Rapid Extraction-Less COVID-19 Diagnostic Assay Detects SARS-CoV-2 in 30 Minutes

A rapid isothermal amplification diagnostic assay for detecting SARS-CoV-2 eliminates the need for RNA extraction and purification, with the sample result occurring in less than 30 minutes.

Prime Discoveries (New York, NY, USA) has developed CovidDetect, a rapid, specific, extraction-less, and cost-effective RT-LAMP test for the detection of SARS-CoV-2 in clinical specimens. The assay uses Mawi DNA Technologies’ (Hayward, CA, USA) new iSWAB Microbiome-EL (Extraction-Less) sample collection technology. This allows RNA release from the sample and maintains stability, protecting it from degradation and allowing room temperature storage and transport. CovidDetect leverages Mawi’s unique iSWAB Microbiome-EL sample collection buffer with Prime’s patented Loop AMPlification (LAMP) technology. This allows isothermal nucleic acid amplification removing the need for expensive thermal cycling equipment required for PCR. The extraction-less protocol bypasses the expensive and complex nucleic acid extraction and purification step, saving 60-90 minutes of sample processing time needed for PCR.

Image: CovidDetect RT-LAMP based detection assay for all known strains of SARS-CoV-2 (Photo courtesy of Prime Discoveries)

Prime has received CE IVD marking for CovidDetect and plans to pursue FDA 510K approval soon. The CE marking will allow the deployment of CovidDetect to countries in Africa and Asia where rapid, inexpensive diagnostics for various infections with minimal technical expertise and equipment infrastructure is highly required.

“The COVID pandemic has shown that there is a big need for rapid diagnostic assays. Prime Discoveries aims to build a portfolio of solutions which can provide results in under 45 minutes with minimal laboratory, reagent and technical skill requirements. This is ideal for point of care testing in rural neighborhoods, mobile testing, border points of entry and clinical locations with minimal infrastructure,” said Arun Manoharan, Ph.D., Chief Science Officer at Prime Discoveries. “Our work with COVID has shown stable performance of the Mawi iSWAB Microbiome-EL for hundreds of clinical samples with similar or superior performance to RT-PCR solutions. Samples have been stable for more than two weeks with minimal RNA degradation along with high compatibility with our isothermal nucleic acid amplification techniques.”

“Our partnership with Mawi enables Prime Discoveries to develop room temperature sampling with Extraction-Less capabilities for our rapid diagnostic solutions in many areas. These include influenza, chlamydia, gonorrhea, trichomonas, HBV, HCV, HPV, TB, herpes, syphilis, etc.,” added Manoharan “We are excited to partner with Mawi for future products empowering customers to test thousands of patients rapidly for various infections including respiratory, gastrointestinal, sexually transmitted pathogens and those with anti-microbial resistance.”

Related Links:
Mawi DNA Technologies 
Prime Discoveries