On-Site Testing of Infectious Diseases: SARS-CoV-2
Background: Nucleic acid detection by RT-PCR method is one of the criteria approved by China FDA and US CDC for diagnosis of COVID-19, which requires highly trained personnel and can create inaccurate test results (for example, high false-negative rate and some false positive rate). Inaccurate results are caused by inadequate detection sensitivity of RT-PCR, low viral load in some patients, difficulty to collect samples from COVID-19 patients, insufficient sample loading during RT-PCR tests, and RNA degradation during the sample handling process. False-negative detection could subject patients to multiple tests before a diagnosis can be made, which burdens the health care system. The delayed diagnosis could cause infected patients to miss the best treatment time window. False-negative detection could also lead to prematurely releasing infected patients who still carry residual SARS-CoV-2 virus infecting many others.
Method / Solution: To resolve the existing issues of RT-PCR BiOptic, Inc. (www.bioptic.com.tw) has created a novel solution for a high sensitivity RNA detection method that utilizes a compact field-portable thermal cycler (Qamp-mini) and a miniature Capillary Gel Electrophoresis (Qsep1-LiteTM) system (Figure 1) helping to double-check the end-point PCR product, which the Ct was above 40 (Figures 2, 3 & 4). And since the capillary gel electrophoresis system has much higher fluorescence detection sensitivity it can identify lower copies of collected samples (weaker signal) for faster and more accurate COVID-19 diagnosis.
Summary:
BiOptic’s MDx platform can provide fast, accurate and cost-effective results, which should be suitable for decentralized testing application of COVID-19.
Advantages of BiOptic’s MDx Platform are:
• No DNA/RNA Extraction: saving 30 to 60 mins
• Application Specific Qampmini PCR: One click to go for 8-sample runs
• Post analysis with Qsep1- Lite CGE System: less than 7 min
• Multiple Genes analyzed in one reaction: Multiplex Direct "RT-PCR"
• High Detection Sensitivity: Validation platform for Real-Time PCR
• Cost Effective
• Field Portable
References:
1. Meya Kuo, et all: “Infectious Diseases Detection Platform: COVID-19” Labcompare, May 15, 2020
2. Neo Yang, et all: “Rapid Genetic Identification of Meat” Labcompare, April 25, 2019
3. Neo Yang, et all: “A Portable CGE System for Cell Free DNA Detection” Labcompare, January 29, 2018 4. www.bioptic.com.tw