Accuracy and stability of saliva as a sample for reverse transcription PCR detection of SARS-CoV-2

Uwamino, Yoshifumi; Nagata, Morio; Aoki, Wataru; Fujimori, Yuta; Nakagawa, Terumichi; Yokota, Hiromitsu; Sakai‐Tagawa, Yuko; Iwatsuki‐Horimoto, Kiyoko; Shiraki, Toshiki; Uchida, Sho; Uno, Shunsuke; Kabata, Hiroki; Ikemura, Shinnosuke; Kamata, Hirofumi; Ishii, Makoto; Fukunaga, Koichi; Kawaoka, Yoshihiro; Hasegawa, Naoki; Murata, Mitsuru

doi:10.1136/jclinpath-2020-206972

Cited by 37 publications

(54 citation statements)

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“…In the context of mass screening, most participants are asymptomatic. Among the 49 studies analysed, only one included exclusively asymptomatic participants 67 and 8 studies both symptomatic and asymptomatic participants but it was impossible to separate the data between the two populations 18,21,26,29,51,56,64,66 . One study of contact cases included a larger number of asymptomatic subjects as compared to study of symptomatic subjects 49 .…”

Section: Discussionmentioning

confidence: 99%

Screening for SARS-CoV-2 by RT-PCR: saliva or nasopharyngeal swab? Systematic review and meta-analysis

Ibrahimi

Delaunay‐Moisan

Hill

et al. 2021

Preprint

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Diagnosis of COVID-19 in symptomatic patients and screening of populations for SARS-CoV-2 infection require access to straightforward, low-cost and high-throughput testing. The recommended nasopharyngeal swab tests are limited by the need of trained professionals and specific consumables and this procedure is poorly accepted as a screening method. The use of alternative validated samples such as saliva is thus much awaited. In order to compare saliva and nasopharyngeal/oropharyngeal samples for the detection of SARS-CoV-2, we designed a meta-analysis searching in PubMed up to December 29th, 2020 with the key words ((SARS-CoV-2 OR COVID-19) AND (saliva OR oral fluid)) NOT (review[Publication Type] applying the following criteria: records published in peer reviewed scientific journals, in English, with at least 15 nasopharyngeal/orapharyngeal swabs and saliva paired samples tested by RT-PCR, studies with available raw data including numbers of positive and negative tests with the two sampling methods. For all studies, concordance and sensitivity were calculated and then pooled in a random-effects model. A total of 318 studies were retrieved, of which 49 were eligible, reporting on 16,272 pairs of nasopharyngeal/oropharyngeal and saliva samples. Meta-analysis showed high concordance, 92.6% (95%CI: 89.6-94.8), across studies and pooled sensitivities of 86.7% (95%CI: 83.5-89.3) and 92.2 (95%CI: 89.4-94.4) from saliva and nasopharyngeal/oropharyngeal swabs respectively. Heterogeneity across studies was 80.0% for saliva and 84.0% for nasopharyngeal/oropharyngeal swabs. Our meta-analysis strongly suggests that saliva could be used for frequent testing of COVID-19 patients and en masse screening of populations.

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Section: Discussionmentioning

confidence: 99%

Screening for SARS-CoV-2 by RT-PCR: saliva or nasopharyngeal swab? Systematic review and meta-analysis

Ibrahimi

Delaunay‐Moisan

Hill

et al. 2021

Preprint

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“…The range of reported sensitivity or percent positive agreement of the saliva collection method, most often compared to NP swab, varies widely from 71 to 100% and is too broad to make a specific guideline without further refinement of the analysis (2-4, 6-19). While our study and others show the acceptability of testing saliva, important variables need to be considered when reviewing various reported conclusions.…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…When this study began, saliva was not an accepted specimen type, an Emergency Use Authorization was required by the Food and Drug Administration for testing saliva, and procurement of saliva collection devices with stabilizers was limiting. Previously published studies on saliva testing for COVID-19 vary from 71 to 100% in their reported percent positive agreement or sensitivity of saliva compared with NP (Table S1) (2)(3)(4)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)). Importantly, the tested population, the saliva collection method, and the processing protocol have varied between the studies, making comparison of results challenging.…”

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confidence: 99%

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Pooled Saliva Specimens for SARS-CoV-2 Testing

Barat

Das

Giorgi

et al. 2020

Preprint

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We evaluated saliva (SAL) specimens for SARS-CoV-2 RT-PCR testing by comparison of 459 prospectively paired nasopharyngeal (NP) or mid-turbinate (MT) swabs from 449 individuals with the aim of using saliva for asymptomatic screening. Samples were collected in a drive-through car line for symptomatic individuals (N=380) and in the emergency department (ED) (N=69). The percent positive and negative agreement of saliva compared to nasopharyngeal swab were 81.1% (95% CI: 65.8% – 90.5%) and 99.8% (95% CI: 98.7% – 100%), respectively. The sensitivity increased to 90.0% (95% CI: 74.4% – 96.5%) when considering only samples with moderate to high viral load (Cycle threshold (Ct) for the NP <=34). Pools of five saliva specimens were also evaluated on three platforms: bioMérieux NucliSENS easyMAG with ABI 7500Fast (CDC assay), Hologic Panther Fusion, and Roche COBAS 6800. The median loss of signal upon pooling was 2-4 Ct values across the platforms. The sensitivity of detecting a positive specimen in a pool compared with testing individually was 100%, 93%, and 95% for CDC 2019-nCoV Real-Time RT-PCR, Panther Fusion® SARS-CoV-2 assay, and cobas® SARS-CoV-2 test respectively, with decreased sample detection trending with lower viral load. We conclude that although pooled saliva testing, as collected in this study, is not quite as sensitive as NP/MT testing, saliva testing is adequate to detect individuals with higher viral loads in an asymptomatic screening program, does not require swabs or viral transport media for collection, and may help to improve voluntary screening compliance for those individuals averse to various forms of nasal collections.

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“…saliva as less sensitive) (15). This discrepancy might depend on the salivary viral load kinetic, the highest load occurring in the first week of symptom onset, followed by a progressive decline during the course of the disease (3,9,14).…”

Section: /27mentioning

confidence: 99%

Salivary SARS-CoV-2 antigen rapid detection: a prospective cohort study

Basso

Aita

Padoan

et al. 2020

Preprint

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BackgroundSARS-CoV-2 quick testing and reporting are now considered relevant for the containment of new pandemic waves. Antigen testing in self-collected saliva might be useful. We compared the diagnostic performance of salivary and naso-pharyngeal swab (NPS) SARS-CoV-2 antigen detection by a rapid chemiluminescent assay (CLEIA) and two different point-of-care (POC) immunochromatographic assays, with that of molecular testing.Methods234 patients were prospectively enrolled. Paired self-collected saliva (Salivette) and NPS were obtained to perform rRT-PCR, chemiluminescent (Lumipulse G) and POC (NPS: Fujirebio and Abbott; saliva: Fujirebio) for SARS-CoV-2 antigen detection.ResultsThe overall agreement between NPS and saliva rRT-PCR was 78.7%, reaching 91.7% at the first week from symptoms onset. SARS-CoV-2 CLEIA antigen was highly accurate in distinguishing between positive and negative NPS (ROC-AUC=0.939, 95%CI:0.903-0.977), with 81.6% sensitivity and 93.8% specificity. This assay on saliva had an overall good accuracy (ROC-AUC=0.805, 95%CI:0.740-0.870), reaching the optimal value within 7 days from symptom onset (Sensitivity: 72%; Specificity: 97%). POC antigen in saliva had a very limited sensitivity (13%), performing better in NPS (Sensitivity: 48% and 66%; Specificity: 100% and 99% for Espline and Abbott respectively), depending on viral loads.ConclusionsSelf-collected saliva is a valid alternative to NPS for SARS-CoV-2 detection not only by molecular, but also by CLEIA antigen testing, for which the highest diagnostic accuracy was achieved in the first week from symptom onset. Saliva is not suitable for POC, although the accuracy of these tests appears satisfactory for NPS with high viral load.

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Accuracy and stability of saliva as a sample for reverse transcription PCR detection of SARS-CoV-2

Cited by 37 publications

References 5 publications

Screening for SARS-CoV-2 by RT-PCR: saliva or nasopharyngeal swab? Systematic review and meta-analysis

Screening for SARS-CoV-2 by RT-PCR: saliva or nasopharyngeal swab? Systematic review and meta-analysis

Pooled Saliva Specimens for SARS-CoV-2 Testing

Salivary SARS-CoV-2 antigen rapid detection: a prospective cohort study

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