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This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with Meso Scale Diagnostics LLC, 1601 Research Blvd, Rockville, MD 20850-3126, USA to procure a V-PLEX COVID-19 Respiratory Panel 1 (IgG) Kit (25 plate bundle) assay for to assess the vaccine response to COVID-19 vaccines in people with immune disorders.

COVID-19 is caused by the novel SARS-CoV-2 and is associated with a hyper-inflammatory immune response which leads to severe and potentially life-threatening symptoms. Little is known about how and the extent to which COVID-19 presents in people with immunodeficiencies, but because of the known severity of the illness in the general population, vaccination against SARS-CoV-2 is critical. Understanding whether immunodeficient individuals produce an adequate immune response to the COVID-19 vaccine is necessary.

The goal of this is project is to understand how COVID-19 vaccination and other COVID-19 prevention policies impacted the exposure and immune response to seasonal coronaviruses and other respiratory viruses and influenza in a cohort of immune deficient individuals. This purchase will provide the analyte panels used to detect anti-virus IgG for a number of common seasonal respiratory viruses. The multiplex detection of IgG antibodies specific to different variants of concern in samples requires the use of highly sensitive, specialized kits and efficient modes of detection. We would need to use the V-PLEX SARS-CoV-2 Variant Panel (IgG) Kit for our upcoming studies as it will enable us to measure the responses to different SARS-CoV-2 variants of concern. These measurements are important to conduct a holistic evaluation of vaccine performance. Furthermore, kits from Meso Scale Discovery LLC are routinely used in the Laboratory of Virology. Therefore, we already have instruments, reagents, and training on the use of these kits and the necessary equipment. The use of alternate reagents would require a significant loss of productivity while we readapt our protocols, and would not allow us to obtain data comparable to the data we have already obtained using the existing reagents in the lab.

The current requirement is for:

1. V-PLEX SARS-CoV-2 Key Variant Spike Panel 1 (IgG) Kit 25PL, catalog # K15651U-4, quantity -2

2. Shipping and Handling

The Place of performance is NIH, Rocky Mountain Laboratories, 903 South 4th Street, Hamilton, MT 59840.

The statutory authority for this sole source requirement is 41 U.S.C.1901 (e) (2) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency

requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-23-2175437) to Rita Davis at

rita.davis@nih.gov by 11:00 am eastern standard time, Tuesday, May 30, 2023. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.