Manufacturing sites are ramping up production of reagents needed to isolate SARS-CoV-2’s genetic material—a key step in testing for the virus.
An RNA extraction kit that is in high demand for COVID-19 testing is on backorder, Germany-based diagnostics and biological supplies company Qiagen tells Politico. At manufacturing sites in Hilden, Germany, and Barcelona, Spain, workers are now staffing three shifts, seven days a week, a Qiagen spokesperson tells STAT, and the company is attempting to make the kits at its Germantown, Maryland, site as well.
The US Food and Drug Administration recently approved the use of another RNA extraction kit made by Roche, Denny Russell, who is leading the coronavirus response for the Washington State Public Health Laboratory, tells Politico. But labs must be equipped to use the Roche method, which requires different equipment than the Qiagen kit does. Michael Mina, a pathologist and assistant professor at the Harvard School of Public Health, tells STAT that Roche’s test is also on backorder. “[It’s] a very big problem.” He adds to Politico, “RNA extraction is the first step in being able to perform [a coronavirus test]. If we cannot perform this step, the [coronavirus] test cannot be performed.”
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So far, approximately 5,000 people in the US have been tested for coronavirus (yielding 647 confirmed COVID-19 cases), and that number is expected to grow rapidly. Until recently, public health labs have been running at least two separate tests for each patient, but the Centers for Disease Control and Prevention (CDC) released updated guidelines on Monday (March 9) that allow labs to combine samples from the nose and throat into one test, halving the number of extraction kits needed. CDC Director Robert Redfield tells Politico that he doesn’t know what his agency would do if RNA extraction kits and reagents become unavailable.
In addition to dwindling reagents for the RNA extraction kits, there is also a shortage of the chemicals needed for SARS-CoV-2 PCR test kits. “We are deeply concerned that as the number of tests increases dramatically over the coming weeks, clinical labs will be unable to deploy them without these critical components,” the American Society of Microbiology (ASM) says about the PCR reagents in a statement. “Increased demand for testing has the potential to exhaust supplies needed to perform the testing itself.”
ASM applauds the CDC’s guidance to use only one test per person, and further commends the agency’s expanded testing criteria released earlier this week “to guide clinicians in deciding who should be tested based on risk, exposure and symptoms.”