ArticleDiagnostics (Basel, Switzerland)2021
SalivaSTAT: Direct-PCR and Pooling of Saliva Samples Collected in Healthcare and Community Setting for SARS-CoV-2 Mass Surveillance.
Article in Diagnostics (Basel, Switzerland), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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Who cites it
16 citing papers in PubMed, 19 citations in OpenAlex.
- Critical evaluation of strategies to achieve direct real-time PCR detection of swine pathogens in oral fluids.Journal of veterinary diagnostic investigation : official publication of the American Association of Veterinary Laboratory Diagnosticians, Inc · 2023Article
- Recent advances in RNA sample preparation techniques for the detection of SARS-CoV-2 in saliva and gargle.Trends in analytical chemistry : TRAC · 2023Review
- Pooled RNA-extraction-free testing of saliva for the detection of SARS-CoV-2.Scientific reports · 2023Article
- Accelerating the Laboratory Testing Capacity through Saliva Pooling Prior to Direct RT-qPCR for SARS-CoV-2 Detection.Diagnostics (Basel, Switzerland) · 2022Article
- Surveillance testing using salivary RT-PCR for SARS-CoV-2 in managed quarantine facilities in Australia: A laboratory validation and implementation study.The Lancet regional health. Western Pacific · 2022Article
- Article
- The Matrix Effect in the RT-PCR Detection of SARS-CoV-2 Using Saliva without RNA Extraction.Diagnostics (Basel, Switzerland) · 2022Article
- Clinical validation of a multiplex PCR-based detection assay using saliva or nasopharyngeal samples for SARS-Cov-2, influenza A and B.Scientific reports · 2022Article
- Investigation of discordant SARS-CoV-2 RT-PCR results using minimally processed saliva.Scientific reports · 2022Article
- Efficient SARS-CoV-2 Quantitative Reverse Transcriptase PCR Saliva Diagnostic Strategy utilizing Open-Source Pipetting Robots.Journal of visualized experiments : JoVE · 2022Article
- Impact of Thermal Pretreatment of Saliva on the RT-PCR Detection of SARS-CoV-2.Advances in virology · 2022Article
- An improvement of current hypercube pooling PCR tests for SARS-CoV-2 detection.Frontiers in public health · 2022Article
- Feasibility of Rapid Diagnostic Technology for SARS-CoV-2 Virus Using a Trace Amount of Saliva.Diagnostics (Basel, Switzerland) · 2021Article
- Mouth Washing Impaired SARS-CoV-2 Detection in Saliva.Diagnostics (Basel, Switzerland) · 2021Article
- Clinical Validation of a Sensitive Test for Saliva Collected in Healthcare and Community Settings with Pooling Utility for Severe Acute Respiratory Syndrome Coronavirus 2 Mass Surveillance.The Journal of molecular diagnostics : JMD · 2021Article
- Making a Difference: Adaptation of the Clinical Laboratory in Response to the Rapidly Evolving COVID-19 Pandemic.Academic pathologyArticle
Corrections and comments
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Authors and funding
16 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesLimitations of widespread current COVID-19 diagnostic testing exist in both the pre-analytical and analytical stages. To alleviate these limitations, we developed a universal saliva processing protocol (SalivaSTAT) that would enable an extraction-free RT-PCR test using commercially available RT-PCR kits.
methodsWe optimized saliva collection devices, heat-shock treatment, and homogenization. Saliva samples (879) previously tested using the FDA-EUA method were reevaluated with the optimized SalivaSTAT protocol using two widely available commercial RT-PCR kits. A five-sample pooling strategy was evaluated as per FDA guidelines.
resultsSaliva collection (done without any media) showed performance comparable to that of the FDA-EUA method. The SalivaSTAT protocol was optimized by incubating saliva samples at 95 °C for 30-min and homogenization, followed by RT-PCR assay. The clinical sample evaluation of 630 saliva samples using the SalivaSTAT protocol with PerkinElmer (600-samples) and CDC (30-samples) RT-PCR assay achieved positive (PPA) and negative percent agreements (NPAs) of 95.0% and 100%, respectively. The LoD was established as ~60-180 copies/mL by absolute quantification. Furthermore, a five-sample-pooling evaluation using 250 saliva samples achieved a PPA and NPA of 92% and 100%, respectively.
conclusionWe have optimized an extraction-free RT-PCR assay for saliva samples that demonstrates comparable performance to FDA-EUA assay (Extraction and RT-PCR).
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