PATIENT: XXXXXXXXXXXXXXXXX TEST REF: TST-NL-XXXX

TEST NUMBER: T-NL-XXXXX (XXXXXXXXXX) COLLECTED: XX/XX/XXXX PRACTITIONER:

GENDER: XYZ RECEIVED: XX/XX/XXXX XXXXXXXXXXXXX
AGE: XX TESTED: XX/XX/XXXX
XXXXXXXXXXXXXXXXXXXX

TEST NAME: GI Effects Comprehensive Profile (GIFX)

2200 GI Effects™ Comprehensive Profile - Stool Powered by Genova AI

Results Overview

MALDIGESTION INFLAMMATION

INFECTION DYSBIOSIS

METABOLITE IMBALANCE

Functional Imbalance Scores

Key : Low Need for Support : Optional Need for Support : Moderate Need for Support : High Need for Support

Need for Need for Need for Need for Need for
Digestive Support Inflammation Modulation Microbiome Support Prebiotic Support Antimicrobial Support
MALDIGESTION INFLAMMATION DYSBIOSIS METABOLIC IMBALANCE INFECTION

5 10 10 0 10
Pancreatic Elastase Calprotectin IAD/Methane Score Total SCFA's Parasitic Infection
Products of Protein Eosinophil Protein X PP Bacteria/Yeast n-Butyrate Conc. PP Bacteria/Yeast
Breakdown Secretory IgA Reference Variance SCFA (%) Total Abundance
Fecal Fats Occult Blood Total Abundance Beta-glucuronidase Pathogenic Bacteria

• Digestive Enzymes • Elimination Diet/ Food • Pre-/Probiotics • Pre-/Probiotics • Antibiotics

• Betaine HCl Sensitivity Testing • Increase Dietary Fiber • Increased Dietary Fiber (if warranted)
• Bile Salts • Mucosa Support: Slippery Intake Intake • Antimicrobial Herbal
• Apple Cider Vinegar Elm, Althea, Aloe, DGL, etc. • Consider SIBO Testing • Increase Resistant Therapy
• Mindful Eating Habits • Zinc Carnosine • Increase Resistant Starches • Antiparasitic Herbal
• Digestive Bitters • L-Glutamine Starches • increase Fermented Therapy (if warranted)
• Quercetin • Increase Fermented Foods • Saccharomyces
• Turmeric Foods • Calcium D-Glucarate boulardii
• Omega-3's • Meal Timing (for high
• GI Referral (If Calpro is beta-glucuronidase)
Elevated)

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 PATIENT: XXXXXXXXXXXXXXXXX TEST REF: TST-NL-XXXX
TEST NUMBER: T-NL-XXXXX (XXXXXXXXXX) COLLECTED: XX/XX/XXXX PRACTITIONER:
GENDER: XYZ RECEIVED: XX/XX/XXXX XXXXXXXXXXXXX
AGE: XX TESTED: XX/XX/XXXX
XXXXXXXXXXXXXXXXXXXX

TEST NAME: GI Effects Comprehensive Profile (GIFX)

Commensal Microbiome Analysis

Commensal Abundance
-30% -10% +10% +30%
Patient Total Commensal Abundance Healthy Cohort
◀ ▶
Potential Microbiome Deficiency 100% Potential Microbiome Overgrowth

Total Commenal Balance: The total commensal abundance is a sum-total of the reported commensal bacteria compared to a
healthy cohort. Low levels of commensal bacteria are often observed after antimicrobial therapy, or in diets lacking fiber and/or
prebiotic-rich foods and may indicate the need for microbiome support. Conversely, higher total commensal abundance may indicate
potential bacteria overgrowth or probiotic supplementation.

Dysbiosis Patterns
36 Dysbiosis Patterns: Genova’s data analysis
has led to the development of unique dysbiosis
Inflammation-Associated Dysbiosis (IAD) 30 110
patterns, related to key physiologic disruptions,
Low High
such as immunosuppresion and inflammation.
9 These patterns may represent dysbiotic
changes that could pose clinical significance.
Methane Dysbiosis Score 5 16
Please see Genova’s published literature for
Low High more details: https://rdcu.be/bRhzv

Zone 1: The commensal profile in this zone

does not align with profiles associated with
intestinal inflammation or immunosuppression. If
30 inflammatory biomarkers are present, other
16
causes need to be excluded, such as infection,
food allergy, or more serious pathology.

Zone 2: This pattern of bacteria is associated

with impaired intestinal barrier function (low
fecal sIgA and EPX). Patients in this zone have
higher rates of opportunistic infections (e.g.
Blastocystis spp. & Dientamoeba fragilis ) as
5 5 well as fecal fat malabsorption. Commensal
abundance is higher in this group suggesting
potential bacterial overgrowth.

Zone 3: Patients in this zone may have more

inflammation compared to those in zone 4.
However, commensal abundance is usually
higher making use of antimicrobial therapy
relatively safer. Patients in this zone may have
30 110 higher rates of pathogenic infections.

Zone 4: This commensal profile is associated

with increased intestinal inflammation. IBD
patients are more likely to have this pattern of
bacteria. Commensal abundance is lower in this
zone; therefore, antibiotic use for GI potential
pathogens should be used with caution. In
addition to standard treatment for intestinal
inflammation, modulation of the commensal gut
profile is encouraged.

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© Copyright 2019 Nordic Laboratories. Reproduction may be made for personal use only. Systematic electronic or print reproduction and distribution including
duplication of any material in this paper for a fee or for commercial purposes, or modification of the content of the paper are prohibited.
 PATIENT: XXXXXXXXXXXXXXXXX TEST REF: TST-NL-XXXX
TEST NUMBER: T-NL-XXXXX (XXXXXXXXXX) COLLECTED: XX/XX/XXXX PRACTITIONER:
GENDER: XYZ RECEIVED: XX/XX/XXXX XXXXXXXXXXXXX
AGE: XX TESTED: XX/XX/XXXX
XXXXXXXXXXXXXXXXXXXX

TEST NAME: GI Effects Comprehensive Profile (GIFX)

Commensal Microbiome Analysis

Commensal Balance

You

*A progressive ranking scale based on a Genova proprietary

algorithm that differentiates healthy and unhealthy
commensal patterns.

**The total number of Commensal Bacteria (PCR) that are

out of reference ranges for this individual.

Relative Commensal Abundance

-50% -25% +25%
Healthy Cohort
Increase in Bacteroides spp. and Odoribacter spp. seen in animal-based
Bacteroidetes Phylum diets; Prevotella increased with plant-based diet
Contains many butyrate-producers; most species responsive to
Firmicutes Phylum plant-based diets; Faecalibacterium spp. is anti-inflammatory
Bifidobacterium is increased with plant-based diets; Collinsella
Actinobacteria Phylum may be proinflammatory, and is elevated with a Western-diet
Some species may be proinflammatory; E. coli consumes simple
Proteobacteria Phylum sugars and is lower in individuals on plant-based diets
*** Methanobrevibacter smithii is associated with methane
Euryarchaeota Phylum production and with diets high in carbohydrates
Certain Fusobacterium spp. may be proinflammatory and
Fusobacteria Phylum increased on low fiber, high fat diets
Akkermansia spp. is involved in gut membrane integrity and
Verrucomicrobia Phylum may be increased with polyphenols and prebiotics

Relative Abundance: The relative abundance compares the quantity of each of 7 major bacterial phyla to a healthy cohort. This can
indicate broader variances in the patient’s gut microbiome profile. Certain interventions may promote or limit individual phyla when clinically
appropriate. Please refer to Genova’s Stool Testing Support Guide for more information on modulation of commensal bacteria through diet &
nutrient interventions. ***Roughly 75% of the healthy cohort had below detectable levels of Methanobrevibacter smithii.

Physician Notes/Recommendations

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duplication of any material in this paper for a fee or for commercial purposes, or modification of the content of the paper are prohibited.
 PATIENT: XXXXXXXXXXXXXXXXX TEST REF: TST-NL-XXXX
TEST NUMBER: T-NL-XXXXX (XXXXXXXXXX) COLLECTED: XX/XX/XXXX PRACTITIONER:
GENDER: XYZ RECEIVED: XX/XX/XXXX XXXXXXXXXXXXX
AGE: XX TESTED: XX/XX/XXXX
XXXXXXXXXXXXXXXXXXXX

TEST NAME: GI Effects Comprehensive Profile (GIFX)

2200 GI Effects™ Comprehensive Profile - Stool

QUINTILE DISTRIBUTION
1st 2nd 3rd 4th 5th
Methodology: GC/MS, Automated Chemistry, EIA Result Reference Range

Digestion and Absorption

100 200
Pancreatic Elastase 1 † 158 L >200 mcg/g

Products of Protein Breakdown (Total*)

(Valerate, Isobutyrate, Isovalerate) 6.0 1.8-9.9 micromol/g

Fecal Fat (Total*) 19.5 3.2-38.6 mg/g

Triglycerides 1.1 0.3-2.8 mg/g

Long-Chain Fatty Acids 12.9 1.2-29.1 mg/g

Cholesterol 0.5 0.4-4.8 mg/g

Phospholipids 5.0 0.2-6.9 mg/g

Inflammation and Immunology

50 120
Calprotectin † 145 H <=50 mcg/g
1.1 4.6
Eosinophil Protein X (EPX)† 4.9 H <=4.6 mcg/g

Fecal secretory IgA 206 <=885 mcg/g

Gut Microbiome Metabolites

Metabolic
Short-Chain Fatty Acids (SCFA) (Total*)
(Acetate, n-Butyrate, Propionate) 81.3 >=23.3 micromol/g

n-Butyrate Concentration 18.1 >=3.6 micromol/g

n-Butyrate % 22.3 11.8-33.3 %

Acetate % 63.1 48.1-69.2 %

Propionate % 14.6 <=29.3 %

Beta-glucuronidase 2,297 368-6,266 U/g

*Total value is equal to the sum of all measurable parts.

†These results are not represented by quintile values.
Tests were developed and their performance characteristics determined by Genova Diagnostics. Unless otherwise noted with ◆, the assays have not been cleared by the U.S. Food
and Drug Administration.

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© Copyright 2019 Nordic Laboratories. Reproduction may be made for personal use only. Systematic electronic or print reproduction and distribution including
duplication of any material in this paper for a fee or for commercial purposes, or modification of the content of the paper are prohibited.
 PATIENT: XXXXXXXXXXXXXXXXX TEST REF: TST-NL-XXXX
TEST NUMBER: T-NL-XXXXX (XXXXXXXXXX) COLLECTED: XX/XX/XXXX PRACTITIONER:
GENDER: XYZ RECEIVED: XX/XX/XXXX XXXXXXXXXXXXX
AGE: XX TESTED: XX/XX/XXXX
XXXXXXXXXXXXXXXXXXXX

TEST NAME: GI Effects Comprehensive Profile (GIFX)

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© Copyright 2019 Nordic Laboratories. Reproduction may be made for personal use only. Systematic electronic or print reproduction and distribution including
duplication of any material in this paper for a fee or for commercial purposes, or modification of the content of the paper are prohibited.
 PATIENT: XXXXXXXXXXXXXXXXX TEST REF: TST-NL-XXXX
TEST NUMBER: T-NL-XXXXX (XXXXXXXXXX) COLLECTED: XX/XX/XXXX PRACTITIONER:
GENDER: XYZ RECEIVED: XX/XX/XXXX XXXXXXXXXXXXX
AGE: XX TESTED: XX/XX/XXXX
XXXXXXXXXXXXXXXXXXXX

TEST NAME: GI Effects Comprehensive Profile (GIFX)

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© Copyright 2019 Nordic Laboratories. Reproduction may be made for personal use only. Systematic electronic or print reproduction and distribution including
duplication of any material in this paper for a fee or for commercial purposes, or modification of the content of the paper are prohibited.
 PATIENT: XXXXXXXXXXXXXXXXX TEST REF: TST-NL-XXXX
TEST NUMBER: T-NL-XXXXX (XXXXXXXXXX) COLLECTED: XX/XX/XXXX PRACTITIONER:
GENDER: XYZ RECEIVED: XX/XX/XXXX XXXXXXXXXXXXX
AGE: XX TESTED: XX/XX/XXXX
XXXXXXXXXXXXXXXXXXXX

TEST NAME: GI Effects Comprehensive Profile (GIFX)

Parasitology
Microscopic O&P Results
Microscopic O&P is capable of detecting all described gastrointestinal parasites. The organisms listed in the box represent those
commonly found in microscopic stool analysis. Should an organism be detected that is not included in the list below, it will be reported
in the Additional Results section.

Genus/species Result
Nematodes - roundworms
Ancylostoma/Necator (Hookworm) Not Detected
Ascaris lumbricoides Not Detected
Capillaria philippinensis Not Detected
Enterobius vermicularis Not Detected
Strongyloides stercoralis Not Detected
Trichuris trichiura Not Detected
Cestodes - tapeworms
Diphyllobothrium latum Not Detected
Dipylidium caninum Not Detected
Hymenolepis diminuta Not Detected
Hymenolepis nana Not Detected
Taenia spp. Not Detected
Trematodes - flukes
Clonorchis/Opisthorchis spp. Not Detected
Fasciola spp./ Fasciolopsis buski Not Detected
Heterophyes/Metagonimus Not Detected
Paragonimus spp. Not Detected
Schistosoma spp. Not Detected
Protozoa
Balantidium coli Not Detected
Blastocystis spp. Rare Detected
Chilomastix mesnili Not Detected
Cryptosporidium spp. Not Detected
Cyclospora cayetanensis Not Detected
Dientamoeba fragilis Moderate Detected
Entamoeba coli Not Detected
Entamoeba histolytica/dispar Not Detected
Entamoeba hartmanii Not Detected
Entamoeba polecki Not Detected
Endolimax nana Not Detected
Giardia Not Detected
Iodamoeba buetschlii Not Detected
Cystoisospora spp. Not Detected
Trichomonads (e.g. Pentatrichomonas) Not Detected
Additional Findings
White Blood Cells Not Detected
Charcot-Leyden Crystals Not Detected
Other Infectious Findings

One negative specimen does not rule out the possibility of a parasitic infection.

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 PATIENT: XXXXXXXXXXXXXXXXX TEST REF: TST-NL-XXXX
TEST NUMBER: T-NL-XXXXX (XXXXXXXXXX) COLLECTED: XX/XX/XXXX PRACTITIONER:
GENDER: XYZ RECEIVED: XX/XX/XXXX XXXXXXXXXXXXX
AGE: XX TESTED: XX/XX/XXXX
XXXXXXXXXXXXXXXXXXXX

TEST NAME: GI Effects Comprehensive Profile (GIFX)

Parasitology
Methodologies: DNA by PCR, Next Generation Sequencing
PCR Parasitology - Protozoa**
Organism Result Units Expected Result

Blastocystis spp. 6.00e2 femtograms/microliter C&S stool Detected Not Detected

Cryptosporidium parvum/hominis <1.76e2 genome copies/microliter C&S stool Not Detected Not Detected
Cyclospora cayetanensis <2.65e2 genome copies/microliter C&S stool Not Detected Not Detected
Dientamoeba fragilis 6.40e2 genome copies/microliter C&S stool Detected Not Detected
Entamoeba histolytica <9.64e1 genome copies/microliter C&S stool Not Detected Not Detected
Giardia <1.36e1 genome copies/microliter C&S stool Not Detected Not Detected

Additional Results
Methodology: Fecal Immunochemical Testing (FIT)
Result Expected Value
Fecal Occult Blood◆ Negative Negative

Color†† Green

Consistency†† Formed/Normal

††Results provided from patient input.

Tests were developed and their performance characteristics determined by Genova Diagnostics. Unless otherwise noted with ◆, the assays have not been cleared by the U.S. Food
and Drug Administration.
Zonulin Family Peptide
Methodology: EIA Result Reference Range Zonulin Family Peptide
Zonulin Family Peptide, Stool 100.0 22.3-161.1 ng/mL This test is for research use only. Genova will not provide
support on interpreting the test results. This test does not
1
detect zonulin. The Scheffler paper suggests that the IDK
kit may detect a zonulin family peptide, such as properdin.
Genova’s unpublished data demonstrated that the current
IDK kit results were associated with stool inflammation
biomarkers and an inflammation-associated dysbiosis
profile.
The performance characteristics of Zonulin Family Peptide
have been verified by Genova Diagnostics, Inc. The assay
has not been cleared by the U.S. Food and Drug
Administration.

Reference:
1. Scheffler L, et al. Widely Used Commercial ELISA Does Not Detect Precursor of Haptoglobin2, but
Recognizes Properdin as a Potential Second Member of the Zonulin Family. Front Endocrinol. 2018;9:22.

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© Copyright 2019 Nordic Laboratories. Reproduction may be made for personal use only. Systematic electronic or print reproduction and distribution including
duplication of any material in this paper for a fee or for commercial purposes, or modification of the content of the paper are prohibited.
 PATIENT: XXXXXXXXXXXXXXXXX TEST REF: TST-NL-XXXX
TEST NUMBER: T-NL-XXXXX (XXXXXXXXXX) COLLECTED: XX/XX/XXXX PRACTITIONER:
GENDER: XYZ RECEIVED: XX/XX/XXXX XXXXXXXXXXXXX
AGE: XX TESTED: XX/XX/XXXX
XXXXXXXXXXXXXXXXXXXX

TEST NAME: GI Effects Comprehensive Profile (GIFX)

Macroscopic/Direct Exam for Parasites

Methodology: Macroscopic Evaluation

No human parasite detected in sample.

Add-on Testing
Methodology: EIA
Result Expected Value
HpSA (Helicobacter pylori stool antigen)
HpSA - H. pylori Negative Negative Helicobacter pylori is a bacterium which causes peptic
ulcer disease and plays a role in the development of
Campylobacter spp.◆** Negative Negative gastric cancer. Direct stool testing of the antigen (HpSA)
is highly accurate and is appropriate for diagnosis and
Clostridium difficile◆** Negative Negative follow-up of infection.

Shiga toxin E. coli◆** Negative Negative

Fecal Lactoferrin◆** Negative Negative

Clostridium difficile
Clostridium difficile is an anaerobic, spore-forming
gram-positive bacterium. After a disturbance of the gut
flora (usually with antibiotics), colonization with
Clostridium difficile can take place. Clostridium difficile
infection is much more common than once thought.
Shiga toxin E. coli
Shiga toxin-producing Escherichia coli (STEC) is a group
of bacterial strains that have been identified as worldwide
causes of serious human gastrointestinal disease. The
subgroup enterohemorrhagic E. coli includes over 100
different serotypes, with 0157:H7 being the most
significant, as it occurs in over 80% of all cases.
Contaminated food continues to be the principal vehicle
for transmission; foods associated with outbreaks include
alfalfa sprouts, fresh produce, beef, and unpasteurized
juices.

Tests were developed and their performance characteristics determined by Genova Diagnostics. Unless otherwise noted with ◆, the assays have not been cleared by the U.S. Food
and Drug Administration.

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 PATIENT: XXXXXXXXXXXXXXXXX TEST REF: TST-NL-XXXX
TEST NUMBER: T-NL-XXXXX (XXXXXXXXXX) COLLECTED: XX/XX/XXXX PRACTITIONER:
GENDER: XYZ RECEIVED: XX/XX/XXXX XXXXXXXXXXXXX
AGE: XX TESTED: XX/XX/XXXX
XXXXXXXXXXXXXXXXXXXX

TEST NAME: GI Effects Comprehensive Profile (GIFX)

Methodology: Vitek 2® System Microbial Antibiotic susceptibility, Manual Minimum Inhibition Concentration
Mycology Sensitivity

Azole Antifungals
Candida species R I S-DD S NI

Fluconazole 0.5

Voriconazole <=0.008

Nystatin =50

Natural Agents
Candida species LOW INHIBITION HIGH INHIBITION

Berberine

Caprylic Acid

Garlic

Undecylenic Acid

Plant tannins

Uva-Ursi

Prescriptive Agents:
The R (Resistant) category implies isolate is not inhibited by obtainable levels of pharmaceutical agent.
The I (Intermediate) category includes isolates for which the minimum inhibition concentration (MIC) values usually approach obtainable pharmaceutical agent
levels and for which response rates may be lower than for susceptible isolates.
The S-DD (Susceptible-Dose Dependent) category implies clinical efficacy when higher than normal dosage of a drug can be used and maximal concentration
achieved.
The S (Susceptible) column implies that isolates are inhibited by the usually achievable concentrations of the pharmaceutical agent.
NI (No Interpretive guidelines established) category is used for organisms that currently do not have established guidelines for MIC interpretation.
Refer to published pharmaceutical guidelines for appropriate dosage therapy.
Nystatin and Natural Agents:
Results for Nystatin are being reported with natural antifungals in this category in accordance with laboratory guidelines for reporting sensitivities. In this assay, inhibition is
defined as the reduction level on organism growth as a direct result of inhibition by a natural substance. The level of inhibition is an indicator of how effective the substance
was at limiting the growth of an organism in an in vitro environment. High inhibition indicates a greater ability by the substance to limit growth, while Low Inhibition a lesser
ability to limit growth. The designated natural products should be considered investigational in nature and not be viewed as standard clinical treatment substances.

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 PATIENT: XXXXXXXXXXXXXXXXX TEST REF: TST-NL-XXXX
TEST NUMBER: T-NL-XXXXX (XXXXXXXXXX) COLLECTED: XX/XX/XXXX PRACTITIONER:
GENDER: XYZ RECEIVED: XX/XX/XXXX XXXXXXXXXXXXX
AGE: XX TESTED: XX/XX/XXXX
XXXXXXXXXXXXXXXXXXXX

TEST NAME: GI Effects Comprehensive Profile (GIFX)

Methodology: Vitek 2® System Microbial Antibiotic susceptibility, Manual Minimum Inhibition Concentration
Bacteria Sensitivity

Prescriptive Agents
Klebsiella pneumoniae R I S-DD S NI

Ampicillin R

Amox./Clavulanic Acid S

Cephalothin S

Ciprofloxacin S

Tetracycline S

Trimethoprim/Sulfa S

Natural Agents
Klebsiella pneumoniae LOW INHIBITION HIGH INHIBITION

Berberine

Oregano

Plant Tannins

Uva-Ursi

Prescriptive Agents:
The R (Resistant) category implies isolate is not inhibited by obtainable levels of pharmaceutical agent.
The I (Intermediate) category includes isolates for which the minimum inhibition concentration (MIC) values usually approach obtainable pharmaceutical agent
levels and for which response rates may be lower than for susceptible isolates.
The S-DD (Susceptible-Dose Dependent) category implies clinical efficacy when higher than normal dosage of a drug can be used and maximal concentration
achieved.
The S (Susceptible) column implies that isolates are inhibited by the usually achievable concentrations of the pharmaceutical agent.
NI (No Interpretive guidelines established) category is used for organisms that currently do not have established guidelines for MIC interpretation.
Refer to published pharmaceutical guidelines for appropriate dosage therapy.
Natural Agents:
In this assay, inhibition is defined as the reduction level on organism growth as a direct result of inhibition by a substance. The level of inhibition is an indicator of how
effective the substance was at limiting the growth of an organism in an in vitro environment. High inhibition indicates a greater ability by the substance to limit growth, while
Low Inhibition a lesser ability to limit growth. The designated natural products should be considered investigational in nature and not be viewed as standard clinical treatment
substances.

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