EFTA00621679.pdf

11111111111111111 GENOVA DIAGNOSTICS VIVIVIgdx.net • 800.577.4767 Ordering Physician: The Natural Medicine Clinic Thomas Rotrano, DC 2401 PGA Blvd Ste 132 Palm Beach Gardens. FL 33410 GI Effects f Stool Profiles U.S. ?steal podIng 2000 2200 GI Effects Comprehensive Profile Accession #. A13123t0035 Date Collected: 12/30/2013 Order it: G8310455 Date Received: 12/31/2013 Reference Dated Report: 01/17/2014 Patient: Jeffrey Epstein Date of Birth: 01/20/1953 Telephone: 5616275816 Age: 60 Fax: 5616275895 Sex: Repriled: Male Comment: • IIMIMISO Methodology: DNA Analysis, GCAWS. Microscopic. Colorimetfic. Automated Chemistry. EtA The GI Effects Gastrointestinal Function Profile (2100) and the GI Effects Microbial Ecology Profile (2105) have been replaced by GI Effects Comprehensive Profile (2200) and a new version of the Microbial Ecology Profile (2205), respectively. Updates on the new GI Effects Comprehensive Profile (2200) and Microbial Ecology Profile (2205) include: o The 2200 and 2205 will Include for parasitology, replacing PCR. To enhance clinical utility for our clients, Genova Diagnostics will now offer gold standard technology on its GI Effects Profiles. When multiple stool samples are provided. Genova utilizes a pooled process known as Optimized Parasitology Recovery (OPR). o In order to optimize clinical utility. pathogens (C. difficile, H. pylori, Shiga Toxin E. coll, and Campylobacter app.) will now only be offered as EIA add ons. Clinical utility is best achieved by applying diagnostic assessment for these pathogens within an appropriate clinical differential. o Drug Resistant Genes will be discontinued from reported profiles. Measurement of drug resistant genes indicates presence of DNA for the gene in stool, but does not provide evidence of gene expression. Therefore, no specific treatment indications can be inferred. o PCR will continue to be utilized for assessment of gut microbiota, including predominant and opportunistic bacteria, and yeast/fungi. If you have any questions regarding these important changes. please feel free to contact Client Services at 800-5224762, or contact us online at www.gclx.net. Georgia Lab Lin code 4067-007 <MIA IDS 1930255349 New Tort Clinical Lab PFI 44578 norioa Clinical Lab Lin #800008124 Tenting Perfoimed by Genova Diagnostics. Inc. 3425 Corporate Way. Duluth. GA 30096 Page 1 Latotalmy Director: Rabat M. David. PhD EFTA00621679 G E NOVA DIAGNOSTICS' www.gdx.net • 800.522.4762 Ordering Physician: The Natural Medicine Clinic Thomas Rofrano, DC 2401 PGA Blvd Ste 132 Palm Beach Gardens, FL 33410 GI GI Effects Stool Profiles 2200 GI Effects Comprehensive Profile Accession tt. A1312310035 Order it G8310455 Reference H: Patient: Jeffrey Epstein Date of Birth: 01/20/1953 Age: 60 Sex: Male Reprinted: Comment: Date Collected: 12130/2013 Date Received: 12131/2013 Date of Report: 01/17/2014 Telephone: 5616275816 Fax: 5616275895 Methodology: DNA Analysis. GOMS.Mtcroscopic. Cotonmetnc. Automated Chermstry, Quintile Ranking I 1st I 2nd I 3rd I 4th 5th Results Predominant Bacteria Obligate Anaerobes 1.6 Bacteroides spp. 6.2 I 1.5 Clostridia spp. 5.3 16 Prevotella spp. 4.6 Fusobacteria spp. 5.1 Streptomyces spp. 4.7 Mycoplasma spp. 3.7 Facultative Anaerobes Lactobacillus spp. 3.8 Bifidobacter spp. 7.1 Escherichia coli (E. coli) 5.4 Opportunistic Bacteria No clinically significant amounts. 1.6 6.7 I I 1 4, 62 62 74 1.6 58 1.7 62 1.8 78 - 1.2 2.3 1.7 76 I I I 7.7 Gastronintesinel Effects Interpretation Interpretive Guides are downloadable at: www.qdx.net/lests/interpretive-guides 95% Reference Range E+007 - 1.8 Expected Value Consistency = Hard/Constipated Predominant Bacteria play major roles n health. They provide colonization resistance aganst potentially pathogenic organisms. aid n digestion and absorption. produce vitamins and SCFA's. and stimulate the GI immune system. DNA probes allow detection of multiple species (spp.) within a genus. so the genera that are reported cover many species. Organisms are detected by DNA analysis. One colony forming unit (CFU) is equivalent to one bacterium. Each genome detected represents one cell. or one CFU. Results are expressed in scientific notation. so an organism reported as 2.5 E+007 CFU/gram is read as 25 milion colony forming units per gram of feces. Opportunistic Bacteria may cause symptoms and be associated with disease. They can affect digestion and absorption. nutrient production. pH and immune state. Antibiotic sensitivity tests will be performed on all opportunistic bacteria found. although clinical history is usually considered to determine treatment since the organisms we not generally considered to be pathogens. Georgia Lab Lie code #067 4007 CLIA IDa 1100255349 New York Clinical Lab PFI a4578 Floods Clinical Lab Lie a800008124 Testfig Performed by Genova Diagnostics. Inc. 3425 corporate Way. Daub% GA 30096 Page 2 Laboratory Director: Robert h1. David. PhD EFTA00621680 G ENOVA DIAGNOSTICS' www.gdx.net • 800.522.4762 Ordering Physician: Date of Report: 01/17/2014 A1312310035 Thomas Rofrano. DC Reprinted: Jeffrey Epstein Comment: 2200 GI Effects Comprehensive Profile Methodology: DNA Analys,s. GC/MS. Microscopic, Colonmetric. Automated Chemistry. EIA Yeast/Fungi Expected Value No clinically significant amounts. Yeast/Fungi Yeast overgrowth has been linked to many chronic conditions. in part because of antigenic responses in some patients to even low rates of yeast growth. Potential symptoms include diarrhea. headache. bloating. atopic dermatitis and fatigue. Positives are reported as +1. +2. +3 or +4 indicating >100. >1000. >10000 or >100000 pg DNA/g. Parasitology Microscopic Exam Results:* Dientamoeba fragilis: Few Trophozoites Parasitology EIA Tests: In Range Cryptosporidium ( Negative ) Giardia lamblia ( Negative ) E. histolytica/dispar ( Negative ) ( ) Out of Range Indicates testrig performed by Genova. Inc. 63 Zlicoa St.. Ashevile. NC 28801-1074 A. L. Peace-Brewer. PhD. D(ABMLI). Lab Director • CLIA LC. 03400655571 • Medicare Lic. 034-8475 Parasitology Parasite Recovery Literature suggests that >90% of enteric parasitic infections are detected in a sample from a single stool collection. Increased sensitivity results from the collection of additional specimens on separate days. Parasites have been detected n 20-24% of U.S. patients with mild to moderate GI symptoms. Adiposity Index Expected Value Firmicutes % 54 Bacteroidetes % 46 <=80 % >= 20 % The Adiposity Index is derived by using DNA probes that detect multiple genera of the phyla Firmicutes and Bacteroidetes. Abnormalities of these phyla may be associated with increased caloric extraction from food. Georgia Lab Lie Code #067-007 CLIA IDS 1030255349 New York Clinical Lab PFI a4578 Florida Clinical Lab Lie N8O00O8124 Testog Performed by Genova Diagnostics. Inc. 3425 Corporate Way. Odell,. GA 30096 Page 3 Laboratory Director: Robert ht. David. PhD EFTA00621681 Ordering Physician: Date of Report: 01/1712014 A1312310035 G E N OVA Thomas Rofrano, DC Reprinted: Jeffrey Epstein DIAGNOSTICS' Comment: • 0114110 www.gdx.net • 800.522.4762 4141414b111 2200 GI Effects Comprehensive Profile Methodology DNA Analysis. GC/MS. Microscopic. Colonmetric. Automated Chemistry. EtA Results quintile Ranking 2nd I 3rd I 4th I 'm I 5th 95% Roforence I Range Beneficial SCFA Total SCFA n-Butyrate 34 3.4 L L 53 35 >- mMig 5.2 3.9 mM/g Acetate % n-Butyrate % Propionate % Valerate % 67 10 21 3.2 52 71 % 47-77 10 25 7-30 % 13 25 % 10-29 1.0 36 0A-4.6 % Inflammation Lactoforrin W0Cs Mucus 0.5 Negative Negative 3.1 c- 6.3 ucliml- Negative-Rare Negative Beneficial SCFA Short chain fatty acids (SCFA) are produced by bacterial fermentation of dietary polysaccharides and fiber. The product. N-butyrate. is taken up and used to sustain the normal activity of colonic epithieial cells. Butyrate has been shown to lower the risk of colitis and colorectal cancer. A healthy balance of GI microbes depends on production of SC FA by one specie to allow the normal growth of another one al a complex cross-feeding network. Inflammation Lactoforrin. an iron-binding glycoprotein. is released in IBD but not in non-inflammatory IBS. High levels are found in Crohn's. UC or infection. WBC's we elevated M general inflammaticonnfection. Mucus is often visualized in acute GI inflammation. Immunology Focal sigA 32 20 144 5 161 mgrdi Immunology High fecal slgA indicates immune system reactions to the presence of antigens from bacteria. yeast or other microbes. Low sigA can result from stress or malnutrition. Georgia Lab Lie Code /1067-007 CLIA IDS 1100255349 New York Clinical Lab PFI $4578 Florida Clinical Lab Lie #800008124 Testing Performed by Genova Diagnostics. Inc. 3425 Corporate Way. DLgulli. GA 30096 Page 4 Latotalmy Director: Rabat M. David. PhD EFTA00621682 G E NOVA Ordering Physician: Date of Report: 01/17/2014 A1312310036 Thomas Rofrano, DC Repnnted: Jeffrey Epstein DIAGNOSTICS' Comment: 41•••• www.gdx.net • 800.522.4762 --•-•4141411 2200 GI Effects Comprehensive Profile Methodology: DNA Analysis. GC/MS. Microscope. Colonmetsic. Automated Chemistry. EtA quintile Ranking 2nd I 3rd I 4th Results I 1st I 95% Reference 5th I Range Additional Tests pl-I 6.6 RBCs Negative Color Brown 5.9 69 I I I I • I 5.7 7.1 Negative Additional Tests pH is influenced by numerous factors. but it is strongly related to the bacterial release of pH-bwerng organic acids and pH-raising ammonia. Positive RBCs can signify GI tract bleeds-Q. Color (other than brown) abnormalities can be due to upper GI bleedng. or bile duct blockage. steatonhea or antibiotic use. Digestion Elastase 1 236 Triglycerides 74 Putrefactive SCFA 1.1 Vegetable Fibers Rare 200 I I l- 119 4.4 > 100 uglg <— 181 mgrdL e 7.4 Mid None-Few Digestion Pancreatic elastase 1 levels below 100 are strongly correlated with severe pancreatic nsufficiency: levels of 100-200 identify moderate pancreatic insufficiency. High triglycerkies signify fat maldigestion. Putrefactive SCFA are a result of bacterial fermentation of undigested protein. High numbers of vegetable fibers indicate maldigestion. Absorption LCFAs 6.8 Total Fat 9.1 Cholesterol <56 91 129 142 *UC = Unable to Calculate REJ' = 'Unable to perform: sample was rejected. Decisions evolving diagnosis and treatment are the responsibility of the clinician. <- 15.1 mmot'L <- 18.9 mmotfL <- 191 mg/dL Absorption High LCFA indicates fat malabsorption due to pancreatic or biliary insufficiency. or acute bacterial infection that produces intestinal cell destruction. High total fat usually signals malabsorption. as does elevated fecal cholesterol. Georgia Lab Lic. Code 4067-007 WA ID, 1100255349 New York Clirical Lab PFI 44578 Florida Clinical Lab Lie. M800005124 Testing Performed by Genova Diagnostics. Inc. 3425 Commie way. Caulk GA 30096 Page 5 Lab:watery Director: Robert M. David. PhD EFTA00621683 II IIIIIglllllllll GENOVA DIAGNOSTICS' nen www.gdx.net• 800.522.4762 Ordering Physician: The Natural Medicine Clinic Thomas Rofrano, DC 2401 PGA Blvd Ste 132 Palm Beach Gardens. FL 33410 Accession g: A1312310035 Date Colected: 12/30:2013 Order ft: G8310455 Date Received: 12/31/2013 Reference g: Date of Report: 01/07/2014 Patient: Jeffrey Epstein Date of Birth: 01120/1953 Telephone: 5616275816 Age: 60 Fax: 5616275895 Sex: Reprinted: Male Comment: GI. GI Effects X Stool Profiles • ?mai pending ZOOS 2130 Campylobacter EIA • 414141 Methodology: EIA Results 1. Campylobacter spp. Negative Expected Value Negative Campylobacter Campylobacterjejuni is the most frequent cause of bacterial-Sidi:Ed diarrhea. While transmission can occur via the fecal-oral mute. infection is primarily associated with the ingestion of contaminated and poorly cooked foods of animal origin. notably. red meat and milk. Decisions evolving diagnosis and treatment are the responsibility of the clinician. Georgia Lab Lie. Code 4067-007 CLIP ICC 1100255349 New York Clinical Lab PFI 44578 Florida Clinical Lab Lie M800005124 Testing Performed by Genova Diagnosbes. Inc. 3425 Corporate Way. Duluth. GA 30096 Page 1 Laboratory Director. Robed U. David. PhD EFTA00621684 GENOVA DIAGNOSTICS' earn www.gdx.net• 800.522.4762 Ordering Physician: The Natural Medicine Clinic Thomas Rofrano, DC 2401 PGA Blvd Ste 132 Palm Beach Gardens, FL 33410 GI Effects ./x Stool Profiles S paten. v.•mnr 200S 2131 Clostridium difficile EIA Accession A: A1312310035 Date Colected: 12/30:2013 Order A: 68310455 Date Received: 12/31/2013 Reference if: Date of Report: 01/17/2014 Patient: Jeffrey Epstein Date 01 Birth: 01/20/1953 Telephone: 5616275816 Age: 60 Fax: 5616275895 Sex: Reprinted: Mate Comment: 411•4141 Methodology: EIA Results 1. Clostridium difficile Negalivet Expectod Value Negative Clostridium difficile Clostridium difficale is an anaerobic, spore-forming gram-positive bacterium which can be part of the normal intestinal flora. Disrupbon of the normal gut flora via antibiotic use (especially those with broad spectrum activity) may result n overgrowth of Clostridium difficile. Symptoms may range in severity from mild diarrhea to fife-threateni-ig colitis. tIndicates testing performed by Genova. Inc. 63 Zillicoa St.. Asheville. NC 28801-1074 A. L. Peace-Brewer. PhD. D(ABMLI). Lab Director' CLIA Lic. #34D0655571 Medicare Lic. 834-8475 Decisions evolving diagnosis and treatment are the responsibility of the clinician. Georgia Lab Lie. Code /1067-007 CLIA IDa 1100255349 New Vont Clinical Lab PFI S4578 Florida Clinical Lab Lic M00008124 Tesbng Performed by Genova Diagnostics. Inc. 3425 Corporate Way. Duluth. GA 30096 Page 1 Laboratory Director. Robed M. David. PhD EFTA00621685 GENOVA DIAGNOSTICS' -*NH www.gdx.net• 800.522.4762 Ordering Physician: The Natural Medicine Clinic Thomas Rofrano, DC 2401 PGA Blvd Ste 132 Palm Beach Gardens, FL 33410 GI . GI Effects six Stool Profiles 'steal palling Me 2132 Shiga toxin E. coli EIA Accession 4: A1312310035 Date Colected: 12/30:2013 Order N: G8310455 Date Received: 12/31)2013 Reference 5: Date of Report: 01/17)2014 Patient: Jeffrey Epstein Date of Birth: 01120/1953 Telephone: 5616275816 Age: 60 Fax: 5616275895 Sex: Reprinted: Male Comment: Methodology: EM Results 1. Shiga toxin E. cell Negalivet Expected Value Negative Shiga toxin E. cell Shiga toxin-producing Escherichia coil (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 stereotypes. with 0157:H7 being the most significant. as it occurs in over 80% of cases. The pathogen is transmitted primarily by food. in particular dairy and beef cattle. tlndicates testing performed by Genova. Inc. 63 Zillicoa St.. Asheville. NC 28801-1074 A. L. Peace-Brewer. PhD. D(ABMLI). Lab Director' CLIA Lic. 03400655571 Medicare Lic. 534-8475 Decisions iwolving diagnosis and treatment are the responsibility of the clinician. Georgia Lab Lie. Code /1067-007 CLIA IDE 1100255348 New York Clinical Lab PFI p4578 Florida Clinical Lab Lin N800008124 Tesbng Performed by Genova Dragnosbes. Inc. 3425 Corporate Way. Duluth. GA 30096 Page 1 Laboratory Director. Robed M. David. PhD EFTA00621686 II II EMINIIIINIM G E NOVA DIAGNOSTICS ••••• www.gdx.net • 800.522.4762 Ordering Physician: The Natural Medicine Clinic Thomas Rofrano, DC 2401 PGA Blvd Ste 132 Palm Beach Gardens, FL 33410 Accession #: A1312310035 Date Collected: 12/30/2013 Order #: G8310455 Date Received: 12/31/2013 Reference #: Date of Report: 01/0872014 Patient: Jeffrey Epstein Date of Birth: 01/20/1953 Telephone: 5616275816 Age: 60 Fax: 5616275895 Sex: Reprinted: Male Comment: GT • GI Effects t/A4 Stool Profiles 2133 Helicobacter pylon Stool Antigen EIA (HpSA) • Methodaiogy EIA Results 1. HpSA - H. pylon Negative Expected Value Negative HpSA (Helicobacter pylori stool antigen) Helicobacter pylori is a bacterium which causes peptic ulcer disease and plays a role in the development of gastric cancer. Direct stool testrig of the antigen (HpSA) is highly accurate and is appropriate for diagnosis and follow-up of infection. Decisions iwolving diagnosis and treatment are the responsibility of the clinician. Georgia Lab Lie. Code /1067-007 CLIA IDe 1100255349 New York Clinical Lab PFI .4578 Florida Clinical Lab Lin n800008124 Testing Performed by Genova Diagnoses. Inc. 3425 Corporate Way. Duluth. GA 30096 Page 1 Laboratory Director. Robed M. David. PTO EFTA00621687