The U.S. Department of Health and Human Services (HHS) has posted a national COVID-19 testing strategy in response to legislation passed in April, and the plan suggests that 300,000 tests per day should suffice to corral the pandemic. That calculation drew immediate fire from House and Senate Democrats, who characterized the plan as an attempt “to paint a rosy picture about testing,” but they also pushed the Senate to pass House legislation that would provide another $75 billion in funding for testing and contact tracing.

The fourth COVID-19 relief bill, the Paycheck Protection Program and Health Care Enhancement Act, required that the Trump administration devise a national testing strategy, and forward that plan to the Congress within 30 days of the date of enactment, which was April 24. The 81-page report states at the outset that testing of “a majority of the U.S. population” on a recurrent basis is neither feasible nor necessary to ensure a safe return to work, school and other activities. In lieu of that, the plan is based on diagnosis, contact tracing and “smart surveillance,” which is described as the optimal approach, “especially when combined with syndromic surveillance and hygiene.”

Mitigation measures a factor in numbers to test

The plan also notes that the specific number of tests needed in a state, territory or tribe “depends on numerous factors,” such as the percent positive. The World Health Organization (WHO) is said to have set a target positivity rate of 10% or lower to press back on the pandemic, not the only organization to propose such a sent point. Among the state and local characteristics of interest in the HHS report are population characteristics – which encodes both vulnerability to poor outcomes and a large number of individuals deemed at risk of contracting the virus – and the degree of mitigation employed in that area. Relaxed mitigation measures are of course associated with a need for more aggressive testing regimes.

The HHS said the daily number of tests conducted in the U.S. numbered 300,000 by mid-May, a metric expected to rise by 25%-30% per week. A key provision in the minds of some critics, however, is that the federal government is “supporting and encouraging states, territories and tribes to build a multi-layered approach” that makes use of all testing facilities within that geographic area. Among the test facilities mentioned in the framework are commercial reference labs, including members of the American Clinical Laboratory Association, and hospital/academic labs.

Public health labs and point-of-care testing are also mentioned, and the plan notes that more than 12 million nucleic acid diagnostic tests have been performed in the U.S. to date, a number that is now increasing by 2 million per week. States that have been hardest hit are conducting “substantially more tests than states” that are less affected by the SARS-CoV-2 virus.

Among the sources of justification for the framework’s approach to testing is the simulation model by the Safra Center at Harvard University, which is said to assume that diagnostic tests offer a sensitivity of 80%. That figure is closer to 95%, the HHS framework states, while the rate of hospitalization was projected by the Safra paper to be 20%, but which the HHS said is less than 5%.

The Safra paper assumes no efficacy for mitigation, which HHS calculates at a 35% reduction in infections, while the difference in days to recovery also differs (15 days for the Safra paper and 11 or less for the HHS calculation). Consequently, HHS’s view is that the volume of daily testing should be roughly 300,000, an order of magnitude lower than that presumed by the authors of the Safra model.

The HHS paper says that the positivity rate in the U.S. now stands at roughly 7.5%, a figure based on surveillance conducted between May 8 and May 15, and which is presumed to be “continually decreasing.” The objective is to achieve a positivity rate of 10% or less, a standard said to have been endorsed by the WHO, and which has been achieved by 41 of the 50 U.S. states. HHS noted that the plan will be updated every 90 days until the associated funding has been expended.

Former FDA commissioner Scott Gottlieb confirmed that the U.S. positivity rate was at roughly 5% in a May 26 tweet that also suggested a downward trend in daily positive cases even as testing volumes exceeded 440,000.

Dems unimpressed, Alexander supportive

In a May 25 press release, four leading Democrats from the House and Senate said the plan supports the argument that Trump’s national testing strategy “is to deny the truth that there aren’t enough tests and supplies, reject responsibility and dump the burden onto the states.” The authors of the statement include House speaker Nancy Pelosi (D-Calif.) and Senate minority leader Chuck Schumer (D-N.Y.). Rep. Frank Pallone (D-N.J.), chairman of the House Energy and Commerce Committee, is also named in the statement, as is the ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, Sen. Patty Murray (D-Wash.).

The four Democrats also pressed Senate Republican majority leader Mitch McConnell (Kentucky) to “stop obstructing the HEROES Act.” The Health and Economic Recovery Omnibus Emergency Solutions Act of 2020 was introduced May 12 and was passed in the House of Representatives in only three days. The bill would add $3 trillion to the amounts already spent on COVID-19 relief, and among the features of the 1,800-page bill is a bolus of $75 billion for testing, contact tracing and containment strategies.

Sen. Lamar Alexander (R-Tenn.), who chairs the Senate HELP Committee, said in a May 25 statement, “the administration’s national testing strategy correctly recognizes that governors do not want President Trump telling them what their state testing plans should be.” Alexander said governors “know best the differences between New York City and rural Tennessee and how to test and find and isolate those who have been infected and exposed.” He voiced support for the notion that the federal government should provide general guidance and resources, and that the private sector “should keep providing supplies, technologies and services to help states implement their plans.”

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