 159 participants.

CONCLUSIONS

Defining a conceptual framework for assessing the sufficiency of patient-collected samples for the detection of SARS-CoV-2 RNA and serologic responses to infection is critical for facilitating public health responses and providing PPE-sparing options to increase testing. Validation of alternative methods of specimen collection should include objective measures of the sufficiency of specimens for testing. A strong evidence base for diversifying testing modalities will improve tools to guide public health responses to the COVID-19 pandemic.

Authors+Show Affiliations

Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.Molecular Testing Labs, Vancouver, WA, United States.Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.Division of Infectious Diseases, Emory University School of Medicine, Atlanta, GA, United States.Division of Infectious Diseases, Emory University School of Medicine, Atlanta, GA, United States.Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, GA, United States.Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.Division of Infectious Diseases, Emory University School of Medicine, Atlanta, GA, United States.Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32310815

Citation

Sullivan, Patrick Sean, et al. "Detection of SARS-CoV-2 RNA and Antibodies in Diverse Samples: Protocol to Validate the Sufficiency of Provider-Observed, Home-Collected Blood, Saliva, and Oropharyngeal Samples." JMIR Public Health and Surveillance, vol. 6, no. 2, 2020, pp. e19054.
Sullivan PS, Sailey C, Guest JL, et al. Detection of SARS-CoV-2 RNA and Antibodies in Diverse Samples: Protocol to Validate the Sufficiency of Provider-Observed, Home-Collected Blood, Saliva, and Oropharyngeal Samples. JMIR Public Health Surveill. 2020;6(2):e19054.
Sullivan, P. S., Sailey, C., Guest, J. L., Guarner, J., Kelley, C., Siegler, A. J., Valentine-Graves, M., Gravens, L., Del Rio, C., & Sanchez, T. H. (2020). Detection of SARS-CoV-2 RNA and Antibodies in Diverse Samples: Protocol to Validate the Sufficiency of Provider-Observed, Home-Collected Blood, Saliva, and Oropharyngeal Samples. JMIR Public Health and Surveillance, 6(2), e19054. https://doi.org/10.2196/19054
Sullivan PS, et al. Detection of SARS-CoV-2 RNA and Antibodies in Diverse Samples: Protocol to Validate the Sufficiency of Provider-Observed, Home-Collected Blood, Saliva, and Oropharyngeal Samples. JMIR Public Health Surveill. 2020 04 24;6(2):e19054. PubMed PMID: 32310815.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Detection of SARS-CoV-2 RNA and Antibodies in Diverse Samples: Protocol to Validate the Sufficiency of Provider-Observed, Home-Collected Blood, Saliva, and Oropharyngeal Samples. AU - Sullivan,Patrick Sean, AU - Sailey,Charles, AU - Guest,Jodie Lynn, AU - Guarner,Jeannette, AU - Kelley,Colleen, AU - Siegler,Aaron Julius, AU - Valentine-Graves,Mariah, AU - Gravens,Laura, AU - Del Rio,Carlos, AU - Sanchez,Travis Howard, Y1 - 2020/04/24/ PY - 2020/04/02/received PY - 2020/04/19/accepted PY - 2020/04/14/revised PY - 2020/4/21/pubmed PY - 2020/5/1/medline PY - 2020/4/21/entrez KW - COVID-19 KW - PCR KW - RNA-PCR KW - SARS-CoV-2 KW - diagnostic KW - infectious disease KW - outbreak KW - public health KW - serology KW - telemedicine KW - testing SP - e19054 EP - e19054 JF - JMIR public health and surveillance JO - JMIR Public Health Surveill VL - 6 IS - 2 N2 - BACKGROUND: The response in the United States to the coronavirus disease (COVID-19) pandemic has been hampered by a lack of aggressive testing for the infection. Testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cornerstone of an effective public health response. However, efforts to test have been hampered by limited reagents, limitations in the availability of swabs used for the collection of nasopharyngeal swab (NPS) specimens, limitations in personal protective equipment (PPE) for health care providers collecting the NPS specimens, and limitations in viral transport media for transporting the specimens. Therefore, more flexible options for screening for SARS-CoV-2 RNA and serologic responses are critical to inform clinical and public health responses. OBJECTIVE: We aim to document the ability of patients to self-collect sufficient specimens for SARS-CoV-2 viral detection and serology. METHODS: Patient self-collection of samples will be done with observation by a health care provider during a telemedicine session. Participants will be mailed a specimen collection kit, engage in a telehealth session with a provider through a HIPPA (Health Insurance Portability and Accountability Act of 1996)-compliant video meeting, and collect specimens while being observed by the provider. Providers will record whether they are confident in the suitability of the specimen for laboratory testing that would inform clinical decision making. We will objectively assess the sufficiency of biological material in the mailed-in specimens. RESULTS: The protocol was approved by the Emory University Institutional Review Board (IRB) on March 30, 2020 (Protocol number 371). To date, we have enrolled 159 participants. CONCLUSIONS: Defining a conceptual framework for assessing the sufficiency of patient-collected samples for the detection of SARS-CoV-2 RNA and serologic responses to infection is critical for facilitating public health responses and providing PPE-sparing options to increase testing. Validation of alternative methods of specimen collection should include objective measures of the sufficiency of specimens for testing. A strong evidence base for diversifying testing modalities will improve tools to guide public health responses to the COVID-19 pandemic. SN - 2369-2960 UR - https://www.unboundmedicine.com/medline/citation/32310815/Detection_of_SARS_CoV_2_RNA_and_Antibodies_in_Diverse_Samples:_Protocol_to_Validate_the_Sufficiency_of_Provider_Observed_Home_Collected_Blood_Saliva_and_Oropharyngeal_Samples_ L2 - https://publichealth.jmir.org/2020/2/e19054/ DB - PRIME DP - Unbound Medicine ER -