Observational studyDisease markers2022
Validation of a Saliva-Based Test for the Molecular Diagnosis of SARS-CoV-2 Infection.
Observational study in Disease markers, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The effect of sample site and collection procedure on identification of SARS-CoV-2 infection.The Cochrane database of systematic reviews · 2024Pooled it
- Application of a Saliva-Based Liquid Biopsy for the Detection of HPV in Patients With Oral Cavity Squamous Cell Carcinoma (OCSCC).Head & neck · 2026Article
- Recent advances in RNA sample preparation techniques for the detection of SARS-CoV-2 in saliva and gargle.Trends in analytical chemistry : TRAC · 2023Review
- Acceptability and Feasibility of Saliva-delivered PCR Coronavirus 2019 Tests for Young Children.Pediatrics · 2023Article
- Accuracy of saliva for SARS-CoV-2 detection in outpatients and their household contacts during the circulation of the Omicron variant of concern.BMC infectious diseases · 2023Article
- Taking a step back from testing: Preanalytical considerations in molecular infectious disease diagnostics.Clinical biochemistry · 2023Review
- Validation of RT-qPCR test for SARS-CoV-2 in saliva specimens.Journal of infection and public health · 2022Article
- Comparison of SARS-CoV-2 Detection from Saliva Sampling and Oropharyngeal Swab.Microbiology spectrum · 2022Article
- Validation of a Saliva-Based Test for the Molecular Diagnosis of SARS-CoV-2 Infection.Disease markers · 2022Observational
- Comprehensive analytical and clinical evaluation of a RNA extraction-free saliva-based molecular assay for SARS-CoV-2.PloS one · 2022Article
Corrections and comments
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSince the beginning of the pandemic, clinicians and researchers have been searching for alternative tests to improve the screening and diagnosis of the SARS-CoV-2 infection. Currently, the gold standard for virus identification is the nasopharyngeal (NP) swab. Saliva samples, however, offer clear, practical, and logistical advantages but due to a lack of collection, transport, and storage solutions, high-throughput saliva-based laboratory tests are difficult to scale up as a screening or diagnostic tool. With this study, we aimed to validate an intralaboratory molecular detection method for SARS-CoV-2 on saliva samples collected in a new storage saline solution, comparing the results to NP swabs to determine the difference in sensitivity between the two tests.
methodsIn this study, 156 patients (cases) and 1005 asymptomatic subjects (controls) were enrolled and tested simultaneously for the detection of the SARS-CoV-2 viral genome by RT-PCR on both NP swab and saliva samples. Saliva samples were collected in a preservative and inhibiting saline solution (Biofarma Srl). Internal method validation was performed to standardize the entire workflow for saliva samples.
resultsThe identification of SARS-CoV-2 conducted on saliva samples showed a clinical sensitivity of 95.1% and specificity of 97.8% compared to NP swabs. The positive predictive value (PPV) was 81% while the negative predictive value (NPV) was 99.5%. Test concordance was 97.6% (Cohen's Kappa = 0.86; 95% CI 0.81-0.91). The LoD of the test was 5 viral copies for both samples.
conclusionsRT-PCR assays conducted on a stored saliva sample achieved similar performance to those on NP swabs, and this may provide a very effective tool for population screening and diagnosis. Collection of saliva in a stabilizing solution makes the test more convenient and widely available; furthermore, the denaturing properties of the solution reduce the infective risks belonging to sample manipulation.
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