The aim of this study is to compare the SARS-CoV-2 detection rate using either a Saliva, oropharyngeal swabs or nasopharyngeal swab method for specimen collection.
The reference test to evaluate patients with suspected respiratory infection caused by virus
is a real-time reverse transcription-polymerase chain reaction (RT-PCR) from a nasopharyngeal
swab (NPS). However, other specimen collection methods like oropharyngeal swabs (OPS) and a
saliva specimen collection have also been accepted by the Centers for Disease Control and
Prevention for SARS-CoV-2 testing during the current coronavirus disease 19 (COVID-19)
pandemic. It is unclear how much the SARS-CoV-2 detection rate differs when using different
sampling methods and the aim of this study is to compare the expected COVID-19 detection rate
using saliva, oropharyngeal swabs or nasopharyngeal swab in a public setting.
We, therefore, aim to investigate the detection rate of SARS-CoV-2 in Saliva, oropharyngeal
swab, and nasopharyngeal swab specimen samples collected in symptomatic and non-symptomatic
individuals tested for COVID-19 in a public test center during the COVID-19 pandemic.
Individuals referred for outpatient COVID-19 testing center will be invited to participate in
a prospective clinical study. They will have saliva, OPS, and NPS specimen collection
performed at the same time and analyzed separately for SARS-CoV-2. The rate for SARS-CoV-2
detection in saliva, OPS, and NPS will be compared using a logistic regression mixed-effect
analysis. A Sample Size Calculation estimated that a sample of 18,000 participants would be
needed for the trial with 80% power at a significance level of 5%.
Diagnostic Test: Sequence of testing.
The participants will be tested in the following sequences of sampling technique: (1) nasopharyngeal swab, oropharyngeal swab, and salvia collection OR (2) oropharyngeal swab, salvia collection, and nasopharyngeal swab OR (3) salvia collection, nasopharyngeal swab, and oropharyngeal swab. Only the sequence is different in the different arm, while the sampling technique for each method is the same in all arms.
Inclusion Criteria:
- volunteers, who are attending the COVID-19 test facilities to obtain a RT-PCR test.
- oral and written informed consent to participate before entering the study.
Exclusion Criteria:
- Failure to understand and provide informed consent.
- Neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or
oropharyngeal anomalies that do not allow for sampling using swabs.
Valby COVID-19 teststed
Copenhagen, Valby, Denmark