Specification Sheet.pdf

Specification Sheet

Contractor will provide 250 mL volume samples of fecal homogenate generated from feces of healthy adults.

Background:

The gut microbiome group within the Dairy and Functional Foods Research Unit (DFFRU) at the Eastern Regional Research Center (ERRC) performs research on the effect of food and food ingredients on the gut microbiota of adult humans. This requires the purchase of fecal samples to serve as the inoculum for culturing of the gut microbiota.

General Scope:

The gut microbiome group in the DFFRU is looking to purchase samples of adult human fecal homogenate. The specifications required are listed below in the Delivery Order Requirements Section.

Estimated Period of Performance:

1 May 2023 – 30 April 2024

Place of Performance:

Homogenates will be generated at the company’s facility.

Government Furnished Property:

No physical property furnished by the USDA

Delivery Order Requirements:

Fecal homogenate samples generated from fresh feces and frozen directly, and kept at -80 C.

• Fecal homogenate definition is a solution of 10% feces homogenized in a 12.5% glycerol saline buffer. Homogenates should be passed through a 20-micron filter to remove debris and should be aliquot in an amount sufficient for use, i.e. <200 mL volume. Each fecal homogenate should be labeled with a donor-specific number.

• Feces should be sourced from healthy American adults and should have a Bristol score of 3 or 4. The adults should be a normal BMI (>18.5 and < 30), antibiotic free for > 3 months, consuming limited alcoholic beverages and coffee. Donors must fill out a health questionnaire before donation.

o Donors must be screened for the following: Hepatitis A, B, C, and E, HIV-1 and HIV-2, and Stronglyoides IgG.

o Donor bloodwork should be performed looking at hepatic function, and donors evaluated for medical conditions, GI disorders, and chronic use of medications.

• Feces must be tested for bacterial and viral pathogens prior to use, including but not limited to the following:

o C. difficile, Camplyobacter, Salmonella, Shigella, Plesiomonas, Vibrio, and Diarrhea associated E.coli, o Organisms that are multi drug resistant including vancomycin resistant Enterocci, Extended Spectrum Beta-Lactamase producing Enterobacteriaceae (ESBL), and Carbapenem-resistant Enterobacteriaceae

(CRE)

o Viral enteropathogens: Norovirus, Rotavirus, Adenovirus, Astrovirus, Sapovirus o Diarrheagenic parasites: Giardia lamblia, Cryptosporidium spp, Isospora and Microsporidia

Delivery Requirements:

Delivery of fecal homogenates should occur within 30 days of the contract implementation.