New COVID-19 testing innovation is a less expensive, quicker choice to tube-based RT-PCR tests

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• Source: Elsevier


• Date: 18 May,2021

Throughout the COVID-19 pandemic, supply chain shortages of reagents and test kits have restricted the rapid expansion of clinical testing required to contain the virus.

Its accuracy was 100 percent predictive in clinical trials, researchers explain in The Journal of Molecular Diagnostics, published by Elsevier.

Sensitivity is critical for early detection of COVID-19 infection where the viral load is minimal to prevent further spreading of the disease. During this pandemic, numerous testing assays have been developed, sacrificing sensitivity for speed and cost. This research offers a cheaper, faster alternative to the most reliable and sensitive test currently used worldwide, without sacrificing sensitivity and reproducibility.”

Peter J. Unrau, PhD, Study Lead Investigator, Department of Molecular Biology and Biochemistry, Simon Fraser University

Researchers validated a microchip PCR technology for detection of SARS-CoV-2 in clinical samples. Empty microchips with 30 microwells were made from aluminum sheets and coated with surface modifiers.

They were then full of CDC-authorized primers and probes to detect SARS-CoV-2. They were individually packaged and delivered to a laboratory for sample testing and identification. Real-time qPCR was performed using 1.2 microliter reaction volume per reaction on a microchip-based PCR analyzer using AriaDNA applications to control the device and get PCR results.

Nasopharyngeal swabs from eight patients with positive COVID-19 test results and 13 patients with negative COVID-19 test results were collected in St. Paul’s Hospital in Vancouver, Canada and tested with the microchip RT-qPCR kit. Of the 21 patient samples, eight tested positive, 12 tested negative, and one contained sample was invalid, which tested negative in both the microchip RT-qPCR assay and hospital testing.

The CDC criteria deemed the sample invalid as the individual internal control wasn’t detected in this sample. The microchip kit miniaturized the response volumes required by 10-fold, resulting in lower reagent consumption and faster assay times (in no more than 30 minutes compared to about 70 minutes), while maintaining the same gold standard in sensitivity as greater volume methods. Since the kit comes preloaded with SARS-CoV-2 primers and probes, it may further decrease operator-associated errors, improving the reliability of analysis in remote settings.

Available internationally, the low-energy (100 watt), compact, lightweight microchip analyzer and COVID-19 detection kits developed by Lumex Instruments Canada and validated by Dr. Unrau and his colleagues may enable point-of-care testing in distant locations, practices, and airports.

“Although additional testing of additional clinical samples and sample types may be required before this assay can be widely deployed,” Dr. Unrau says,”these preliminary results demonstrate a promising, versatile technology that can be easily configured and mobilized to detect infections of current and future emerging viruses, beating current bottlenecks and ensuring a faster response in the future.”