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Order Code

173

Preferred Specimen

2 mL of serum. Allow the serum separator tube (SST) to clot in an upright position for a minimum of 30 minutes. Centrifuge the specimen within 2 hours of collection. Keep refrigerated.
The patient must fast for 9–12 hours prior to specimen collection.
THSteps (Medicaid) samples must be submitted to the DSHS laboratory.

ContainerType

serum separator tube

Alternate Specimen Requirements

2 mL of serum obtained from a plain red top tube. Let the sample clot upright for at least 60 minutes. Centrifuge, then transfer the serum into a plastic transport tube within 2 hours of collection. Clearly indicate that the sample is from a plain red top tube. Refrigeration is required.
The patient should fast for 9–12 hours before specimen collection.

Minimum Volume

2 mL

Transport Temperature

refrigerated

Specimen Stability

5 days room temperature; 1 week refrigerated

Methodology

Roche COBAS enzymatic;colorimetric gen 2
Roche COBAS enzymatic colorimetric

Rejection Criteria

  • gross hemolysis

Overview

A lipid panel evaluates the types and quantities of fats and fat-like substances circulating in the bloodstream. These lipids serve as energy sources for cells, contribute to membrane structure, and act as precursors in the formation of bile acids and steroid hormones. Cholesterol and triglycerides are examples of lipids that do not dissolve in blood unless incorporated into lipoproteins—complexes made up of proteins, cholesterol, triglycerides, and phospholipids. Lipoproteins are categorized by density into very low-density lipoproteins (VLDL), low-density lipoproteins (LDL), and high-density lipoproteins (HDL) (AACC, 2019).

A comprehensive lipid profile helps in evaluating cardiovascular disease (CVD) risk by quantifying total cholesterol, HDL cholesterol, and triglycerides. LDL cholesterol may be calculated from these measurements or directly tested. Additional parameters may include the cholesterol-to-HDL ratio, non-HDL cholesterol, and LDL particle count.

Clinical Significance

  • Evaluate CVD risk in individuals without established disease
  • Periodically monitor lipid levels when risk factors are present (e.g., diabetes, hypertension, smoking)
  • Assess treatment efficacy
  • Identify potential hereditary lipid disorders
Additional Information

CVD risk assessment tools help pinpoint individuals aged 40–79 who may benefit most from preventive interventions. These calculators incorporate evidence-based variables such as age, sex, race, total and HDL cholesterol, blood pressure, diabetes status, and tobacco use (AACC, 2019).

The role of LDL cholesterol in risk assessment has evolved. The 2013 AHA/ACC guidelines shifted away from fixed LDL targets for preventing coronary heart disease, instead focusing on the degree of LDL reduction required via statin therapy, based on clinical risk. A 2018 update partially reinstated LDL goals for higher-risk populations. Meanwhile, other guidelines, such as the AACE/ACE 2017 update, still advocate for LDL targets determined by individual risk profiles (Wu, 2016).

Interpretative Information

Lipid measurements are essential in determining CVD risk. Online calculators for estimating 10-year risk include:

ACC ASCVD Risk Estimator Plus

2013 ACC/AHA Risk Calculator

Limitations

Total Cholesterol:

  • Falsely low readings: May occur due to elevated levels of N-acetylcysteine (NAC) or N-acetyl-p-benzoquinone imine (NAPQI, a metabolite of acetaminophen), particularly at concentrations found in overdose scenarios.
  • Falsely elevated readings: Can be seen during pregnancy or with the use of certain medications (e.g., anabolic steroids, oral contraceptives, beta-blockers).

HDL Cholesterol:

  • Falsely decreased levels: Can result from high concentrations of NAC, NAPQI, or metamizole (a pain reliever used in some countries but not approved in the U.S.).

LDL Cholesterol:

  • Routine assays may also detect intermediate-density lipoprotein (IDL) and lipoprotein(a) [Lp(a)], though these typically have minimal influence on the overall LDL value. Complex cases should be referred to a specialized lipid center.
  • Medications that may increase LDL: Thiazide diuretics, beta-blockers, amiodarone, SGLT2 inhibitors, protease inhibitors, cyclosporine, and anabolic steroids.
  • Medications that may reduce LDL: Statins, niacin, and estrogen therapy.

LDL Particle Number (LDL-P):
As of 2018, there are no established guidelines for initiating therapy or setting treatment goals based on LDL particle count.

Triglycerides:

  • Falsely high levels: May result from unesterified glycerol in the bloodstream or the presence of lipid-based intravenous solutions (e.g., total parenteral nutrition).
  • Falsely low levels: May be seen with ascorbic acid, elevated NAC, NAPQI (in overdose situations), or calcium dobesilate (a vasoprotective agent not used in the U.S.).
References

Beaumont JL, Carlson LA, Cooper GR, Fejfar Z, Fredrickson DS, Strasser T. Classification of hyperlipidaemias and hyperlipoproteinaemias. Bull World Health Organ. 1970;43(6):891-915.4930042

Castelli WP. Epidemiology of coronary heart disease: the Framingham study. Castelli WP. Am J Med. 1984;76(2A):4-12.6702862

Catapano AL, Graham I, De Backer G, et al. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J. 2016;37(39):2999-3058.27567407

Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001;285(19):2486-2497.11368702

Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents; National Heart, Lung, and Blood Institute. Expert panel on integrated guidelines for cardiovascular health and risk reduction in children and adolescents: summary report. Pediatrics. 2011;128 Suppl 5:S213-56.22084329

Framingham Heart Study. A Project of Boston University and the National Heart, Lung, and Blood Institute. Framingham Heart Study website. http://www.framinghamheartstudy.org. Accessed March 6, 2019.

Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502.4337382

Goff DC Jr, Lloyd-Jones DM, Bennett G, et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(25 Pt B):2935-2959.24239921

Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary [published online November 10, 2018]. Circulation.30565953

Jellinger PS, Handelsman Y, Rosenblit PD, et al. America association of clinical endocrinologists and american college of endocrinology guidelines for management of dyslipidemia and prevention of cardiovascular disease. Endocr Pract. 2017;23(Suppl 2):1-87.28437620

Lipid Panel. AACC website https://labtestsonline.org/tests/lipid-panel# Updated July 22, 2019. Accessed July 25, 2019.

Mir F. LDL Cholesterol. Medscape website. http://emedicine.medscape.com/. Updated March 4, 2014. Accessed March 7, 2019.

Nayor M, Vasan RS. Recent Update to the US Cholesterol Treatment Guidelines: A Comparison With International Guidelines. Circulation. 2016;133(18):1795-1806.27143546

Rollins G. Universal lipid screening in children. Clinical Laboratory News website https://www.aacc.org/publications/cln/articles/2012/march/lipid-screening-children. Accessed February 21, 2019.

Rosenson RS. Measurement of blood lipids and lipoproteins. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 19, 2019.

Sathiyakumar V, Blumenthal RS, Elshazly MB. New Information on Accuracy of LDL-CEstimation. https://www.acc.org/latest-in-cardiology/articles/2020/03/19/16/00/new-information-on-accuracy-of-ldl-c-estimation March 20, 2020. Accessed June 27, 2021.

Singh G, Hussain Y, Xu Z, Sholle E, Michalak K, Dolan K, Lee BC, van Rosendael AR, Fatima Z, Peña JM, Wilson PWF, Gotto AM Jr, Shaw LJ, Baskaran L, Al’Aref SJ. Comparing a novel machine learning method to the Friedewald formula and Martin-Hopkins equation for low-density lipoprotein estimation. PLoS One. 2020 Sep 30;15(9):e0239934. doi: 10.1371/journal.pone.0239934.32997716

Solberg HE. Establishment and Use of Reference Values. In: Burtis CA, Ashwood ER, eds. Tietz Textbook of Clinical Chemistry. 3rd ed. Philadelphia, PA: WB Saunders Co; 1999:336-356.

Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(25 Pt B):2889-2934.24239923

Wu NQ, Li JJ. Clinical considerations of lipid target and goal in dyslipidemia control. Chronic Dis Transl Med. 2016;2(1):3-6.29063017

Yang EH. Lipid Management Guidelines. Medscape website. http://emedicine.medscape.com/. Updated November 30, 2018. Accessed February 14, 2019.

Diagnostic Role

For adults, routine fasting lipid profile screening is advised every 5 years starting at age 20. More frequent testing is advised if initial results are abnormal, if risk factors are present (eg, strong family history, diabetes, hypertension, tobacco use), or if the presence of cardiovascular disease (CVD) is established (eg, prior myocardial infarction, stroke, peripheral vascular disease) (Jellinger 2017). For children and adolescents, the National Heart Lung and Blood Institute (NHLBI) recommends testing non-HDL cholesterol (which may be performed nonfasting) once in all children between 9 and 11 years old, and again between 17 and 21 years old. High-risk children should be tested between 2 and 8 years old with a fasting lipid profile.

A lipid panel may be followed at regular intervals to monitor effectiveness of lipid-lowering lifestyle changes such as diet and exercise, or to determine the effectiveness of drug therapy.

Alias

  • coronary risk
  • lipid panel
  • lipid panel w/calc LDL/HDL ratio

Test Setup Days

Monday through Friday

CPT

80061 AMA Defined Profile.
Limited Coverage Test For Medicare.
Advance Beneficiary Notice Of Non-Coverage (ABN)
Required If Diagnosis Not Covered.
Frequency Limit Test For Medicare.
Advance Beneficiary Notice Of Non-Coverage (ABN)
Always Required For Frequency.

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