POC-OTC Antigen Test JA_Redacted.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION FOR

CORONA VIRUS ANTIGEN & OVER THE COUNTER (OTC) TESTS UNDER THE

AUTHORITY OF 10 U.S.C. 2304(c)(2) immunoassay for the qualitative detection of nucleocapsid protein antigen from SARS-COV-

2. The need for this type of test is critical for individuals that do not have access to a Point of Care facility.

The antigen tests being procured detect pieces of particular proteins that coat viruses, in this instance SARS-COV-2, and provide positive or negative results depending on whether those proteins were detected. Antigen tests provide results in minutes. This is much faster than results obtained by other common forms of testing for COVID-19 used to diagnose active infections. For instance, another widely used type of test, Reverse Transcription-Polymerase Chain Reaction (RT-PCR) may take up to seven (7) days to obtain results. Moreover, most facilities lack the specialized and expensive equipment for RT-PCR testing, meaning that any RT-PCR tests will be completed off site, further delaying the testing process. For these reasons, results from other types of COVID-19 testing, like RT-PCR, may not be available in time to be useful for decision making. Although the sensitivity of antigen tests is generally lower than RT-PCR, meaning that their results may be less accurate, the faster results from antigen tests allow facilities to take immediate action to prevent the spread of COVID-19.

Depending on the results of an individual’s antigen test and their circumstances, confirmatory RT-PCR testing may also be conducted.

According to the CDC, the increase in COVID-19 cases indicate that the variants are much more infectious and are leading to increased transmissibility when compared with previous variants, even with some vaccinated individuals. These new strains of COVID-19 variants and the limited data on the effectiveness of the vaccines against them have dramatically increased the urgency for the availability of self-contained, visually read antigen tests and OTC Home tests, as individuals who have received the vaccine or have been previously diagnosed with COVID-19 may still need to receive a test to ensure they are not carrying a new variant of the virus.

Delaying award of the contracts will result in serious injury to the Government in the fight against COVID-19. The unanticipated rise in COVID-19 cases due to the variants, even in the vaccinated, coupled with the start of the school year and the fall and winter months on the horizon has increased requirements well past the current contract holder’s capacity for antigen tests. The harm would be the inability to detect COVID-19 early in vulnerable populations, including children age 12 and under who are unable to receive the vaccine, as well as the unvaccinated and vaccinated persons with reduced immune response, risking the rapid spread of the virus through the fall and winter months. The result would extend the COVID-19 pandemic well into 2022 and could significantly increase deaths from the virus, currently projected to be 5,800 – 18,600 weekly by the end of September, per the CDC.

Delaying new contract coverage to meet the new testing requirements would be directly contrary to the Government’s critical goal of decreasing infections and deaths. Further, it would limit needed sustained production to be able to surge additional manufacturing should it be needed in the future. It is assumed that within a year worth of time that the trajectory of the virus will decrease due to increased rollout of the vaccine.

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION FOR

CORONA VIRUS ANTIGEN & OVER THE COUNTER (OTC) TESTS UNDER THE

AUTHORITY OF 10 U.S.C. 2304(c)(2)

I have reviewed this justification for legal sufficiency.

Date

DLA Acting General Counsel

I have reviewed and hereby approve this justification.

Date MATTHEW R. BEEBE

Senior Procurement Executive

BEEBE.MATTHE

W.RICHARD.10

12725473

Digitally signed by

BEEBE.MATTHEW.RICHARD

.1012725473 Date: 2021.09.08 14:55:28 -04'00'