New England Biolabs Inc. (NEB) has launched its research use only product that can be utilized for the detection of the novel coronavirus, SARS-CoV-2 RNA. It is intended to serve as an alternative to RT-qPCR, enabling visual detection of amplification of SARS-CoV-2 nucleic acid in half an hour.

"RT-qPCR, the predominant nucleic acid amplification technology, requires a laboratory with sophisticated equipment, and can take hours to produce a readout," said Steven Chiu, product marketing manager, DNA Amplification, at Ipswich, Mass.-based NEB. "With the SARS-CoV-2 Rapid Colorimetric LAMP assay kit, all you need is a simple heat source and 30 minutes to visually detect amplification of SARS CoV-2 RNA. This assay thus has the potential to be very beneficial in a low-resource or point-of-care setting."

NEB supplies scientists globally, offering recombinant and native enzymes for genomic research. It also is eyeing alliances that enable new technologies to reach key market sectors, including molecular diagnostics development.

LAMP

The SARS-CoV-2 Rapid Colorimetric LAMP assay was carried out using the indicated controls and either positive or negative sample. Valid results for Non-Template Control (NTC, pink), Positive Control (PC, yellow) and Internal Control (IC, yellow) are shown. In the positive test sample, isothermal amplification of SARS-CoV-2 RNA leads to a color change from pink to yellow. Credit: New England Biolabs Inc.

Of note, the kit uses loop-mediated isothermal amplification (LAMP) to detect specific segments of the viral genome. It is an isothermal approach to nucleic acid amplification that does not require the thermal cycling of PCR. It allows for the use of more portable as well as less expensive instruments, or even simple incubators or water baths. Further, LAMP tends to produce more DNA than PCR and in a more rapid incubation time.

This latest offering uses a clear visual detection of amplification, based on the generation of protons and the subsequent drop in pH that occurs from the DNA polymerase activity in a LAMP reaction. A decrease in pH produces a color change, with pink indicating a negative result and yellow indicating a positive one.

Ted Davis, executive director, business and product development at NEB, noted that many of his company’s products are being used by customers to develop and manufacture vaccines and diagnostic tools to battle the pandemic. "This kit further solidifies NEB's position as a supplier for virologists and molecular diagnostics developers alike, and we are proud to continue our support of COVID-19 research."

This is not the first time the company has worked to help combat COVID-19. For example, it reported May 26 that it had pledged $100,000 to the Vaccine and Immunotherapy Center at Mass General Hospital. The funds were earmarked for finding a vaccine against SARS-CoV-2.

LAMP vs. PCR

The U.S. FDA has granted emergency use authorizations to a host of tests during the current pandemic, most of which have been designed to detect viral RNA via PCR methods. Test developers and researchers have toiled to come up with new approaches to testing, such as research into LAMP. In fact, researchers opined in an article that was published April 7, 2020, in the Journal of Molecular Diagnostics that this approach, which the authors claim offers sensitivity comparable to PCR, is suitable for point-of-care deployment.

Other researchers also see hope with LAMP. Writing in The Journal of Molecular Diagnostics in an article appearing April 25, 2020, researchers put forward the idea "that recent advancements in enhanced LAMP protocols assay perhaps represent the best chance for a rapid and robust assay for field diagnosis of COVID-19[.]” As others have noted, they said it would not require specialized equipment or highly trained professionals to assess the results.

NEB noted that LAMP assays have also been designed for the detection of a range of RNA and DNA targets from a host of sample types. Beyond COVID-19, tests are available for filariasis in humans and insects, food and water quality in-field applications and detection of the Zika virus in human samples.

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