HHS, DoD to Increase Domestic Swab Production for COVID-19 Tests

HHS and the Department of Defense (DoD) recently awarded an $11.6 million contract to Puritan Medical Products Company, LLC to boost domestic production of nasal swabs used for COVID-19 tests.

The nasal swabs, called Cue Sample Wands, are used with Cue Health’s molecular point-of-care COVID-19 test, which is a rapid, portable test that can generate patient test results in just 20 minutes. 

Specifically, the contract will allow Puritan Medical to increase the production capability of Cue’s nasal swabs to 3 million per month by March 2021 at its Maine facility, HHS said. 

In mid-June, FDA granted emergency use authorization to Cue Health for its Cue COVID-19 Test.

The test kit transmits test results to the Cue Health App on a connected mobile device. The emergency use authorization allows the test to be used anywhere under the supervision of a qualified medical professional. 

The Biomedical Advanced Research and Development Authority (BARDA) funded the development of Cue Health’s COVID-19 test.

Just weeks ago, HHS distributed 27,000 portable Cue Health test kits to Alaska, Florida, Louisiana, New Jersey, and Texas for a pilot test. The distribution was part of a $481 million contract awarded to Cue Sample Wands in October.

The department aims to increase production to 100,000 test kits per day by March 2021.

HHS and DoD have been continuously addressing the growing demand for testing supplies, while also supporting facility capacity and vaccine allocation in the US. 

In April, the federal government awarded a $75.5 million contract to Puritan to increase the company’s capacity to manufacture non-proprietary foam specimen collection swabs to 20 million swabs per month by July. 

Then to further this effort, HHS and DoD awarded $51.15 million to Puritan Medical to expand industrial production capacity of flock tip testing swabs at its Maine location at the end of July.

The expansion, funded by the CARES Act, aimed to meet or exceed demand for swabs for testing both COVID-19 and the flu.  

Point-of-care testing allows for more rapid clinical decision making during a patient’s diagnosis, treatment choice and monitoring, and prognosis. When administered correctly, the tests have the potential to improve patient outcomes by providing faster results and earlier therapeutic interventions. 

Since the start of the pandemic, top pharmaceutical companies have developed point-of-care COVID-19 tests, including Cellex, Thermo Fisher Scientific, and Abbott. 

At the beginning of September, FDA issued an emergency use authorization to Abbott for its BinaxNOW Ag Card, a point-of-care COVID-19 antigen test that can provide test results in 15 minutes.

The test does not need the use of an analyzer and is authorized for use in doctor’s offices, emergency rooms, and some schools. 

The BinaxNOW Ag Card determines the presence of the antigen using nasal swabs from individuals suspected of having the coronavirus. 

The Trump Administration also announced in August it would deploy 150 million of the rapid, point of care tests nationally. At the time, just 32 states and the District of Columbia (DC) shared how they will use the tests.

Two months later, HHS announced that it distributed 389,040 Abbott BinaxNOW COVID-19 rapid tests at no cost to 83 Historically Black Colleges and Universities in 24 states. 

The states received the tests as part of the distribution included North Carolina (52,040 tests) Georgia (41,000), Louisiana (39,000), Texas (28,200), Alabama (26,520), Maryland (26,120), Virginia (21,400), South Carolina (18,040), Tennessee (18,000), and Florida (18,000). 

At the beginning of November, states began to report what communities they will distribute Abbott’s BinaxNOW COVID-19 test to assist ongoing reopening efforts. 

The states that provided preliminary reports have deployed BinaxNOW to local health departments, K-12 schools, colleges and universities, nursing homes, hospitals, and correctional facilities.