Test Definition: FNMR2 NMR LipoProfile w/ir Markers

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1 Reporting Title: Performing Location: Labcorp Burlington Specimen Requirements: Submit only one of the following specimens: Serum Draw blood in a plain red-top tube(s). (Serum gel tube is not acceptable.) Spin down and send 2 ml serum refrigerate in a plastic vial. Note: 1. Patient should be fasting (12-14 hours) 2. Specimen must be received at LabCorp within 6 days of collection. 3. Label specimen appropriately (serum). Plasma Draw blood in a (lavender-top) EDTA tube(s). (Plasma gel tube is not acceptable.) Spin down and send 2 ml plasma refrigerate in a plastic vial. Note: 1. Patient should be fasting (12-14 hours) 2. Specimen must be received by LabCorp within 6 days of collection. 3. Label specimen appropriately (plasma). Specimen Type Temperature Time Varies Refrigerated 6 days Result Codes: Result ID Reporting Name Type Unit LOINC Z4440 LDL-P Numeric nmol/l Z4441 LDL-C Numeric mg/dl Z4442 HDL-C Numeric mg/dl Z4443 Triglycerides Numeric mg/dl Z4444 Cholesterol, Total Numeric mg/dl Z4445 HDL-P (Total) Numeric umol/l Z4446 Small LDL-P Numeric nmol/l Z4447 LDL Size Numeric nm Z4448 Large VLDL-P Numeric nmol/l Z4449 Small LDL-P Numeric nmol/l Z4450 Large HDL-P Numeric umol/l Document generated July 31, 2015 at 1:45pm CDT Page 1 of 5

2 Result ID Reporting Name Type Unit LOINC Z4451 VLDL Size Numeric nm Z4452 LDL Size Numeric nm Z4453 HDL Size Numeric nm Z4454 LP-IR Score Numeric nm LOINC and CPT codes are provided by the performing laboratory. Supplemental Report: NO Components: Test ID Reporting Name CPT Units CPT Code Always Performed Orderable Separately FLPDN LDL Particle Number Yes No FLIPS Lipids Yes No FLHP LDL and HDL Particles Yes No FIRD Insulin Resistance/Diab. Risk Yes No FIRSC Insulin Resistance Score Yes No CPT Code Information: Reference Values: LDL Particle Number LDL-P <1000 nmol/l Low: <1000 nmol/l Moderate: Borderline-High: High: Very High: >2000 Lipids LDL-C Document generated July 31, 2015 at 1:45pm CDT Page 2 of 5

3 0-9 yrs: mg/dl yrs: mg/dl >24 yrs: 0-99 mg/dl Optimal: <100 Above Optimal: Borderline: High: Very High: >189 Comment: LDL-C is inaccurate if patient is non-fasting. HDL-C >36 mg/dl Triglycerides 0-9 yrs: 0-74 mg/dl yrs: 0-89 mg/dl yrs: mg/dl >24 yrs: mg/dl Total Cholesterol 0-19 yrs: mg/dl yrs: mg/dl >24 yrs: mg/dl LDL and HDL Particles HDL-P (Total) Small LDL-P LDL Size >or= 30.5 umol/l <or= 527 nmol/l >20.5 nm PARTICLE CONCENTRATION AND SIZE <-- Lower CVD Risk Higher CVD Risk--> LDL AND HDL PARTICLES Percentile in Reference Population HDL-P (total) High 75th 50th 25th Low > <26.7 Small LDL-P Low 25th 50th 75th High < >839 LDL Size <-- Large (Pattern A) --> <-- Small (Pattern B) --> Document generated July 31, 2015 at 1:45pm CDT Page 3 of 5

4 Comment: Small LDL-P and LDL Size are associated with CVD risk, but not after LDL-P is taken into account. These assays were developed and their performance characteristics determined by LipoScience. These assays not been cleared by the US Food and Drug Administration. The clinical utility of these laboratory values have not been fully established. Insulin Resistance and Diabetes Risk Large VLDL-P Small LDL-P Large HDL-P VLDL Size LDL Size HDL Size <or= 2.7 nmol/l <or= 527 nmol/l >or = 4.8 umol/l <or= 46.6 nm >20.58 nm >or= 9.2 nm Insulin Resistance Score LP-IR Score < or = 45 Comment: LP-IR Score is inaccurate if patient is non-fasting. INSULIN RESISTANCE/DIABETES RISK MARKERS <--Insulin Sensitive Insulin Resistant --> Percentile in Reference Population Large VLDL-P Low 25th 50th 75th High < >6.9 Small LDL-P Low 25th 50th 75th High < >839 Large HDL-P High 75th 50th 25th Low > <3.1 VLDL Size Small 25th 50th 75th Large < >52.5 LDL Size Large 75th 50th 25th Small > <20.4 HDL Size Large 75th 50th 25th Small Insulin Resistance Score > <8.9 LP-IR SCORE Low 25th 50th 75th High < >63 The LP-IR score is a laboratory developed index that has been associated with insulin resistance and diabetes risk and should be used as one component of a physician's clinical assessment. Neither the LP-IR score nor the subclasses listed above have been Document generated July 31, 2015 at 1:45pm CDT Page 4 of 5

5 cleared by the US Food and Drug Administration. Test Performed by: Lab-Corp Burlington 1447 York Court Burlington, NC Document generated July 31, 2015 at 1:45pm CDT Page 5 of 5

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