Lipid Panel With GlycA (Inflammation) and Diabetes Risk Index (DRI)

CPT: 80061; 81599; 0024U
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Test Includes

Cholesterol, total; DRI; GlycA; high-density lipoprotein (HDL) cholesterol; low-density lipoprotein (LDL) cholesterol (calculation); non-high-density lipoprotein (non-HDL) cholesterol (calculation = total cholesterol minus HDLC); triglycerides


Expected Turnaround Time

1 - 3 days


Related Documents


Specimen Requirements


Specimen

Serum or plasma, shipped refrigerated


Volume

1 mL


Minimum Volume

0.5 mL (Note: This volume does not allow for repeat testing.)


Container

Plain red-top tube (preferred); NMR LipoTube (black-and- yellow-top tube), lavender-top (EDTA-no gel) tube, or green-top (heparin-no gel) tube is acceptable.


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 1800 to 2200xg 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.


Storage Instructions

Refrigerate.


Stability Requirements

Temperature

Period

Room temperature

LipoTube Serum: 1 day; Plain Serum: 1 day; EDTA Plasma: 8 hours; Sodium Heparin Plasma: 8 hours

Refrigerated

LipoTube Serum: 8 days; Plain Serum: 8 days; EDTA Plasma: 8 days; Sodium Heparin Plasma: 7 days

Frozen

All tubes: 14days (Note: Triglyceride values in frozen samples with high values >400 mg/dL may be decreased more than 10% when frozen.)


Patient Preparation

Patient fasting is not required; however, in conditions where triglyceride values provide a priori diagnostic information, such as screening for familial hypercholesterolemia or early onset heart disease, pancreatitis, or confirming hypertriglyceridemia, the patient should be counseled to fast 12 to 14 hours prior to blood draw.


Causes for Rejection

Unspun LipoTube or unseparated plain red-top or EDTA tube; serum or plasma specimen drawn in gel-barrier collection tube other than the NMR LipoTube; hemolysis (may reduce GlycA concentrations more than 10%)


Test Details


Use

GlycA is hypothesized to be a nonspecific measure of global inflammation status. Unlike existing biomarkers of inflammation that are discrete molecular species, such as CRP or inflammatory cytokines, GlycA is a composite biomarker that integrates the protein levels and glycosylation states of several of the most abundant acute- phase proteins in serum. This allows for a more stable measure of systemic inflammation with lower intra-individual variability of GlycA than hsCRP. While guidelines recommend two serial measurements be taken at least two weeks apart when using hsCRP for CV disease risk assessment, only one measurement is necessary for evaluation of a patient's CV risk using the GlycA test.

The Diabetes Risk Index (DRI) is intended for use in adult subjects for the quantitative determination of a risk score in serum or plasma. The DRI score (1-100) may be used as an aid in stratifying the risk of developing type 2 diabetes in individuals with normo-glycemia or prediabetes. The Diabetes Risk Index (DRI) is a nuclear magnetic resonance spectroscopy (NMR)-derived multimarker score (values 1-100) that predicts a patient's risk of developing type 2 diabetes mellitus (T2D) independent of glycemic status. DRI derives its performance from the weighted addition of the Lipoprotein Insulin Resistance Index (LP-IR) scores with simultaneously-measured levels of branched-chain amino acids (BCAA).1-6


Limitations

If triglyceride level is >800 mg/dL, LDL cholesterol will not be calculated.

GlycA measurements from EDTA plasma specimens are, on average, 3% to 5% lower than from serum samples. GlycA measurements from NMR LipoTube specimens are, on average, 5% to 6% higher than from serum samples collected in red-top tubes. DRI measurements from plasma specimens are on average 8 points lower than from serum specimens.

GlycA is an indicator for a wide range of disease processes and should not be interpreted without a complete clinical history. Recent medical events resulting in tissue injury, infections, or inflammation, which may cause elevated GlycA levels, should also be considered when interpreting results. Hemolysis may reduce GlycA concentrations more than 10%. DRI measurements from plasma specimens are on average 8 points lower than from serum specimens.

DRI measurements from plasma specimens are on average 8 points lower than from serum specimens.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.


Methodology

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.


Footnotes

1. Shalaurova I, Connelly MA, Garvey WT, Otvos JD. Lipoprotein insulin resistance index: a lipoprotein particle-derived measure of insulin resistance. Metab Syndr Relat Disord. 2014 Oct; 12(8):422-429.24959989
2. Mackey RH, Mora S, Bertoni AG, et al. Lipoprotein particles and incident type 2 diabetes in the multi-ethnic study of atherosclerosis. Diabetes Care. 2015 Apr; 38(4):628-636.25592196
3. Harada PHN, Demler OV, Dugani SB, et al. Lipoprotein insulin resistance score and risk of incident diabetes during extended follow-up of 20 years: The Women's Health Study. J Clin Lipidol. 2017 Sep-Oct;11(5):1257-1267.e2.28733174
4. Flores-Guerrero JL, Connelly MA, Shalaurova I, et al. Lipoprotein insulin resistance index, a high-throughput measure of insulin resistance, is associated with incident type II diabetes mellitus in the Prevention of Renal and Vascular End-Stage Disease study. J Clin Lipidol. 2019 Jan-Feb;13(1):129-137.e1.30591414
5. Wolak-Dinsmore J, Gruppen EG, Shalaurova I, et al. A novel NMR-based assay to measure circulating concentrations of branched-chain amino acids: Elevation in subjects with type 2 diabetes mellitus and association with carotid intima media thickness. Clin Biochem. 2018 Apr;54:92-99.29432757
6. Flores-Guerrero JL, Oste MCJ, Kieneker LM, et al. Plasma Branched-Chain Amino Acids and Risk of Incident Type 2 Diabetes: Results from the PREVEND Prospective Cohort Study. J Clin Med. 2018 Dec 4;7(12):513.30518023

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
123559 Lipid Panel+GlycA+DRI 123477 Cholesterol, Total mg/dL 2093-3
123559 Lipid Panel+GlycA+DRI 123476 Triglycerides mg/dL 2571-8
123559 Lipid Panel+GlycA+DRI 123475 HDL-C mg/dL 2085-9
123559 Lipid Panel+GlycA+DRI 123478 Non-HDL Cholesterol mg/dL 43396-1
123559 Lipid Panel+GlycA+DRI 123479 LDL-C (NIH Calc) mg/dL 13457-7
123559 Lipid Panel+GlycA+DRI 123851 GlycA umol/L 82730-3
123559 Lipid Panel+GlycA+DRI 123856 Diabetes Risk Index (DRI) 94560-0
123559 Lipid Panel+GlycA+DRI 123857 References: N/A

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