Abbott JA_Redacted.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

Abbott Coronavirus Rapid Detection Tests lead to rapid spread of the virus resulting in possible fatalities for students and staff.

The Contracting Officer has confirmed via the Food and Drug Administration (FDA) website that an Emergency Use Authorization (EUA) has been approved for Abbott’s BinaxNOW™ COVID- 19 Ag Card rapid tests. This is the fourth EUA approved point-of-care antigen detection test for rapid detection of COVID-19. The other three are; (1) the Sofia 2 SARS Antigen FIA manufactured by Quidel Corporation; (2) the Veritor TM System for Rapid Detection of SARS- CoV-2 manufactured by BD; and (3) LumiraDx SARS-CoV-2 Ag Test manufactured by LumiraDx UK Ltd. All four tests are approved for rapid detection of the nucleocapsid protein antigen from SARS-CoV-2 (COVID-19). These rapid detection type of tests can provide results in approximately fifteen (15) minutes and are very specific in the detection of COVID-19, unlike the Polymerase Chain Reaction (PCR) tests, which can take up to seven (7) days to obtain results. A positive result from a rapid detection antigen test indicates that the tested person may have COVID-19, and therefore further investigation and testing is necessary to confirm the preliminary diagnosis. Additionally, the BinaxNOW test is a lateral flow test. Lateral flow tests, also known as lateral flow immunochromatographic assays, are simple devices intended to detect the presence of a target substance in a liquid sample without the need for specialized and costly equipment.

These tests are widely used in medical diagnostics for home testing, point of care testing, or laboratory use. Abbott’s BinaxNOW lateral flow tests run the liquid sample along the surface of a test strip with reactive molecules that show a visual positive or negative result.

Abbott’s BinaxNOW lateral flow test is a self-contained COVID-19 test that does not require a separate analyzer to administer. The BinaxNOW test is conducted in cardboard “cards” supplied by Abbott that are similar in dimensions to a credit card. To perform the test, a nasal swab is taken from the individual being tested. Second, a card is opened up and six drops of reagent are placed in a well on one side of the card. Third, the swab is placed in the well with the reagent, and the card is closed. The card subsequently indicates either a positive or negative test result through a simple communication scheme – one line appearing on the card indicates a negative result and two lines appearing on the card indicate a positive result. The self-contained nature of Abbott’s BinaxNOW test allows for greater ease of use and simpler administration. In contrast, the three other antigen tests referenced above all require the use of a separate analyzer, a larger, more complex piece of hardware. The self-contained nature of the BinaxNOW test and the ease of its use and administration make it optimally suited for testing in schools and testing a school-aged population. Additionally, for the BinaxNOW test, the collection nasal swab is inserted less than one inch in the test subject’s nostrils. The shorter extension of the collection swab in the nose will cause less discomfort, making the BinaxNOW test more suitable for school-aged children.

The BinaxNOW lateral flow test received EUA approval from the FDA in time to allow schools to implement or transition to in-person education, estimated to occur between September and December 2020. Having a self-contained, simple to administer and use test that could readily and quickly be deployed on site at schools is a significant advantage in immediately detecting and reacting to any suspected infections of students or staff. Immediate detection of the virus allows for easier contact tracing to avoid mass infections among students who could carry infections back home to more vulnerable family and friends.

The Abbott BinaxNOW received EUA approval in time to support necessary COVID-19 testing and will allow schools to implement or transition to in person education. The ability to receive results in a matter of minutes with a self-contained, easier to administer test unit via the lateral flow rapid response test is critical against the spread of COVID-19. It is essential that DHHS receive adequate quantities of this test, the only self-contained lateral flow antigen detection test for COVID-19 that has received EUA approval by the FDA. Not acquiring these tests to enable

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

Abbott Coronavirus Rapid Detection Tests

I have reviewed and hereby approve this justification.

Date MATTHEW BEEBE Senior Procurement Executive

BEEBE.MATTHEW.RI

CHARD.1012725473

Digitally signed by

BEEBE.MATTHEW.RICHARD.1012

725473 Date: 2020.08 27 12:45:43 -04'00'