Clinical diagnostic testing has been a major bottleneck throughout the global response to the COVID-19 pandemic, with severe shortages of testing reagents, lack or slow adaptation of existing infrastructure to administer tests, and very rapidly growing demand that is outpacing supply. The extraordinary demand for COVID-19 testing has strained the production capabilities of vendors in the nucleic acid preparation (NA prep) market.
Sars-cov-19, the coronavirus responsible for the COVID-19 illness, encodes its genome in a single-stranded RNA. In vitro diagnosis of COVID-19 is done by qPCR, but first RNA must be extracted from a patient sample and reverse transcribed. But the production requirements for RNA extraction kits, which are required to be free of RNase enzymes which degrade samples, makes it difficult to quickly scale up production or convert production facilities for making RNA extraction consumables.
“We have gone from 4,500 samples per week to 2 million samples per week processed with our recommended nucleic acid extraction kit”
As demand for RNA extraction skyrockets, vendors are stepping up to the challenge. “We have seen an exponential rise in demand for our nucleic acid extraction kits due to COVID-19 testing needs. We have gone from 4,500 samples per week to 2 million samples per week processed with our recommended nucleic acid extraction kit,” said Nathan Harris, Senior Product Manager, Sample Prep., at Thermo Fisher Scientific.
Robert Reitze, Senior Manager, Public Relations, at QIAGEN, commented, “We are doing everything we can to ramp up productions. [We have] expanded the capacities at our manufacturing sites in Germany and Spain dramatically—moving from 1.5 million RNA extractions per month to 20 million in the second half of the year (each extraction supports one test).” Mr. Reitze continued, “The actions we have taken included new hires, moving to three shifts working 24/7, a switch to larger kit sizes, and the utilization of our manufacturing capacity in Germantown, Maryland” Demand for RNA prep is expected to continue its unprecedented growth through the year, as reopening efforts move forward.
QIAGEN and Thermo Fisher have both adapted their products and product formats in response to the COVID-19 crisis. Mr. Reitz said “[QIAGEN is] encouraging the use of larger kit sizes to facilitate production of higher volumes.” Meanwhile, “[Thermo Fisher has] optimized the nucleic acid extraction protocol in order to make it as simple as possible and to maximize the number of samples that can be processed with our kits,” said Mr. Harris. “To do this, we reduced the amount of sample required per test and we eliminated a step at the end of the protocol to save time and materials. These changes would not necessarily make sense if we were working with other microorganisms and collection media, but it did for this particular coronavirus and the media it is stored in.”
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