Rapid Salivary Test suitable for a mass screening program to detect SARS-CoV-2: A diagnostic accuracy study

Azzi, Lorenzo; Baj, Andreina; Alberio, Tiziana; Lualdi, Marta; Veronesi, Giovanni; Carcano, Giulio; Ageno, Walter; Gambarini, Cinzia; Maffioli, Lorenzo; Saverio, Salomone Di; Gasperina, Daniela Dalla; Genoni, Angelo; Premi, Elias; Donati, Simone; Azzolini, Claudio; Grandi, Anna Maria; Dentali, Francesco; Tangianu, Flavio; Sessa, Fausto; Maurino, Vittorio; Tettamanti, L; Siracusa, Claudia; Vigezzi, Andrea; Monti, Emanuele; Iori, Valentina; Iovino, Domenico; Ietto, Giuseppe; Grossi, Paolo; Tagliabue, Angelo; Fasano, Mauro

doi:10.1016/j.jinf.2020.06.042

Cited by 74 publications

(96 citation statements)

References 7 publications

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“…After title and abstract screening, 127 studies entered full-text assessment. Overall, 37 studies ( 24–55 - 56–60 ) were included ( Appendix Figure ), comprising 7169 participants with 7332 paired saliva samples and nasopharyngeal swabs. Summary characteristics of included studies are reported in Table 1 and individual study characteristics in Tables 6 and 7 of Supplement 1 .…”

Section: Resultsmentioning

confidence: 99%

The Sensitivity and Costs of Testing for SARS-CoV-2 Infection With Saliva Versus Nasopharyngeal Swabs

et al. 2021

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Section: Resultsmentioning

confidence: 99%

The Sensitivity and Costs of Testing for SARS-CoV-2 Infection With Saliva Versus Nasopharyngeal Swabs

et al. 2021

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“…When only the C-line is visible, the test is “negative.” The test is “invalid” when the C-line is invisible, regardless of the presence of the T-line. This picture represents the proof of concept and the prototype of the diagnostic test published by our group ( Azzi, Baj, et al. 2020 ).…”

Section: Rapid Salivary Antigen Tests and Point-of-need Devicesmentioning

confidence: 78%

“…Keeping these priorities in mind, we have recently published the results of a study dealing with the diagnostic accuracy of a Rapid Salivary Test (RST) based on the LFA to detect SARS-CoV-2 ( Azzi, Baj, et al 2020 ). The test provided results in less than 10 min, detecting the presence of the spike protein in the salivary sample.…”

Section: Rapid Salivary Antigen Tests and Point-of-need Devicesmentioning

confidence: 99%

Diagnostic Salivary Tests for SARS-CoV-2

et al. 2020

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The diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection relies on the detection of viral RNA by real-time reverse transcription polymerase chain reaction (rRT-PCR) performed with respiratory specimens, especially nasopharyngeal swabs. However, this procedure requires specialized medical personnel, centralized laboratory facilities, and time to provide results (from several hours up to 1 d). In addition, there is a non-negligible risk of viral transmission for the operator who performs the procedure. For these reasons, several studies have suggested the use of other body fluids, including saliva, for the detection of SARS-CoV-2. The use of saliva as a diagnostic specimen has numerous advantages: it is easily self-collected by the patient with almost no discomfort, it does not require specialized health care personnel for its management, and it reduces the risks for the operator. In the past few months, several scientific papers, media, and companies have announced the development of new salivary tests to detect SARS-CoV-2 infection. Posterior oropharyngeal saliva should be distinguished from oral saliva, since the former is a part of respiratory secretions, while the latter is produced by the salivary glands, which are outside the respiratory tract. Saliva can be analyzed through standard (rRT-PCR) or rapid molecular biology tests (direct rRT-PCR without extraction), although, in a hospital setting, these procedures may be performed only in addition to nasopharyngeal swabs to minimize the incidence of false-negative results. Conversely, the promising role of saliva in the diagnosis of SARS-CoV-2 infection is highlighted by the emergence of point-of-care technologies and, most important, point-of-need devices. Indeed, these devices can be directly used in workplaces, airports, schools, cinemas, and shopping centers. An example is the recently described Rapid Salivary Test, an antigen test based on the lateral flow assay, which detects the presence of the virus by identifying the spike protein in the saliva within a few minutes.

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“…The reported viral load of saliva specimens ranged from 9.9 × 10 2 to 1.2 × 10 8 copies/mL (Azzi, Baj, et al 2020; Cheng et al 2020; Han, Seong, Heo, et al 2020; Han, Seong, Kim, et al 2020; Iwasaki et al 2020; To, Tsang, Leung, et al 2020; To, Tsang, Yip, et al 2020; Yoon et al 2020; Zhu et al 2020). In addition to viral load, the efficiency of saliva collection was investigated and compared with oro-/nasopharyngeal swabs for viral detection.…”

Section: Resultsmentioning

confidence: 99%

Saliva in the Diagnosis of COVID-19: A Review and New Research Directions

et al. 2020

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This review presents literature that highlights saliva’s utility as a biofluid in the diagnosis and monitoring of COVID-19. A systematic search was performed in 5 electronic databases (PubMed, Embase, LILACS, Scopus, and Web of Science). Studies were eligible for inclusion if they assessed the potential diagnostic value and/or other discriminatory properties of biological markers in the saliva of patients with COVID-19. As of July 22, 2020, a total of 28 studies have investigated the presence of SARS-CoV-2 RNA in saliva. Several of those studies confirmed reliable detection of SARS-CoV-2 in the saliva of patients with COVID-19. Saliva offered sensitivity and specificity for SARS-CoV-2 detection comparable to that of the current standard of nasopharyngeal and throat swabs. However, the utility of saliva in diagnosing COVID-19 infection remains understudied. Clinical studies with larger patient populations that measure recordings at different stages during the disease are still necessary to confirm the accuracy of COVID-19 diagnosis with saliva. Nevertheless, the utility of saliva as a diagnostic tool opens the possibility of using rapid and less invasive diagnostic strategies by targeting bioanalytes rather than the pathogen.

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Rapid Salivary Test suitable for a mass screening program to detect SARS-CoV-2: A diagnostic accuracy study

Cited by 74 publications

References 7 publications

The Sensitivity and Costs of Testing for SARS-CoV-2 Infection With Saliva Versus Nasopharyngeal Swabs

The Sensitivity and Costs of Testing for SARS-CoV-2 Infection With Saliva Versus Nasopharyngeal Swabs

Diagnostic Salivary Tests for SARS-CoV-2

Saliva in the Diagnosis of COVID-19: A Review and New Research Directions

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