Abstract

Scaling up SARS-CoV-2 testing and tracing continues to be plagued with the limitation of the sample collection method, which requires trained healthcare workers to perform and causes discomfort to the patients. In response, we assessed the performance and user preference of gargle specimens for qRT-PCR-based detection of SARS-CoV-2 in Indonesia. Inpatients who had recently been diagnosed with COVID-19 and outpatients who were about to perform qRT-PCR testing were asked to provide nasopharyngeal and oropharyngeal (NPOP) swabs and self-collected gargle specimens. We demonstrated that self-collected gargle specimens can be an alternative specimen to detect SARS-CoV-2 and the viral RNA remained stable for 31 days at room temperature storage. The developed method was validated for use on multiple RNA extraction kits and commercially available COVID-19 RT-PCR kits. Our developed method achieved a sensitivity of 91.38% when compared to paired NPOP swab specimens (Ct < 35), with 97.10% of patients preferring the self-collected gargle method.

Highlights

  • Scaling up SARS-CoV-2 testing and tracing continues to be plagued with the limitation of the sample collection method, which requires trained healthcare workers to perform and causes discomfort to the patients

  • We found that the detection of both target genes remained stable for 31 days at room temperature, − 20 °C, and − 80 °C (Fig. 1A, B), while no viral RNA was detected on gargle specimens stored at 4 °C after 7 days

  • We observed that there was a shift of 5 cycle threshold (Ct) values or higher in spiked gargle specimens without Collection Buffer after incubation at room temperature for 2 days (Fig. 1C)

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Summary

Introduction

Scaling up SARS-CoV-2 testing and tracing continues to be plagued with the limitation of the sample collection method, which requires trained healthcare workers to perform and causes discomfort to the patients. Inpatients who had recently been diagnosed with COVID-19 and outpatients who were about to perform qRT-PCR testing were asked to provide nasopharyngeal and oropharyngeal (NPOP) swabs and self-collected gargle specimens. While there are methods, such as the IgM/IgG lateral flow test and rapid antigen tests, WHO recommended the diagnosis of SARS-CoV-2 in suspected cases with a nucleic acid amplification test, such as real-time PCR (qRT-PCR), with respiratory specimens 3. These respiratory specimens include nasopharyngeal and/or oropharyngeal swabs. This study was carried out to evaluate the analytical performance and sample stability of self-collected gargle specimens in the population setting (inpatients and outpatients) for the initial diagnosis of SARS-CoV-2 infection in Semarang, Indonesia

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