Non-Invasive Saliva Collection and the Power of RT‑PCR at the Point-of-Care

Easy to collect saliva samples | Easy to operate system

The Sal6830 system is a pathogen detection and gene expression system relevant in both the infectious disease and precision medicine fields.  The Sal6830 saliva test, developed to help address the global COVID-19 pandemic, is the first validated test for the Sal6830 system.

MicroGEM’s technical approach to viral enrichment, RNA extraction, and RT-PCR provides an unparalleled solution to quickly and accurately identify people infected with SARS-CoV-2. Our approach captures intact virus, a strong indicator of a person’s true state of infectivity. Non-invasive and easily administered wherever testing is needed, this technology is a valuable new tool to detect active cases of COVID-19.

MicroGEM's enrichment matrix captures whole virus. A novel thermophilic enzyme achieves RNA extraction. Microfluidic movement allows extracted RNA to be converted to cDNA and detected by RT-PCR amplification.

The Sal6830 system is based on fully automated sample preparation (nanoparticle mediated viral concentration, nucleic acid extraction and purification), followed by RT-PCR amplification and detection.

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RNA from the SARS-CoV-2 Test

The Sal6830 saliva test is a fast, portable, non-invasive real-time reverse transcription polymerase chain reaction (RT-PCR) point of care (POC) test that runs on the Sal6830 system. The test is designed to capture and enrich viruses and cells, including bacteria and epithelial cells, from saliva and then detect extracted RNA from the SARS-CoV-2 virus if present in the saliva specimens.  The testing system automates and integrates saliva sample collection, nucleic acid extraction, reverse transcription, real-time PCR amplification, and detection of the target sequences in a simple design.  

The system consists of an instrument preloaded with software for running the test, interpreting and viewing the results. The system requires the use of single-use disposable saliva collection cups and cartridges that hold the reagents.

Saliva is first gathered in the mouth and then allowed to flow into a single-use disposable saliva collection cup  (included in the test kit). The test is non-invasive and saliva collection is easily self-administered. When the collection cup is sealed with the collection cap provided, an enrichment matrix is used to isolate and concentrate virus particles and cells from the saliva. The use of sealed saliva collection cups and single-use disposable assay cartridges reduces any potential for cross contamination. Once the sealed saliva cup is assembled with the test cartridge and introduced in the instrument to start a run, the device performs a systems-check, processes the sample, performs the analysis, and generates the result output with no further user intervention. At the end of the instrument run, the screen indicates whether the SARS-CoV-2 virus was detected or not detected.

RNA extraction is achieved using elevated temperatures and a thermophilic proteinase, which ensures that RNA is efficiently released, RNases are destroyed, and the virus is inactivated. The extraction is performed in a reaction vessel made from thermally responsive polymers which, at elevated temperature, push the lysate through a purification matrix and into eight PCR chambers where a rapid RT-PCR is conducted using gene specific primers and probes.