Abstract
Background: The reference standard for the molecular diagnostic testing for COVID-19 is the use of nasopharyngeal or combined nasopharyngeal and oropharyngeal (NP/OP) swabs. Saliva has been proposed as a minimally invasive specimen whose collection reduces the risks for health care personnel.Objective: To assess the suitability of saliva for COVID-19 diagnosis as a replacement of the reference standard NP/OP swab in the setting of a tertiary care pediatric unit.Study design: A paired study based in the prospective cohort design in patients suspected of having COVID-19.Methods: RT-PCR was used to detect SARS-CoV-2 in paired samples of saliva and NP/OP swab collected from May through August 2020 from 156 pediatric participants, of whom 128 has at least one comorbidity and 91 showed clinical symptoms related to SARS-CoV-2 infection. Additionally, we studied a group of 326 members of the hospital staff, of whom 271 had symptoms related to SARS-CoV-2 infection.Results: In the group of pediatric participants the sensitivity of the diagnostic test in saliva was 82.3% (95% CI 56.6–96.2) and the specificity 95.6% (95% CI 90.8–98.4). The prevalence of COVID-19 was 10.9% (17/156). In 6 of the 23 participants who tested positive for SARS-CoV-2 in at least one specimen type, the virus was detected in saliva but not in NP/OP swab, while in 3 participants the NP/OP swab was positive and saliva negative. In the group of adults, the sensitivity of the test in saliva was 77.8% (95% CI 67.2–86.3) and prevalence 24.8% (81/326). Discordant results between the two types of specimens showed a significant association with low viral load in the pharynx of adults but not of pediatric participants.Interpretation: In the context of a pediatric tertiary care hospital, the sensibility of the test in saliva is not high enough to replace the use of NP/OP swab for COVID-19 diagnosis. Neither NP/OP swab nor saliva could detect all the participants infected with SARS-CoV-2.
Highlights
Pediatric patients infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who have concurrent conditions are at high-risk to develop severe forms of the infection [1,2,3]
The use of oral saliva collected by the patients themselves at any hour of the day would be convenient for children in the context of a tertiary care unit as an alternative specimen for COVID-19 diagnosis
This approach resulted in an estimated sensitivity of 82.3%, when the result of nasopharyngeal and oropharyngeal (NP/OP) swab was taken as reference standard in a group of children and adolescents, the majority of whom had comorbidities, and of 77.8% in members of the hospital staff
Summary
Pediatric patients infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who have concurrent conditions are at high-risk to develop severe forms of the infection [1,2,3]. SARS-CoV-2 detection is based on real-time reverse transcription PCR (RT-PCR) amplification of viral genes from nasopharyngeal (NP), combined NP and oropharyngeal (OP), or nasal and oral swabs. This requires sampling by a trained health care worker who is exposed to aerosols from patients. Saliva has been explored as alternative specimen for SARS-CoV-2 detection; it is minimally invasive and can be obtained by patients themselves. The reference standard for the molecular diagnostic testing for COVID-19 is the use of nasopharyngeal or combined nasopharyngeal and oropharyngeal (NP/OP) swabs. Saliva has been proposed as a minimally invasive specimen whose collection reduces the risks for health care personnel
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