Apolipoprotein B

Single-analyte tests

• Apolipoprotein B 167015

  Serum · Fasting not stated · Turnaround 1 - 2 days

  Method and collection

  Method

  Immunologic

  Collection

  Separate serum or plasma from cells. Transfer specimen to a plastic transport tube.

  Reference notes

  Apolipoprotein B (mg/dL) Desirable | Borderline High | High | Very High <90 | 90–99 | 100–130 | >130 ASCVD Risk Category | Therapeutic Target APO B (mg/dL) Very High Risk | <80 (if extreme risk <70) High Risk | <90 Moderate Risk | <90

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Panels that include this biomarker

• Apolipoprotein Assessment 216010

  3 analytes · Serum · Fasting not stated · Turnaround 1 - 2 days

  Method and collection

  Method

  Immunologic

  Collection

  Separate serum or plasma from cells within 45 minutes. Transfer specimen to a plastic transport tube.

  Reference notes

  See tables. Apolipoprotein A-1 Male (mg/dL) 0 to 14 d | 62−91 15 d to 11 m | 53−175 1 to 5 y | 80−164 6 to 12 y | 107−175 >12 y | 101−178 Female (mg/dL) 0 to 14 d | 71−97 15 d to 11 m | 53−175 1 to 5 y | 80−164 6 to 80 y | 116−209 >80 y | 114−214 Apolipoprotein B1 Age | Male (mg/dL) | Female (mg/dL) 0 to 14 d | 9−67 | 9−67 15 d to 11 m | 19−123 | 19−123 1 to 5 y | 41−93 | 41−93 >5 y | 52−135 | 54−133 Apolipoprotein B:A-1 Ratio Male | Female Average risk | 0.7 | 0.6 2x average risk | 0.9 | 0.9 3x average risk | 1.0 | 1.0

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• Extended Lipid Panel With LDL-C Equivalent Calculation from Apolipoprotein B (ApoB) 167651

  6 analytes · Serum · No fasting · Turnaround 1 - 2 days

  Method and collection

  Method

  See individual tests.

  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.

  Collection

  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.

  Reference notes

  *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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• Lipid Panel With Apolipoprotein B (ApoB) 123544

  6 analytes · Serum · No fasting · Turnaround 1 - 3 days

  Method and collection

  Method

  Nuclear magnetic resonance (NMR) Note: The NMR method for Triglycerides, unlike the routine chemical method, is not affected by endogenous glycerol, which might be found in very rare clinical conditions such as Hyperglycerolemia (glycerol kinase deficiency-GKD), an X-linked genetic disorder. Large quantitative differences in the chemical and NMR method results may be attributable to high blood glycerol.

  Preparation

  Patient fasting is not required; however, in conditions where triglyceride values provide a prior diagnostic information, such as screening for familial hypercholesterolemia or early onset heart disease, pancreatitis, or confirming hypertriglyceridemia, the patient should be counseled to fast eight to 12 hours prior to blood draw.

  Collection

  Collect specimen in NMR LipoTube (black-and-yellow-top, gel-barrier), which is the preferred tube. Keep upright at room temperature for 30 minutes and allow to clot. Immediately after clotting, centrifuge at 1600 to 1800 xg for 10 to 15 minutes. The NMR LipoTube should then be stored at 2°C to 8°C until shipped. Do not open NMR LipoTube. For plain serum (red-top, no gel), keep upright at room temperature for 45 minutes and allow to clot. Centrifuge immediately after clotting. Separate serum and transfer to a plastic transport tube. The serum should then be stored at 2°C to 8°C until shipped. For EDTA plasma (lavender-top, no gel), invert tube several times to mix contents and centrifuge immediately after collection. Separate plasma and transfer to a plastic transport tube. The plasma should then be stored at 2°C to 8°C until shipped. Serum or plasma drawn in gel-barrier collection tubes other than the NMR LipoTube should not be used.

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• Lipid Panel With Apolipoprotein B (ApoB), GlycA (Inflammation), Diabetes Risk Index (DRI) 123567

  8 analytes · Serum · Fasting not stated · Turnaround 1 - 3 days

  Method and collection

  Method

  Nuclear magnetic resonance (NMR) Note: The NMR method for Triglycerides, unlike the routine chemical method, is not affected by endogenous glycerol, which might be found in very rare clinical conditions such as Hyperglycerolemia (glycerol kinase deficiency-GKD), an X-linked genetic disorder. Large quantitative differences in the chemical and NMR method results may be attributable to high blood glycerol.

  Preparation

  Patient should be fasting for a minimum of eight to 12 hours.

  Collection

  Collect specimen in plain red-top tube (no gel), which is the preferred specimen. Hold tube upright at room temperature for 45 minutes and allow to clot. Centrifuge specimen after clotting according to manufacturer's specifications. Transfer to a transport tube for storage at (2°C to 8°C) until shipped. For NMR LipoTube (black-and-yellow-top tube), keep upright at room temperature for 30 minutes and allow to clot. Centrifuge at 1600 to 1800 xg for 10 to 15 minutes immediately after clotting. If the sample cannot be centrifuged immediately, it must be refrigerated at (2°C to 8°C) and centrifuged within 24 hours of collection. The NMR tube should then be stored at (2°C to 8°C) until shipped. Separate plasma from lavender-top (EDTA-no gel) tube or green-top (heparin-no gel) tube immediately after collection and transfer to a plastic transport tube for shipment to the laboratory. Serum or plasma drawn in gel-barrier collection tubes other than the NMR LipoTube should not be used.

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Single-analyte tests

• Apolipoprotein B 5224

  Serum · Fasting not stated

  Method and collection

  Method

  Immunoturbidimetric

  Reference notes

  <90 mg/dL Risk Category Optimal | <90 mg/dL Moderate | 90-129 mg/dL High | ≥130 mg/dL A desirable treatment target may be <80 mg/dL or lower depending on the risk category of the patient including patients on lipid lowering therapies, patients with ASCVD, diabetes with >1 risk factors, Stage 3 or greater CKD with albuminuria, or heterozygous familial hypercholesterolemia. ApoB relative risk category cut points are based on AACE/ACE and ACC/AHA recommendations (Grundy SM, et al. 2019. doi:10.1016/j.jacc.2018.11.002; Handelsman Y, et al. 2020. doi:10.4158/CS-2020-0490).

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• Cardio IQ® Apolipoprotein B 91726

  Serum · Fasting not stated · Turnaround Set up: Sun-Fri

  Method and collection

  Method

  Immunoturbidimetric

  Reference notes

  <90 mg/dL Risk Category Optimal | <90 mg/dL Moderate | 90-129 mg/dL High | ≥130 mg/dL A desirable treatment target may be <80 mg/dL or lower depending on the risk category of the patient including patients on lipid lowering therapies, patients with ASCVD, diabetes with >1 risk factors, Stage 3 or greater CKD with albuminuria, or heterozygous familial hypercholesterolemia. ApoB relative risk category cut points are based on AACE/ACE and ACC/AHA recommendations (Grundy SM, et al. 2019. doi:10.1016/j.jacc.2018.11.002; Handelsman Y, et al. 2020. doi:10.4158/CS-2020-0490).

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Panels that include this biomarker

• Apolipoprotein Evaluation 7018

  3 analytes · Serum · Fasting not stated

  Method and collection

  Method

  Immunoturbidimetric

  Reference notes

  Apolipoprotein A1 Male | ≥115 mg/dL Female | ≥125 mg/dL Risk Category | Male | Female Optimal | ≥115 mg/dL | ≥125 mg/dL High | <115 mg/dL | <125 mg/dL Cardiovascular event risk category cut points (optimal, high) are based on the AMORIS study, Walldius G et al. J Intern Med. 2004;255:188-205. Apolipoprotein B | <90 mg/dL Risk Category Optimal | <90 mg/dL Moderate | 90-129 mg/dL High | ≥130 mg/dL A desirable treatment target may be <80 mg/dL or lower depending on the risk category of the patient including patients on lipid lowering therapies, patients with ASCVD, diabetes with >1 risk factors, Stage 3 or greater CKD with albuminuria, or heterozygous familial hypercholesterolemia. ApoB relative risk category cut points are based on AACE/ACE and ACC/AHA recommendations (Grundy SM, et al. 2019. doi:10.1016/j.jacc.2018.11.002; Handelsman Y, et al. 2020. doi:10.4158/CS-2020-0490). Apolipoprotein B/A1 Ratio Male | <0.77 Female | <0.63 Risk Category | Male | Female Optimal | <0.77 | <0.63 Moderate | 0.77-0.95 | 0.63-0.78 High | >0.95 | >0.78 Cardiovascular event risk category cut points (optimal, moderate, high) are based on the AMORIS study, Walldius G et al. J Intern Med. 2004;255:188-205.

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• Cardio IQ® Apolipoprotein Evaluation 91727

  3 analytes · Serum · Fasting not stated

  Method and collection

  Method

  Immunoturbidimetric

  Reference notes

  Apolipoprotein A1 Male | ≥115 mg/dL Female | ≥125 mg/dL Risk Category | Male | Female Optimal | ≥115 mg/dL | ≥125 mg/dL High | <115 mg/dL | <125 mg/dL Cardiovascular event risk category cut points (optimal, high) are based on the AMORIS study, Walldius G et al. J Intern Med. 2004;255:188-205. Apolipoprotein B | <90 mg/dL Risk Category Optimal | <90 mg/dL Moderate | 90-129 mg/dL High | ≥130 mg/dL ⁠⁠⁠⁠⁠⁠⁠A desirable treatment target may be <80 mg/dL or lower depending on the risk category of the patient including patients on lipid lowering therapies, patients with ASCVD, diabetes with >1 risk factors, Stage 3 or greater CKD with albuminuria, or heterozygous familial hypercholesterolemia. ApoB relative risk category cut points are based on AACE/ACE and ACC/AHA recommendations (Grundy SM, et al. 2019. doi:10.1016/j.jacc.2018.11.002; Handelsman Y, et al. 2020. doi:10.4158/CS-2020-0490). Apolipoprotein B/A1 Ratio Male | <0.77 Female | <0.63 Risk Category | Male | Female Optimal | <0.77 | <0.63 Moderate | 0.77-0.95 | 0.63-0.78 High | >0.95 | >0.78 Cardiovascular event risk category cut points (optimal, moderate, high) are based on the AMORIS study, Walldius G et al. J Intern Med. 2004;255:188-205.

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• Cardiometabolic Disease Assessment (CMDA) Panel 14273

  11 analytes · Serum · Fasting not stated

  Method and collection

  Method

  Spectrophotometry (SP) • Immunoturbidimetric • Enzymatic • Immunocapture Liquid Chromatography/Tandem Mass Spectrometry • Electronic Cell Sizing/Counting/Cytometry/Microscopy • Immunoassay (IA)

  Preparation

  Patient should be fasting 9-12 hours Additional Considerations for Patient Preparation: Albumin, Random Urine with Creatinine: Exercise within 24 hours, infection, fever, congestive heart failure, marked hyperglycemia, and marked hypertension may elevate urinary albumin excretion over baseline values. Cholesterol and Triglyceride testing: The assay manufacturer Beckman Coulter advises "N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been determined to interfere with assays for cholesterol, uric acid" where "NAC interference may lead to falsely low results." According to Beckman Coulter, the NAC interference should be insignificant by 12 hours after completion of the initial loading dose of an IV infusion treatment regime consisting of an initial loading dose of 150 mg/kg administered over 1 hour, a second dose of 50 mg/kg administered over 4 hours and a third dose of 100 mg/kg administered over 16 hours. Comprehensive Metabolic Panel: Administration of STRENSIQ may interfere in certain assays and may falsely elevate values. For patients receiving STRENSIQ, consideration should be given to using alternate methods. ⁠⁠⁠⁠⁠⁠⁠TSH: Specimen collection after fluorescein dye angiography should be delayed for at least 3 days. For patients on hemodialysis, specimen collection should be delayed for 2 weeks after angiography. According to the assay manufacturer Siemens: samples containing fluorescein can produce falsely depressed values.

  Collection

  Serum: Allow serum samples to clot completely before centrifugation. Random urine: Mix-well if aliquoting. Whole blood: Maintain specimen at room temperature. Do not refrigerate. If multiple draw, collect lavender-top tube last. Traumatic venipuncture tap can introduce thromboplastin and trap white blood cells and platelets. Refrigeration can precipitate fibrin and trap white blood cells and platelets.

  Reference notes

  See Laboratory Report

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