Test, Don’t Guess!Integrative and Functional Nutrition

Laboratory AssessmentMary Beth Augustine RD CDN FAND

Kathie Madonna Swift MS RDN LDN FAND

Disclosures

Mary Beth Augustine, RDN, CDN, FAND

• Employee- Vibrant America Clinical Laboratory

• Elected Positions- Dietitians in Integrative and Functional Medicine Delegate, Academy of Nutrition and Dietetics House of Delegates

• No other disclosures

Kathie Madonna Swift MS RDN LDN FAND

• Founder- Integrative and Functional Nutrition Academy

• Advisory Board- GenoMind®

• Advisory Board- Wonderful Co. ®

• Advisory Board- Evexia Diagnostics®

• No other disclosures

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Continuum of Chronic Disease Pathology

Health

Physiological Changes

Impaired Cellular

Response

Functional Changes/Early Stage Disease

Diagnosed Pathology

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Jessie: Depressed and Stressed

• 34 y old mother of 2 young children (5y & 3y)

• Concerns: Depression, moody, intermittent tingling in hands, feet

• “Ultimately, I want to be less depressed. Things I’m curious about are my micronutrient status, gut-brain health, and other things affecting the chemicals in my brain.”

• At desired “happy” weight: 65”/123 lbs/BMI: 20.5

• Diet: Mediterranean diet, avoids dairy, caffeine, shellfish allergy, processed carbs for mood lift; struggles with menu planning, juggling kids

• Some yoga, walking, playing with kids

• Sleep 6-8 hours, OK quality

• Supplements: MV, Mg, CoQ10, methylfolate, mood pack, omega 3’s, probiotic, curcumin

• Other: Working with a therapist

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Significant Lab Findings

• MCV: ↑

• Methylmalonic acid: ↑

• Anti-parietal cell antibody ↑

– Parietal cells make and release IF needed to absorb B12

• Clinical Pearl:

– Confirmed clinical suspicions

– Tailored intervention

– Targeted further investigation

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Missed and Dismissed

• Lori: Digestive distress - “in her head”

• Charles: Basic lipid profile, family history CVD

• Elaine: Eczema, skin itching, fatigue

• Alicia: Exhausted, hair thinning, constipation

• Rhonda: Mouth sores, chronic anemia, “that’s just normal for me”

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J Am Diet Assoc. 2011;111:902-913 7

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Why do laboratory testing?

• Testing can confirm your clinical suspicions

• Testing may uncover early stages of dysfunction and imbalances

• Testing can make sure you don’t miss something critical (anemia, B12 deficiency, hypothyroidism…)

• Testing improves clinical decision making

• Testing provides objective proof of results

• Testing results can be a motivator for people to make dietary and lifestyle changes

• Testing guides therapies and modifications and efficacy of treatment protocols

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Words of Wisdom

• Do your laboratory due diligence. Know thy lab as thyself!

• Don’t get enamored by results and miss the clinical picture!

• Consider cost, learn to prioritize lab testing.

• When reviewing results, start with the positive findings.

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Laboratory Diagnostics

How Reliable is Laboratory Testing?

Accuracy (Trueness) Precision (Repeatability)

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Sensitivity and Specificity

89% Sensitivity11% False Negatives

94% Specificity6% False Positives

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Patient’s Brain

Physician’s Brain

Ordering

Collection

TransportationPre-Analytic

Phase

Analytic

Phase

Reporting

Laboratory’s Brain

‘Brain-to-Brain Loop’of Laboratory Diagnostics

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Types and Rates of Error in Laboratory TestingTesting Phase Type of Error Rates of Error

Pre-Analytical Inappropriate test ordered 46-68%

Order entry error

Misidentification of patient

Container inappropriate

Sample collection/transport inadequate

Insufficient sample volume

Sorting and routing errors

Labeling errors

Analytical Equipment malfunction 7-13%

Sample mix-ups/interference

Undetected failure in quality control

Procedure not followed

Post-Analytical Failure in reporting 18-47%

Erroneous validation of analytical data

Improper data entry15

Quality Control, Lab Error & Diagnostic Harms

• Laboratory Accreditation

– College of American Pathologists (CAP)

– Clinical Laboratory Improvement Amendments (CLIA) Certification

• 5 Causes of Lab Diagnostic Error

1. Inappropriate test is ordered

2. Appropriate test not ordered

3. Appropriate test result is misapplied

4. Appropriate test ordered, but delayed results

5. Appropriate test ordered, but results inaccurate

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The Rise of Precision Medicine

• Real world data

• Human biospecimens (13 billion annually)

• Consented patients

• Wellness and screening tests vs. diagnostic tests

• Payment models

• Laboratory Developed Tests (LDTs) vs. FDA approved In-Vitro Diagnostics (IVDs)– FDA enforcement: low risk, moderate risk, high risk LDTs

• Next Generation Sequencing (NGS) tests

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Direct Access Testing (DAT)

• The beginning- FSBG and EPT

• DAT key players: 23andMe, Any Lab Test Now, Direct Labs, DNA4Life, Genomind, LabCorp, Natera, Quest Diagnostics, Veritas Genetics

• DAT Labs must be CLIA certified

• Risks, benefits, uncertainties

• Clinical and ethical challenges

• Genetic Information Nondiscrimination Act (GINA)

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Direct Access Testing Examples

QuestDirect® HealthCheck®

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Baseline Assessment of Nutrition Status

Baseline Assessment of Nutrition Status

Basic

• Amino acid analysis, LC/MS, plasma (fasting)

• Fatty acid profile, comprehensive (fasting)

• Micronutrients

Comprehensive

• Amino acid analysis, urine (first morning void)

• Organic acids test

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Amino Acids and Organic Acids Sample Reports

LabCorpAmino Acid Profile, Quantitative

Great Plains LaboratoryOrganic Acids Test (OAT)

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Fatty Acid Test Sample Reports

Quest DiagnosticsFatty Acid Profile, Comprehensive

Great Plains LaboratoryComprehensive Fatty Acids Test

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Micronutrient Test Sample Reports

Genova Diagnostics NutrEval®

Vibrant AmericaMicronutrient Test®

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Multi-Systemic Nutrition Tests

• Glycemic control biomarkers

• Genetic SNPs

• Hormones

• Inflammatory biomarkers

• Immunity biomarkers

• Oxidative stress biomarkers

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Multi-Systemic Nutrition Tests

Precision AnalyticaDUTCH® Test

Cyrex LaboratoriesMultiple Autoimmune Screen

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Multisystemic Nutrition Tests- Examples

Oxidative StressQuest Lipid Peroxide

Oxidative StressQuest Total Glutathione

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Multi Systemic Tests- Deep Dive Resources!

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Food Sensitivity Tests

Food Sensitivity Tests• Food allergy vs. food sensitivity

• Food sensitivity testing– Test strengths, limitations, and benefits and harms

– Scientific uncertainties, scientific agreement, minority opinion

– Research gaps and practice gaps

Food Sensitivity Testing

Medical History

Dietary History

Nutrition Focused Physical

Exam

Food SensitivityDiagnosis

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IgG Antibodies in Platelet Activation and Anaphylaxis

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Pathways of Anaphylaxis and Food AllergyFour distinct pathways of response seem possible--1. “Classic” pathway involving IgE, FceRI, mast cells, and histamine2. “Alternative” pathway involving IgG1, FcyRIII, macrophages and PAF3. IgG-basophil-PAF pathway 4. IgG-neutrophil-PAF pathway via FcyRIV activation

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Organ System Tests

Nathan Neuro Logical

Test, Don’t Guess!

• ID

• Concerns

• Anthropometrics

• Diet

• Activity

• Sleep

• Supplements

• Other

• Lab Findings

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Neurological System Tests

Comprehensive

• Neural antibodies

• Blood brain barrier permeability biomarkers

• TBI biomarkers

• Genomic tests

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Neurological SystemBlood Brain Barrier

in Systemic InflammationVibrant America

Neural Zoomer Plus®

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Neurological System- Sample ReportsGenoMind

Mindful DNA®GenoMind

Drug Interaction Guide- DIG®

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Cardi O. Vascular

• ID

• Concerns

• Anthropometrics

• Diet

• Activity

• Sleep

• Supplements

• Other

• Lab Findings

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• Apolipoproteins

• Aspartate aminotransferase

• Atrial natriuretic peptide

• B-type natriuretic peptide (BNP)

• Cholesterol

• Creatine kinase

• Creatine phosphokinase

• Fibrinogen

Cardiovascular System- Basic

• High-sensitivity CRP

• Homocysteine

• Lactate dehydrogenase

• Lipoproteins

• L-PAC

• N-terminal pro b-type natriuretic peptide (NT-proBNP)

• Triglycerides

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• 11-dhTXB2 (aspirin effect)

• 1-5anhydroglucitol (1,5AG)

• ADMA-sdma

• Adiponectin

• Ferritin

• F2-isoprostanes

• Galactin-3

• Microalbumin

• Myeloperoxidase

• TMAO

Cardiovascular System- Comprehensive

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Cardiovascular System Sample ReportsQuest Diagnostics

Cardio IQ®LabCorp

NMR LipoProfile®

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Cardiovascular System Sample ReportsBoston Heart

Cholesterol Balance®Cleveland Heart Lab

Inflammation & Lipids Panels

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Bill E. Harry

• ID

• Concerns

• Anthropometrics

• Diet

• Activity

• Sleep

• Supplements

• Other

• Lab Findings

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Hepatobiliary System

Basic • Alanine aminotransferase (ALT)

• Alkaline phosphatase (ALP)

• Aspartate aminotransferase (AST)

• Ammonia

• Amylase, blood, urine

• Bilirubin

• Cholesterol

• Chymotrypsin, stool

• Gamma-glutamyltranspeptidase (GGT)

• Lactate dehydrogenase (LDH)

• Lipase

• Elastase, stool

Comprehensive

• Bile acids, fractionated and total

• BPA

• Glyphospate

• Heavy metals, whole blood, random urine, 24-hour urine non-provoked, urine provoked

• Pancreatic elastase

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Hepatobiliary System Sample Reports

Quest DiagnosticsHeavy Metals Urine

Lab Corp Heavy Metals Profile II, Urine

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Hepatobiliary System Sample Reports

Genova DiagnosticsDetoxigenomic® Profile

Great Plains LaboratoryGPL-TOX®

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GI Jane

Test, Don’t Guess!

• ID

• Concerns

• Anthropometrics

• Diet

• Activity

• Sleep

• Supplements

• Other

• Lab Findings

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Gastrointestinal System

Basic• Anti-saccharomyces

cerevisiae antibodies (ASCA)

• Calprotectin, stool

• Candida albicans antibodies (IgG, IgA, IgM)

• Fecal fat, qualitative

• Lactoferrin, qualitative, stool

• pH feces

• Reducing substances, stool

• D-xylose absorption, urine

Comprehensive

• Anti-vinculin antibody

• Anti-cytolethal distending toxin B (CdtB)

• Hydrogen/methane breath test (SIBO test)

• Microbial tests

• Stool metabolites

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GI System Sample Reports

Genova Diagnostics GI Effects®

Diagnostic Solutions GI-MAP®

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Jen Ito Urinary

• ID

• Concerns

• Anthropometrics

• Diet

• Activity

• Sleep

• Supplements

• Other

• Lab Findings

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Genitourinary System

Basic• Anion gap

• Kidney stone risk panel

• Uric acid, random urine

• Urinalysis

• Urine albumin

• Urine albumin/creatinine ratio (ACR)

• Urine creatinine

• Urine osmolality

• Urine protein

Comprehensive

• Urine fluoride

• Urine halides (pre/post load)

• Urine hormones

• Urine iodine (pre/post load)

• Urine neurotransmitters

• Urine pathogens

• Urine toxic and essential elements

• Urine inflammatory markers

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Urine Testing- The Time Has Come!

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Mike Myalgia

Test, Don’t Guess!

• ID

• Concerns

• Anthropometrics

• Diet

• Activity

• Sleep

• Supplements

• Other

• Lab Findings

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Musculoskeletal System

• Alkaline phosphatase

• ANA

• Connective tissue disorder profile

• Deoxypyridinoline crosslinks (Dpd), urine

• Erythrocyte sedimentation rate (ESR)

• Myoglobin, urine

• Myoglobin, serum

• N-telopeptide crosslinks (NTx), serum

• Osteocalcin

• RBC magnesium

• Uric acid, serum

• Vitamin D

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Laboratory Resources

Online Laboratory Resources

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Thank you!MaryBethAugustine.com

KathieSwift.com