Assistant Secretary for Health Admiral Brett Giroir, MD, defended the nation's strategic plan for COVID-19 testing as the Department of Health and Human Services announced an investment in diagnostic labs to expand capacity.
Giroir said reports of shortages of tests are being misrepresented using a false narrative and "statistical shell games with data."
"There is a national strategy, the national strategy is working," Giroir said during a press briefing today.
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The strategy is for strategic testing to test those who are sick or are in need of a test, not to have a program of blanket testing for the population.
The latter can lead to a false sense of security because having a negative test today does not mean a person will test negative tomorrow, he said.
Rates of infection are down, Giroir said.
"It is clear that the number of cases are decreasing and that decrease is real," he said.
Hospitalizations have also decreased. What is lagging, Giroir said, is the mortality rate, with the deaths being seen today the result of infections from four to eight weeks ago.
Turnaround times for results are also not the 10-14 days being reported, he said.
About 80% of test results are returned within three days, but Giroir said he wanted that down to 24 hours.
"We will continue to focus on turnaround," he said.
WHY THIS MATTERS
The Department of Health and Human Services is expanding testing capacity through investments in two commercial diagnostic labs, Aegis Sciences Corporation and Sonic Healthcare USA.
In addition, Beckman Coulter Life Sciences will provide laboratory equipment and Thermo Fisher Scientific will increase staffing and infrastructure to allow the U.S. to perform an additional one million tests each week by early October.
The combined investment of $6.5 million will expand capacity to conduct up to four million additional COVID-19 tests per month.
This means that by September, the U.S. will have the capacity to do 90 million tests a month if needed, Giroir said.
Aegis is expected to rapidly expand its laboratory workforce and begin construction on new laboratory space at its testing facilities in Nashville, Tennessee, to meet its goal of processing more than 60,000 test samples per day beginning in September.
Sonic Healthcare USA is collaborating with HHS to ramp up their testing capacity at eight testing facilities.
Thermo Fisher Scientific is supplying HHS with 56 KingFisher Flex extraction and purification systems and 40 QuantStudio 7 Flex Real-time polymerase chain reaction (PCR) tests. Each PCR test can run 384 samples at a time.
These 96 systems – capable of running more than 140,000 samples per day, in total – will be placed at Aegis Sciences Corporation laboratories in Nashville and at Sonic Healthcare USA labs around the country.
THE LARGER TREND
This week, the American Medical Association and other organizations sent a letter to HHS that said testing shortages continue, along with gaps in the supply chain for reagents, swabs, plastics, viral transport media and personal protection equipment.
The letter asked the administration to update the testing guidelines to prioritize those with a medically-indicated need for a COVID-19 test, including those with symptoms of the virus, those with known exposure and those in need of pre-procedure testing.
ON THE RECORD
"We are committed to leveraging every possible opportunity to expand the nation's SARS-CoV-2 testing capacity over the next several months," Giroir said by statement. "For this opportunity, we were able to match available instrumentation and reagents with commercial labs that were ready to immediately expand their services. We are honored to work with these labs and life sciences tools companies to ensure increased access to testing as may be needed this fall."
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