News, Policy & Media

28Jul

US Department for Health calls for point-of-care COVID antibody test submissions

The US Department of Health and Human Services (HHS) has released a call for submissions of point-of-care coronavirus antibody tests. The Governmental department is seeking to produce and distribute more than 20 million testing units per month as part of its strategy to control the spread of coronavirus and generate transmission data from across the country. The HHS is tasked with protecting the civilian population by providing leadership in the use of effective medical countermeasures to treat the adverse health effects resulting from a variety of situations, including emerging infectious diseases and pandemics.

The desired tests must be suitable for use by non-professionals, accurate and low-cost. In terms of production, the tests must be able to reach more than 20 million per month. Individuals with no medical expertise should be able to administer the test and interpret its results simply by reading its instructions. Specifically, HHS is seeking assays that have received or are eligible to receive a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver. Proposals will be evaluated in terms of; ease-of-use at point of care, end-to-end domestic production, diagnostic accuracy, cost and production scale. In an effort to seek Small Business participation in the Made-in-America Point of Care Antibody Test COVID-19 requirement, HHS invites interested Small Businesses to submit a Capability Statement in the areas of consideration for which they may seek award as prime contractor. 

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