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DOMESTICALLY MANUFACTURED ALLERGY DIAGNOTIC EQUIPMENT WITH A HIGH SPECIFICITY THROUGH MOLECULAR ALLERGENS AUTOMATIC PROCESSING SYSTEM (AMBIS 2231182)

Waiver type - Procurement: Nonavailability

Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6640 | Last Modified: 08/30/2024

Procurement Summary

The National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. Within the NIAID, the Laboratory of Clinical Immunology and Microbiology (LCIM) conducts clinical and basic science, and epidemiologic research into human immunologic, inflammatory, and infectious diseases. Primary immunodeficiencies (PIDs) that arise from a variety of mutations in genes involved in the immune system are a major focus area of the laboratory. To develop a comprehensive understanding of the natural history and pathogenesis of PIDs, the LCIM integrates clinical studies with laboratory investigations at molecular-, cellular-, and systems-level scales. Through exploiting knowledge gained in the clinic and in the laboratory, the LCIM aims to develop novel diagnostic methods and therapeutic approaches to manage and, ideally, cure patients of PIDs and infectious diseases. Description of the supplies or services to be purchased: Dr. Ian Myles ETU/LCIM; Building 298, Room 5NN24 will use the lgE assessment assay in his ongoing research under project # 147170 to identify activation pathways in the human and mouse immune systems. To continue to make scientific discoveries that promote the development of new vaccines, diagnostics, and therapeutics that improve human health. The current requirements are: 1. lmageXplorer Bundle, Item 87-IXBUNDLE-02, Qty 1 2. lmageXplorer with US Power Cord, Item 87-11-0000-02, Qty 1 3. Lab Rocker w/ U.S. Power Cord, Item 87-13-0000-00, Qty 1 4. ConfigXplorer (CX) Test Array, Item 87-30-0100-02, Qty 1 5. Array Holder, Item 87-14-0000-00, Qty 2 6. Incubation Chamber, Item 87-15-0000-00, Qty 1 7. Laptop, Item 06-LAPTOP, Qty 1 8. ALEX2 Allergy Explorer Kit (20 Tests), Item 87-02-2001-02, Qty 10 Specifications: • Fully automated or manual systems available. • Process 50/10 samples (automatically) or one sample manually in one run. • Samples per manual run 1. • Assay runs per day 2. • Max number of results/day 28.000. • Total assay time not to exceed 4.5 hours. • Hands on time not to exceed approx. 1 hour. • Power connection supply through USB port & US power cord. • Required sample volume 100 μl. • Allergy test Panel Kits (20 Tests) ○ ELISA-based IgE multiplex assay ○ 117 extracts & 178 molecular allergens ○ 50+ unique molecular allergens ○ Total IgE included. ○ Nonspecific IgE antibodies against cross-reactive carbohydrate determinants (CCDs) are automatically blocked. ○ High specificity & lower interpretative burden ○ Nano-bead technology ○ CCD-FREE DETECTION • Option for at least 15 predefined software panels (based on allergen groups) • Design your allergen panel via on-demand multiplex feature. • Incubation Chamber • Array Holder • Lab Rocker w/ U.S. power cord • Test Array Size requirements: (cannot exceed to fit in available lab space) • Net weight not to exceed 10 lbs – to easily be moved. • Width < 20 in, Depth < 20 in, Height < 20 in

Waiver Rationale Summary

Due to compatibility and required specifications, the equipment is needed to complete studies and gather data to develop vaccines. Dr. Ian Myles ETU/LCIM; Building 298, Room SNN24 will use the 'high specificity through molecular allergens automatic processing system, which is allergy diagnostics equipment, to perform an lgE assessment assay in his ongoing research under project# 147170 to identify activation pathways in the human and mouse immune systems. An immunoglobulin E (lgE) assessment assay, also known as an allergen-specific lgE test, is a blood test that measures the level of lgE antibodies in a person's blood. lgE antibodies are proteins produced by the immune system to protect the body from allergens, bacteria, and viruses. The equipment will be used to continue to make scientific discoveries that promote the development of new vaccines, diagnostics, and therapeutics that improve human health. The requirement is for specific instrumentation and if the required instrumentation is not granted, this would impact data and results that would prevent the development of vaccinations.

Did / Will the solicitation include one of the standard BAA provisions announcing the agency’s intention to provide a price preference for domestic end products and construction material?

Yes

Was a sources sought or Request for Information issued?

Yes

OMB Determination

Consistent with Policy

Product

LABORATORY EQUIPMENT AND SUPPLIES

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

Date Submitted

08/21/2024

Procurement Instrument Identifier (PIID)

N/A

Solicitation ID

N/A

Procurement Stage

Pre-solicitation

Expected Maximum Duration of the Proposed Waiver

0 - 6 months

Waiver Coverage

Individual Waiver

Funding Agency

NATIONAL INSTITUTES OF HEALTH