BIOME-Preserve Anaerobic Microbiome Collection Kit

BIOME-Preserve Anaerobic Microbiome Collection Kit

BIOME-Preserve is a collection kit that preserves live microbiome samples (such as stool or fecal samples) for growth and isolation of anaerobic and facultatively anaerobic microorganisms. The product effectively preserves microorganisms under anaerobic conditions at room temperature for up to 120 hours without substantial loss of viability. Samples may also be directly frozen in BIOME-Preserve for longer term cryogenic storage. For research use only, and not intended for use in the diagnosis or treatment of any infection or disease.

BIOME-Preserve Packaging
and Tube with Scoop

Notice: BIOME-Preserve is currently in final stages of development and is not a currently marketed and publicly available product. Performance data on preservation and culture recovery from stool is available upon request.

The product may be available for early access use on an “research us only” basis, with proper agreements in place. This product has not been evaluated or approved by the FDA, and may not be used in for diagnosis or treatment purposes. Please contact Anaerobe Systems customer service for more information: customerservice@anaerobesystems.com

Product InsertSDS

Product Description & Summary

BIOME-Preserve is a pre-reduced non-nutritive phosphate buffered saline containing mineral salts, oxygen scavengers, antioxidants, and cryopreservants. BIOME-Preserve is intended for the self-collection, storage, transportation, and preservation for recovery of live microbiota samples such as stool or feces. BIOME-Preserve can maintain the viability of the majority of microorganisms contained within the sample for up to 120 hours at room temperature during transportation from the collection site to the processing laboratory. The collection kit consists of a foil pouch containing a tube filled with BIOME-Preserve liquid medium. The cap of the tube has an integrated 1-gram defined volume scoop to facilitate collecting and inserting the sample into the tube. This media is prepared, dispensed, and packaged under oxygen-free conditions to prevent the formation of oxidized products prior to use.

Physical Appearance: BIOME-Preserve should appear clear and colorless in a 16 x 100 mm polypropylene conical bottom vial and brown cap integrated with a 1mL collection scoop.

Odor: BIOME-Preserve, when opened, will have a faint sulfur (rotten egg) odor.

Precautions

For RESEARCH USE only. BIOME-Preserve is not intended to be used in the diagnosis or treatment of a disease or condition. Medical treatment should not be performed based on data or analysis from samples collected in BIOME-Preserve. Utilize approved biohazard precautions and aseptic technique when using this product. Analysis of samples collected in this product is for use only by properly trained and qualified personnel. Sterilize all biohazard waste prior to disposal. Appropriate review and consent should be obtained before collecting human samples.

Instructions for Use

Specimen Collection: Do not remove BIOME-Preserve tube from the foil package until the time of sample collection. Collect the microbiota sample in a suitable container or toilet accessory (not provided). Do not collect samples directly from toilet bowl.

  1. Remove the BIOME-Preserve tube from the foil package.
  2. Produce a stool sample on to an appropriate stool collection device, such as a paper toilet accessory or commode bucket style container. Do not get urine mixed with the stool sample.
  3. Unscrew the tube cap and collect 1 scoop of stool using the scoop attached to the BIOME-Preserve cap.
  4. Place the scoop and cap back on the BIOME-Preserve tube, and tighten the cap. Do not overtighten cap, but ensure it is fully sealed. The BIOME-Preserve tube should not stay opened for longer than 2 minutes.
  5. Shake the tube for 10 seconds to mix the stool in the scoop with the liquid inside.

Sample Transport and Storage: Transport samples to laboratory and process samples within 120 hours of collection. Samples are intended to be stored and transported at room temperature. Samples should not be frozen for transport unless the sample will remain frozen until final processing. Refrigerating a sample is not necessary but may help slow potential growth and metabolism of organisms. Check local/state/country regulations for required labeling and packaging requirements for shipping stool samples.

Interpretation of Results & Limitations

Results for the recovery of bacteria will largely depend on proper and adequate specimen collection, timely transport, and processing in the laboratory. If used properly, this medium should maintain the viability of the majority of microorganisms present within a sample until transported and processed within the laboratory for up to 120 hours.

BIOME-Preserve is designed as a specimen collection and transport device to maintain viability of microorganisms contained within a specimen during transport. This medium will not provide complete information for identification of microbial isolates or microbial population. Additional test procedures and culture media are required for complete recovery, isolation, and/or identification. BIOME-Preserve is not intended to maintain the bacterial population distribution or abundance of microorganisms in the sample. Other kits may be required for analysis of the sample prior to culture recovery. Specimens should be transported and processed in the laboratory in a timely manner as delays may result in overgrowth by one or more organism present in a specimen.

BIOME-Preserve is for research use only. BIOME-Preserve has not been evaluated or approved by the FDA for collection and transport of clinical samples for the purpose of diagnosing or in the treatment of any disease.

Product Storage & Shelf Life

Storage: Upon receipt, store at room temperature in original package until used. Avoid overheating or freezing prior to use. Do not use media if there are signs of deterioration (discoloration or damage to packaging) or contamination. The expiration date applies to the product in its original packaging and stored as directed. Do not use product past the expiration date shown on the label.

Shelf Life:  6 months from date of manufacture.

Materials Required, but Not Provided

Additional supplies may be necessary for the person providing the sample such as detailed user instructions, a device to catch the stool sample, sample labels, plastic isolation bag for sample shipping, desiccant or absorbent pad for shipping, and a return shipment box.

Standard microbiological supplies and equipment such as loops, saline blanks, slides, staining supplies, microscope, incinerator / autoclave, incubators, anaerobic chamber / anaerobic jars, disinfectant, other culture media, and serological / biochemical reagents.

Quality Control

The following organisms are routinely used for quality assurance testing at Anaerobe Systems. To determine the holding capacity of BIOME-Preserve, an ATCC isolate strain (listed below), from 24-hour growth, is inoculated into the media aerobically and held for 72 hours at room temperature. Each organism is streaked onto Anaerobic Brucella Blood Agar (BRU, catalog #: AS-111) in an anaerobic environment to obtain isolated colonies. Plates are incubated at 35–37oC for 48 hours and growth is observed.

Organism Tested ATCC #

 

Results Time
Bacteroides fragilis* 25285 Growth 24 hrs
Prevotella melaninogenica* 25845 Growth 24 – 48 hrs
Propionibacterium acnes* 6919 Growth 24 – 48 hrs
Fusobacterium nucleatum* 25586 Growth 24 hrs
Peptostreptococcus anaerobius* 27337 Growth 24 hrs
* Organisms specified by CLSI for Quality Control testing of Anaerobic Microbiological Transport Systems.