Self-Collected Saline Gargle Samples as an Alternative to Health Care Worker-Collected Nasopharyngeal Swabs for COVID-19 Diagnosis in Outpatients

Goldfarb, David M.; Tilley, Peter; Al‐Rawahi, Ghada N.; Srigley, Jocelyn A.; Ford, Geoffrey; Pedersen, Heather; Pabbi, Abhilasha; Hannam-Clark, Stephanie; Charles, Marthe; Dittrick, Michelle; Gadkar, Vijay; Pernica, Jeffrey M.; Hoang, Linda

doi:10.1128/jcm.02427-20

Cited by 91 publications

(124 citation statements)

References 13 publications

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“…Results are conflicting but there is FDA approval for some of these methods. [ 12 ] However, saliva testing is less convenient for the patients [ 25 ], and might be more complicated to process in the lab due to its high viscosity and presence of inhibitory saliva proteins [ 26 ], which may further increase laboratory workload.…”

Section: Discussionmentioning

confidence: 99%

The role of mouthwash sampling in SARS-CoV-2 diagnosis

Biber

Lev

Mandelboim

et al. 2021

Eur J Clin Microbiol Infect Dis

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Background The current practice of COVID-19 diagnosis worldwide is the use of oro-nasopharyngeal (ONP) swabs. Our study aim was to explore mouthwash (MW) as an alternative diagnostic method, in light of the disadvantages of ONP swabs. Methods COVID-19 outpatients molecular-confirmed by ONP swab were repeatedly examined with ONP swab and MW with normal saline (0.9%). Other types of fluids were compared to normal saline. The Cq values obtained with each method were compared. Results Among 137 pairs of ONP swabs and MW samples, 84.6% (116/137) of ONP swabs were positive by at least one of the genes (N, E, R). However MW detected 70.8% (97/137) of samples as positive, which means 83.6% (97/116) out of positive ONP swabs, missing mainly Cq value > 30. In both methods, the N gene was the most sensitive one. Therefore, MW samples targeting N gene, which was positive in 95/137 (69.3%), are comparable to ONP swabs targeting E and R genes which gave equal results—95/137 (69.3%) and 90/137 (65.7%), respectively. Comparing saline MW to distilled water gave equal results, while commercial mouth-rinsing solutions were less sensitive. Conclusions MW with normal saline, especially when tested by N gene, can effectively detect COVID-19 patients. Furthermore, this method was not inferior when compared to R and E genes of ONP swabs, which are common targets in many laboratories around the world.

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Section: Discussionmentioning

confidence: 99%

The role of mouthwash sampling in SARS-CoV-2 diagnosis

Biber

Lev

Mandelboim

et al. 2021

Eur J Clin Microbiol Infect Dis

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“…The significant decrease of SARS-CoV-2 detection in OP after mouth washing and the remaining detection of the human cellular control (HNRP), in saliva, suggest that the virus detection corresponds more to it accumulation in buccal cavity rather than a direct secretion by salivary glands [34]. These data could explain some mitigate results obtained by direct drooling into plastic tubes for COVID-19 diagnosis [35,36]. At the time that saliva tests happened to the rule for schooled children in France, the determination of the performance of saliva collection procedures become imperative.…”

Section: Discussionmentioning

confidence: 96%

Mouth Washing Impaired SARS-CoV-2 Detection in Saliva

Costa

Nicolas

Tissot‐Dupont

et al. 2021

Preprint

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Background. A previous study demonstrated the performance of the Salivette® (SARSTEDT, Numbrecht, Germany) as a homogeneous saliva collection system to diagnose COVID-19 by RT-qPCR, notably for symptomatic and asymptomatic patients. However, for convalescent patients, the corroboration of molecular detection of SARS-CoV-2 in paired nasopharyngeal swabs (NPS) and saliva samples was unsatisfactory. Objectives. The aim of the present work was to assess the concordance level of SARS-CoV-2 detection between paired sampling of NPSs and saliva collected with Salivette® at two time points, with ten days of interval. Results. A total of 319 paired samples from 145 outpatients (OP) and 51 healthcare workers (HW) were collected. Due to significant waiting rate at hospital, most of the patients ate and/or drank in waiting their turn. Consequently, a mouth washing was systematically proposed prior saliva collection. None of the HW were diagnosed SARS-CoV-2 positive using NPS or saliva specimens at both time points (n=95) by RT-qPCR. The virus was detected in 56.3% (n=126/224) of the NPS samples from OP, but solely 26.8% (n=60/224) of the paired saliva specimens. The detection of the internal cellular control, the human RNase P, in more than 98% of the saliva samples, underlined that the low sensitivity of saliva specimens (45.2%) for SARS-CoV-2 detection was not attributed to an improper saliva sample storing or RNA extraction. Conclusions. Then, the mouth washing decreased viral load of buccal cavity conducting to impairment of SARS-CoV-2 detection. Viral loads in saliva neo-produced appeared insufficient for molecular detection of SARS-CoV-2. At the time that saliva tests could be a rapid, simple and noninvasive strategy to assess on large scale schooled children in France, the determination of the performance of saliva collection become imperative to standardize procedures.

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“…Cost-effectiveness is an important consideration for an ongoing program. Gargling a saline solution or filtered water can be carried out independently [38,39], saving the costs of support from clinical personnel and the accompanying personal protective equipment [39]. Moreover, gargle tests have been established as providing an effective approach to diagnosing respiratory infection among children [40], and they have been shown specifically to be effective in the diagnosis of SARS-CoV-2 infection [41].…”

Section: Testing Strategymentioning

confidence: 99%

Pool Testing as a Strategy for Prevention of SARS-CoV-2 Outbreaks in Schools: Protocol for a Feasibility Study

Sweeney‐Reed¹,

Wolff²,

Niggel³

et al. 2021

JMIR Res Protoc

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Background School closures are a widely implemented strategy for limiting infection spread in the current COVID-19 pandemic. The negative impact of school closures on children and young people is increasingly apparent, however. Objective We aim to evaluate the feasibility of an infection monitoring program in schools to enable targeted quarantining to replace school closures. The program is currently being implemented in two model schools in Magdeburg, Germany, within the framework of the Study of Coronavirus Outbreak Prevention in Magdeburg Schools (Studie zur Ausbruchsvermeidung von Corona an Magdeburger Schulen [STACAMA]). Methods Five pupils per class are pseudorandomly selected twice a week and asked to provide a gargle sample over a 16-week evaluation period. RNA is extracted from each sample individually in a laboratory and pooled according to school class for real-time reverse transcription polymerase chain reaction (rRT-PCR) analysis. Immediate individual sample testing will be carried out in the case of a positive pool test. Individual RNA extraction prior to pooling and application of rRT-PCR result in high test sensitivity. Testing will be performed in strict adherence to data protection standards. All participating pupils will receive a 16-digit study code, which they will be able to use to access their test Results When the study commenced on December 2, 2020, 520 (52%) pupils and their families or guardians had consented to study participation. The study was suspended after four test rounds due to renewed school closures resulting from rising regional infection incidence. Testing resumed when schools reopened on March 8, 2021, at which time consent to participation was provided for 54% of pupils. We will quantitatively and qualitatively evaluate the logistics and acceptability of the program. Conclusions The findings from this study should inform the design of infection surveillance programs in schools based on gargle samples and a PCR-based pool testing procedure, enabling the identification of aspects that may require adaptation before large-scale implementation. Our focus on each step of the logistics and on the experiences of families should enable a robust assessment of the feasibility of such an approach. International Registered Report Identifier (IRRID) DERR1-10.2196/28673

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Self-Collected Saline Gargle Samples as an Alternative to Health Care Worker-Collected Nasopharyngeal Swabs for COVID-19 Diagnosis in Outpatients

Cited by 91 publications

References 13 publications

The role of mouthwash sampling in SARS-CoV-2 diagnosis

The role of mouthwash sampling in SARS-CoV-2 diagnosis

Mouth Washing Impaired SARS-CoV-2 Detection in Saliva

Pool Testing as a Strategy for Prevention of SARS-CoV-2 Outbreaks in Schools: Protocol for a Feasibility Study

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