Usability and Clinical Evaluation of Self-Sampling for SARS-CoV-2 Diagnostic Testing Using Nasal and Saliva Specimens in South Africa: Study Protocol (Preprint)

BACKGROUND The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a coronavirus novel discovered in December 2019 and is currently the cause of a global pandemic. A critical aspect of fighting this pandemic is by obtaining accurate and timeous test results so that positive identified cases can be isolated to reduce the spread. Research has shown that saliva is a promising candidate for SARS-CoV-2 diagnostics because collection is minimally invasive and can reliably be self-administered. However, little research has been conducted on saliva testing and SARS-CoV-2 self-sampling (SARS-CoV-2SS) in sub-Saharan Africa. OBJECTIVE The primary objective is to estimate the clinical sensitivity and specificity of the participant self-collected samples (nasal and oral) for SARS-CoV-2 against a reference method collected and tested sample by a healthcare professional. The secondary objectives are to evaluate the usability of nasal self-sampling and saliva self-sampling as a sample collection method for SARS-CoV-2 using failure mode and error assessment. METHODS Participants will be recruited from the general population using various methods, Participants will be screened progressively as they present at the clinical trial sites as well as the Primary Healthcare catchment areas in the inner city of Johannesburg. In the event that recruitment numbers are low, the study will utilize its mobile van to recruit from outlying areas of Johannesburg. 250 participants will be enrolled onto this study in approximately 6 weeks. Two sample types will be obtained i.e. one self-administered nasal swab and one self-administered saliva collection from each participant and a professional healthcare worker will collect one swab using a nasopharyngeal swab, the standard reference method. RESULTS The protocol has been approved by the University of the Witwatersrand Human Research Ethics Committee on July 31,2020. To date, 120 participants have been enrolled. CONCLUSIONS SARS-CoV-2SS may offer many benefits by allowing initial self-identification of symptoms, and collection of samples without involving third parties and risk of infection if the sample can be entered into a collection system safely. The results of this study will provide preliminary data on the acceptability, feasibility, and usability of SARS-CoV-2SS from the general population for future implementation. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/24811.