Metabolomix+ (Formerly Optimal Nutritional Evaluation - ONE FMV (Urine)

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Category:

Turnaround Time: 14 Days
CPT Code:

82139, 83921x17, 83497, 83520, 82108, 83015, 82542, 82726x5, 82300, 82340, 82570, 83150, 83605,83655, 84311, 83735, 83885, 84210, 84585

Test Type: Kit-Based, Urine

Overview:

The Metabolomix+ is a unique combination of nutritional tests that provides an analysis of key nutritional biomarkers. A first morning void (FMV) urine collection, with optional add-on bloodspot finger stick and buccal swab, the Metabolomix+ nutritional test is a non-invasive, patient-friendly way to assess the functional need for antioxidants, B-vitamins, minerals, digestive support, fatty acids, and amino acids. Insights gained from the Metabolomix+ nutritional test allows clinicians to target nutritional therapies to the precise needs of their patients.

Additional markers are available for an even greater overview of a patient's nutritional status with easy to add modules based on a patient's unique needs.

What is a functional nutritional assessment?

Marked accumulation of organic acids in urine can signal a metabolic inhibition or block. The metabolic block may be due to a nutrient deficiency, an inherited enzyme deficit, toxic build-up, or drug effect.

Enzymes that are responsible for metabolizing organic acids are vitamin and mineral dependent. With this, elevations in organic acids can reflect a functional need for these nutrients on a cellular and biochemical level, even despite normal serum levels.1-5 Recommendations for nutrient supplementation based on elevated organic acid results are generated using a literature-based proprietary algorithm.

Traditionally, urinary organic acid assessment has been used in neonatal/pediatric medicine to identify genetic inborn errors of metabolism, with severity depending on the degree and type of error.* In many cases of genetic inborn errors, the enzymatic defect may be compensated for by high doses of specific vitamin and mineral cofactors and/or dietary interventions. Intervention with higher-dose nutrient cofactors may also be effective in cases of decreased enzyme activity due to causes other than frank inborn errors.

* Genova's organic acid testing is not intended for the diagnosis of neonatal inborn errors of metabolism.

Which patients might benefit from functional nutritional testing?

Common clinical indications for testing include:

  • Mood Disorders6,7
  • Mitochondrial Dysfunction8
  • Fatigue9
  • Chronic Stress10
  • Inflammation11

Several diseases are associated with abnormal organic acid, amino acid, and fatty acid levels such as depression, anxiety, cardiovascular disease, neurocognitive decline, diabetes, cancer, anorexia, and many others.12-15

About the Metabolomix+ Profile

The Metabolomix+ Profile report allows for easy interpretation and clinically actionable results. It includes a Suggested Supplement Schedule that provides personalized recommendations based on test results. The Interpretation-At-A-Glance section of the report provides facts related to nutrient function, causes and complications of their deficiencies, and dietary sources.

The Metabolomix+ Profile report categorizes results into several metabolic areas:

    • Organic Acids
      • Malabsorption and Dysbiosis
      • Cellular Energy and Mitochondrial Metabolites
      • Neurotransmitter Metabolites
      • Vitamin Markers
      • Toxin and Detoxification Markers
      • Tyrosine Metabolism
    • Amino Acids
      • Nutritionally Essential Amino Acids
      • Nonessential Protein Amino Acids
      • Intermediary Metabolites
      • Dietary Peptide Related Markers
    • Oxidative Stress Markers
    • Essential and Metabolic Fatty Acids - Bloodspot (if selected as add-on profile)
      • Omega 3 Fatty Acids
      • Omega 6 Fatty Acids
      • Omega 9 Fatty Acids
      • Saturated Fatty Acids
      • Monounsaturated Fatty Acids
      • Delta-6 Desaturase Activity
      • Cardiovascular Risk
    • Nutrient and Toxic Elements (if selected as add-on profile)
    • Genomics (if one or more of the following SNPs are selected as add-ons)
      • APO E (C112R + R158C)
      • MTHFR Combined (A1298C + C677T)
      • TNF-α
      • COMT (V158M)

References

  1. Kaluzna-Czaplinska J. Noninvasive urinary organic acids test to assess biochemical and nutritional individuality in autistic children. Clin Biochem. 2011;44(8-9):686-691.
  2. Broquist HP, Luhby AL. Detection and isolation of formiminoglutamic acid from urine in folic acid deficiency in humans. Proc Soc Exp Biol Med. 1959;100(2):349-354.
  3. Sun A-l, Ni Y-h, Li X-b, et al. Urinary methylmalonic acid as an indicator of early vitamin B12 deficiency and its role in polyneuropathy in type 2 diabetes. J Diab Res. 2014;2014.
  4. Kwok T, Cheng G, Lai W, Poon P, Woo J, Pang C. Use of fasting urinary methylmalonic acid to screen for metabolic vitamin B12 deficiency in older persons. Nutrition. 2004;20(9):764-768.
  5. Brown R, Thornton MJ, Price J. The effect of vitamin supplementation on the urinary excretion of tryptophan metabolites by pregnant women. J Clin Invest. 1961;40(4):617-623.
  6. Lykouras L, Markianos M, Hatzimanolis J, Malliaras D, Stefanis C. Association of biogenic amine metabolites with symptomatology in delusional (psychotic) and nondelusional depressed patients. Prog Neuro-Psychopharmacol Biol Psych. 1995;19(5):877-887.
  7. Frankenhaeuser M, Lundberg U, Von Wright MR, Von Wright J, Sedvall G. Urinary monoamine metabolites as indices of mental stress in healthy males and females. Pharmacol Biochem Behav. 1986;24(6):1521-1525.
  8. Mitochondrial Medicine Society's Committee on D, Haas RH, Parikh S, et al. The in-depth evaluation of suspected mitochondrial disease. Mol Genet Metab. 2008;94(1):16-37.
  9. Dimmock DP, Lawlor MW. Presentation and Diagnostic Evaluation of Mitochondrial Disease. Pediatr Clin North Am. 2017;64(1):161-171.
  10. Wu H, Jiang K, Gu G, Wu Y, Yu S. [The relationship of occupational stress and the level of some hormone metabolites in urine]. Chin J Indust Hyg Occup Dis. 2014;32(2):83-86.
  11. Jeon SW, Kim Y-K. Inflammation-induced depression: Its pathophysiology and therapeutic implications. J Neuroimmunol. 2017;313:92-98.
  12. Rao TSS, Asha MR, Ramesh BN, Rao KSJ. Understanding nutrition, depression and mental illnesses. Indian J Psychiatry. 2008;50(2):77-82.
  13. O'Connell BS. Select vitamins and minerals in the management of diabetes. Diabetes Spectr. 2001;14(3):133-148.
  14. Harris WS. Omega-3 fatty acids and cardiovascular disease: a case for omega-3 index as a new risk factor. Pharmacol Res. 2007;55(3):217-223.
  15. Spencer SJ, Korosi A, Layé S, Shukitt-Hale B, Barrientos RM. Food for thought: how nutrition impacts cognition and emotion. Sci Food. 2017;1(1):1-8.

 

Performing Lab: Genov

Collection Details:

Patient Preparation:

There are multiple samples requested for this testing and you will notice multiple collection containers.

2 Days before the test

  • Discontinue all of the following (unless instructed otherwise by your physician):
    Supplements containing creatine, vitamin C or any mineral elements measured on this test
    Other substances that may influence urinary element excretion of elements
    Seafood (unless asked to continue by your healthcare provider)
    Continue with the above food restrictions until your sample is completely collected

24 hrs before the test:

  • Eat usual diet, but avoid over-consuming any single food or extreme diet
    • Fluid intakes should be limited to eight (8) 8-ounce glasses of fluid over a 24 hour period

BAG ONE contains the collection instructions supplies needed to collect a

Blood Spot Essential & Metabolic Fatty Acid Profile

(note this may or may not be requested by your Health Care Provider, please see requisition form to determine if this collection is necessary. This is typically collected the morning of Day 1 and requires an 8 hour fast)

 BAG TWO contains the collection instructions and supplies needed to collect urine specimens for a Metabolomix+

 (note this requires an 8 hour fast and is typically collected the morning of Day 2) as well as collection instructions and supplies needed to collect a buccal swab for genetic markers (note this may or not be requested by your Health Care Provider, please see requisition form to determine if this collection is necessary. This is also typically collected the morning of Day 2)

Ship the Specimen to the Lab:

Specimen must be returned in the Genova Diagnostics kit box for correct delivery to the lab. Not following these instructions may result in a shipping charge.

  • Plan to ship the specimen Monday–Friday overnight delivery.
  • Call 1.800.GoFedEx(1.800.463.3339) to schedule shipping. 
  • Lay the bag with urine specimens on top of the freezer brick in the foam box. Secure the foam box lid with the rubberband.
  • Slide the foam box back inside the kit box, and place the completed and signed requisition on top before closing. Do not staple or tape the box.
  • Print your name and address in the section marked “From” on the prepaid shipping envelope label. DO NOT mark or write in any other sections.
  • Put the kit box into the envelope and seal the envelope.
  • Keep your shipment and tracking numbers for future reference and tracking purposes.

Specimen Requirements:

  • 1 green-top preservative tube - FMV urine (frozen);
  • 1 blue-top amber tube - FMV urine (frozen);
  • 1 green-top tube - FMV urine (frozen);
  • Additional add-ons include 1 bloodspot card;2 genomic buccal swabs

Collection Instructions:

Testing is not available for patients less than 2 years old.

Urine Collection -

1. Label all tubes with the patient's date of birth. Do not discard the tube fluid.

2. Write the patient's first and last name, date of birth, gender, and date of collection on the Test Requisition Form.

3. If you wake up to urinate during the night (within six hours of waking) collect that urine into one of the provided urine cups (3/4 full), place the lid on cup then refrigerate. Upon waking, collect your urine into the second urine cup (3/4 full), and pass any additional urine into the toilet. Mix the two urine collections back and forth between the 2 cups to achieve a uniform mixture.

4. Use the pipette to transfer urine from the collection container into the Green-top Preservative Tube, Blue-top Amber Tube, and Green-top Urine Tube until all are nearly full.

5. Recap the tubes tightly and shake.

6. Place the tubes into the biohazard bag labeled BAG ONE and freeze for a minimum of 2 hours.

Blood Spot Collection:

1. Write first and last name and date of collection in the blood spot card.

2. Wash your hands with warm water for a minimum of 20 seconds, then dry your hands. - to improve circulation; Hold your hand lower than heart level and gently massage the entire length of gthe middle finger for 30 seconds. Firmly grasp the top knuckle of the middle finger for a few seconds to restrict circulation. Hang arm down and gently shake your fingers a few seconds to increase blood pools in the finger.

3. Clean the tip of your finger with the alcohol pad.

4. Remove the clear cover from the lancet. One end of the lancet has a small hole in the center; this will be the end that you press firmly against your finger to engage the lancet.

5. Locate the appropriate site at the tip of the middle finger.

6. Place the hole-end of the lancet firmly against your fingertip to depress the tip and release the lancet. The lancet will immediately retract safely after depression.

7. Using your thumb, gently massage the entire length of the pricked finger to form repeated blood drops. As each drop forms, touch the tip of the drop to a circle on the collection card. Do not smear. Do Not touch the fingertip to the card!!

8. Repeat until blood has soaked to the boarder of the circle in the collection card. Continue this procedure for all four circles. - If you are unable to get enough blood from the first collection, repeat this procedure with a different finger. If necessary, use the absorbant pad to dry the site on your finger after your collection. Use the enclosed adhesive bandage as needed.

9. Allow absorbant collection card to air dry overnight, approximately 24 hours, before placing in the resealable plastic bag with desiccant/moisture absorbant pack for shipping. If the card is not completely dry, your sample may not be usable.