The vaccine effect on SARS-CoV-2 testing

With the roll out of the first vaccinations, there is hope that things will begin to go back to normal. So what is the outlook for SARS-CoV-2 testing in 2021? Many testing labs are asking that question. 

While there is no crystal ball, many in the in vitro diagnostics industry expect that high testing demand will continue throughout at least the first half of this year. It’s likely that this high demand will continue to stress testing capacity around the world.

We have already experienced several surges in COVID-19 cases in multiple countries including the United States. We may experience new surges driven by the emergence of SARS-CoV-2 variants with greater transmissibility and possible impacts on vaccine effectiveness. Depending on multiple factors, however, projections from the Institute for Health Metrics and Evaluation indicate that COVID-19 cases and testing in the U.S. may plateau in the months ahead.

A plan to deal with peaks and valleys in COVID-19 testing

Laboratories may be thinking about how to transition from SARS-CoV-2 dominating their everyday processes to becoming a more manageable and permanent resident in the laboratory. In the long term, many predict there will still be community outbreaks. These will require high volume testing in short bursts. So how does a testing lab juggle reserving throughput for SARS-CoV-2 while meeting other testing demands? 

One solution is to dedicate a single platform to SARS-CoV-2. This would free other platforms for their pre-COVID uses. Such a single, dedicated SARS-CoV-2 platform would require a consistent supply chain during swings in testing volume.

Mammoth Bioscience’s high-throughput testing solution

The Mammoth Biosciences DETECTR BOOST® SARS-CoV-2 reagent kit is a high-throughput system that will utilize customized Agilent Bravo or Hamilton Microlab® CRISPRdetect STAR™ liquid handlers to process thousands of samples per day with less than 1 hour of hands-on time. This will be up to 5 times more tests than most other high-throughput platforms. Enabled by the speed of CRISPR, this automated platform will compress the time from sample to result. Using CRISPR detection reagents, the DETECTR BOOST® SARS-CoV-2 reagent kit will have less supply chain risk and comes with all reagents required for extraction through detection. 

DETECTR BOOST® SARS-CoV-2 reagent kit meets the needs of today and tomorrow. It can provide the extra capacity needed as either your lab’s primary SARS-CoV-2 testing solution or as a backup should other platforms fail. Once testing plateaus and begins to recede, the platform can easily handle impending swings in SARS-CoV-2 testing volume in a single batch per day. This will reduce the need to juggle other assays on other platforms. Once SARS-CoV-2 testing falls to less than 1,000 test per day, the DETECTR BOOST® SARS-CoV-2 Reagent Kit will be able to handle your entire SARS-CoV-2 testing volume in 4 hours or less. 

Our DETECTR BOOST®SARS-CoV-2 Reagent Kit is not expected to be impacted by the emerging B.1.1.7 and B.1.315 SARS-CoV-2 variants based on in silico analyses and experimental data. Mammoth will continue to monitor emerging SARS-CoV-2 variants as they arise. Beyond the current crisis, this reprogrammable platform may be able to test for other pathogens in the future.

This project is supported by the NIH Rapid Acceleration of Diagnostics (RADx) program and has been funded in whole or in part with Federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92020C00011.

This product has not been FDA cleared or approved, it has been authorized by the FDA under an Emergency Use Authorization. This product has been authorized only for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, anterior nasal, mid-turbinate nasal or oropharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider, not for any other viruses or pathogens and only with the Agilent Bravo BenchCel DB liquid handling platform.

The emergency use of this test is limited to authorized laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet requirements to perform high complexity tests, and for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

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