Tab 1- Antigen Test JA Finalvgf with DG Signature 3-24-21 EC Redactions v3_Redacted.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION FOR

CORONA VIRUS ANTIGEN TESTS UNDER THE AUTHORITY OF 10 U.S.C.

2304(c)(2)

1. Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, is the contracting activity.

2. The action being approved is for the acquisition of Government requirements on an other than full and open competition basis, in accordance with FAR 6.302-2.

3. The Government has the following urgent requirements for Coronavirus Rapid Detection

Tests:

Item Description:

a. A Point of Care (POC) test that is a visually read, lateral flow immunoassay for the qualitative detection of nucleocapsid protein antigen from SARS-COV-2.

Test shall not require a separate reader or use a mobile device and software download. The test shall be authorized by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA). The test shall be authorized for use at POC, i.e., in a patient care setting operating under a Clinical Laboratory Improvement Amendments of 1988 (CLIA) Certificate of Waiver.

b. A control kit that includes control swabs and is authorized by the FDA under an EUA to be used with the test described above. These controls kits are separate to the internal and external quality controls included in the antigen tests. These external quality control kits provide additional swabs that may be used with tests in order to conform with local, state, and federal regulations or accrediting groups and site-specific standard quality control procedures.

Contract Dollar Values:

Estimated Dollar Value: $255,480,000.00 Maximum Dollar Value: $766,440,000.00

The contract was awarded on March 8, 2021. The award was made to Abbott Rapid Dx North America, LLC (Abbott). The contract is for an eight (8) month period, with the contract period ending on November 8, 2021. There are no option periods. The contract is a Fixed-Price Indefinite Delivery/Indefinite Quantity (IDIQ). An IDIQ contract permits flexibility due to the evolving nature of the demand for the required items.

The estimated quantity of tests, provided by the Department of Health and Human Services (DHHS), is fifty (50) million tests and eight (8) thousand control kits for the life of the contract. This estimate is based on DHHS’s usage over the last few months of Abbott’s BinaxNOW™ COVID-19 Ag Card rapid tests and BinaxNOW™ COVID-19 Ag Card Control via contract SPE2DE-20-D-0027 and their planning for the future trajectory of the virus. The estimated dollar value and maximum dollar value above are based on the awarded contract prices of $5.10 per test and $60.00 per control kit. The estimated dollar value and maximum dollar value amounts account for unanticipated demand resulting from the test that is simple to administer. Lateral flow tests, the type of tests being purchased by this acquisition, are simple devices intended to detect the presence of a target substance in a sample. They are also known as lateral flow immunochromatographic assays or immunoassays. The Centers for Medicare & Medicaid Services (CMS), the Federal agency responsible for quality standards in long term care facilities, has created rules for COVID-19 testing regimes for long term care facility residents and staff. This acquisition will assist long term care facilities in complying with the CMS rules.

The awarded contract will provide tests for use in nursing homes and long-term care facilities, where there is a need for rapid testing to immediately identify cases of SARS- COV-2 infection and implement infection prevention and control strategies. These strategies include separating infected residents from uninfected residents, implementing a separate SARS-COV-2 area of the facility if possible, and ensuring staff and health care professionals are aware of infected individuals so they take precautions to avoid exposure to the virus. As the population of individuals in these facilities require frequent care, it would be impossible to avoid staff member interaction with residents regardless of SARS-CoV-2 exposure or infection. In facilities where residents are already separated from each other, there still exists the possibility of infection from staff members, who might then infect other residents as they tend to their needs.

Antigen tests 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 approximately fifteen (15) 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 nursing homes and long-term care facilities lack the specialized and expensive equipment for RT-PCR testing, meaning that any RT-PCR tests of their residents 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 nursing homes and long-term care 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.

Over the summer of 2020, one of DHHS’s focuses was to procure COVID-19 antigen tests and related supplies. In support of DHHS’s mission, DLA Troop Support awarded contract SPE2DE-20-D-0027 to Abbott for its BinaxNOW™ rapid tests and the BinaxNOW™ COVID-19 Ag Card Control Kit. Contract SPE2DE-20-D-0027 expired on December 31, 2020. However, as cases of COVID-19 and its spread continue to be unpredictable, there is an ongoing, urgent need for self-contained antigen tests in order to fight the virus throughout the United States. In order to ensure continued availability of these tests to nursing homes, long-term care facilities and other vulnerable populations, DHHS requested further support from DLA Troop Support to put in place this emergency measure.

While there was speculation during the summer of 2020 that there would be an increase in COVID-19 infections throughout the United States during the fall and winter, which would likely be complicated by the normal onset of flu cases during that same time period, the surge in COVID-19 infections and hospitalizations that occurred in that time period was greater than could have been reasonably anticipated. Infections rose dramatically in the winter, including in regions where the pandemic appeared to be contained. Instead of seeing an increase in cases on a smaller scale, because of this extreme and unexpected increase of infections, there is an urgent and pressing need to provide self-contained antigen tests to nursing homes and long-term care facilities

In addition to the unforeseeable increase of cases during the winter of previously recognized strains of the COVID-19 virus, three new variants of COVID-19 have been detected in the United States. The United Kingdom (UK) Strain, also known as B.1.1.7, was first detected in Colorado in December 2020. According to the Center for Disease Control (CDC), the transmission rate for the UK strain is 35% to 45% higher than the other strains in the United States and currently has been traced to thirty-three (33) states. The South African Strain, also known as 501.V2, was first detected in South Carolina in January 2021. According to the CDC, this variant, just like the UK strain, seems to be more contagious than the other strains currently in the United States. Also, this new strain appears to be able to infect individuals even if they have recovered from the original strain of COVID-19. The Brazil Strain, also known as P.1, was first detected in Minnesota in January 2021. According to the CDC, this variant can infect individuals who have antibodies from COVID-19. Although Moderna, Johnson & Johnson, and Pfizer, the manufacturers of the three COVID-19 vaccines being utilized in the United States, are confident that their vaccines can be effective against these strains, data to support this is limited due to the relatively recent and unforeseeable variant outbreaks. These new strains of COVID-19 and the limited data on the effectiveness of the current vaccines against them have dramatically increased the urgency for continued availability of self-contained, visually read antigen 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 that they are not carrying a new variant of the virus.

Additionally, contract SPE2DE-20-D-0027 was awarded under sole source conditions for Abbott’s BinaxNOW™ COVID-19 Ag Card rapid tests and the BinaxNOW™ COVID-19 Ag Card Control Kit for a relatively short period of performance due to the expectation that the cases of the COVID-19 virus would substantially decrease as the vaccine begins to be dispersed nationwide. However, in view of the new variants of COVID-19 recently detected, the unprecedented surge of cases during the winter, and the initial slower rollout of the vaccine than had been anticipated, there is an ongoing, immediate need to continue the Government’s support of antigen tests for nursing homes, long term care facilities, and other vulnerable populations. Delaying award to follow routine procedures for competitive acquisitions would have been unacceptable due to the urgency of the requirement.

Prior to issuing the solicitation, the Contracting Officer confirmed via the FDA website that EUAs had been granted for Access Bio Inc.’s CareStart COVID-19 test and Quidel’s

QuickVue tests, which are equivalent to the Abbott’s BinaxNOW™ COVID-19 Ag Card rapid tests. There are other COVID-19 antigen tests with FDA EUA. However, Access Bio Inc.’s CareStart, Quidel’s QuickVue, and Abbott’s BinaxNOW™ COVID-19 Ag Card rapid tests are the only Clinical Laboratory Improvement Amendments (CLIA) waived POC tests that are visually read, lateral flow immunoassay for qualitative detection of nucleocapsid protein antigen from SARS-COV-2 that do not require a separate reader or display results using a mobile device and software download. In other words, the other COVID-19 antigen tests with FDA EUA are not “self-contained.” The other antigen tests are not self-contained because they require the use of a separate piece of specialized hardware known as a “reader” or “analyzer,” or the use of a mobile device to display results. Readers are durable, non-disposable electronic appliances. A “visually read” test is a test that can have its results visually interpreted by a person without the use of a separate device or piece of hardware – antigen tests that are not self-contained because they require a reader, analyzer, or mobile device to display the test results are not “visually read.”

There are two reasons why tests requiring the use of “readers” or “analyzers” do not meet DHHS’s needs. First, antigen tests employing readers are subject to logistics bottlenecks.

Self-contained tests can be physically performed at almost any location. By contrast, tests utilizing readers are dependent on the availability of a working reader at the testing location.

Unless a reader is present on site, and is working properly, testing with separate reader/analyzer tests will not be possible. The need for a working reader is a potential testing chokepoint, and the purchase of tests utilizing readers for DHHS’s requirements necessitates the creation of an additional supply chain to ensure that the reader is available at a testing location. The difficulty in determining if there is a working reader at a location is compounded by the fact that some antigen test systems employ readers that can only be used to perform a limited number of tests. For instance, the reader for Becton, Dickinson and Company’s (BD) antigen test, the BD Veritor Plus Analyzer, can only be used for approximately 3,500 tests. In view of the fact that deliveries are anticipated to be made to approximately 25,000 locations each week, the administrative burden of managing a separate supply chain for readers would be substantial. Moreover, mistakes would inevitably occur – sometimes tests would be shipped to locations without a working reader. Whenever a working reader is unavailable at a nursing home or long-term care facility, a suspension in testing may occur.

Second, the reader is an additional piece of hardware that adds to the complexity of the testing process. Self-contained antigen tests are simpler – the individual conducting the test does not need to be knowledgeable about how to use the reader and does not need to properly use a specialized piece of hardware when performing the test. Under normal circumstances, antigen tests requiring readers would primarily be performed by experienced testing and medical personnel, mitigating the potential difficulties stemming from those more complex tests that use readers. However, during the emergency circumstances of the COVID-19 pandemic, inexperienced individuals have been tasked with conducting antigen testing at nursing homes and long-term care facilities. In view of the lack of experience of some individuals conducting antigen testing in nursing homes, long-term care facilities, and other