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1.
Clinical Cancer Research ; 27(6 SUPPL 1), 2021.
Article in English | EMBASE | ID: covidwho-1816890

ABSTRACT

Objectives Sensitive and high throughput molecular testing availability is essential during the COVID-19 pandemic. The vast majority of the SARS-CoV-2 molecular assays use nasopharyngeal or oropharyngeal swab specimens collected from suspected individuals. However, collecting these specimens has apparent drawbacks, including discomfort to patients and exposure risk to healthcare workers. Methods We developed and validated of QuantiVirus™ SARS-CoV-2 multiplex test using saliva as the testing specimens with pooling. Results The analytical sensitivity (LOD) was confirmed to be 100-200 copies/mL. For clinical evaluation, 85 known positive and 90 knowns negative NPS specimens were showed a positive predictive agreement of 100% and a negative predictive agreement of 98.9%. Twenty paired NPS and saliva samples were tested and showed overall 80% concordance rate without significant difference between NPS and saliva specimens by Wilcoxon signed-rank test (p=0.13). On a large scale of saliva-based population screening, the positive test rate was 1.79% among 389 saliva specimens. Furthermore, saliva sample pooling up to 6 samples for SARS-CoV-2 detection is feasible with sensitivity of 94.8% and specificity of 100%. Conclusions These results demonstrated that the clinical performance of saliva-based testing is comparable to that of NPS-based testing, and that pooling of saliva specimens for SARS-CoV-2 detection is feasible.

2.
PLoS ONE ; 16(2), 2021.
Article in English | CAB Abstracts | ID: covidwho-1410710

ABSTRACT

Background: Sensitive and high throughput molecular detection assays are essential during the coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The vast majority of the SARS-CoV-2 molecular assays use nasopharyngeal swab (NPS) or oropharyngeal swab (OPS) specimens collected from suspected individuals. However, using NPS or OPS as specimens has apparent drawbacks, e.g. the collection procedures for NPS or OPS specimens can be uncomfortable to some people and may cause sneezing and coughing which in turn generate droplets and/or aerosol particles that are of risk to healthcare workers, requiring heavy use of personal protective equipment. There have been recent studies indicating that self-collected saliva specimens can be used for molecular detection of SARS-CoV-2 and provides more comfort and ease of use for the patients. Here we report the performance of QuantiVirusTM SARS-CoV-2 test using saliva as the testing specimens with or without pooling. Methods Development and validation studies were conducted following FDA-EUA and molecular assay validation guidelines. Using SeraCare Accuplex SARS-CoV-2 reference panel, the limit of detection (LOD) and clinical performance studies were performed with the QuantiVirusTM SARS-CoV-2 test. For clinical evaluation, 85 known positive and 90 known negative clinical NPS samples were tested. Additionally, twenty paired NPS and saliva samples collected from recovering COVID-19 patients were tested and the results were further compared to that of the Abbott m2000 SARS-CoV-2 PCR assay. Results of community collected 389 saliva samples for COVID-19 screening by QuantiVirusTM SARS-CoV-2 test were also obtained and analyzed. Additionally, testing of pooled saliva samples was evaluated.

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