GlycA

CPT: 82985
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Test Details

Use

As an (1) aid in the identification and stratification of individuals at risk for future cardiovascular (CV) disease, (2) independent marker of prognosis for recurrent cardiovascular events in patients with stable coronary disease or acute coronary syndrome, (3) aid in the assessment of disease activity and risk of CV disease in adult Rheumatoid Arthritis (RA) and psoriasis patients, when used in conjunction with standard clinical assessment and for monitoring of anti-inflammatory treatment.

Limitations

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

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%.

This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA).

Methodology

Nuclear magnetic resonance (NMR)

Reference Interval

GlycA Medical decision limit:

• Low <400 μmol/L

• High ≥400 μmol/L

Additional Information

The GlycA test quantifies an NMR signal that appears in a region of the NMR LipoProfile® test spectrum separate from that used for lipoprotein particle analysis. Data indicate that this signal is a marker of systemic inflammation, suggesting it may have clinical utility similar or complementary to high sensitivity C-reactive protein (hsCRP), fibrinogen, and other biomarkers of inflammation.1,2

The NMR signal, named "GlycA," originates from the N-acetyl methyl groups of the N-acetylglucosamine moieties on the carbohydrate portions of circulating glycoproteins.1,3 The measured amplitude of this signal reflects the extent of plasma protein glycosylation (not to be confused with nonenzymatic glycation reflecting glucose levels). Most acute phase proteins, released from the liver during an inflammatory response, are glycosylated, and some are glycosylated differentially as a function of inflammation. Acute-phase proteins, such as α1-acid glycoprotein (also known as orosomucoid), haptoglobin, α1-antitrypsin, α1-antichymotrypsin, and transferrin circulate at high enough concentrations to make major contributions to the GlycA signal.1 Therefore, 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 for GlycA than hsCRP.1 While guidelines recommend two serial measurements be taken at lease 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.

Specimen Requirements

Specimen

Serum, shipped refrigerated or plasma

Volume

1 mL

Minimum Volume

0.5 mL

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.

Patient Preparation

Patient fasting is not necessary prior to draw.

Collection

Collect specimen in plain red-top tube, 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 2200g 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.

Do not open NMR LipoTube. Serum or plasma drawn in gel-barrier collection tubes other than the NMR LipoTube should not be used.

Storage Instructions

Refrigerate; stable for 14 days. Stable at room temperature for 60 hours or frozen for 24 months. Freeze/thaw cycles: x3

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%)

Clinical Information

Footnotes

1. Otvos JD, Shalaurova I, Wolak-Dinsmore J, et al. GlycA: A novel nuclear magnetic resonance biomarker of systemic inflammation. Clin Chem. 2015 May; 61(5):714-723. 25779987
2. Akinkuolie AO, Buring JE, Ridker PM, Mora S. A novel protein glycan biomarker and future cardiovascular disease events. J Am Heart Assoc 2014; 3:e001221.
3. Bell JD, Sadler PJ, Macleod AF, Turner PR, La Ville A. 1H NMR studies of human blood plasma. Assignment of resonances for lipoproteins. FEBS Lett. 1987; 219(1):239-243.

References

Akinkuolie AO, Glynn RJ, Ridker PM, Mora S. Protein glycan side-chains, rosuvastatin therapy, and incident vascular events; An analysis from the JUPITER trial. Circulation. 2014; 130:A17731.
Bell JD, Brown JC, Nicholson JK, Sadler PJ. Assignment of resonances for 'acute phase' glycoproteins in high resolution proton NMR spectra of human blood plasma. FEBS Lett. 1987 May 11;215(2):311-315.2438159
Chung CP, Ormseth MJ, Connelly MA, et al. GlycA, a novel marker of inflammation, is elevated in systemic lupus erythematosus. Lupus. 2016 Mar; 25(3):296-300.26637290
Dungan K, Binkley P, Osei K. GlycA is a novel marker of inflammation among non-critically ill hospitalized patients with type 2 diabetes. Inflammation. 2015; 38(3):1357-1363.25586483
Lauridsen MB, Bliddal H, Christensen R, et al. 1H NMR spectroscopy-based interventional metabolic phenotyping: a cohort study of rheumatoid arthritis patients. J Proteome Res. 2010 Sep 3;9(9):4545-4553.20701312
Lawler P, Akinkuolie AO, Buring JE, Ridker P, Glynn R, Mora S. A novel biomarker of circulating glycoproteins and cardiovascular and all-cause mortality among 39,521 initially healthy adults. J Am Coll Cardiol. 2015;65(10):A1358.
McGarrah R, Craig D, Haynes C, Dowdy ZE, Shah S, Kraus W. High-density lipoprotein subclass measurements improve mortality risk prediction, discrimination and reclassification in a cardiac catheterization cohort. Artherosclerosis. 2016 Mar;246:229-23526803432
Ormseth MJ, Chung CP, Oeser AM, et al. Utility of a novel inflammatory marker, GlycA, for assessment of rheumatoid arthritis disease activity and coronary atherosclerosis. Arthritis Res Ther. 2015 May 9;17:117. 25956924

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
123850 GlycA 82730-3 123851 GlycA umol/L 82730-3
Reflex Table for GlycA
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 123852 Disclaimer: 123852 Disclaimer: N/A

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