Saliva as an Alternate Specimen Source for Detection of SARS-CoV-2 in Symptomatic Patients Using Cepheid Xpert Xpress SARS-CoV-2

McCormick-Baw, Clare; Morgan, Kristi; Gaffney, Donna; Cazares, Yareli; Jaworski, Karen; Byrd, Adrienne; Molberg, Kyle; Cavuoti, Dominick

doi:10.1128/jcm.01109-20

Cited by 126 publications

(181 citation statements)

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“…Here, we present evidence for the clinical usefulness of saliva specimens in diagnosing COVID-19. Previous studies reported that the sensitivity of RT-qPCR-analyzed saliva specimens was 69.2-100% for COVID-19 compared with the initial diagnosis using throat and nasopharyngeal swabs initially collected from hospitalized patients (12)(13)(14)(15)(16)(17)(18)20). The difference in sensitivity probably reflects differences in the clinical background and timing of sampling in each study.…”

Section: Discussionmentioning

confidence: 96%

“…Previously reported sensitivities of RT-qPCR assays were lower for upper respiratory specimens (32-61% for pharyngeal swabs and 63-73% for nasopharyngeal swabs) than they were for lower respiratory specimens (72-93% for sputum and 93-100% for bronchoalveolar lavage fluid) (9)(10)(11). Recently, several reports highlighted the clinical usefulness of RT-qPCR analysis of saliva specimens (12)(13)(14)(15)(16)(17)(18). Saliva specimens can be easily collected by the patients themselves by spitting into a collection tube; thus, using saliva specimens can reduce the burden on a patient, reduce the risk of exposure to viral droplets for medical workers, and reduce the time (1.38-fold shorter) and cost (2.09-fold lower) of the testing procedure compared to using nasopharyngeal swabs (19).…”

Section: Introductionmentioning

confidence: 99%

“…Saliva specimens can be easily collected by the patients themselves by spitting into a collection tube; thus, using saliva specimens can reduce the burden on a patient, reduce the risk of exposure to viral droplets for medical workers, and reduce the time (1.38-fold shorter) and cost (2.09-fold lower) of the testing procedure compared to using nasopharyngeal swabs (19). However, the clinical usefulness of saliva specimens for diagnosing COVID-19 remains controversial because the reported diagnostic sensitivity varies widely between 69.2 and 100%, and it has yet to be thoroughly evaluated due to small sample sizes and lack of detailed clinical information (12)(13)(14)(15)(16)(17)(18)20).…”

Section: Introductionmentioning

confidence: 99%

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Clinical Evaluation of Self-Collected Saliva by Quantitative Reverse Transcription-PCR (RT-qPCR), Direct RT-qPCR, Reverse Transcription–Loop-Mediated Isothermal Amplification, and a Rapid Antigen Test To Diagnose COVID-19

et al. 2020

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Background: The clinical performance of six molecular diagnostic tests and a rapid antigen test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were clinically evaluated for the diagnosis of coronavirus disease 2019 (COVID-19) in self-collected saliva. Methods: Saliva samples from 103 patients with laboratory-confirmed COVID-19 (15 asymptomatic and 88 symptomatic) were collected on the day of hospital admission. SARS-CoV-2 RNA in saliva was detected using a quantitative reverse-transcription polymerase chain reaction (RT-qPCR) laboratory-developed test (LDT), a cobas SARS-CoV-2 high-throughput system, three direct RT-qPCR kits, and reverse-transcription loop mediated isothermal amplification (RT-LAMP). The viral antigen was detected by a rapid antigen immunochromatographic assay. Results: Of the 103 samples, viral RNA was detected in 50.5–81.6% of the specimens by molecular diagnostic tests and an antigen was detected in 11.7% of the specimens by the rapid antigen test. Viral RNA was detected at a significantly higher percentage (65.6–93.4%) in specimens collected within 9 d of symptom onset compared to that of specimens collected after at least 10 d of symptom onset (22.2–66.7%) and that of asymptomatic patients (40.0–66.7%). Conclusions: Self-collected saliva is an alternative specimen option for diagnosing COVID-19. LDT RT-qPCR, cobas SARS-CoV-2 high-throughput system, direct RT-qPCR except for one commercial kit, and RT-LAMP showed sufficient sensitivity in clinical use to be selectively used according to clinical settings and facilities. The rapid antigen test alone is not recommended for initial COVID-19 diagnosis because of its low sensitivity.

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Section: Discussionmentioning

confidence: 96%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Clinical Evaluation of Self-Collected Saliva by Quantitative Reverse Transcription-PCR (RT-qPCR), Direct RT-qPCR, Reverse Transcription–Loop-Mediated Isothermal Amplification, and a Rapid Antigen Test To Diagnose COVID-19

et al. 2020

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“…Several studies have suggested that the relative sensitivity of self-collected saliva specimens compared with nasopharyngeal specimens is more than 85% [ [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] ]. However, the methods and instructions on collection varied between the studies and the optimal method remains uncertain, from gargling with saline solutions, spitting, collection of drools, or use of pipet of special sponges [ 18 , 19 , 22 , [24] , [25] , [26] , [27] ]. The use of deep-throat saliva, which is the self-collection of the posterior oropharyngeal secretion, was particularly studied in depth.…”

Section: Specimen Typesmentioning

confidence: 99%

Laboratory testing for the diagnosis of COVID-19

Lai

Lam

2021

Biochemical and Biophysical Research Communications

102

104

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Rapid and accurate laboratory diagnosis of active COVID-19 infection is one of the cornerstones of pandemic control. With the myriad of tests available in the market, the use of correct specimen type and laboratory-testing technique in the right clinical scenario could be challenging for non-specialists. In this mini-review, we will discuss the difference in diagnostic performance for different upper and lower respiratory tract specimens, and the role of blood and fecal specimens. We will analyze the performance characteristics of laboratory testing techniques of nucleic acid amplification tests, antigen detection tests, antibody detection tests, and point-of-care tests. Finally, the dynamics of viral replication and antibody production, and laboratory results interpretation in conjunction with clinical scenarios will be discussed.

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“…In the following weeks, other studies investigated the role of saliva as a diagnostic tool by also recruiting symptomatic patients with a milder form of the disease ( Becker et al 2020 ; Caulley et al. 2020 ; Iwasaki et al 2020 ; Jamal et al 2020 ; Kim, Lee, et al 2020 ; McCormick-Baw et al 2020 ; Migueres et al. 2020 ; Nagura-Ikeda et al 2020 ; Pasomsub et al 2020 ; Williams et al 2020 ; Wyllie et al 2020 ).…”

Section: The Detection Of Sars-cov-2 In Salivamentioning

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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Saliva as an Alternate Specimen Source for Detection of SARS-CoV-2 in Symptomatic Patients Using Cepheid Xpert Xpress SARS-CoV-2

Abstract: Among the many facets of the SARS-CoV-2 pandemic is the unprecedented pressure it has placed on different points of the supply chain for hospital systems worldwide such as collection devices for the diagnosis of COVID-19.…

Cited by 126 publications

References 0 publications

Clinical Evaluation of Self-Collected Saliva by Quantitative Reverse Transcription-PCR (RT-qPCR), Direct RT-qPCR, Reverse Transcription–Loop-Mediated Isothermal Amplification, and a Rapid Antigen Test To Diagnose COVID-19

Clinical Evaluation of Self-Collected Saliva by Quantitative Reverse Transcription-PCR (RT-qPCR), Direct RT-qPCR, Reverse Transcription–Loop-Mediated Isothermal Amplification, and a Rapid Antigen Test To Diagnose COVID-19

Laboratory testing for the diagnosis of COVID-19

Diagnostic Salivary Tests for SARS-CoV-2

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