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

UNSTRUCTURED: Background: The US response to the SARS-CoV-2 epidemic has been hampered by a lack of aggressive testing for infection. Testing for SARS-CoV-2 infection 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 collection of nasopharyngeal swab (NPS) specimens, limitations in personal protective equipment (PPE) for healthcare 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 specimens for SARS-CoV-2 viral detection and serology. Methods: In this protocol, patient collection of samples will be done with observation by a provider during a telemedicine session. Participants will be mailed a specimen collection kit, engage in a telehealth session with a healthcare provider through a HIPPA-compliant video meeting, and collect specimens while observed by the provider. Providers will record whether they are confident in the sufficiency of the specimen for laboratory testing that would inform clinical decision making. We will objectively assess the laboratory evidence of sufficient biological material in the mailed-in specimens. 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 specimen collection should include objective measures of the sufficiency of specimens for testing. A strong evidence base for diversifying testing modalities will improve the tools to guide public health responses to the COVID-19 epidemic.