The role of diagnostic and surveillance testing in the COVID-19 pandemic is unquestionably critical, but the volume and type of tests needed to bring the economy back online is complex. Susan Van Meter, director of Advamed Dx, said on an April 22 press briefing that while molecular and serological tests will continue to play a vital role, “we’re going to see millions of antigen tests available in the coming weeks,” a development that will prove crucial in efforts to restore normal economic activity.

Scott Whitaker, president and CEO of the Advanced Medical Technology Association (Advamed), led the conference call by noting that because of the pandemic, makers of devices and diagnostics have “mobilized in a way that no one could have imagined.” He cited the 3M Company of St. Paul, Minn., as “a shining example” of that response in connection with the company’s production of N95 masks. 3M said recently that it will turn out 50 million of these items per month for domestic use.

Van Meter said a number of companies make immunoassays for antigen testing, a method that she said can be deployed as a point-of-care (POC) test. Such tests may be more economical than lab-based molecular tests, which in the case of the SARS-CoV-2 virus is typically handled via polymerase chain reaction testing. PCR testing is still the gold standard for arriving at a diagnosis, and Van Meter said the availability of both serology and molecular testing capacity will continue to expand in the coming weeks and months.

Van Meter said antigen testing can detect an infection within two to three days, possibly even prior to the onset of symptoms. This is one of the characteristics that make this approach tremendously useful for bringing employees back to the workplace. “A number of our member companies will have some exciting news soon” about antigen testing, Van Meter continued, predicting that the availability will be in the millions of tests per month in the aggregate.

Ventilator production to continue to expand

Whitaker said companies that make ventilators in the U.S. had produced roughly 700 units a week prior to the pandemic, a volume that will nearly triple to 2,000 or so a week by the end of April. Despite the importance of ventilators and personal protective equipment, “the name of the game is testing,” he said, adding that as many as seven in 10 clinical decisions are based on a diagnostic.

A commonly asked question is whether the U.S. has sufficient supplies of sampling kits and reagents which Whitaker said, “isn’t necessarily the right question.” He made the case that the issue is also about whether the testing infrastructure can meet the demand that will emerge in the weeks and months ahead. Whitaker said he is looking forward to the availability of rapid antigen testing, in part because of its ability to detect infections prior to the onset of symptoms.

The demand on labs may be overwhelming over the coming weeks and months, but Whitaker said the current capacity may not be sufficient to handle the anticipated volume. He noted that the variability in testing regimes includes whether the reagent is included in a testing kit sent to a lab, although there are some kits in development that use extraction-free methods for molecular testing.

One Advamed Dx member company, which Whitaker declined to identify, was making extraction reagents for several hundred thousand tests per month, but will ramp up to 10 million per month and twice that by year’s end. However, he advised that the U.S. lab capacity includes some sites that are underutilized. One of the questions is how to identify those sources of spare capacity, something the White House task force began to take up recently. However, Whitaker said it is not clear whether a lab that processes a sample that is from the jurisdiction of a different Medicare administrative contractor can send the claim to that lab’s home MAC rather than the MAC where the sample originated.

Advamed expects that as many as 28 million tests per month will be available by the end of April, a massive increase over the two million EUA tests that were available March 20. Whitaker said the target volume for the end of April is “based on information we’ve received from our industry collectively,” over the past few weeks. The objective for molecular testing via PCR is to boost volume to 300,000 per day, a doubling of the current capacity.

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