GI Effects

GI Effects® Comprehensive Profile – Stool

Gastrointestinal function is critical for good health. Emerging evidence has associated overall GI function and gut microbiome status with a wide variety of common illnesses.

GI Effects is an innovative stool test measuring premier biomarkers of gastrointestinal function, providing valuable clinical insight into digestive performance, gut inflammation, and the gut microbiome — areas affecting not only GI health, but overall health as well.

The sophisticated biomarkers from the GI Effects Comprehensive Profile are reported using an intuitive DIG framework, providing key clinical information for three main gastrointestinal functional areas:

Digestion/Absorption:

Pancreatic Elastase-1, a marker of exocrine pancreatic function

 Products of Protein Breakdown, markers of undigested protein reaching the colon

 Fecal Fat, markers of fat breakdown and absorption

Inflammation/Immunology:

 Calprotectin, a marker of neutrophil-driven inflammation; produced in abundance at sites of inflammation, this FDA-cleared biomarker has been proven clinically useful in differentiating between inflammatory gastrointestinal conditions and non inflametory conditions.

 Eosinophil Protein X, a marker of eosinophil-driven inflammation and allergic response

 Fecal Secretory IgA, a marker of gut secretory immunity and barrier function

Gut Microbiome:

 Metabolic indicators, demonstrating specific and vital metabolic functions performed by the microbiota

 Short-Chain Fatty Acids, a metabolomic indicator of GI microbiome health

 Beta-glucuronidase, an inducible enzyme involved in the metabolism and bioavailability of food and drug compounds; also produced by gut bacteria

Commensal Bacteria, demonstrating the composition, diversity, and relative abundance of gut organisms, all of which are linked to both gastrointestinal and general health

 More than 95% of commensal gut organisms are anaerobic and are difficult to recover by traditional (aerobic) culture techniques; molecular DNA techniques are now considered the standard for anaerobic bacteria assessment in research, permitting identification and quantification of multiple organisms with a single specimen.

 The Polymerase Chain Reaction (PCR) methodology can identify bacterial populations at any level of taxonomy, as broadly as phylum and as narrowly as species. This ability permits analysis of the gut microbiome at a desired degree of complexity.

 GI Effects assesses a key set of 24 clinically relevant genera/species that map to 7 major phyla.

Bacterial and mycological culture, which demonstrate the presence of specific beneficial and pathological organismsTraditional bacterial culture complements DNA-based tests to provide an expanded survey of a patient’s gut microbiota, beyond the specific organisms targeted by PCR.

Parasitology

 GI Effects provides microscopic examination of fecal specimens for ova and parasites (O&P), the gold standard of diagnosis for many parasites.

 Enzyme immunoassay (EIA), widely recognized for its diagnostic utility in the detection of pathogenic antigens, is used for the identification of Cryptosporidium, Entamoeba histolytica, and Giardia lamblia.

 Determination of one-day or three-day sample collection is based on clinician’s clinical index of suspicion for parasitic infection. If no/low suspicion, a one day sample will likely be adequate. If high suspicion, a three day sample collection is optimal.

Additional biomarkers available:

 Campylobacter EIA

 Clostridium difficile EIA

 Escherichia coli EIA

 Helicobacter pylori Stool Antigen EIA

 Pl ask your provider if you wish to have any of these checked

Instructions for one day collection:

• Write patient’s first and last name, date of birth, gender and date of collection on the Test Requisition Form (located in the pouch on top of the Specimen Collection Kit Box), as well as on all 3 tubes and the cup, using a permanent marker.
IMPORTANT: To ensure accurate test results you must provide the requested information.

1. Put on the disposable gloves.
2. Collect your stool specimen using the enclosed collection container. DO NOT contaminate the specimen with either urine or water from the toilet.

Stool specimen Collection
Stool specimen Collection

3 . Record stool consistency on the tube labels using a permanent marker.
On the Test Requisition Form write the actual consistency of your stool specimen on the “stool consistency” line. (see images)

Stool types
Stool type

4 Remove the top from the green-top tube and, using the attached spoon, transfer stool specimen into the tube. Take multiple portions from different areas of the collection container. Fill the tube to the “fill line”. Mix and mash the specimen until the sample is thoroughly mixed and is smooth as possible. Screw the top on tightly. DO NOT OVERFILL.

Sampling from stool collection
Sampling from stool collection

Green Tube
Green Tube

5. Shake the tube vigorously for approximately 30 seconds to mix the stool specimen with the preservative in the tube.

6. Repeat Steps 3 – 5 with orange-top tube

Orange-Top tube
Orange-Top tube

7. Rep eat Steps 3 – 5 with pink-top tube

Pink-Top tube
Pink-Top tube

8. Remove the top from the white-top cup. Find and mark the 40-ml line. Using the flat wooden stick provided, pick up several portions of stool from collection container. Add sufficient stool sample to reach the 40-ml line. Recap the container and check to ensure it is securely fastened. DO NOT OVERFILL.

White-Top cup
White-Top cup

9. Dispose of the remaining specimen and the collection container appropriately using the black disposable bag.

10. Refrigerate the tubes in biohazard bags provided until ready to ship or bring to office.

For 3 days collection

DAY TWO:
8. Repeat Steps 1 – 5 with green-top tube

DAY THREE:
9. Repeat Steps 1 – 5 with green-top tube
10. Repeat Steps 1 – 5 with orange-top tube
11. Repeat Steps 1 – 5 with pink-top tube
12. Remove the top from the white-top cup. Find and mark the 40-ml line. Using the flat wooden stick provided, pick up several portions of stool from contrasting areas in the collection tub. Add sufficient stool sample to reach the 40-ml line. Recap the container and check to ensure it is securely fastened. DO NOT OVERFILL. .

13. Dispose of the remaining specimen and the collection container appropriately using the black disposable bag.

14. Refrigerate the tubes in biohazard bags provided until ready to ship.

PATIENT PREPARATION •

It is best to ship your specimen within 24 hours of last collection. Please refer to the enclosed shipping instructions before you collect to determine what days you can ship your specimen.

• Refrain from taking digestive enzymes, antacids, and aspirin for two days prior to specimen collection, unless otherwise instructed by your healthcare provider

• If taking antibiotics, antiparasitics, antifungals, probiotic supplements (acidophilus, etc.), or consuming food products containing beneficial flora (e.g. Activia®), it is recommended that you wait a minimum of 14 days after your last dose before beginning the test; 28 days may be preferred after antibiotics have been utilized (unless instructed otherwise by your physician).There may be times when your healthcare provider prefers that you stay on one of these agents (e.g. acidophilus) during testing in order to evaluate its effectiveness. Follow your healthcare provider’s recommendation

• Never discontinue prescription medications without consulting your healthcare provider first.
• Use caution when opening the tubes. At high altitudes, tubes may be under pressure. Cover tube top with a cloth and remove top slowly.

• Avoid contact with the skin and eyes. For eye contact, flush with water thoroughly for 15 minutes. For skin contact, wash thoroughly with soap and water. For accidental ingestion, contact your local poison control center immediately.

CAUTION: FLUID IN TUBES. KEEP OUT OF REACH OF CHILDREN

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