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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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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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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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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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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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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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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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 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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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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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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