PCR System Moves Ultra-Fast Testing From Lab to Patients at Point of Need

A next generation person-portable diagnostic device aims to move complex molecular biology testing out of highly skilled laboratories to non-laboratory settings where they can be used quickly at the point of need.

MicroGEM International’s (Charlottesville, VA, USA) Sal6830 Point of Care PCR System is a pathogen detection and gene expression system relevant in both the infectious disease and precision medicine fields, and produces lab-quality results in 27 minutes. Its innovative cartridge design allows new targets to be added or replaced quickly, significantly reducing both assay and product development time. The platform's small size is easily incorporated at testing sites such as mobile testing labs, ambulatory surgical centers, emergency departments, and CLIA-waived testing sites at the workplace.

Image: Sal6830 Point of Care PCR System (Photo courtesy of MicroGEM International)

The Sal6830 SARS-CoV-2 Saliva Test is the first validated test for the Sal6830 Point of Care PCR System. It is also the first FDA emergency use authorized saliva test for SARS-CoV-2 using PCR directly at the point of care where people can wait for fast results after providing a sample. 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 specimen. The approach automates and integrates saliva sample collection, nucleic acid extraction, reverse transcription, real-time ultra-fast PCR amplification, and detection of the target sequences in a simple design.  The technology employs simplified automation with essentially no moving parts and provides easy-to-read visual cues indicating whether SARS-CoV-2 is detected (+) or not detected (-)

Clinically tested during both the Delta and Omicron waves of the pandemic, the Sal6830 SARS-CoV-2 Saliva Test has proven to be robust through the viral mutations that have occurred. The Sal6830 SARS-CoV-2 Saliva Test is easy to operate. Its simple workflow and easy saliva collection reduce workload for healthcare workers and limit their exposure to the sample. Requiring only a small amount of saliva, it eliminates the discomfort of swab testing, making it more comfortable for routine testing. The company's plans include seeking authorization to expand the test menu and ruggedize the system to address austere field conditions presented in military and disaster medicine. Plans are also underway to adapt the system for the fast-growing precision medicine healthcare market with quantitative gene expression panels used as biomarkers.

"The introduction of the MicroGEM Sal6830 Point of Care PCR System marks a historic step in our mission to democratize molecular diagnostics by moving ultra-fast, high-performance testing out of laboratories and closer to people at the point of need, thus allowing decisions to be made in real time," said MicroGEM CEO Jeff Chapman.

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MicroGEM International