Cardio IQ® Diabetes and ASCVD Risk Panel with Scores

Test Code
92063


CPT Codes
80061, 82947, 83036

Includes

Cardio IQ® Glucose
Cardio IQ® Hemoglobin A1c
Cardio IQ® Cholesterol, Total
Cardio IQ® HDL Cholesterol
Cardio IQ® Triglycerides
Cardio IQ® Non-HDL and Calculated Components
Cardio IQ® Risks and Personal Factors

Reflex criteria: If Triglyceride is >400 mg/dL, then Cardio IQ® Direct LDL will be performed at an additional charge (CPT code: 83721).

If Triglyceride is extremely elevated, >1293 mg/dL, this causes interference in the Cardio IQ® Direct LDL assay, therefore this test cannot be added.



Preferred Specimen
4 mL serum collected in a Serum Separator Tube (SST®) spun, and 1 mL whole blood collected in an EDTA (lavender-top) tube


Patient Preparation
If a cholesterol measurement is to be performed along with Triglycerides, but not part of a lipid panel, then the patient should be fasting 9-12 hours prior to collection. If the cholesterol is ordered as part of a lipid panel, then a fasting sample is not required.
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 regimen consisting of an initial loading dose of 150 mg/kg administered over 1 hour, a second dose of 50 mg/kg administered over 4 hrs and a third dose of 100 mg/kg administered over 16 hrs.

Minimum Volume
2 mL serum • 0.5 mL whole blood


Instructions
For risk calculations to be performed, the following patient-specific information must be provided at the time of order:
Age: Years
Gender: M (for male) or F (for female)
Race - African American: Y (for yes) or N (for no)
Systolic Blood Pressure: mmHg
Treatment for High B.P.: Y (for yes) or N (for no)
Diabetes Status: Y (for yes) or N (for no)
Smoking Status: Y (for yes) or N (for no)


Transport Temperature
Refrigerated (cold packs)


Specimen Stability
Serum
Room temperature: 48 hours
Refrigerated: 7 days
Frozen: 28 days

Whole blood
Room temperature: 7 days
Refrigerated: 7 days
Frozen: 6 months


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Unspun serum or plasma separator tube (SST® or PST) • Red-top or green-top tube (serum or heparanized plasma not separated from cells) • Red-top tube (no gel) • Moderate to grossly icteric • Sodium fluoride/oxalate (grey-top) tube • Heparinized plasma


Methodology
Enzymatic • Spectrophotometry (SP)

Setup Schedule
Set up: Tues-Sat; Report available: 4-7 days


Reference Range
See Laboratory Report


Clinical Significance
The increasing prevalence of obesity has led to an epidemic of diabetes mellitus and related complications, including ASCVD. Prediction of the risk of ASCVD and of developing diabetes in the Cardio IQ® lab report will simplify and improve the communication of those risks to patients.
This panel provides the 10-year and lifetime risk of ASCVD events and the 8-year risk of developing diabetes. The lipid panel results will aid in the assessment of ASCVD. Assessment of 10-year risk of a first atherosclerotic cardiovascular (ASCVD) event is recommended by the 2013 ACC/AHA Guidelines on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults. These guidelines recommend initiating statin therapy based on 10-year ASCVD risk score. Assessment of 8-year risk of developing diabetes mellitus is based on laboratory test results with anthropomorphic data and family history. This algorithm was developed in the Framingham cohort, and is intended to aid in the identification of patients at risk for developing diabetes, permitting pharmacological or lifestyle interventions.




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.