Saliva-based PCR tests for SARS-CoV-2 detection

Takeuchi, Yoshimasa; Furuchi, Mika; Kamimoto, Atsushi; Honda, Kazumasa; Matsumura, Hideo; Kobayashi, Ryosuke

doi:10.2334/josnusd.20-0267

Cited by 46 publications

(47 citation statements)

References 6 publications

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“…Differences in sensitivity have been reported among various upper respiratory specimens including nasopharyngeal, oropharyngeal, midturbinate, anterior nares, and saliva. 15-17 Therefore, our results cannot be extrapolated to other specimen types. Further, several publications have demonstrated increased detection rates in lower respiratory specimens, 18 , 19 including instances of symptomatic patients with negative nasopharyngeal but positive bronchioalveolar lavage results.…”

Section: Discussionmentioning

confidence: 91%

Distribution of SARS-CoV-2 PCR Cycle Threshold Values Provide Practical Insight Into Overall and Target-Specific Sensitivity Among Symptomatic Patients

Buchan

Hoff

Gmehlin

et al. 2020

American Journal of Clinical Pathology

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Objectives We examined the distribution of reverse transcription polymerase chain reaction (RT-PCR) cycle threshold (CT) values obtained from symptomatic patients being evaluated for coronavirus disease 2019 (COVID-19) to determine the proportion of specimens containing a viral load near the assay limit of detection (LoD) to gain practical insight to the risk of false-negative results. We also examined the relationship between CT value and patient age to determine any age-dependent difference in viral load or test sensitivity. Methods We collected CT values obtained from the cobas severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) assay corresponding to 1,213 combined nasopharyngeal-oropharyngeal specimens obtained from symptomatic individuals that were reported as positive or presumptive positive for SARS-CoV-2. CT values were stratified by SARS-CoV target and patient age group. Results In total, 93.3% to 98.4% of specimens demonstrated CT values greater than 3× the assay LoD, at which point false-negative results would not be expected. The mean of CT values between age groups was statistically equivalent with the exception of patients in age group 80 to 89 years, which demonstrated slightly lower CTs. Conclusions Based on the distribution of observed CT values, including the small proportion of specimens with values near the assay LoD, there is a low risk of false-negative RT-PCR results in combined nasopharyngeal-oropharyngeal specimens obtained from symptomatic individuals.

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Section: Discussionmentioning

confidence: 91%

Distribution of SARS-CoV-2 PCR Cycle Threshold Values Provide Practical Insight Into Overall and Target-Specific Sensitivity Among Symptomatic Patients

Buchan

Hoff

Gmehlin

et al. 2020

American Journal of Clinical Pathology

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“…These results confirm the possibility of the presence of SARS-CoV-2 in saliva [ 17 , 23 ]. Thus, several dental clinics in Japan are currently performing pre-clinical COVID-19 PCR tests using a saliva-based detection kit [ 24 ].…”

Section: Discussionmentioning

confidence: 99%

Saliva specimens for detection of severe acute respiratory syndrome coronavirus 2 in Kuwait: A cross-sectional study

Altawalah

Alhuraish

Alkandari

et al. 2020

Journal of Clinical Virology

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“…CDC guidance recommends nasopharyngeal (NP) swabs for collection of samples for SARS-CoV-2 RT-PCR testing (13). NP sample collection can be uncomfortable, is not suitable for self-collection, and puts the health care professional at risk of infection (14,15). Some of the challenges for collection of NP sample include: (i) Difficulty in collection as the NP probe must be inserted deep into the nostril causing discomfort to the patient and often a gag/cough response.…”

Section: Introductionmentioning

confidence: 99%

COVID-19 Diagnostic Testing For All - Using Non-Dilutive Saliva Sample Collection, Stabilization and Ambient Transport Devices

Carrington

Orlino

Romero

et al. 2021

Preprint

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COVID-19 testing is not accessible for millions during this pandemic despite our best efforts. Without greatly expanded testing of asymptomatic individuals, contact tracing and subsequent isolation of spreaders remains as a means for control. In an effort to increase RT-PCR assay testing for the presence of the novel beta-coronavirus SARS-CoV-2 as well as improve sample collection safety, GenTegra LLC has introduced two products for saliva collection and viral RNA stabilization: GTR-STM™ (GenTegra Saliva Transport Medium) and GTR-STMdk™ (GenTegra Saliva Transport Medium Direct to PCR). Both products contain a proprietary formulation based on GenTegra’s novel “Active Chemical Protection™” (ACP) technology that gives non-dilutive, error-free saliva sample collection using RNA stabilization chemicals already dried in the collection tube.GTR-STM can be used for safer saliva-based sample collection at home (or at a test site). Following saliva collection, the sample-containing GTR-STM can be kept at ambient temperature during shipment to an authorized CLIA lab for analysis. SARS-CoV-2 viral RNA in GTR-STM is stable for over a month at ambient temperature, easily surviving the longest transit times from home to lab. GTR-STM enhances patient comfort, convenience, compliance and reduces infectious virus exposure to essential medical and lab professionals.Alternatively, the GTR-STMdk direct-into-PCR product can be used to improve lab throughput and reduce reagent costs for saliva sample collection and testing at any lab site with access to refrigeration. GTR-STMdk reduces lab process time by 25% and reagent costs by 30% compared to other approaches. Since GTR-STMdk retains SARS-CoV-2 viral RNA stability for three days at ambient temperature, it is optimized for lab test site rather than at home saliva collection. SARS-COV-2 viral RNA levels as low as 0.4 genome equivalents/uL are detected in saliva samples using GTR-STMdk. The increased sensitivity of SARS-CoV-2 detection can expand COVID-19 testing to include asymptomatic individuals using pooled saliva.One Sentence SummaryGTR-STM and Direct-into-PCR GTR-STMdk offer substantive improvements in SARS-CoV-2 viral RNA stability, safety, and RT-PCR process efficiency for COVID-19 testing by using a non-dilutive saliva sample collection system for individuals at home or onsite respectively.

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Saliva-based PCR tests for SARS-CoV-2 detection

Cited by 46 publications

References 6 publications

Distribution of SARS-CoV-2 PCR Cycle Threshold Values Provide Practical Insight Into Overall and Target-Specific Sensitivity Among Symptomatic Patients

Distribution of SARS-CoV-2 PCR Cycle Threshold Values Provide Practical Insight Into Overall and Target-Specific Sensitivity Among Symptomatic Patients

Saliva specimens for detection of severe acute respiratory syndrome coronavirus 2 in Kuwait: A cross-sectional study

COVID-19 Diagnostic Testing For All - Using Non-Dilutive Saliva Sample Collection, Stabilization and Ambient Transport Devices

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