Brand Name or Equal specifications 2047623.docx

Justification for Other than Full and Open Competition:

Brand-Name at or Below the Simplified Acquisition Threshold

Project Title: STA Satellite

Identification of the agency and contracting activity DHHS, NIH, NIAID, DIR Veterinary Research Associates

Description of the project, and supplies or services required to meet the agency’s

FOR COVID-19

The NIAID’s Veterinary Research Associates section, has growing evidence in the clinics that patients infected with SARS CoV2, the virus that causes COVID 19 have a high risk of developing coagulation dysfunction leading to blood clot formation both in the adult and in the young. This may lead to stroke and other life-threatening conditions. The mechanism by which the virus triggers the clot formation is widely unknown. The Nonhuman Primate (NHP) has been identified as a suitable animal model infected with SARS CoV2. We are highly concerned and in need of recognizing the formation of severe blood clots, so that remediation measures before leading to complications can be timely performed in our animal model. Changes can be recognized and measured by blood test. We identified a blood test machine specifically validated for NHP to measure changes in clotting times and proteins of fibrin degradation.

Description and purpose of the Requirement:

This machine must be on site and immediate test results with high specificity is required in the assessment of health condition. More importantly the blood test will identify the requirement for veterinary attention in any situation.

Demonstration that the proposed brand name product’s salient charictoristics (specific features, qualities and/or the nature of the acquisition) requires use of the authority cited.

A. Name and address of the proposed contractor Diagnostica Stago, Inc 5 Century Drive, Ste 200 Parsippany, NJ 07054

B. Describe why only the requested brand or brand name feature of the supply/service will meet the government’s needs They use a patented VBDS (Viscosity Based Detection System) and have Mechanical Clot Technology for PT, PTT, and Fibrinogen. Their PT, PTT, Fibrinogen and D-Dimer assays are all pre-calibrated. With VBDS technology, the clotting time starts at 3 seconds standardly and up to 999 seconds, this is needed for animal testing where cloating times are much shorter than in humans. This equipment has D-Dimer assay (Immunoturbidimetric Method) now used in conjunction with COVID testing.

The benchtop size is required for available space in the lab, no larger than , height 30.8 X width 31.5 X depth 35.4 inches.

We need SMALL TEST volumes (1000 ul total for all four tests) we need small volumes because we have to stay within our monthly limits for animals. We need to run many samples simultaneously.