Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF JULY 20, 2022 SAM #7537
SOLICITATION NOTICE

65 -- V-PLEX SARS-CoV-2 Panel 27 (IgG) Kit (25 PL)

Notice Date

7/18/2022 12:49:15 PM
 

Notice Type

Presolicitation
 

NAICS

325414 — Biological Product (except Diagnostic) Manufacturing
 

Contracting Office

NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
 

ZIP Code

20892
 

Solicitation Number

NOI-NIAID-2136567
 

Response Due

7/24/2022 2:00:00 PM
 

Point of Contact

Dana Monroe, Phone: 4063759814
 

E-Mail Address

dana.monroe@nih.gov
(dana.monroe@nih.gov)
 

Description

PRE-SOLICITATION NOTICE NOI-NIAID-2136567 NAICS � 325414, Biological Product Mfg 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 Discovery, a division of Meso Scale Diagnostics, LLC of Rockville, MT to procure V-PLEX SARS-CoV-2 Panel 27 (IgG) Kit (25 PL), catalog # K15606U (QTY 3 EA) to be used by the NIH Vaccine Research Center (VRC) Vaccine Immunology Program (VIP) to perform assay testing in support of a SARS CoV2 therapeutic antibody isolation and development project. The Vaccine Immunology Program (VIP) aids the Vaccine Research Center (VRC) by supporting the development of monoclonal antibodies and vaccines for infectious diseases such as HIV, Influenza, Ebola, and more recently SARS-CoV-2 Coronavirus. The goal of the lab is to perform antigenic characterization of the proteins/antigens that are used to vaccinate animals in the pre-clinical setting. Since it is essential to know if the proteins produced in house at the VRC are in the correct conformation, so that they can induce desired antibody response when vaccinated in animals, VIP performs antigenic characterization assays, which is also a way of quality control and antigenic analysis between different lots of the proteins produced. In order to do so, the lab screens the proteins (antigens) against a large panel of well characterized antibodies on the MSD platform and measure the binding data of the antigen to antibodies. Right now, the experiments are focused on assays devoted to COVID studies. Humoral response is also very important along with cell mediated immune response to provide protection by our immune system against a pathogen. One of the basic immunological assays to test if a vaccine has induced any humoral response is to test the binding antibody titers against the specific vaccine insert. To perform this test, the most common method is ELISA (Enzyme Linked Immuno-Absorbent Assay). With the advancements in the technology, Meso Scale Discovery has developed a platform with more sensitivity and dynamic range than a traditional ELISA. This platform enables VIP to obtain binding data of antibodies against vaccine inserts/proteins in a very highly reproducible format and enables to obtain consistent date of antigens against a large panel of antibodies in a very robust and controlled manner. The three plate types are for biotin coated antigens and unbiotinylated antigens. All three platforms are critical for our current COVID experiments. MSD platform with the principle of electrochemiluminescence improves sensitivity and dynamic range of the assay compared to traditional ELISA. Electrochemiluminescence detection uses labels that emit light when electrochemically stimulated. Background signals are minimal because the stimulation mechanism (electricity) is decoupled from the signal (light). Labels are stable, non-radioactive and offer a choice of convenient coupling chemistries. They emit light at ~620 nm, eliminating problems with color quenching. Multiple excitation cycles of each label amplify the signal to enhance light levels and improve sensitivity. MSD platform also enables the multiplexing technology (e.g. U-Plex), allowing to test up to 10 analytes in a single well if required. This dramatically increases the throughput of the assay and also eliminating the plate-to-plate variation. Also, all of the COVID experiments have been performed using these MSD kits. Changing a major variable in the middle of critical clinical studies related to world health would be a major set-back to the studies. The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) 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-2136567) to Dana Monroe at dana.monroe@nih.gov, by 5:00pm eastern daylight savings time July 24, 2022. �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.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/02a1042ad09447dbbf5c0742acaf7641/view)
 

Place of Performance

Address: Bethesda, MD 20892, USA

Zip Code: 20892

Country: USA
 

Record

SN06392801-F 20220720/220718230101 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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