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Comprehensive menu of state-of-the-art tests

No single test can determine the overall risk of cardiovascular disease. That’s why our test offering includes exclusive advanced risk and genotyping tests which aid in the selection of appropriate therapeutic options, and a comprehensive offering of lipid, lipoprotein, apolipoprotein, cardiometabolic, liver, kidney and muscle tests.

Getting Started

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    • View our video on how HDL is made.
    • View our video on how triglycerides are metabolized in the bloodstream and enter cells.

Boston Heart HDL Map®

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Test Code

801

Description

The Boston Heart HDL Map® test measures the five most significant HDL subpopulations in CVD risk. A two-dimensional gel electrophoresis process measures the amount of apoA-I protein in each of the five HDL subclasses, providing information to accurately identify patients at increased CVD risk.

Methodology

Two-dimensional gel electrophoresis

Patient Preparation

8-12 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: UNSTABLE
Refrigerated:  2 days (sample must be received within 2 days of collection)

Lab Values

Male

                   Optimal       Borderline     High Risk for CVD
α-1              >20.0           14.0-20.0       <14.0
α-2              >55.0           45.0-55.0       <45.0
α-3              <25.0           25.0-30.0       >30.0
α-4              <15.0           15.0-18.0       >18.0
Preβ-1        <10.0           10.0-15.0       >15.0

Female

                Optimal       Borderline     High Risk for CVD
α-1              >30.0           20.0-30.0       <20.0
α-2              >65.0           55.0-65.0       <55.0
α-3              <25.0           25.0-30.0       >30.0
α-4              <15.0           15.0-18.0       >18.0
Preβ-1        <10.0           10.0-15.0       >15.0

Clinical Significance
(α-1 levels)

 

  • Every 1mg/dL apoA-I increase in very large α-1 HDL is associated with a 26% decrease in CVD risk.
  • Low α-1 level is a significant predictor of recurrent CVD events.
  • Change in α-1 is significantly associated with change in coronary artery stenosis.

Treatment Options

  • Diet, exercise, weight loss if indicated and smoking cessation.
  • Initiate appropriate treatment after correcting contributing causes for low high-density lipoprotein cholesterol (HDL-C) and high triglycerides (TGs).
    • Niacin
    • Statins
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Boston Heart Cholesterol Balance®

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Test Code

501

Description

Boston Heart Diagnostics Cholesterol Balance® test measures markers of cholesterol production (lathosterol and desmosterol) and absorption (beta-sitosterol, campesterol, and cholestanol) 

Methodology

Lipid extraction followed by capillary column gas liquid chromatography and mass spectrometry (GC/MS)

Patient Preparation

8-12 hour fast prior to collection.  Patient may drink water only.

Preferred Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Alternate Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 5 days
Refrigerated: 5 days

Lab Values

 

Lathosterol
(Marker of cholesterol production)

  • Optimal: <90 μmol/mmol of total cholesterol (TC)
  • Borderline: 90–160 μmol/mmol of TC
  • High: >160 μmol/mmol of TC
  • Very high absolute value: >7.0 mg/L

Desmosterol
(Marker of cholesterol production)

  • Optimal: <90 μmol/mmol of TC
  • Borderline: 90–120 μmol/mmol of TC
  • High: >120 μmol/mmol of TC
  • Very high absolute value: >5.0 mg/L

Beta-sitosterol (Marker of cholesterol absorption)

  • Optimal: <100 μmol/mmol of TC
  • Borderline: 100–180 μmol/mmol of TC
  • High: >180 μmol/mmol of TC
  • Very high absolute value: >7.0 mg/L

Campesterol
(Marker of cholesterol absorption)

  • Optimal: <150 μmol/mmol of TC
  • Borderline: 150–260 μmol/mmol of TC
  • High: >260 μmol/mmol of TC
  • Very high absolute value: >10.0 mg/L

Cholestanol
(Marker of cholesterol absorption)

  • Very high absolute value: >15.0 mg/L

Cholesterol Balance Score
(Production/Absorption)

  • Very low: 0.2
  • Low: <0.5
  • Normal: 0.5-1.1
  • High: >1.1
  • Very high: >2.1

Clinical Significance

High lathosterol and desmosterol: indicate cholesterol overproduction

  • Associated with higher LDL-C and increased CVD risk
  • Associated with familial combined hyperlipidemia

High campesterol and beta-sitosterol: indicate cholesterol overabsorption

  • Associated with higher LDL-C and increased CVD risk
  • Associated with phytosterolemia

High absolute value of cholestanol: indicates decreased conversion of cholesterol to the bile acid chenodeoxycholate

  • May be associated with tendon xanthomas, neurologic disease, and cerebrotendinous xanthomatosis

Treatment Options

Initiate appropriate treatment after correcting contributing causes for high LDL-C

  • Elevated lathosterol and desmosterol: statins
  • Elevated campesterol and  beta-sitosterol: ezetimibe
  • Elevated absolute cholestanol: chenodeoxycholate therapy
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Boston Heart Statin Induced Myopathy (SLCO1B1) Genotype Test

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Test Code

835

Description

Solute carrier organic anion transporter (SLCO1B1) encodes for the organic anion transporting polypeptide 1B1 (OATP1B1) which is an influx transporter produced in the liver that mediates the hepatic uptake and metabolism of statins. Inherited variations in the SLCO1B1 gene known as SNPs (single nucleotide polymorphisms) affect the function of this transporter. The intended use of SLCO1B1 testing is as an aid in the selection of the appropriate statin for treatment in individuals. The genetic test identifies individuals with a specific drug transporter defect associated with statin-induced myopathy, thus allowing the healthcare provider to select a statin that is less likely to cause this adverse event.

Methodology

Real time polymerase chain reaction (PCR)

Patient Preparation

None

Preferred Specimen

1.0 mL whole blood collected in EDTA (Lavender Top) tube

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated 15 days

Lab  Values

  1. Normal Statin Metabolizer :  Genotype T/T (valine/valine)
  2. Decreased Statin Metabolizer:  Genotype T/C (valine/alanine)
  3. Markedly Decreased Statin Metabolizer:  Genotype C/C (alanine/alanine)

Clinical Significance

  1. The T/T genotype - normal statin metabolizer
  2. The T/C genotype – decreased statin metabolizer
    Increased risk of statin induced myopathy
    These subjects have a decreased ability to metabolize statins, get less LDL-C lowering response, and have a 4-fold increased risk of developing myopathy on statin therapy
  3. The C/C genotype  – markedly decreased statin metabolizer
    Markedly increased risk of statin induced myopathy
    These subjects have a significantly decreased ability to metabolize statins, get less
    LDL-C lowering, and are at a 17-fold increased risk of developing myopathy on statin therapy

Treatment Options

 

1) T/T genotype: standard doses of statins, if indicated, are recommendedThese subjects have a normal ability to metabolize statins

2) T/C genotype: Moderate to low doses of water soluble statins (in order of solubility: pravastatin, pitavastatin, rosuvastatin or fluvastatin), if indicated, are recommended

3) C/C genotype: Low doses of water soluble statins (in order of solubility: pravastatin, pitavastatin, rosuvastatin or fluvastatin), if indicated, are recommended

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Boston Heart HDL Map®

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Test Code

801

Description

The Boston Heart HDL Map® test measures the five most significant HDL subpopulations in CVD risk. A two-dimensional gel electrophoresis process measures the amount of apoA-I protein in each of the five HDL subclasses, providing information to accurately identify patients at increased CVD risk.

Methodology

Two-dimensional gel electrophoresis

Patient Preparation

8-12 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: UNSTABLE
Refrigerated: 2 days (sample must be received within 2 days of collection)

Lab Values

Male

                   Optimal       Borderline     High Risk for CVD
Preβ-1        <17.0           17.0-25.0       >25.0
α-4              <13.5           13.5-25.0       >25.0
α-3              <13.5           13.5-30.0       >30.0
α-2              >34.0           27.0-34.0       <27.0
α-1              >20.0          14.0-20.0       <14.0             

Female

                Optimal       Borderline     High Risk for CVD
Preβ-1        <17.0           17.0-25.0       >25.0
α-4              <13.5           13.5-25.0       >25.0
α-3              <13.5           13.5-30.0       >30.0
α-2              >45.0           34.0-45.0       <34.0
α-1              >30.0           20.0-30.0       <20.0

Clinical Significance
(α-1 levels)

 

  • Every 1mg/dL apoA-I increase in very large α-1 HDL is associated with a 26% decrease in CVD risk.
  • Low α-1 level is a significant predictor of recurrent CVD events.
  • Change in α-1 is significantly associated with change in coronary artery stenosis.

Treatment Options

  • Diet, exercise, weight loss if indicated, and smoking cessation.
  • Initiate appropriate treatment after correcting contributing causes for low high-density lipoprotein cholesterol (HDL-C) and high triglycerides (TGs).
    • Niacin
    • Statins
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Total Cholesterol (TC)

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Test Code

101

Description

Total cholesterol is a measure of the amount of cholesterol contained in the cholesterol- containing lipoproteins HDL, non-HDL and LDL

Methodology

Enzymatic Colorimetric

Patient Preparation

8-12 hour fast prior to collection. Patient may drink water only. (If ordered as part a stand-alone test, fasting is not required)

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 7 days
Refrigerated: 7 days

Lab Values

 

  • Optimal: <200 mg/dL
  • Borderline: 200-240 mg/dL
  • High risk: >240 mg/dL

Clinical Significance

  • Total cholesterol used in combination with LDL-C and HDL-C provides information related to the determination of cardiovascular disease risk.

Treatment Options

  • Assess for elevations in LDL-C and VLDL-C.
  • Treatment is based on the parameter causing the elevation in TC.
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Low-Density Lipoprotein Cholesterol, Direct (LDL-C)

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Test Code

222

Description

LDL-C is a measure of the amount of cholesterol in the atherogenic  low-density lipoproteins.  The direct measurement of LDL-C  is not affected by non-fasting state.  Values are somewhat higher than calculated LDL-C.

Methodology

Enzymatic colorimetric.

Patient Preparation

8-12 hour fast prior to collection.  Patient may drink water only.  (If ordered as part a stand-alone test, fasting is not required.)

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:   7 days

Lab Values Without CVD

 

 

 

Lab Values With CVD

 

  • Optimal: <100 mg/dL
  • Borderline: 100-160 mg/dL
  • High risk: >160 mg/dL

 

  • Optimal: <70 mg/dL
  • Borderline: 70-100 mg/dL
  • High risk: >100 mg/dL

Clinical Significance

  • Elevated LDL-C is the primary risk factor for CVD per NCEP-ATP III.
  • Elevated levels are an independent risk factor for CVD.

Treatment Options

  • Diet, exercise and weight loss
  •  Statins
  •  Bile acid sequestrants
  •  Cholesterol absorption inhibitors
  •  Niacin
  •  Fibrates
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Small Dense LDL Cholesterol (sdLDL-C)

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Test Code

223

Description

The assay quantifies the amount of cholesterol in sdLDL particles which are denser and more atherogenic LDL-particles.

Methodology

Enzymatic

Patient Preparation

8-12 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 3 days

Lab Values

  • Optimal: <20 mg/dL
  • Borderline: 20–40 mg/dL
  • High risk: >40 mg/dL

Clinical Significance

High levels are associated with a 2- to 3-fold increased risk for CVD events and rate of arteriographic progression.

Treatment Options

  • Diet, exercise and weight loss, if indicated
  • Control diabetes mellitus
  • Treat insulin resistance
  • Statins
  • Omega-3 fatty acids
  • Niacin
  • Fibrates
  • Metformin
  • Thiazolininediones
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% Small Dense LDL Cholesterol (%sdLDL)

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Test Code

259  (includes direct LDL-C and direct sdLDL-C)

Description

This is a calculated value which indicates the percentage of total LDL-C due to sdLDL-C.

Methodology

% sdLDL-C is calculated as follows:
%sdLDL-C = (sdLDL-C/LDL-C ) X 100

Patient Preparation

8-12 hour fast prior to collection.  Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:   3 days

Lab Values

  • Optimal: <20%
  • Borderline: 20–30%
  • High risk: >30%

Clinical Significance

A high percentage of LDL as small dense LDL has been associated with an increased risk for CVD events and rate of progression of coronary disease.

Treatment Options

  • Diet, exercise and weight loss if indicated
  • Control diabetes mellitus if present 
  • Statins
  • Cholesterol absorption inhibitors
  • Combination therapy
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Very Low Density Lipoprotein Cholesterol (VLDL-C)

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Test Code

255 (includes Total Cholesterol, Direct LDL, Direct HDL)

Description

VLDL-C is a calculation that indicates the amount of VLDL lipoproteins in the bloodstream.

Methodology

VLDL-C is calculated as follows:
TC - Direct LDL-C – Direct HDL-C = VLDL-C

Patient Preparation

8-12 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 7 days 
Refrigerated: 7 days

Lab Values

 

  • Optimal: <30 mg/dL
  • Borderline: 30-40 mg/dL
  • High risk: >40 mg/dL

Clinical Significance

  • VLDL-C values >40 mg/dL are associated with increased CVD risk.

Treatment Options

  • Weight loss if indicated
  • Statins
  • If additional lowering is needed consider adding niacin, fish oil or fenofibrate.
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Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)

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Test Code

250 (Includes total cholesterol, HDL and non-HDL)

Description

Non-HDL-C is a calculation that represents the cholesterol carried by all atherogenic particles including:

    • Chylomicron remnants
    • VLDL
    • IDL
    • LDL
    • Lp(a)

Methodology

Non-HDL-C is calculated as follows:
Non-HDL-C = Total cholesterol – High-density cholesterol

Patient Preparation

8-12 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days

Lab Values

Without CVD

  • Optimal: <130 mg/dL
  • Borderline: 130-190 mg/dL
  • High risk: >190 mg/dL

With CVD

  • Optimal: <100 mg/dL
  • Borderline: 100-130 mg/dL
  • High risk: >130 mg/dL

Clinical Significance

  • When TGs are high, LDL-C does not accurately reflect the amount of circulating atherogenic particles.  In this situation, non-HDL-C may be a better predictor of CVD risk than LDL-C.
  • Non-HDL-C has been shown in many studies to be superior to calculated LDL-C in predicting heart disease risk.

Treatment Options

  • Diet, exercise and weight loss
  • Statins
  • Bile acid sequestrants
  • Cholesterol absorption inhibitors
  • Niacin
  • Fibrates
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Total Cholesterol/High-Density Lipoprotein Cholesterol (TC/HDL-C)

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Test Code

254 (includes total cholesterol and HDL-C)

Description

The ratio of total cholesterol/high density lipoprotein cholesterol

Methodology

TC/HDL-C is calculated as follows:
TC/HDL-C = Total cholesterol/High-density cholesterol

Patient Preparation

8-12 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days

Lab Values

Without CHD

  • Optimal: <4.0
  • Borderline: 4.0–6.0
  • High risk: >6.0

With CHD or CHD Risk Equivalent

  • Optimal: <3.0
  • Borderline: 3.0–5.0
  • High risk: >5.0

Clinical Significance

  • The TC/HDL-C ratio has been shown in many studies to be a more significant CVD risk factor than either LDL-C or HDL-C alone, or in combination.

Treatment Options

  • Diet, exercise and weight loss
  • Control diabetes mellitus if present
  • Statins
  • Cholesterol absorption inhibitors
  • Bile acid sequestrants
  • Niacin
  • Fibrates
  • Combination therapy
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Triglycerides (TG)

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Test Code

102

Description

Triglycerides are composed of 3 fatty acids attached to glycerol that function as fat storage (adipose tissue) or may be used for energy.  Triglycerides are the primary lipid component in chylomicrons and very low-density lipoproteins.

Methodology

Enzymatic colorimetric

Patient Preparation

8-12 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days

Lab Values

 

  • Optimal: <150 mg/dL
  • Borderline: 150-200 mg/dL
  • High risk: >200 mg/dL

Clinical Significance

  • Elevated TG is a secondary risk factor for CVD per NCEP-ATP III.
  • Elevated levels increase CVD risk by altering lipoprotein metabolism:
    • Enhances the formation of small dense LDL particles.
    • Contributes to low levels of large HDL particles.

Treatment Options

  • Avoid alcohol intake and initiate low simple carbohydrate diet.
  • Control diabetes and insulin resistance.
  • Niacin
  • Fibrates
  • Omega-3 fatty acids
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Very Low-Density Lipoprotein Cholesterol/Triglycerides Ratio (VLDL-C/TG)

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Test Code

257 (includes VLDL-C and triglycerides)  

Description

VLDL-C/TG ratio is a measure of the cholesterol content of VLDL.

Methodology

The VLDL-C ratio is  calculated as follows:
VLDL-C/TG ratio  = VLDL-C/TG

Patient Preparation

8-12 hour fast prior to collection.  Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  7 days

Lab Values

 

  • Optimal: < 0.20
  • Borderline: 0.20 – 0.30
  • High risk: > 0.30

Clinical Significance

  • When the VLDL-C/TG ratio is > 0.30 it indicates the presence of of cholesterol-rich chylomicron and VLDL remnant lipoproteins, which increase CVD risk
  • A VLDL-C/TG ratio of > 0.30 has been associated with an increased risk of CVD and dysbetalipoproteinemia often associated with the apoE2/2 genotype

Treatment Options

  • Diet, exercise and weight loss if indicated
  • Control diabetes mellitus if present
  • Statins
  • Cholesterol absorption inhibitors
  • Bile acid sequestrants
  • Niacin
  • Fibrates
  • Combination therapy
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Apolipoprotein B (apoB)

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Test Code

302

Description

ApoB is a protein produced in both the liver and intestine that provides structure to the triglyceride (TG) carrying atherogenic lipoprotein particles. Each particle carries only one apoB protein. Thus, apoB is a direct measure of the number of atherogenic particles in the circulation. ApoB is also a surrogate marker for LDL particle concentration or LDL particle number. ApoB is found on:

  • Very low-density lipoproteins (VLDL)
  • Intermediate-density lipoproteins (IDL)
  • Low-density lipoproteins (LDL)
  • Lp(a)
  • Chylomicrons

Methodology

Immunoturbidimetric

Patient Preparation

8-12 hour fast prior to collection.  Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 1 day
Refrigerated: 8 days

Lab Values

  • Optimal: <80 mg/dL
  • Borderline: 80–120 mg/dL
  • High risk: >120 mg/dL

Clinical Significance

Elevated levels of apoB are significant predictors of heart disease and are a more significant indicator of CVD than LDL-C.

Treatment Options

  • Diet, exercise and weight loss if indicated
  • Statins
  • Cholesterol absorption inhibitors
  • Bile acid sequestrants
  • Niacin
  • Fibrates
  • Combination therapy to optimize profile
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Apolipoprotein B/Apolipoprotein A-I Ratio (ApoB/ApoA-I)

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Test Code

303  (includes Apolipoprotein B and Apolipoprotein A-I) 

Description

The ratio of apolipoprotein B/apolipoprotein A-I is a strong predictor of heart disease risk. One molecule of apoB is carried per chylomicron, VLDL, LDL, and/or Lp(a) particle. ApoA-I is the major protein of HDL particles. 

Methodology

ApoB/ApoA-I is  calculated as follows:
ApoB/ApoA-I Ratio = ApoB/ApoA-I

Patient Preparation

8-12 hour fast prior to collection.  Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  7 days

Lab Values

 

 

Lab Values

 

Male

  • Optimal: <0.6 
  • Borderline: 0.6 – 0.9 
  • High risk: >0.90 

Female

  • Optimal: <0.5 
  • Borderline: 0.5 – 0.7 
  • High risk: >0.7

Clinical Significance

  • The apoB/apoA-I ratio has been shown in many studies to be a more significant CVD risk factor than either LDL-C or HDL-C alone, or in combination.

Treatment Options

  • Diet, exercise and weight loss if indicated
  • Control diabetes mellitus if present
  • Statins
  • Cholesterol absorption inhibitors
  • Bile acid sequestrants
  • Niacin
  • Fibrates
  • Combination Therapy
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Lipoprotein(a) (Lp(a))

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Test Code

224

Description

Lp(a) is a plasma lipoprotein that is composed of two parts:

  • LDL-like particle
  • Apolipoprotein (a) [apo(a)], a protein made in the liver and attached to the apoB portion of this particle

Methodology

Immunoturbidimetric assay

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 2 weeks

Lab Values

  • Optimal: <20 mg/dL
  • Borderline: 20–30 mg/dL
  • High risk: >30 mg/dL

Clinical Significance

Elevated levels are an independent risk factor for myocardial infarction, coronary artery disease, cerebral vascular disease, vein graft stenosis and retinal artery occlusion.

Treatment Options

  • Optimize LDL-C, sdLDL-C and apoB
  • Niacin to lower Lp(a)
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High-Density Lipoprotein Cholesterol (HDL-C)

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Test Code

221

Description

HDL-C is a measure of the amount of cholesterol in non-atherogenic HDL particles.

Methodology

Enzymatic colorimetric.

Patient Preparation

8-12 hour fast prior to collection.  Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days

Lab Values

Male

  • Optimal: >50 mg/dL
  • Borderline: 40-50 mg/dL
  • High risk: <40 mg/dL

Female

  • Optimal: >60 mg/dL
  • Borderline: 50-60 mg/dL
  • High risk: <50 mg/dL

Clinical Significance

  • Low HDL-C is:
    • Independently associated with CVD risk.
    • A secondary risk factor for CVD per NCEP-ATP III Guidelines.
    • A  characteristic of the metabolic syndrome and insulin resistance.

Treatment Options

  • Weight loss
  • Treat diabetes  
  • Smoking cessation
  • Niacin
  • Statins
  • Fibrates
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High-Density Lipoprotein Cholesterol/Triglycerides Ratio (HDL-C/TG)

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Test Code

256 (includes HDL-C and triglycerides ) 

Description

The ratio of high density lipoprotein cholesterol/triglycerides is a calculated measure. Low levels of this ratio are very strongly linked to diabetes, insulin resistance, and metabolic syndrome.

Methodology

HDL-C/TG Ratio is calculated as follows:
HDL-C/TG Ratio = HDL-C/TG 

Patient Preparation

8-12 hour fast prior to collection. Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days

Lab Values

 

  • Optimal: >0.50
  • Borderline: 0.25–0.50  
  • High risk: <0.25

Clinical Significance

  • Low levels of the HDL-C/TG ratio are strongly linked to CVD risk, diabetes, insulin resistance, and metabolic syndrome. 

Treatment Options

  • Diet, exercise and weight loss
  • Niacin
  • Statins
  • Fibrates
  • Combination therapy
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Apolipoprotein A-I (apoA-I)

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Test Code

301

Description

ApoA-I is a protein produced in both the liver and intestine. It provides structure to HDL particles as well as activates enzymes that add a fatty acid to cholesterol (esterifies cholesterol) and allows it to enter the core of HDL. Reflects the amount of apoA-I protein available to form HDL particles.

Methodology

Immunoturbidimetric

Patient Preparation

8-12 hour fast prior to collection.  Patient may drink water only.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature: 1 day
Refrigerated: 8 days

Lab Values

Male

  • Optimal: >160 mg/dL
  • Borderline: 120–160 mg/dL
  • High risk: <120 mg/dL

Female

  • Optimal: >180 mg/dL
  • Borderline: 140–180 mg/dL
  • High risk: <140 mg/dL

Clinical Significance

Low level is associated with higher CVD risk.

Treatment Options

  • Niacin
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High Sensitivity C-Reactive Protein (hs-CRP)

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Test Code

601

Description

CRP is a protein that is produced in the liver in response to systemic inflammation and is an acute phase reactant. The “high sensitivity” CRP test is needed to detect very low levels of CRP that may be seen with vascular and/or systemic inflammation.

Methodology

Immunoturbidimetric  

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  11 days
Refrigerated:   2 months

Lab Values

  • Optimal: <1.0 mg/L
  • Borderline: 1.0–2.0 mg/L
  • High risk: >2.0 mg/L

Clinical Significance

Independent predictor of developing CVD events. Provides independent prognostic information after initiating treatment.

Treatment Options

  • Diet, exercise and weight loss if indicated
  • Statins
  • Metformin
  • Niacin
  • Fibrates
  • Thiazolidinediones
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Fibrinogen

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Test Code

701

Description

 

Fibrinogen or Factor I is an acute phase inflammatory plasma protein synthesized by the liver and is an essential component in the clotting cascade.

Methodology

Immunoturbidimetric

Patient Preparation

None

Preferred Specimen

0.5 mL EDTA plasma collected in plasma separator tube (Pearl Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 3 days

Lab Values

  • Optimal: <370 mg/dL
  • Borderline: 370-470 mg/dL
  • High risk: >470 mg/dL

Clinical Significance

  • Fibrinogen is converted by thrombin to form fibrin. Fibrin is then crosslinked by factor XIII, and is the final step in the formation of a blood clot.
  • Elevated levels are associated with inflammation.
  • Every 100 mg/dL increase in plasma fibrinogen level > 370 mg/dL has been associated with a 1.8 fold increased risk of CVD.

Treatment Options

  • Weight loss if indicated
  • Smoking cessation
  • Statins
  • Fibrates
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Lipoprotein-Associated Phospholipase A2 [LpPLA2] (PLAC Assay)

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Test Code

602

Description

 

LpPLA2 is an enzyme produced by monocytes/macrophages that breaks down phospholipids. Increased blood levels are associated with increased atherosclerosis.

Methodology

Enzyme immunoassay

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  1 day
Refrigerated:  7 days

Lab Values

  • Optimal:  <200 ng/mL
  • Borderline: 200–235 ng/mL
  • High risk: >235 ng/mL

Clinical Significance

Predicts CVD risk independent of LDL-C and other inflammatory markers. Associated with:

  • 2-fold increased risk for coronary events
  • 2-fold increased risk for stroke
  • 11-fold increased stroke risk if CRP is also elevated

Treatment Options

  • Statins
  • Fibrates
  • Niacin
  • Omega-3 fatty acids
  • Ezetimibe
  • Statin with niacin
  • Statin with omega-3 fatty acids
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N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)

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Test Code

1101

Description

 

Brain natriuretic peptide (BNP) is a neurohormone that affects body fluid homeostasis via diuresis and natriuresis. Elevated levels are seen in patients with congestive heart failure, and a decreased ejection fraction. NT-proBNP is  the precursor molecule for BNP.

Methodology

Immunoassay 

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top). 

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top).  Separate plasma as soon as possible after collection.

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  3 days
Refrigerated:   6 days

Lab Values

Age: ≤75 yrs

  • Optimal: <125 pg/mL
  • Borderline: 125–450 pg/mL
  • High risk: >450 pg/mL

Age: >75 yrs

  • Optimal: <450 pg/mL
  • High risk: >450 pg/mL

Clinical Significance

Elevated levels Identify subjects with left ventricular dysfunction.

  • Every incremental increase in values above normal is associated with an incremental increase in CV risk.
  • Levels >450 pg/mL in subjects with stable CAD are associated with a 2- to 6-fold increased risk for cardiac morbidity and/or mortality.
  • Normal levels exclude cardiac dysfunction.

Treatment Options

Identify etiology of elevated NT-proBNP with physical assessment and additional diagnostic tests, such as echocardiography, as indicated.

Treatment is based on cause of elevated NT-proBNP and may include:

  • Preload  medications
  • Afterload medications
  • Rate control medications
  • Cardiac pacing
  • Stenting
  • Cardiac surgery
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Uric Acid

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Test Code

1009

Description

Uric acid is the final product of purine metabolism.

Methodology

Enzymatic colorimetric

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  5 days

Lab Values    
                        

Male

  • Optimal/normal: <7.0 mg/dL
  • Borderline: 7.0-10.0 mg/dL
  • High risk: >10.0 mg/dL

Female

  • Optimal/normal: <6.0 mg/dL
  • Borderline: 6.0-10.0 mg/dL
  • High risk:  >10.0 mg/dL 

Clinical Significance

  • Elevated uric acid elevations are seen in renal disorders, gout, leukemia, psoriasis, starvation and patients receiving cytotoxic drugs.

Treatment Options

  • Identify etiology of elevated uric acid with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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Homocysteine

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Test Code

603

Description

Homocysteine is a thiol-containing amino acid formed from methionine. Values >15 µmol/L have been associated with increased risk of cardiovascular disease and dementia. 

Methodology

Enzymatic 

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top).  Centrifuge blood samples immediately after collection to separate the serum from the blood cells.  If immediate centrifugation is not possible, collected blood specimens should be kept refrigerated and centrifuged within an hour.

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top).  Centrifuge blood samples immediately after collection to separate the plasma from the blood cells.  If immediate centrifugation is not possible, collected blood specimens should be kept refrigerated and centrifuged within an hour.

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  4 days
Refrigerated:   2 weeks

Lab  Values

  • Optimal: <10 µmol/L
  • Borderline: 10–15 µmol/L
  • High Risk: >15 µmol/L

Clinical Significance

Hyperhomocysteinemia is a risk factor for:

  • Cardiovascular disease
    • Ischemic heart disease
    • Fatal and non-fatal myocardial infarction and sudden cardiac death
    • Premature coronary artery disease
    • Extracranial carotid-artery stenosis
    • Venous thrombosis
  • Cerebrovascular disease
    • Stroke
    • Cognitive deficits without diagnosis of dementia
    • Dementia, such as Alzheimer’s disease
    • Smaller brain volume
    • Silent brain infarcts
  • Peripheral vascular disease
  • Osteoporosis
  • Pregnancy complications
    • Spina bifida
    • Neural tube defects

Treatment Options

 

 

Treatment of hyperhomocysteinemia for high risk values >15 µmol/L:

  • Control all standard cardiovascular disease factors:
    • Blood glucose: <125 mg/dL
    • HbA1c: <6.5%
    • Systolic blood pressure: <130 mmHg
    • LDL-C: <100 mg/dL
  • Folate (800 µg/day),vitamin B12 (0.5 mg/day) and vitamin B6 (20 mg/day),and recheck values in 6 months

Treatment of borderline values between 10-15 µmol/L:

  • Daily multivitamin tablet containing the recommended daily allowances of folate (400 µg/day), vitamin B12 (2.4 µg/day) and vitamin B6 (1.5 mg/day)
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Hemoglobin A1c (HbA1c)

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Test Code

404

Description

This test measures the concentration of glucose attached to the hemoglobin in red blood cells. It assesses the average amount of glucose in blood over the last two to three months.

Methodology

Turbidimetric inhibition immunoassay

Patient Preparation

None

Preferred Specimen

1.0 mL whole blood collected in EDTA (Lavender Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  3 days
Refrigerated:   7 days

Lab Values

  • Optimal: <5.7%
  • Borderline: 5.7–6.4%
  • High risk: >6.4%

Clinical Significance

Monitors efficacy of diabetes treatment over time and identifies patients at risk of developing diabetes.

  • Increased risk: 5.7–6.4% 
  • Diagnosis of diabetes:  >6.4%      

Treatment Options

Mono, dual or triple therapy with:

  • Metformin
  • Dipeptidyl-peptidase-4 inhibitors
  • Incretin mimetics
  • Thiazolidinediones
  • α-glucosidase inhibitors
  • Sulfonylureas
  • Meglitinides
  • Insulin
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Glucose

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Test Code

401

Description

Glucose is the major short term source of energy for the body, and is obtained from the diet, as well as being produced in the liver.

Methodology

Enzymatic 

Patient Preparation

Minimum 8 hour fast prior to collection.  Patient may drink water only. 

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top) Allow sample to clot for 30 minutes and centrifuge immediately thereafter.

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top). Centrifuge blood samples immediately after collection to separate the plasma from the blood cells.  If immediate centrifugation is not possible, collected blood specimens should be kept refrigerated and centrifuged within 30 minutes.

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:   3 days

Lab Values

  • Normal:  70-99 mg/dL  
  • Borderline: 100 – 125 mg/dL
  • High: > 126 mg/dL, classified as diabetes mellitus

Clinical Significance

A fasting glucose level ≥ 126 mg/dL indicates the presence of diabetes mellitus, associated with a significantly increased risk of developing CVD, stroke, peripheral vascular disease, kidney failure, neuropathy, and retinopathy. The test needs to be confirmed by also having an elevated HbA1c level. A value < 30 mg/dL indicates significant hypoglycemia.

Treatment Options to Opitimize Glucose and HbA1c levels

  • Diet, exercise and weight loss if indicated
  • Metformin
  • Thiazolidinediones
  • Sulfonylureas
  • Dipeptidyl-peptidase-4 inhibitors
  • Incretin mimetics
  • Meglitinides
  • α-glucosidase inhibitors
  • Insulin
  • Combination therapy
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Insulin Resistance

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Test Code

408  (Includes glucose and insulin)

Description

The standard measure of insulin resistance is the homeostasis model, based on both fasting insulin and fasting glucose level.

Methodology

Insulin Resistance is calculated as:
Homeostasis Model of Insulin Resistance (HOMA-IR)  = [fasting insulin (uU/ml) X fasting glucose (mg/dl)] /401.85

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:   3 days

Lab Values

  • Optimal:  <2.0  
  • Borderline: 2.0 – 3.0 
  • High Risk: >3.0

Clinical Significance

The presence of insulin resistance (value > 3.0) indicates a high risk of developing:

  • Coronary heart disease
  • Stroke
  • Peripheral vascular disease
  • Type 2 diabetes mellitus
  • Hypertension
  • Hyperlipidemia

Treatment Options in Patients with Diabetes Mellitus Depending on level of  insulin resistance

  • Diet, exercise and weight loss if indicated
  • Metformin
  • Thiazolidinediones
  • Sulfonylureas
  • Dipeptidyl-peptidase-4 inhibitors
  • Incretin mimetics
  • Meglitinides
  • α-glucosidase inhibitors
  • Insulin
  • Combination therapy
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Insulin

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Test Code

402

Description

 

Insulin is a hormone responsible for the transportation and storage of glucose in cells. It regulates glucose levels in blood. This test measures the amount of insulin in blood.

Methodology

Immunoassay

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:   5 days

Lab Values

  • Low : <5 µU/mL  An Insulin test result of < 5 uU/ml is normal in a non-diabetic, but low if the patient has diabetes (consistent with type 1 diabetes).
  • Optimal: 5-15 µU/mL
  • High: >15 µU/mL      

Clinical Significance

Insulin may be used in conjunction with glucose or glucose tolerance test to:

  • Diagnose insulin resistance
  • Diagnose insuloma
  • Monitor amount of endogenous insulin production
  • Determine when a type 2 diabetic may need to start insulin therapy

Presence of insulin resistance indicates a higher risk to develop:

  • Type 2 diabetes
  • Hypertension
  • Hyperlipidemia
  • Heart disease

Treatment Options (for elevated fasting insulin levels)

  • Diet, exercise and weight loss if indicated
  • Metformin
  • Combination therapy
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Thyroid Stimulating Hormone (TSH)

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Test Code

1005

Description

TSH is a peptide hormone synthesized and secreted by the anterior pituitary gland.  TSH regulates thyroid gland function.

Methodology

Immunoassay

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:   7 days

Lab Values

  • Low:  <0.27 µlU/mL
  • Optimal/normal: 0.27-4.20 µlU/mL
  • High:  >4.20 µlU/mL   

Clinical Significance

  • TSH is used in the differential diagnosis of primary, secondary, & tertiary hypothyroidism.
  • Is also useful in screening for hyperthyroidism.
  • Allows adjustment of thyroid replacement in hypothyroid patients.

Treatment Options

  • Identify etiology of elevated or decreased TSH with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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Vitamin D, 25-OH

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Test Code

625

Description

 

25-hydroxy vitamin D is a hormone precursor that promotes bone, calcium and phosphorus metabolism.

Methodology

Antibody-based chemiluminescence

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 5 days

Lab Values

  • Low: <30 ng/mL
    • Deficient: <10 ng/mL
    • Insufficient: 10–29 ng/mL   
  • Optimal: 30–100 ng/mL
  • High: >100 ng/mL

Clinical Significance

Vitamin D insufficiency is associated with:

  • Secondary hyperparathyroidism
  • Muscle weakness with increased fall risk
  • Myalgias

Vitamin D insufficiency may be associated with:

  • Deleterious effects on cardiovascular system
  • Impaired pancreatic function
  • Increased mortality

Treatment Options

 

 

 

 

 

 

 

Vitamin D Replacement Options for Vitamin D Deficiency:

  • Oral dose of 4,000 IU/day vitamin D if 25-hydroxy vitamin D level <10 ng/mL.
  • Oral dose of 2,000 IU/day vitamin D for 25-hydroxy vitamin D levels of 10–30 ng/mL.
  • Recheck levels after 3 months.

Maintenance therapy:

  • Oral dose of 1,000 IU/day vitamin D if 25-hydroxy vitamin D levels are >30 ng/mL, but <100 ng/mL
  • Obese individuals sequester vitamin D in body fat and may need up to 4,000 IU of vitamin D daily.
  • Sunlight exposure for 5–10 minutes for Caucasians between 10 AM and 3 PM; darker-skinned individuals need longer exposure time.
  • The goal is to achieve levels of serum 25-hydroxy vitamin D to >30 ng/mL, but <100 ng/mL.
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Aspartate Aminotransferase (AST)

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Test Code

1002

Description

AST is an enzyme that is widely distributed in tissue, mainly hepatic, cardiac, muscle, and kidney. 

Methodology

Enzymatic 

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature 1 Day
Refrigerated:  7 Days

Lab Values

  • Optimal/normal: <40 U/L
  • Borderline: 40-120 U/L
  • High risk:   >120 U/L

Clinical Significance

  • Elevated serum levels are found in diseases involving hepatic, cardiac, muscle, and kidney tissues.

Treatment Options

  • Identify etiology of elevated AST with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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Alanine Aminotransferase (ALT)

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Test Code

1003

Description

ALT is an enzyme that has been reported as present in a variety of tissues.  The liver is the major source of ALT.

Methodology

Enzymatic  

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  3 days
Refrigerated:   7 days

Lab Values

  • Optimal/normal: <40 U/L
  • Borderline:  40-120 U/L
  • High risk:  >120 U/L  

Clinical Significance

  • Elevated serum levels are found in liver diseases.

Treatment Options

  • Identify etiology of elevated ALT with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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Alkaline Phosphatase (Alkaline Phos)

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Test Code

1004

Description

Alkaline phosphatase is an enzyme that is found primarily in liver and biliary tract cells, as well as bone.

Methodology

Colorimetric

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  7 days
Refrigerated:   7 days

Lab Values

  • Optimal/normal: <130 U/L 
  • Borderline: 130-200 U/L
  • High risk: >200 U/L 

Clinical Significance

  • Elevated levels of alkaline phosphatase may indicate injury to liver or biliary tracts cells or bone.

Treatment Options

  • Identify etiology of elevated alkaline phosphatase with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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Blood Urea Nitrogen (BUN)

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Test Code

1006

Description

Urea is the major end product of protein nitrogen metabolism.  Urea is synthesized in the liver and excreted mostly by the kidneys.

Methodology

Enzimatic

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  7 days
Refrigerated:   7 days

Lab Values

  • Optimal/normal: 3.0-25.0 mg/dL
  • High risk: >25.0 mg/dL

Clinical Significance

  • Elevated levels of BUN may indicate increased production of urea, reduced renal perfusion, renal disease, or mechanical obstruction of urine excretion.

Treatment Options

  • Identify etiology of elevated BUN with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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Creatinine

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Test Code

1007

Description

Creatinine is the break-down product of creatine phosphate in muscle and is usually produced at a fairly constant rate. Creatinine is filtered by the kidneys and is not re-absorbed to any significant extent.

Methodology

Enzymatic

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  7 days
Refrigerated:   7 days

Lab Values     
                         

Male

  • Optimal/normal: 0.67-1.17 mg/dL
  • High risk:>1.17 mg/dL

Female

  • Optimal/normal: 0.51-0.95 mg/dL
  • High risk: >0.95 mg/dL

Clinical Significance

  • Elevated levels of creatinine may indicate kidney dysfunction.
  • Creatinine is used to evaluate renal function and in monitoring renal dialysis.

Treatment Options

  • Identify etiology of elevated creatinine with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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BUN/Creatinine Ratio

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Test Code

1013 (test includes BUN and Creatinine) 

Description

BUN/Creatinine Ratio is a calculation using serum urea nitrogen (BUN) and creatinine.

Methodology

BUN/Creatinine ratio is calculated as follows:
BUN divided by Creatinine

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  7 days
Refrigerated:   7 days

Lab Values

  • Optimal/normal: <40
  • High risk: >40

Clinical Significance

  • An elevated BUN/Creatinine ratio may present in acute or chronic renal disease, reduced renal perfusion, or urinary tract obstruction.
  • Increased urea production may also elevate the ratio.

Treatment Options

  • Identify etiology of elevated BUN and creatinine with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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Creatine Kinase (CK)

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Test Code

1001

Description

CK is an enzyme that is found in muscle, heart, and brain tissues.

Methodology

Enzymatic

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST/Tiger Top)

Alternate Specimen

1.0 mL EDTA plasma (0.5 mL minimum) collected in plasma separator tube (Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  2 days
Refrigerated:   7 days

Lab Values 
                       

Male

  • Optimal/normal: <300 U/L
  • Borderline: 300-1500 U/L
  • High risk: >1500 U/L

Female

  • Optimal/normal: <200 U/L
  • Borderline:   200-1000 U/L
  • High Risk:    >1000 U/L

Clinical Significance

  • Elevated serum levels are found in skeletal muscle diseases, myocardial infarction, and cerebral ischemia/injury.

Treatment Options

  • Identify etiology of elevated CK with physical assessment and additional diagnostic tests as indicated.
  • Treatment is based on etiology of elevation.
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Apolipoprotein E (apoE) Genotype Test

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Test Code

806

Description

ApoE is a critical protein component of very low-density lipoprotein (VLDL) and chylomicrons. ApoE is important for:

  • Cholesterol absorption from the intestine
  • Uptake of triglyceride-rich lipoproteins  by the liver
  • The intended use of ApoE genetic testing is an aid in the selection of optimal cholesterol lowering protocols by the healthcare provider. The genetic test identifies individuals with altered lipid transport. Depending on the apoE genotype, cholesterol-lowering dietary interventions are very effective in these individuals, so determination of the genotype allows the physician to select the most efficacious treatment regimen for the patient for lowering low density lipoprotein cholesterol and reducing heart disease risk.

The APOE gene has three common alleles (e2, e3, e4) that encode for three protein isoforms (E2, E3, E4). ApoE3 is the most common form of apoE. Population frequencies for these APOE alleles are:

  • e2 (15%)
  • e3 (65%) 
  • e4 (20%)

Methodology

Real time polymerase chain reaction (PCR)

Patient Preparation

None

Preferred Specimen

1.0 mL whole blood collected in EDTA (Lavender Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 15 days

Lab Values

  • E3/E3
  • E2/E2, E2/E3
  • E4/E4, E3/E4
  • E2/E4

Clinical Significance

E3/E3

Most common genotype; associated with:

  • Decreased uptake of cholesterol by the liver
  • Lower total cholesterol and LDL-C

E2/E2, E2/E3

Associated with lower LDL-C levels than the common E3/E3 genotype

E4/E4, E3/E4

Associated with higher LDL-C levels than the common E3/E3 genotype

Also associated with increased:

  • Cholesterol absorption in the intestine
  • Uptake of intestinal cholesterol by the liver
  • Total cholesterol and LDL-C

Treatment Options

E3/E3

If LDL-C or non-HDL-C lowering is needed, in addition to lifestyle change, statin therapy is recommended

E2/E2, E2/E3

If LDL-C or non-HDL-C lowering is needed, in addition to lifestyle change, statin therapy is recommended

E4/E4, E3/E4

If LDL-C or non-HDL-C lowering is needed, in addition to lifestyle change, combination therapy with statin and ezetimibe is recommended

E2/E4

If LDL-C or non-HDL-C lowering is needed, in addition to lifestyle change, statin therapy is recommended

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Factor V Leiden Genotype Test

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Test Code

816

Description

 

Factor V is a coagulation protein produced by the liver. The factor V Leiden genotype is a variant form of factor V with a change in one of the amino acids resulting in increased clot formation. The intended use of Factor V Leiden testing is as an aid in selection of appropriate thrombosis prevention regimens. The genetic test identifies individuals with defects in clotting factors, thus allowing the physician to determine the need for more aggressive thrombosis prevention measures for these individuals. Such therapy prevents life-threatening clots, especially those that travel from veins in the legs to the lungs (pulmonary emboli).

Methodology

Real time polymerase chain reaction (PCR)

Patient Preparation

None

Preferred Specimen

1.0 mL whole blood collected in EDTA (Lavender Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 15 days

Lab Values

  • Genotypes -/-, +/-, +/+

Clinical Significance

  • Genotype -/-: normal risk of clot formation
  • Genotypes +/-:  increased risk of developing clots, especially if on oral estrogen therapy
  • Genotype +/+: markedly increased risk of developing clots, especially if on oral estrogen therapy

Treatment Options

  • Genotypes +/-, +/+:  consider low dose aspirin treatment
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Prothrombin (Factor II) G20210A Genotype Test

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Test Code

826

Description

Factor II (prothrombin) is a coagulation protein produced by the liver. The factor II
genotype is a variant form of factor II with a change in one of the amino acids resulting inincreased clot formation. The intended use for Prothrombin (Factor II) testing is as an aid in selection of appropriate thrombosis prevention regimens. The genetic test identifies individuals with defects in clotting factors, thus allowing the physician to determine the need for more aggressive thrombosis prevention measures for these individuals. Such therapy prevents life-threatening clots, especially those that travel from veins in the legs to the lungs (pulmonary emboli).

Methodology

Real time polymerase chain reaction (PCR)

Patient Preparation

None

Preferred Specimen

1.0 mL whole blood collected in EDTA (Lavender Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 15 days

Lab Values

  • Genotypes -/-, +/-, +/+

Clinical Significance

  • Genotype -/-: normal risk of clot formation
  • Genotypes +/-:  increased risk of developing clots, especially if on oral estrogen therapy
  • Genotype +/+: markedly increased risk of developing clots, especially if on oral estrogen therapy

Treatment Options

  • Genotypes +/-, +/+:  consider low dose aspirin treatment
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Clopidogrel Response (CYP2C19) Genotype Test

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Test Code

830

Description

CYP2C19 polymorphisms are inherited variations in the DNA sequence of the gene that codes for the cytochrome P450 (CYP) enzyme 2C19.  This enzyme is found in the liver and converts the pro-drug clopidogrel (PLAVIX®) to its active form.  Knowing CYP2C19 genotype is important prior to angioplasty to assure proper treatment with clopidogrel or prasugrel to prevent the complications of either stent closure or significant bleeding.  The intended use of CYP2C19 testing is as an aid in treatment decisions related to dosage of clopidogrel (Plavix). The genetic test identifies individuals that have reduced metabolism of clopidogrel, thus requiring higher amounts of the drug in order to reach an efficacious dose of the active agent, or sometimes require a different agent such as prasurgrel or ticagrelor, because they do not metabolize clopidogrel to its active form at all. Moreover there is another group of patients identified by this testing who has increased metabolism of clopidogrel to its active form, and such patients require a decreased dose of clopidogrel to prevent bleeding complications.

Methodology

Real time polymerase chain reaction (PCR)

Patient Preparation

None

Preferred Specimen

1.0 mL whole blood collected in EDTA (Lavender Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 15 days

Lab  Values

  • Normal Clopidogrel Metabolizers
    • Genotype *1/*1
    • Genotype *2/*17 (metabolism is not known but is assumed to fall in the normal category)
    • Genotype *3/*17 (metabolism is not known but is assumed to fall in the normal category)
  • Increased Clopidogrel Metabolizer
    • Genotype *1/*17
  • Decreased Clopidogrel Metabolizers
    • Genotype *1/*2
    • Genotype *1/*3
  • Markedly Increased Clopidogrel Metabolizer
    • Genotype *17/*17
  • Markedly Decreased Clopidogrel Metabolizers
    • Genotype *2/*2
    • Genotype *3/*3
    • Genotype *2/*3
    •  

Clinical Significance

  • See lab values section above.

Treatment Options

 

 

 

 

 

 

 

  • Normal Clopidogrel Metabolizers (genotypes *1/*1, *2/*17, *3/*17)
    • Normal doses of clopidogrel can be used
  • Increased Clopidogrel Metabolizer (genotype *1/*17)
    • Only normal doses of clopidogrel, if indicated, are recommended
  • Decreased Clopidogrel Metabolizers (genotypes *1/*2, *1/*3)
    • The clopidogrel dose, if indicated, may need to be increased
  • Markedly Increased Clopidogrel Metabolizer (genotype *17/*17)
    • Only normal doses or lower than normal doses of clopidogrel are recommended, if indicated
  • Markedly Decreased Clopidogrel Metabolizers (genotypes *2/*2, *3/*3, *2/*3)
    • Another agent such as ticagrelor or prasugrel, if indicated, is recommended
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Dehydroepiandrosterone Sulfate (DHEA-S)

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Test Code

1134

Description

DHEA-S is an androgenic steroid secreted by the adrenal cortex and is the major androgen precursor in females. 

Methodology

Immunoassay-Competitive principle

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  Data not available
Refrigerated:  5 days

Lab Values

 

Females:
Age                                                   

 

10-14

33.9-280

15-19

65.1-368

20-24

148-407

25-34

98.8-340

35-44

60.9-337

45-54

35.4-256

55-64

18.9-205

65-74

9.40-246

=>75

12.0-154

Males:
Age

 

10-14

24.4-247

15-19

70.2-492

20-24

211-492

25-34

160-449

35-44

88.9-427

45-54

44.3-331

55-64

51.7-295

65-74

33.6-249

=>75

16.2-123

        Alert Values: N/A

Clinical Significance

  • Elevated DHEA-S values aid in the diagnosis of hirsutism and virilism
  • Elevated DHEA-S levels may be useful for the diagnosis of:
    • All forms of excess androgen
    • Hyperprolactinemia
    • Polycystic ovarian syndrome
    • Exclusion of an androgen producing tumor of the adrenal cortex
    • Genetic enzyme defects of the adrenal cortex (adrenogenital syndrome)
    • Hyperplasia of the adrenal cortex as well as androgen producing tumors

Treatment Options

  • Identify etiology of elevated DHEA-S levels with physical assessment and additional diagnostic tests as indicated
  • Treatment is based on etiology of abnormal hormone level
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Estradiol (Estrogen Fraction E2)

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Test Code

1128

Description

Estradiol is the most potent naturally occurring estrogen.  Estrogens are the female hormones produced by the ovaries, adrenal cortex, placenta and testes.  Estrogens prepare the uterus for implantation of the fertilized ovum and promotes the maturation of and maintenance of female secondary sex characteristics and reproductive organs.

Methodology

Immunoassay - Competitive principle

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  Data not available
Refrigerated:  7 days

Lab Values

 

Sex/Phase 

pg/mL

Men

7.63-42.6

Women

Follicular phase

12.5-166

Ovulation phase

85.8-498

Luteal phase

43.8-211

Postmenopause

< 5.00-54.7

Pregnancy

1st trimester

215-> 4300

Alert Values: N/A

Clinical Significance

  • Estradiol is used in the assessment of menopausal status, fertility disorders in the hypothalamus-pituitary-gonad axis, gynecomastia, estrogen-producing ovarian and testicular tumors and in hyperplasia of the adrenal cortex
  •  Is also used for monitoring of fertility therapy and determining the time of ovulation within the framework of in vitro fertilization.

Treatment Options

  • Identify etiology of elevated or decreased estradiol levels with physical assessment and additional diagnostic tests as indicated
  • Treatment is based on etiology of abnormal hormone level
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Follicle Stimulating Hormone (FSH)

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Test Code

1122

Description

FSH is one of the gonadotropins of the anterior pituitary gland that stimulates the growth and maturity of graafian follicles in the ovary and spermatogenesis in the testes.

Methodology

Immunoassay - Sandwich principle

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  Data not available
Refrigerated: 2 days

Lab Values

 

Sex/Phase

mIU/mL

Men

1.5-12.4

Women

 

Follicular phase

6.8-12.5

Ovulation phase

4.7-21.5

Luteal phase

1.7-7.7

Postmenopause

25.8-134.8

Alert Values: N/A

Clinical Significance

  • FSH is used to assess for dysfunctions within the hypothalamic-pituitary-gonadal system
  • FSH in conjunction with LH is used for the following indications:
    • Menopausal syndrome
    • Polycystic ovarian syndrome (PCOS)
    • Testosterone deficiency
    • Amenorrhea (causes)
    • Congenital diseases with chromosomal aberrations

Treatment Options

  • Identify etiology of elevated or decreased FSH levels with physical assessment and additional diagnostic tests as indicated
  • Treatment is based on the etiology of abnormal hormone levels
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Luteinizing Hormone (LH)

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Test Code

1120

Description

LH is one of the gonadotropins of the anterior pituitary gland that works with FSH to induce ovulation of mature follicles and secretion of estrogen by the ovary.  LH is also involved with the formation of the corpus luteum.  In the male LH stimulates the development of the interstitial cells of the testes and their secretion of testosterone.

Methodology

Immunoassay - Sandwich principle

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  Data not available
Refrigerated:  14 days

Lab Values

 

Sex/Phase

mIU/mL

Men

1.7-8.6

Women

Follicular phase

2.4-12.6

Ovulation phase

14.0-95.6

Luteal phase

1.0-11.4

Postmenopause

7.7-58.5

Alert Values: N/A

Clinical Significance

  • LH is used to assess for dysfunctions within the hypothalamic-pituitary-gonadal system
  • LH in conjunction with FSH is utilized for the following indications:
    • Menopausal syndrome
    • Polycystic ovarian syndrome (PCOS)
    • Testosterone deficiency
    • Amenorrhea (causes)
    • Congenital diseases with chromosomal aberrations

Treatment Options

  • Identify etiology of elevated or decreased LH levels with physical assessment and additional diagnostic tests as indicated
  • Treatment is based on the etiology of abnormal hormone levels
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Progesterone

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Test Code

1124

Description

Progesterone is a steroid hormone secreted by the corpus luteum and placenta to promote normal sexual function and secondary sex characteristics in women, as well as to prepare the uterus for implantation of the fertilized ovum and to maintain pregnancy.

Methodology

Immunoassay - Competitive principle

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  Data not available
Refrigerated:  2 days

Lab Values

 

Sex/Phase

ng/mL

Men

0.2-1.4

Women

Follicular phase

0.2-1.5

Ovulation phase

0.8-3.0

Luteal phase

1.7-27

Postmenopause

0.1-0.8

Alert Values: N/A

Clinical Significance

Progesterone is used in the assessment of menopausal status and fertility diagnosis.

Treatment Options

  • When giving estrogen to post-menopausal women with an intact uterus, also use oral micronized progesterone to prevent uterine cancer
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Sex Hormone Binding Globulin (SHBG)

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Test Code

1130

Description

SHBG is a glycoprotein that binds to sex hormones, specifically testosterone and estradiol.

Methodology

Immunoassay - Sandwich principle

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  Data not available
Refrigerated:  5 days

Lab Values

 

Sex/Age

SHBG (nmol/L)

Males 20-49 yrs

16.5-55.9

Males =>50 yrs

19.3-76.4

Females 21-49 yrs

24.6-122

Females =>50 yrs

17.3-125

Alert Values: N/A

Clinical Significance

  • Elevated SHBG levels can be seen
    • In elderly men
    • In patients with hyperthyroidism and cirrhosis of the liver
    • When oral contraceptives or antiepileptic drugs are taken
  • Markedly higher SHBG levels are seen in pregnant women due to their increased estrogen production
  • Decreased SHBG concentrations are often seen with
    • Hypothyroidism
    • Polycystic ovarian syndrome (PCOS)
    • Obesity
    • Hirsutism
    • Elevated androgen levels
    • Alopecia
    • Acromegaly

Treatment Options

  • Identify etiology of elevated or decreased LH levels with physical assessment and additional diagnostic tests as indicated
  • Treatment is based on etiology of abnormal hormone level
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Total Testosterone

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Test Code

1126

Description

Total testosterone is a measurement of free and protein bound testosterone, and is the most potent naturally occurring androgen.  It is produced by interstitial cells in the testes in response to stimulation by luteinizing hormone (LH).  Testosterone is also produced by the ovary and adrenal cortex in small amounts, and is responsible for the regulation of gonadotropic secretion and spermatogenesis, as well as the development of male secondary sex characteristics.

Methodology

Immunoassay - Competitive principle

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  Data not available
Refrigerated:  7 days

Lab Values

 

Sex/Age

ng/dL

Males
20-49 years

249-836

Males
=>50 years

193-740

Females
20-49 years

8.40-48.1

Females
=>50 years

2.90-40.8

Patients < 20 years old- Reference Range Not Established

Clinical Significance

  • Testosterone is used in the diagnosis and treatment of the following disorders:
    • Primary and secondary hypogonadism
    • Delayed or precocious puberty
    • Impotence in males
    • Hirsutism (excessive hair) and virilization (masculinization) in females due to polycystic ovaries, tumors and adrenogenital syndromes

Treatment Options

  • Identify etiology of elevated or decreased total testosterone levels with physical assessment and additional diagnostic tests as indicated
  • Treatment is based on etiology of abnormal hormone level
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Free Testosterone

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Test Code

1127

Description

Free testosterone is a measurement of testosterone that is not bound to SHBG.  Testosterone is the most potent naturally occurring androgen and is produced by the interstitial cells of the testes in response to stimulation by luteinizing hormone (LH).  Testosterone is also produced by the ovary and adrenal cortex in small amounts and is responsible for the regulation of gonadotropic secretion and spermatogenesis as well as the development of secondary sex characteristics.

Methodology

Calculation

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  Data not available
Refrigerated:  5 days

Lab Values

 

Sex/Age

pg/mL

Males

50.0-210.0

Females

1.0-8.5

Alert Values: N/A

Clinical Significance

  • Testosterone is used in the diagnosis and treatment of the following disorders:
    • Primary and secondary hypogonadism
    • Delayed or precocious puberty
    • Impotence in males
    • Hirsutism (excessive hair) and virilization (masculinization) in females due to polycystic ovaries, tumors and adrenogenital syndromes

Treatment Options

  •  Identify etiology of elevated or decreased free testosterone levels with physical assessment and additional diagnostic tests as indicated
  • Treatment is based on etiology of abnormal hormone level
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Albumin

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Test Code

403

Description

Albumin is the major plasma protein responsible for regulating plasma osmotic pressure as well as providing transport for large organic anions and some drugs.  This test measures the amount of albumin in plasma.

Methodology

Colorimetric Principle

Patient Preparation

None

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Room Temperature:  2.5 months
Refrigerated:  5 months

Lab Values

 

  • Optimal: 3.5-5.2 g/dL
  • Borderline: NA
  • Increased/High Risk: <3.5g/dL; >5.2 g/dL

 

Clinical Significance

  • Elevated levels associated with dehydration
  • Decreased levels associated with:
    • Liver disease
    • Chronic disease
    • Reduced protein intake
    • Increased catabolism due to tissue damage or inflammation
    • Malabsorption of amino acids
    • Nephrotic syndrome
    • Protein loss via stool in neoplastic disease

Treatment Options

  •  Identify etiology of elevated or decreased total testosterone levels with physical assessment and additional diagnostic tests as indicated
  • Treatment is based on etiology of abnormal hormone level
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Boston Heart Prediabetes Assessment™

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Test Name

Boston Heart Prediabetes Assessment™

Test Code

420 (Reflex) – Assessment only completed if fasting glucose level is 100-125 mg/dL and/or HbA1c is 5.7-6.4%.

Description

A method of predicting the risk of developing diabetes (fasting serum glucose > 125 mg/dL) in subjects with prediabetes (fasting serum glucose 100 – 125 mg/dL). This method uses information about the person’s height, weight, parental history of diabetes, and use of cholesterol lowering medications (statins and niacin) along with the following measurements:  fasting glucose, glycated serum protein, adiponectin, and triglycerides.  This method provides a highly accurate assessment of the 10 year diabetes risk (over 92% accurate). 

Methodology

Refer to individual assays for more detailed information.

  • Turbidimetric
  • Colorimetric
  • Enzymatic

Patient Preparation

Patient must be fasting for at least 9 hours (may drink water) at the time of collection.

Preferred Specimen

1.0 mL  serum (0.5 mL minimum) collected in a serum separator tube (SST/Tiger Top) and
1.0 mL whole blood collected in EDTA (Lavender Top)

Alternate Specimen

N/A

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 3 days

Lab Values

 

Prediabetes Assessment of the 10 year diabetes risk 

  • Low Risk: < 10%   
  • Borderline Risk: 10 – 20% 
  • High Risk: > 20%  

Clinical Significance

Prediabetes Assessment predicts the risk of developing diabetes  in subjects with prediabetes .

Treatment Options

Diet
Exercise
Medications

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Serum Adiponectin

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Test Name

Serum Adiponectin

Test Code

407

Description

Adiponectin is a measure of the amount of a hormone produced by fat cells that protects against developing heart disease and diabetes.

Methodology

Immunoassay - Competitive principle

Patient Preparation

Patient must be fasting for at least 9 hours (may drink water) at the time of collection.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  3 days

Lab Values    
                        

Male

  • Optimal: >10.0 µg/dL
  • Borderline: 7.0-10.0 µg /dL
  • High risk: <7.0 µg/dL

Female

  • Optimal: >13.0 µg/dL
  • Borderline: 9.0-13.0 µg /dL
  • High risk: <9.0 µg/dL

Alert Values: N/A

Clinical Significance

  • Borderline or high values indicate increased risk of diabetes

Treatment Options

  • Structured diet and exercise program
  • Medications
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Glycated Serum Protein (GSP)

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Test Name

Glycated Serum Protein (GSP)

Test Code

409

Description

GSP is the amount of glucose attached to total serum proteins that indicate the average amount of glucose in the blood over the previous two to three weeks.

Methodology

Immunoassay-Competitive principle

Patient Preparation

Patient must be fasting for at least 9 hours (may drink water) at the time of collection.

Preferred Specimen

1.0 mL serum (0.5 mL minimum) collected in serum separator tube (SST / Tiger Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated:  3 days

Lab Values

 

  • Optimal: <200 µmol/L
  • Borderline: 200-250 µmol/L
  • High risk: >250 µmol/L

Alert Values: N/A

Clinical Significance

  • Borderline or high values indicate increased risk of diabetes

Treatment Options

  • Structured diet and exercise program
  • Medications
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Myeloperoxidase (MPO)

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Test Code

604

Description

 

This is an enzyme made by white blood cells in the artery wall. Elevated levels of MPO indicate the presence of unstable plaque or buildup in the arterial wall and a high risk of having a near term cardiovascular event (within one to six months). In patients with high levels of MPO, careful evaluation of CVD risk should be considered by the healthcare professional.

Methodology

One-step enzyme immunoassay

Patient Preparation

None

Preferred Specimen

1.0 mL EDTA plasma collected in plasma separator tube (Pearl Top)

Alternate Specimen

None

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 3 days

Lab Values

  • Optimal: <582 pmol/L
  • Borderline: 582-633 pmol/L
  • High risk: >633 pmol/L
  • Alert: >1658 pmol/L

Clinical Significance

  • Elevated MPO levels >633 pmol/L have been shown to be a significant independent risk factor for a major adverse cardiac event (MACE) over the ensuing one to six months in patients presenting with chest pain who have normal levels of troponin.
  • This is especially the case if levels of high sensitivity C- reactive protein (hs-CRP) are also elevated (>2 mg/L), along with increased (>235 ng/mL) lipoprotein associated phospholipase A2 (LpPLA2).
    • Elevated serum levels of CRP are a marker of generalized and liver inflammation.
    • Elevated levels of LpPLA2 are a marker of inflammation in the arterial wall.
  • Simultaneous elevated levels of MPO (>633 pmol/L), hs-CRP (>2.0 mg/L), and LpPLA2 (>235 ng/mL) are associated with markedly increased six-month risk of a MACE.

Treatment Options

  • Evaluate cardiovascular disease (CVD) status with physical exam, stress testing and other CVD diagnostic modalities.
  • Modify all existing CVD risk factors.
  • Medications to reduce elevated MPO levels may include:
    • Statins
    • Beta-blockers
    • Angiotensin enzyme converting inhibitors
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Estimated Glomerular Filtration Rate (eGFR)

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Test Code

N/A -- automatically calculated when serum creatinine is ordered.

Description

 

Glomerular filtration rate (GFR) provides a measure of kidney filtering capacity. Total GFR can be used as an index of functioning renal mass.
Estimated GFR (eGFR) is derived from the equation shown below.

Methodology

Serum creatinine and age are used to calculate eGFR, taking sex and race into account. The specific equation used is:

GFR = 141 x min(Scr/κ, 1)α x max(Scr/κ, 1)-1.209 x 0.993Age x 1.018 [if female] x 1.159 [if black]

κ = 0.7 if female
κ = 0.9 if male

α = -0.329 if female
α = -0.411 if male

min = The minimum of Scr/κ or 1
max = The maximum of Scr/κ or 1

Patient Preparation

None

Preferred Specimen

NA

Alternate Specimen

NA

Transport Temperature

NA

Stability

NA

Lab Values

  • Optimal: >60 mL/min/1.73 m2
  • Borderline: 30-60 mL/min/1.73 m2
  • High Risk:  <30 mL/min/1.73 m2

Clinical Significance

eGFR Reference Ranges and Associated Clinical Signficance

≥90 mL/min/1.73m2

“Optimal” - Normal unless proteinuria is present which indicates stage 1 CKD

60-89 mL/min/1.73m2

“Borderline” Stage 2 CKD – further evaluation to determine potential causes of kidney disease recommended

30-59 mL/min/1.73m2

“High Risk” Stage 3 CKD – further evaluation and treatment of complications recommended

15-29 mL/min/1.73m2

Stage 4 CKD – recommend preparing for kidney replacement therapy (e.g., hemodialysis or kidney transplantation)

<15 mL/min/1.73m2

Stage 5 CKD – kidney replacement therapy recommended

  • A low or decreasing eGFR is an indicator of chronic kidney disease (CKD).
  • Monitoring changes in eGFR can delineate progression of kidney disease.
  • The level of GFR is a strong predictor of the time to onset of kidney failure as well as the risk of complications of CKD.
  • Monitoring eGFR allows proper dosing of drugs excreted by glomerular filtration to avoid drug toxicity.

Treatment Options

Treatment is based on the cause of the renal dysfunction.

Reference: National Kidney Foundation: K/DOQI clinical practice guidelines for chronic kidney disease: Evaluation, classification, and stratification Kidney Disease Outcomes Quality Initiative. Am J Kidney Dis. 2002;39(suppl 1)S1-266.

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Total T4 (Thyroxine or T4)

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Test Code

1015

Description

 

Total T4 (thyroxine) is a hormone produced by the thyroid gland and is converted in the body’s tissue to the major active thyroid hormone T3.

Methodology

Chemiluminescence immunoassay

Patient Preparation

None

Preferred Specimen

1.0 mL serum collected in a serum separator tube (tiger top)

Alternate Specimen

1.0 mL plasma in an EDTA plasma separator tube (pearl top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days
Frozen -20°C: 30 days

Lab Values

  • Low: <4.5 µg/dL
  • Optimal: 4.5-11.7 µg/dL
  • High : >11.7 µg/dL

Clinical Significance

  • Low Total T4 levels are consistent with an underactive thyroid gland or inadequate thyroid hormone replacement.
  • High Total T4 levels are consistent with either an overactive thyroid gland or excess thyroid hormone replacement.

Treatment Options

  • Treatment is based on the cause of Total T4 elevation/reduction.
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Free T4 (Free Thyroxine or FT4)

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Test Code

1016

Description

 

The amount of T4 hormone that is freely circulating in blood.

Methodology

Chemiluminescence immunoassay

Patient Preparation

None

Preferred Specimen

1.0 mL serum collected in a serum separator tube (tiger top)

Alternate Specimen

1.0 mL plasma in an EDTA plasma separator tube (pearl top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days  (2 days on SST)
Frozen -20°C: 30 days

Lab Values

  • Low: <0.93 ng/dL
  • Optimal: 0.93-1.70 ng/dL
  • High: >1.70 ng/dL

 

Clinical Significance

  • Low Free T4 levels are consistent with an underactive thyroid gland or inadequate thyroid hormone replacement.
  • High Free T4 levels are consistent with either an overactive thyroid gland or excess thyroid hormone replacement.

Treatment Options

  • Treatment is based on the cause of FT4 elevation/reduction.
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Total T3 (Triiodothyronine or T3)

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Test Code

1014

Description

 

Total T3 (triiodothyronine) is a hormone generated by converting T4 to T3 in the body’s tissue.  T3 is the active thyroid hormone and is necessary for normal body metabolism.

Methodology

Chemiluminescence immunoassay

Patient Preparation

None

Preferred Specimen

1.0 mL serum collected in a serum separator tube (tiger top)

Alternate Specimen

1.0 mL plasma in an EDTA plasma separator tube (pearl top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days
Frozen -20°C: 30 days (freeze only once)

Lab Values

  • Low: <0.8 ng/mL
  • Optimal: 0.8-2.0 ng/mL
  • High: >2.0 ng/mL

Clinical Significance

  • Low Total T3 levels are consistent with hypothyroidism or inadequate thyroid hormone replacement.
  • High Total T3 levels are consistent with either hyperthyroidism or excess thyroid hormone replacement.

Treatment Options

  • Treatment is based on cause of Total T3 elevation/reduction.
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Free T3 (Free Triiodothyronine or FT3)

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Test Code

1017

Description

 

The amount of T3 hormone that is freely circulating in blood.

Methodology

Chemiluminescence immunoassay

Patient Preparation

None

Preferred Specimen

1.0 mL serum collected in a serum separator tube (tiger top)

Alternate Specimen

1.0 mL plasma in an EDTA plasma separator tube (pearl top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days  (2 days on SST)
Frozen -20°C: 30 days (freeze only once)

Lab Values

  • Low: <2.0 pg/mL
  • Optimal: 2.0-4.4 pg/mL
  • High: >4.4 pg/mL

Clinical Significance

  • Low Free T3 levels are consistent with hypothyroidism or inadequate thyroid hormone replacement.
  • High Free T3 levels are consistent with either hyperthyroidism or excess thyroid hormone replacement.

Treatment Options

  • Treatment is based on the cause of FT3 elevation/reduction.
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Boston Heart Fatty Acid Balance™ Test

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Test Code

575

Description

 

Measures all the major fatty acids in plasma and reports:

  • Saturated Fatty Acid  Index
  • Trans Fatty Acid Index
  • Monounsaturated Fatty Acid Index
  • Unsaturated/Saturated Ratio Index
  • Omega-3 Fatty Acid Index
  • Omega-6 Fatty Acid Index
  • AA/EPA Ratio Index
  • Omega-6/Omega-3 Ratio Index
  • Levels of all the major omega-3 fatty acids including EPA, DHA and ALA as well as the two major omega-6 fatty acids AA and LA

Methodology

Gas liquid column chromatography/mass spectrometry (GC/MS) after lipid extraction

Patient Preparation

Patient must be fasting for at least 8 hours (may drink water) at the time of collection.  Non-fasting samples will be rejected.

Preferred Specimen

1.0 mL plasma collected in EDTA plasma separator tube (White/Pearl Top)

Transport Temperature

Refrigerated (ship on frozen cold packs)

Stability

Refrigerated: 7 days

Lab Values

 

Test Name

Optimal

Borderline

High Risk

Saturated Fatty Acid Index

< 30.0

30.0 - 32.0

> 32.0 %

Trans Fatty Acid Index

< 0.80

0.80 - 1.10

> 1.10 %

 

Test Name

Optimal

Borderline

Low

Monounsaturated Fatty Acid Index

> 22.0

19.0 - 22.0

< 19.0 %

Unsaturated/Saturated Ratio Index

> 2.25

2.00 - 2.25

< 2.00

Omega-3 Fatty Acid Index

> 4.50

1.85 - 4.50

< 1.85 %

Eicosapentaenoic Acid (EPA)

> 50.0

10.0 - 50.0

< 10.0 µg/mL

Docosahexaenoic Acid (DHA)

> 100.0

45.0 - 100.0

< 45.0 µg/mL

Alpha-linolenic Acid (ALA)

> 30.0

12.0-30.0

< 12.0 µg/mL

 

Test Name

Low

Mid

High

Omega-6 Fatty Acid Index

< 41.0

41.0 - 46.0

> 46.0 %

Linoleic Acid (LA)

< 825.0

825.0 - 1040.0

> 1040.0 µg/mL

Arachidonic Acid (AA)

< 220.0

220.0 - 290.0

> 290.0 µg/mL

AA/EPA Index

< 13.0

13.0 - 25.0

> 25.0

Omega-6/Omega-3 Ratio Index

< 15.0

15.0 - 24.0

> 24.0%

Clinical Significance

  • A high saturated fatty acid index > 32% of fat increases heart disease risk.3
  • A high trans fatty acid  index of > 1.10 % increases heart disease risk.
  • A monounsaturated fatty acid index of < 19% increases heart disease risk.  
  • A low unsaturated/saturated  ratio index of < 2.0 increases heart disease risk.
  • An omega 3 fatty acid index of < 1.85% increases heart disease risk.
  • EPA levels > 150 ul/L have been associated with significant heart disease risk reductions using EPA supplementation.
  • ALA may be helpful for heart disease risk reduction.                        

Treatment Options

  • Choose poultry without skin, fish, low fat dairy products, and very lean cuts of meats. Replace butter with vegetable oil or tub margarine.
  • Replace foods high in trans fats with trans fat free tub margarine and vegetable oils.
  • Increase intake of olive oil and or canola oil in salads or use more of these oils in cooking.   
  • Increase intake of vegetable fats (nuts, seeds, canola, soybean or other oils) and decrease intake of animal fats (fatty meats, cheese, ice cream).
  • Increase intake of oily fish such as salmon, herring, tuna, or mackerel, or take at least two fish oil or pure EPA capsules daily. Use of fish oil capsules has been associated with heart disease risk reduction. Doses of about 6 grams per day of fish oil or 4 grams of concentrated fish oil can also significantly lower triglyceride levels.

 

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