2023 FDA Science Forum
Direct Detection and Identification of Viruses in Saliva in Real-Time Using a SpecID™ Mass Spectrometer
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Contributing OfficeNational Center for Toxicological Research
Abstract
The COVID-19 (SARS-CoV-2) pandemic has led to a significant number of negative health consequences and deaths globally. Accurate early diagnosis, surveillance, and prophylaxis are considered essential measures to reduce the spread of SARS-CoV-2. There remains a need for a reliable, fast, high-throughput screening method to identify individuals infected with SAR-CoV-2. Since respiratory viruses are typically present in nasal and oral secretions, saliva could be a good target for testing. Polymerase chain reaction (PCR) remains the most sensitive detection method of SARS-CoV-2 infection in biological samples at down to 500 virions per ml, and is widely used by hospitals; however, PCR has a false-negative rate of 15–20% . Although ELISA tests are now relatively common, they are less sensitive and associated with even higher rates of false negatives. Saliva testing has slowly gained popularity in the diagnostic market for testing, based on biomarkers and other constituents ranging from organic compounds (e.g., food additives) and peptides to microorganism and viral pathogens, including SARS-CoV-2. In this study, the SpecID mass spectrometer was evaluated for the detection of viruses in saliva at very low levels, in seconds, and with no sample prep. The main goal of the study was to investigate the ability of a portable, high-throughput, rapid, modified mass spectrometer to detect viruses in saliva. The platform is not limited to SARS-CoV-2 but can potentially detect any virus in saliva and other body fluids. While work is being done to expand the utility of the platform, the portability and speed could make it useful in the field for screening patients, such as in hospital triage areas, or public health laboratories.
