Test Details
Methodology
See individual tests.
Result Turnaround Time
1 - 2 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Test Includes
Cholesterol, total; high-density lipoprotein (HDL) cholesterol; low-density lipoprotein (LDL) cholesterol NIH calculation; LDL cholesterol equivalent calculation from apoB; triglycerides; very low-density lipoprotein (VLDL) cholesterol (calculation); apolipoprotein B (ApoB)
Use
Low-density lipoprotein cholesterol (LDL-C), the most commonly measured atherogenic lipid particle, has been associated with diagnostic, prognostic, and therapeutic goal attainment criteria for several decades. The LDL molecule is comprised of various lipids- primarily cholesterol as cholesterol esters and free cholesterol, as well as some triglyceride and a single Apolipoprotein B (ApoB) which is a key structural component of all atherogenic lipoproteins. It is well established that the measurement of LDL-C lacks correlation to the actual number of LDL particles in circulation due to the changing cholesterol content of the LDL particle; thus, monitoring LDL-C levels may not provide adequate assurance that therapeutic treatment to LDL-C goals is achieved. However, as each atherogenic lipoprotein particle contains exactly one molecule of ApoB, its measurement is a powerful tool for assessment of atherogenic lipid status providing a direct correlation to circulating atherogenic LDL particles.
The National Institutes of Health has demonstrated that ApoB measurements may be translated to LDL-C values so that conventional risk assessment and therapeutic targets that utilize LDL-C could continue to be used. This would provide a transition of ApoB measurements into an equivalent LDL unit until ApoB guided decision making can be facilitated. The new LDL-C equivalent (LDL-C EQ) calculation is derived from an ApoB measurement, and is incorporated into in a standard lipid panel that includes the current LDL-C (NIH) calculation, ApoB, as well as traditional triglycerides, total cholesterol and high density lipoprotein cholesterol (HDL-C). The side-by-side LDL-C (NIH) and LDL-C EQ calculation from ApoB will allow the clinician to quickly assess the necessity if more stringent intervention is needed to obtain therapeutic goals based on the LDL-C EQ value.
Special Instructions
State patient's age and sex on the request form.
Limitations
Patients with obstructive liver disease may develop lipoprotein abnormalities. Serum lipid factors have not been demonstrated to have a strong influence on recurrent stenosis following coronary angioplasty, the pathogenesis of which is presently not well understood. The LDL-C using the NIH equation cannot be calculated if triglyceride is >800 mg/dL. The LDL-C calculation from ApoB is not affected by high triglycerides.
Custom Additional Information
Investigation of serum lipids is indicated in those with coronary arterial disease, especially when it is premature (typically <40 years), and in those with family history of atherosclerosis or of hyperlipidemia. In addition, serum lipids are indicated in patients presenting with xanthomas or arcus cornealis. Lipid profiling for evaluation of risk factors for coronary arterial disease, may lead to detection of some cases of hypothyroidism. Primary hyperlipoproteinemia includes hypercholesterolemia, a direct risk factor for coronary heart disease. Secondary hyperlipoproteinemia includes increases of lipoproteins secondary to hypothyroidism, nephrosis, renal failure, obesity, diabetes mellitus, alcoholism, primary biliary cirrhosis, and other types of cholestasis. Decreased lipids are found with some cases of malabsorption, malnutrition, and advanced liver disease. In abetalipoproteinemia, cholesterol is <70 mg/dL in the absence of lipid lowering therapy.
| Apolipoprotein B and LDL-C Treatment Goals | ||
|---|---|---|
| Treatment goals | ||
| Risk factors/10-year risk | LDL-C (mg/dL) | ApoB (mg/dL) |
Progressive ASCVD including unstable angina in patients achieving an LDL-C <70 mg/dL Established clinical cardiovascular disease in patients with DM, CKD 3/4 or HeFH History of premature ASCVD (<55 male, <65 female) | <55 | <70 |
Established or recent hospitalization for ACS, coronary, carotid or peripheral vascular disease Diabetes OR CKD 3/4 with one or more risk factor(s) HeFH | <70 | <80 |
| >/= 2 risk factors and 10-year risk >10% or CHD risk equivalent, including diabetes or CKD 3/4 with no other risk factors | <100 | <90 |
| >/= 2 risk factors and 10-year risk <10% | <130 | NR |
| </= 1 risk factor | <160 | NR |
Investigation of serum lipids is indicated in those with coronary arterial disease, especially when it is premature (typically <40 years), and in those with family history of atherosclerosis or of hyperlipidemia. In addition, serum lipids are indicated in patients presenting with xanthomas or arcus cornealis. Lipid profiling for evaluation of risk factors for coronary arterial disease, may lead to detection of some cases of hypothyroidism. Primary hyperlipoproteinemia includes hypercholesterolemia, a direct risk factor for coronary heart disease. Secondary hyperlipoproteinemia includes increases of lipoproteins secondary to hypothyroidism, nephrosis, renal failure, obesity, diabetes mellitus, alcoholism, primary biliary cirrhosis, and other types of cholestasis. Decreased lipids are found with some cases of malabsorption, malnutrition, and advanced liver disease. In abetalipoproteinemia, cholesterol is <70 mg/dL in the absence of lipid lowering therapy.
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Investigation of serum lipids is indicated in those with coronary arterial disease, especially when it is premature (typically <40 years), and in those with family history of atherosclerosis or of hyperlipidemia. In addition, serum lipids are indicated in patients presenting with xanthomas or arcus cornealis. Lipid profiling for evaluation of risk factors for coronary arterial disease, may lead to detection of some cases of hypothyroidism. Primary hyperlipoproteinemia includes hypercholesterolemia, a direct risk factor for coronary heart disease. Secondary hyperlipoproteinemia includes increases of lipoproteins secondary to hypothyroidism, nephrosis, renal failure, obesity, diabetes mellitus, alcoholism, primary biliary cirrhosis, and other types of cholestasis. Decreased lipids are found with some cases of malabsorption, malnutrition, and advanced liver disease. In abetalipoproteinemia, cholesterol is <70 mg/dL in the absence of lipid lowering therapy.
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Specimen Requirements
Specimen
Serum (preferred) or plasma
Volume
2 mL
Minimum Volume
1 mL (Note: This volume does not allow for repeat testing.)
Container
Red-top tube, gel-barrier tube or green top (lithium-heparin) tube; do not use oxalate, EDTA or citrate plasma
Red-top tube, gel-barrier tube or green top (lithium-heparin) tube |
Red-top tube, gel-barrier tube or green top (lithium-heparin) tube; do not use oxalate, EDTA or citrate plasma |
Collection Instructions
Separate serum or plasma from cells within 45 minutes of collection. Transfer serum to a plastic transport tube. Lipid panels are best avoided for three months following acute myocardial infarction, although cholesterol can be measured in the first 24 hours.
Separate serum or plasma from cells within 45 minutes of collection. Transfer serum to |
Separate serum or plasma from cells within 45 minutes of collection. Transfer serum to a plastic transport tube. Lipid panels are best avoided for three months following acute myocardial infarction, although cholesterol can be measured in the first 24 hours. |
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 3 days |
| Refrigerated | 14 days |
| Frozen | 14 days |
| Freeze/thaw cycles | Stable x2 |
Reference Range
| *The LDL-cholesterol Equivalent Calculation from ApoB should be considered the more accurate estimation of LDL to determine therapeutic goals when there is a discrepancy between this value and the LDL-cholesterol calculation by NIH. | LDL-Cholesterol Equivalency Risk Categories (mg/dL) | |
| Optimal | <100 | |
| Near optimal | 100–129 | |
| Borderline high | 130–159 | |
| High | 160–189 | |
| Very high | >189 | |
| Risk factors/10-year risk | Treatment Goals LDL-Cholesterol (mg/dL) | |
Progressive ASCVD including unstable angina in patients achieving an LDL-C <70 mg/dL Established clinical cardiovascular disease in patients with DM, CKD 3/4 or HeFH History of premature ASCVD (<55 male, <65 female) | <55 | |
Established or recent hospitalization for ACS, coronary, carotid or peripheral vascular disease Diabetes or CKD 3/4 with one or more risk factor(s) HeFH | <70 | |
| >/= 2 risk factors and 10-year risk >10% or CHD risk equivalent, including diabetes or CKD 3/4 with no other risk factors | <100 | |
| >/= 2 risk factors and 10-year risk <10% | <130 | |
| </= 1 risk factor | <160 | |
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Storage Instructions
Maintain specimen at room temperature.
Patient Preparation
Patient should be on a stable diet, ideally for two to three weeks prior to collection of blood. Fasting is not necessary for this profile; however, fasting (12 to 14 hours preferred; eight hours acceptable) prior to collection of the specimen is recommended where the triglyceride value provides a prior diagnostic information such as screening for familial hypercholesterolemia or early onset heart disease, pancreatitis or confirming hypertriglyceridemia.
Causes for Rejection
Hemolysis
References
Cole J, Otvos JD Remaley AT. Translational Tool to Facilitate Use of Apolipoprotein B for Clinical Decision‐Making. Clin Chem. 2023 Jan 4:69(1);41‐47. PubMed 36366949
Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm – 2019 Executive Summary. Endocr Pract. 2019 Jan;25(1):69‐100. PubMed 30742570
Kohli-Lynch CN, Thanassoulis G, Moran AE, Sniderman AD. The Clinical Utility of ApoB Versus LDL‐C/non‐HDL‐C. Clin Chem Acta. 2020 Sep;508;103-108. PubMed 32387091
Marston NA, Giugliano RP, Melloni Giorgio EM, et al. Association of Apolipoprotein B–Containing Lipoproteins and Risk of Myocardial Infarction in Individuals with and Without Atherosclerosis Distinguishing Between Particle Concentration, Type, and Content. JAMA Cardiol. 2022 Mar 1:7(3);250‐256. PubMed 34773460
Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. The Expert Panel. Arch Intern Med. 1988 Jan;148(1):36‐69. PubMed 3422148
Cole J, Otvos JD Remaley AT. Translational Tool to Facilitate Use of Apolipoprotein B for Clinical Decision‐Making. Clin Chem. 2023 Jan 4:69(1);41‐47. PubMed 36366949 Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm – 2019 Executive Summary. Endocr Pract. 2019 Jan;25(1):69‐100. PubMed 30742570 Kohli-Lynch CN, Thanassoulis G, Moran AE, Sniderman AD. The Clinical Utility of ApoB Versus LDL‐C/non‐HDL‐C. Clin Chem Acta. 2020 Sep;508;103-108. PubMed 32387091 Marston NA, Giugliano RP, Melloni Giorgio EM, et al. Association of Apolipoprotein B–Containing Lipoproteins and Risk of Myocardial Infarction in Individuals with and Without Atherosclerosis Distinguishing Between Particle Concentration, Type, and Content. JAMA Cardiol. 2022 Mar 1:7(3);250‐256. PubMed 34773460 Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. The Expert Panel. Arch Intern Med. 1988 Jan;148(1):36‐69. PubMed 3422148 |