Cleveland Clinic Laboratories
Technical Update • September 2016
Cleveland Clinic Laboratories is dedicated to keeping you updated and informed about recent testing changes. That’s why we are happy to provide this technical update on a monthly basis. Recently changed tests are bolded, and could include revisions to methodology, reference range, days performed or CPT code. For your convenience, tests are listed alphabetically and the order and billing codes are provided. If you wish to compare the new information with previous test information, refer to the Test Directory, which can be accessed at clevelandcliniclabs.com. Deleted tests and new tests are listed separately. Please update your database as necessary. For additional detail, contact Client Services at 216.444.5755 or 800.628.6816 or via email at [email protected].
Days Performed/Reported Specimen Requirement Component Change(s) Special Information Test Discontinued Reference Range
Name Change Methodology Test Update Billing Code Order Code New Test Stability Page # CPT Summary of Changes Fee by Test Name
3 Albumin 3, 28 Albumin, Fluid 4 Alkaline Phosphatase 4 Alpha Galactosidase, Serum 4 ALT 4 Amylase 5 Amylase, Body Fluid 5 AST 6 Bilirubin, Fluid 6 Bilirubin, Total 25 Bird Fanciers Precipitin Panel I 6 BUN 7 BUN, Pre Dialysis 7 BUN, Post Dialysis 25- Catecholamines Fractionated by 27 LC-MS/MS, Urine Free 7, 8 Catecholamines, Fractionated, Plasma 28 Catecholamines, Urine 24 Hour 28 Catecholamines, Urine Random 8 Chloride 9 Cholesterol, Body Fluid 9 Cholesterol, Total
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 1 Days Performed/Reported Specimen Requirement Component Change(s) Special Information Test Discontinued Reference Range
Name Change Methodology Test Update Billing Code Order Code New Test Stability Page # CPT Summary of Changes Fee by Test Name
9 CK Isoenzymes 9 CO2 10 Comprehensive Metabolic Panel 10 Creatinine, Fluid 10 Creatinine, Serum 11 EBV by PCR Qualitative 11 FISH for FGFR1 28 Folate, RBC 11, Galactokinase Activity 12 12 Glucose 12 Glucose, Body Fluid 13 Helicobacter pylori Breath Test, Adult 13, Helicobacter pylori Breath Test, Pediatric 14 14 Her-2-Neu Serum 28 High Resolution Respirometry, Fibroblasts 27 Human Papillomavirus (HPV) DNA Detection with Genotyping 16,18, High-Risk Types by PCR, Sure Path 14 IDH1/IDH2 Mutation, Blood/Bone marrow 14 Ketorolac 14 Lactate Dehydrogenase 15 Lactate Dehydrogenase, Body Fluid 15 Lindane 15 Lipase 16 Lipase, Fluid 16, Lyme Antibodies, IgG, IgM 28 16 Megaloblastic Anemia Panel 17 Mephenytoin & Normephenytoin 17 Myasthenia Gravis Evaluation, Adult 18 Myasthenia Gravis/Lambert-Eaton Syndrome 18 Mycoplasma pneumoniae IgA 18 Neoencephalitis Paraneoplastic Profile with Recombx 19 Neuromyelitis Optica (NMO)/ Aquaporin-4-IgG FACS Assay, CSF 19 Neuromyelitis Optica (NMO)/ Aquaporin-4-IgG FACS Assay, Serum 20 Paraneoplastic Autoantibody Evaluation, CSF 21 Paraneoplastic Autoantibody Evaluation, Serum 21 PDGFRB Rearrangement by FISH 21 Potassium 22 Prealbumin
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 2 Days Performed/Reported Specimen Requirement Component Change(s) Special Information Test Discontinued Reference Range
Name Change Methodology Test Update Billing Code Order Code New Test Stability Page # CPT Summary of Changes Fee by Test Name
22 Protein, Body Fluid 22 Protein, Total 28 RBC Folate 22 Sodium 23 Supersaturation Profile, 24 Hour Urine 24 Urea Nitrogen, Fluid 24 Vitamin A 24 Vitamin B2 24 Vitamin E
Test Changes
Test Name Order Code Billing Code Change Effective Date
Albumin ALB 82040 Specimen Requirement: 1 mL plasma from a lithium heparin (light 9/8/16 green) plasma separator tube (PST); Minimum: 0.4 mL; Submit in original tube or aliquot specimen into CCL aliquot tube; Centrifuge and refrigerate *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Centrifuge and refrigerate Stability: Ambient: 2.5 months Refrigerated: 5 months Frozen: 4 months Reference Range: 0–4 Days: 2.8–4.4 g/dL 4–364 Days: 3.8–5.4 g/dL 1–14 Years: 3.8–5.4 g/dL 14–17 Years: 3.2–4.5 g/dL 18–99 Years: 3.9–4.9 g/dL
Albumin, Fluid FLALB 77789 Clinical Information: Body Fluid Albumin may be used in 9/8/16 classifying ascitic fluid into high-gradient or low-gradient fluids as determined by the serum-ascites albumin gradient, which is calculated as (serum albumin) – (ascites albumin). The serum and fluid specimens should be drawn with a minimal intervening time interval to appropriately analyze the gradient. Gradients = 1.1 g/dL are considered high, which reflects a high hydrostatic pressure, commonly caused by cirrhosis or other processes generating portal hypertension. In samples where gradients are < 1.1 g/dL, ascites generated from conditions without portal hypertension should be considered. References: 1. CLSI. Analysis of Body Fluids in Clinical Chemistry; Approved Guideline. CLSI document C49-A. Wayne, PA: Clinical Laboratory Standards Institute; 2007. 2. Runyon BA. Serum-to-ascites albumin gradient. UpToDate. 2015. Accessed on April 13, 2016. Specimen Requirement: 1 mL body fluid in a sterile container; Viscous specimens will be rejected; Indicate source of fluid; Minimum: 0.5 mL; Refrigerated Stability: Ambient: 2.5 months Refrigerated: 5 months Frozen: 4 months Reference Range: Refer to Clinical Information
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 3 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Alkaline ALKP 30005 Clinical Information: A pediatric reference range table will be 9/8/16 Phosphatase appended to all pediatric results. Specimen Requirement: 1 mL plasma from a lithium heparin (light green) plasma separator tube (PST); Minimum: 0.4 mL; Submit in original tube or aliquot specimen into CCL aliquot tube; Centrifuge and refrigerate *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Centrifuge and refrigerate Stability: Ambient: 7 days Refrigerated: 7 days Frozen: 2 months Reference Range: Male 18–99 Years: 36–108 U/L Female 18–99 Years: 32–117 U/L
Alpha Galactosidase, ALPGAL 89506 Special Information: Thawed specimens are unacceptable. Effective Serum immediately
ALT ALT 84460 Clinical Information: For patient population 0-17 years of age: 9/8/16 Reference ranges for this patient’s age group have not been established. These reference ranges reflect verified or established ranges for the adult population. Interpret these ranges with caution using the clinical context and additional reference resources. Specimen Requirement: 1 mL plasma from a lithium heparin (light green) plasma separator tube (PST); Minimum: 0.4 mL; Submit in original tube or aliquot specimen into CCL aliquot tube; Centrifuge and refrigerate *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Centrifuge and refrigerate Stability: Ambient: 3 days Refrigerated: 7 days Frozen: > 7 days Reference Range: Male 0–99 Years: 10–54 U/L Female 0–99 Years: 7–38 U/L
Amylase AMYL 82150 Clinical Information: For patient population 0–17 years of age: 9/8/16 Reference ranges for this patient’s age group have not been established. These reference ranges reflect verified or established ranges for the adult population. Interpret these ranges with caution using the clinical context and additional reference resources. Specimen Requirement: 1 mL plasma from a lithium heparin (light green) plasma separator tube (PST); Minimum: 0.4 mL; Submit in original tube or aliquot specimen into CCL aliquot tube; Centrifuge and refrigerate *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Centrifuge and refrigerate Stability: Ambient: 7 days Refrigerated: 1 month Frozen: Unacceptable Reference Range: 0–99 Years: 30–104 U/L
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 4 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Amylase, Body Fluid FAMYL 78735 Clinical Information: Pleural fluids: Amylase measurement in 9/8/16 pleural fluid is considered a useful test for detecting amylase-rich pleural effusions, which may be caused by exudative conditions associated with pancreatitis, esophageal rupture, malignancy, pneumonia, and liver cirrhosis. A ratio of pleural fluid amylase to a concurrent serum amylase >1 is defined as an amylase-rich pleural effusion. Peritoneal fluids and drainage fluids: Pancreatic damage causes extravasation of amylase from the exocrine cells into the peritoneal space. In cases of pancreatitis, fluid amylase should be at least several-fold times higher in fluid of pancreatic origin compared to concurrent serum amylase values. Pancreatic cyst fluid: Pancreatic cyst fluid amylase may aid in characterizing tumors and should be interpreted along with other clinical and laboratory information. References: 1. Block DR, Algeciras-Schimnich A. Body fluid analysis: clinical utility and applicability of published studies to guide interpretation of today’s laboratory testing in serous fluids. Crit Rev Clin Lab Sci, 2013;50(4-5):107-124. 2. CLSI. Analysis of Body Fluids in Clinical Chemistry; Approved Guideline. CLSI document C49-A. Wayne, PA: Clinical Laboratory Standards Institute; 2007. 3. Snozek CLH, Mascarenhas RC, O’Kane DJ. Use of cyst fluid CEA, CA19-9, and amylase for evaluation of pancreatic lesions. Clinical Biochemistry. 2009;42:1585-1588. Specimen Requirement: 1 mL body fluid in a sterile container; Minimum: 0.5 mL; Viscous specimens will be rejected; Indicate source of fluid; Refrigerated Stability: Ambient: 7 days Refrigerated: 1 month Frozen: Unacceptable Reference Range: Refer to Clinical Information
AST AST 84450 Clinical Information: For patient population 0-17 years of age: 9/8/16 Reference ranges for this patient’s age group have not been established. These reference ranges reflect verified or established ranges for the adult population. Interpret these ranges with caution using the clinical context and additional reference resources. Specimen Requirement: 1 mL plasma from a lithium heparin (light green) plasma separator tube (PST); Minimum: 0.4 mL; Submit in original tube or aliquot specimen into CCL aliquot tube; Centrifuge and refrigerate *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Centrifuge and refrigerate Stability: Ambient: 24 hours Refrigerated: 7 days Frozen: Unacceptable Reference Range: Male 0–99 Years: 14–40 U/L Female 0–99 Years: 13–35 U/L
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 5 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Bilirubin, Fluid FLBIL 76060 Clinical Information: Serous fluids: Bilirubin measurement 9/8/16 in peritoneal or drainage fluids is considered a useful test for detecting the presence of bile leaking through a defect in the biliary ducts. For postoperative hepatectomy patients, a ratio of drain fluid total bilirubin to a concurrent serum total bilirubin = 3.0 indicates bile leakage according to the International Study Group of Liver Surgery (ISGLS). References: 1. CLSI. Analysis of Body Fluids in Clinical Chemistry; Approved Guideline. CLSI document C49-A. Wayne, PA: Clinical Laboratory Standards Institute; 2007. 2. Taguchi Y, Ebata T, Yokoyama Y et al. The Determination of Bile Leakage in Complex Hepatectomy Based on the Guidelines of the International Study Group of Liver Surgery. World J Surg. 2014;38:168-176. Specimen Requirement: 1 mL body fluid in a sterile container; Minimum: 0.5 mL; Viscous specimens will be rejected; Indicate source of fluid; Refrigerated Stability: Ambient: 1 day if care is taken to prevent exposure to light Refrigerated: 7 days if care is taken to prevent exposure to light Frozen: 6 months if care is taken to prevent exposure to light Reference Range: Refer to Clinical Information
Bilirubin, Total TBIL 35008 Clinical Information: For patient population 0-17 years of age: 9/8/16 Reference ranges for this patient’s age group have not been established. These reference ranges reflect verified or established ranges for the adult population. Interpret these ranges with caution using the clinical context and additional reference resources. Specimen Requirement: 1 mL plasma from a lithium heparin (light green) plasma separator tube (PST); Minimum: 0.4 mL; Submit in original tube or aliquot specimen into CCL aliquot tube; Centrifuge and refrigerate *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Centrifuge and refrigerate Stability: Ambient: 1 day if care is taken to prevent exposure to light Refrigerated: 7 days if care is taken to prevent exposure to light Frozen: 6 months if care is taken to prevent exposure to light Reference Range: 0–30 Days: Results are flagged as abnormal due to the age- related nature of reference intervals in this patient population. Clinician review of acceptable bilirubin levels and risk categories is recommended using age-related or other pertinent reference information (e.g. Bhutani nomograms). 31 Days–365 Days: 0.2–1.3 mg/dL 1–99 Years: 0.2–1.3 mg/dL
BUN BUN 84520 Specimen Requirement: 1 mL plasma from a lithium heparin (light 9/8/16 green) plasma separator tube (PST); Minimum: 0.4 mL; Submit in original tube or aliquot specimen into CCL aliquot tube; Centrifuge and refrigerate *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Centrifuge and refrigerate Stability: Ambient: 7 days Refrigerated: 7 days Frozen: 1 year Reference Range: 0–364 Days: 4–19 mg/dL 1–17 Years: 5–18 mg/dL Male 18–99 Years: 9–24 mg/dL Female 18–99 Years: 7–21 mg/dL
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 6 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
BUN, Pre Dialysis BUNPR 78738 Specimen Requirement: 1 mL plasma from a lithium heparin (light 9/8/16 green) plasma separator tube (PST); Minimum: 0.4 mL; Submit in original tube or aliquot specimen into CCL aliquot tube; Centrifuge and refrigerate *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Centrifuge and refrigerate Stability: Ambient: 7 days Refrigerated: 7 days Frozen: 1 year Reference Range: 0–364 Days: 4–19 mg/dL 1–17 Years: 5–18 mg/dL Male 18–99 Years: 9–24 mg/dL Female 18–99 Years: 7–21 mg/dL
BUN, Post Dialysis BUNPO1 78739 Specimen Requirement: 1 mL plasma from a lithium heparin (light 9/8/16 green) plasma separator tube (PST); Minimum: 0.4 mL; Submit in original tube or aliquot specimen into CCL aliquot tube; Centrifuge and refrigerate *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Centrifuge and refrigerate Stability: Ambient: 7 days Refrigerated: 7 days Frozen: 1 year Reference Range: 0–364 Days: 4–19 mg/dL 1–17 Years: 5–18 mg/dL Male 18–99 Years: 9–24 mg/dL Female 18–99 Years: 7–21 mg/dL
Catecholamines, PLCAT 41000 For Interfaced Clients Only: Test build may need to be modified 10/26/16 Fractionated, Plasma Includes: Norepinephrine Epinephrine Dopamine Catecholamine Interpretation Special Information: Patient should be calm and supine for 30 minutes prior to collection. Separate specimens must be submitted when multiple tests are ordered. This test is New York DOH approved. Clinical Information: Not a first-line test for suspected catecholamine-secreting neuroendocrine tumors (pheochromocytoma or neuroblastoma). Small increases in catecholamines (less than 2 times the upper reference limit) usually are the result of physiological stimuli, drugs, or improper specimen collection. Significant elevation of one or more catecholamines (2 or more times the upper reference limit) is associated with an increased probability of a neuroendocrine tumor. Measurement of plasma or urine fractionated metanephrines provides better diagnostic sensitivity than measurement of catecholamines. Higher catecholamine concentrations are observed in specimens collected from upright or standing adults. Epinephrine may be increased by approximately 20%; norepinephrine up to 700 pg/mL; dopamine, unchanged.
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9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 7 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Catecholamines, Medications that may interfere with catecholamines and Fractionated, Plasma metabolites include amphetamines and amphetamine- (continued from like compounds, appetite suppressants, bromocriptine, page 7) buspirone, caffeine, carbidopa-levodopa (Sinemet), clonidine, dexamethasone, diuretics (in doses sufficient to deplete sodium), ethanol, isoproterenol, labetalol, methyldopa (Aldomet), MAO inhibitors, nicotine, nose drops, propafenone (Rythmol), reserpine, theophylline, tricyclic antidepressants, and vasodilators. The effect of drugs on catecholamine results may not be predictable. Children, particularly those under 2 years of age, often show an elevated catecholamine response to stress. Specimen Requirement: 4 mL plasma from a sodium heparin green top tube; Minimum: 2.1 mL; Collect on ice; Centrifuge, aliquot and freeze within one hour of collection; Critical Frozen *OR* 4 mL plasma from a lithium heparin green top tube; Minimum: 2.1 mL; Collect on ice; Centrifuge, aliquot and freeze within one hour of collection; Critical Frozen Stability: Ambient: After separation from cells: Unacceptable Refrigerated: After separation from cells: Unacceptable Frozen: After separation from cells: 1 month at minus 20 °C; 1 year at minus 70 °C Methodology: High Performance Liquid Chromatography (HPLC) Reference Range: Epinephrine 2–10 Days: 36–400 pg/mL 11 Days–3 Months: 55–200 pg/mL 4–11 Months: 55–440 pg/mL 12–23 Months: 36–640 pg/mL 24–35 Months: 18–440 pg/mL 3–17 Years: 18–460 pg/mL 18–99 Years: 10–200 pg/mL Norepinephrine 2–10 Days: 170–1180 pg/mL 11 Days–3 Months: 370–2080 pg/mL 4–11 Months: 270–1120 pg/mL 12–23 Months: 68–1810 pg/mL 24–35 Months: 170–1470 pg/mL 3–17 Years: 85–1250 pg/mL 18–99 Years: 80–520 pg/mL Dopamine 2 Days–99 Years: 0–20 pg/mL Days Performed: Sunday, Tuesday–Saturday Reported: 2–5 days
Chloride CL 82435 Clinical Information: For patient population 0-17 years of age: 9/8/16 Reference ranges for this patient’s age group have not been established. These reference ranges reflect verified or established ranges for the adult population. Interpret these ranges with caution using the clinical context and additional reference resources. Specimen Requirement: 1 mL plasma from a lithium heparin (light green) plasma separator tube (PST); Minimum: 0.4 mL; Submit in original tube or aliquot specimen into CCL aliquot tube; Centrifuge and refrigerate *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Centrifuge and refrigerate Stability: Ambient: 7 days Refrigerated: 7 days Frozen: Stable Reference Range: 0–99 Years: 97–105 mmol/L
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 8 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Cholesterol, Body FCHOL 79977 Clinical Information: Synovial fluids: Synovial fluid cholesterol 9/8/16 Fluid measurement may be useful in classifying various joint disorders. The reference range for adult synovial fluid cholesterol measurement is = 65% of the concurrent plasma cholesterol measurement. Serous fluids: Serous fluid cholesterol measurement may be useful in determining the etiology of the effusion. A serous fluid cholesterol measurement > 200 mg/dL is suggestive of a pseudochylous effusion. A serous fluid cholesterol measurement = 45 mg/dL is suggestive of an exudate. A serous fluid cholesterol measurement < 45 mg/dL is suggestive of a transudate. Reference: 1. CLSI. Analysis of Body Fluids in Clinical Chemistry; Approved Guideline. CLSI document C49-A. Wayne, PA: Clinical Laboratory Standards Institute; 2007. Specimen Requirement: 1 mL body fluid in a sterile container; Minimum: 0.5 mL; Viscous specimens will be rejected; Indicate source of fluid; Refrigerated Stability: Ambient: 7 days Refrigerated: 7 days Frozen: 3 months Reference Range: Refer to Clinical Information
Cholesterol, Total CHOL 82465 Specimen Requirement: 1 mL plasma from a lithium heparin (light 9/8/16 green) plasma separator tube (PST); Minimum: 0.4 mL; Submit in original tube or aliquot specimen into CCL aliquot tube; Centrifuge and refrigerate *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Centrifuge and refrigerate Stability: Ambient: 7 days Refrigerated: 7 days Frozen: 3 months
CK Isoenzymes CKISO 142 Days Performed: Tuesday, Thursday, Saturday Effective Reported: 5–7 days immediately
CO2 CO2 35016 Clinical Information: For patient population 0-17 years of age: 9/8/16 Reference ranges for this patient’s age group have not been established. These reference ranges reflect verified or established ranges for the adult population. Interpret these ranges with caution using the clinical context and additional reference resources. Specimen Requirement: 1 mL plasma from a lithium heparin (light green) plasma separator tube (PST); Minimum: 0.4 mL; Submit in original tube or aliquot specimen into CCL aliquot tube; Centrifuge and refrigerate *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Centrifuge and refrigerate Stability: Ambient: 40 hours Refrigerated: 7 days Frozen: Unacceptable Reference Range: 0–99 Years: 22–30 mmol/L
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 9 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Comprehensive CMP 79629 Clinical Information: For patient population 0-17 years of age: 9/8/2016 Metabolic Panel Reference ranges for this patient’s age group have not been Note: Stability established. These reference ranges reflect verified or established changes are ranges for the adult population. Interpret these ranges with effective caution using the clinical context and additional reference immediately resources. Stability: Ambient: 8 hours Refrigerated: After separation from cells: 72 hours Frozen: After separation from cells: 6 months Reference Range: Refer to individual components Anion Gap: 0–99 Years: 9–18 mmol/L
Creatinine, Fluid FCRE 78950 Clinical Information: Serous fluids: Creatinine measurement 9/8/16 in peritoneal or drainage fluids is considered a useful test for detecting the presence of urine leaking through a defect in the urinary tract. A ratio of serous fluid creatinine to a concurrent serum creatinine > 1.0 indicates possible urine extravasation. Amniotic fluid: Creatinine measurement can be performed on amniotic fluid. The interpretation of the result is dependent on the clinical context, including gestational age. See references below. References: 1. CLSI. Analysis of Body Fluids in Clinical Chemistry; Approved Guideline. CLSI document C49-A. Wayne, PA: Clinical Laboratory Standards Institute; 2007. 2. Benzie RJ, Doran TA, Harkins JL, Owen VM, Porter CJ. Composition of the amniotic fluid and maternal serum in pregnancy. Am J Obstet Gynecol 1974;119:798-810. Specimen Requirement: 1 mL body fluid in asterile container; Minimum: 0.5 mL; Viscous specimens will be rejected; Indicate source of fluid; Refrigerated Stability: Ambient: 7 days Refrigerated: 7 days Frozen: 3 months Reference Range: Refer to Clinical Information
Creatinine, Serum CRET1 84336 Clinical Information: Neonates (premature): 0.33 to 0.98 mg/ 9/8/16 dL; Neonates (full term): 0.31 to 0.88 mg/dL; 2-12 months: 0.16 to 0.39 mg/dL; 1- < 3 years: 0.18 to 0.35 mg/dL; 3- < 5 years: 0.26 to 0.42 mg/dL; 5–< 7 years: 0.29 to 0.47 mg/dL; 7–< 9 years: 0.34 to 0.53 mg/dL; 9- < 11 years: 0.33 to 0.64 mg/dL; 11- < 13 years: 0.44 to 0.68 mg/dL; 13- < 15 years: 0.46 to 0.77 mg/dL. References: Creatinine plus ver.2 (CREP2) [package insert V 7.0 English]. Roche Diagnostics, Indianapolis, IN; September 2014. Specimen Requirement: 1 mL plasma from a lithium heparin (light green) plasma separator tube (PST); Minimum: 0.4 mL; Submit in original tube or aliquot specimen into CCL aliquot tube; Centrifuge and refrigerate *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Centrifuge and refrigerate Stability: Ambient: 7 days Refrigerated: 7 days Frozen: 3 months Reference Range: Male 18–99 Years: 0.58–0.96 mg/dL Female 18–99 Years: 0.73–1.22 mg/dL
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 10 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
EBV by PCR EBPCR 79049 Special Information: Useful for rapid qualitative detection of 9/1/16 Qualitative Epstein-Barr virus DNA in specimens for laboratory diagnosis of disease due to this virus. New York State approved. Clinical Information: Epstein-Barr virus (EBV) is the causative agent of infectious mononucleosis, Burkitt lymphoma, and in southern China, nasopharyngeal carcinoma. EBV-associated central nervous system (CNS) disease is most commonly associated with primary CNS lymphoma in patients with AIDS. In addition, CNS infection associated with the detection of EBV DNA can be detected in immunocompetent patients. Detection of Epstein-Barr virus supports the clinical diagnosis of disease due to the virus. A negative result does not eliminate the possibility of Epstein-Barr virus (EBV). Although the reference range is typically "negative" for this assay, this assay may detect viremia or viral shedding in asymptomatic individuals. However, this assay is only to be used for patients with a clinical history and symptoms consistent with EBV infection, and must be interpreted in the context of the clinical picture. This test should not be used to screen asymptomatic patients.
FISH for FGFR1 FGFR1F 88770 Specimen Requirement: 5 mL whole blood in an EDTA lavender 9/22/16 top tube; Refrigerated *OR* 3 mL bone marrow in an EDTA lavender top tube; Refrigerated *OR* 5 mL whole blood in a sodium heparin green top tube; Refrigerated *OR* 3 mL bone marrow in a sodium heparin green top tube; Refrigerated
Galactokinase GALKIN 82759 For Interfaced Clients Only: Test build may need to be modified 9/16/16 Activity Includes: Galactokinase, B Interpretation (GALK) Test Name: Previously Galactokinase Special Information: Specimen CANNOT be frozen. Specimen must arrive at performing lab within 48 hours of collection. New York State approved. Clinical Information: Useful for diagnosis of galactokinase deficiency. Galactokinase (GALK) deficiency is the second most common form of galactosemia, affecting approximately 1/250,000 live births, with a higher frequency in the Romani population. Individuals with GALK deficiency have a milder clinical presentation than that seen in patients with classic galactosemia, galactose-1-phosphate uridyltransferase (GALT) deficiency. The major clinical manifestation is bilateral juvenile cataracts. GALK deficiency is treated with a lactose-restricted diet. Early treatment may prevent or reverse the formation of cataracts. In GALK deficiency, erythrocyte galactose- 1-phosphate levels are generally normal and plasma galactose levels are generally elevated. The diagnosis is established by demonstrating deficient GALK enzyme activity in erythrocytes. Testing for GALK deficiency should be performed when there is a suspicion of galactosemia, either based upon the patient's clinical presentation or laboratory studies and GALT deficiency has been excluded. Specimens sent for GALT analysis may be used for GALK testing if the original specimen was received in the laboratory within 48 hours of draw. GALK deficiency is caused by mutations in the GALK1 gene. Gene analysis is available from some commercial laboratories. Cautions: It is important to notify the laboratory if the patient has been transfused prior to specimen collection. The results of testing performed in erythrocytes are invalid following a transfusion, including analysis of enzymes, biochemical phenotyping, or galactose-1-phosphate.
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9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 11 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Galactokinase Specimen Requirement: 4 mL whole blood in an EDTA lavender Activity top tube; Minimum: 2 mL; Refrigerated (continued from *OR* 4 mL whole blood in a sodium or lithium heparin green top page 11) tube; Minimum: 2 mL; Refrigerated *OR* 4 mL whole blood in a yellow top (ACD) tube; Minimum: 2 mL; Refrigerated Stability: Ambient: 72 hours Refrigerated: 10 days Frozen: Unacceptable Methodology: Enzyme Reaction Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) Reference Range: ≥ 0.7 nmol/h/mg Hgb Days Performed: Monday Reported: 9–16 days
Glucose GLU 82947 Clinical Information: For patient population 0-17 years of age: 9/8/16 Reference ranges for this patient’s age group have not been established. These reference ranges reflect verified or established ranges for the adult population. Interpret these ranges with caution using the clinical context and additional reference resources. Specimen Requirement: 1 mL plasma from a potassium oxalate/ sodium fluoride (gray) tube; Minimum: 0.4 mL; Ambient *OR* 1 mL plasma from a lithium heparin (light green) plasma separator tube (PST); Minimum: 0.4 mL; Centrifuge and refrigerate *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Centrifuge and refrigerate Stability: Ambient: 8 hours Lithium Heparin Plasma (Light green) or 3 days Fluoride Plasma (Gray) Refrigerated: 3 days Frozen: Unacceptable Reference Range: 0–99 Years: 74–99 mg/dL
Glucose, Body Fluid BFGLUC 77597 Special Information: Indicate body fluid type/source. 9/8/16 Clinical Information: Synovial fluid: Synovial fluid glucose measurement may be useful in classifying various joint disorders. A concurrent plasma glucose measurement should be performed to determine the (glucose plasma) – (glucose synovial fluid) difference, which is normally = 10.0 mg/dL. Artificial lowering of synovial fluid glucose, due to glycolytic action of leukocytes, may result from analyses that occur more than one hour from the time of collection. Reference: 1. CLSI. Analysis of Body Fluids in Clinical Chemistry; Approved Guideline. CLSI document C49-A. Wayne, PA: Clinical Laboratory Standards Institute; 2007. Specimen Requirement: 1 mL body fluid in asterile container; Viscous specimens will be rejected; Indicate source of fluid; Minimum: 0.4 mL; Refrigerated Stability: Ambient: 8 hours Refrigerated: 3 days Frozen: Unacceptable Reference Range: Refer to Clinical Information
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 12 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Helicobacter pylori HPYLBR 82747 Special Information: Collection of breath samples should be 9/1/16 Breath Test, Adult performed by trained healthcare personnel only; per instructions in collection kit. Phenylketonurics: Contains Phenylalanine. Hypersensitivity: Patients who are hypersensitive to mannitol, citric acid, or Aspartame should avoid taking the drug solution as the drug solution contains these ingredients. Risk of Aspiration: Use with caution in patients with difficulty in swallowing or who may be at high risk for aspiration due to medical or physical conditions. Pregnancy/Lactation: The safety of the BreathTek UBT kit during pregnancy and lactation is not established. Safety and effectiveness have not been assessed in children below the age of three. If particulate matter is visible in the reconstituted Pranactin-Citric solution after thorough mixing, the solution should not be used. Fast at least 1 hour prior to administering the BreathTek UBT. Patient should not have taken antibiotics, proton pump inhibitors or bismuth preparations within 2 weeks prior to administering the BreathTek UBT. The effect of histamine 2-receptor antagonists may reduce urease activity on urea breath tests. They may be discontinued for 24-48 hours before the BreathTek UBT. Use of Antacids does not appear to affect the accuracy of the BreathTek UBT. Do not use any straw other than the straw provided in the kit. If repeat testing is needed, BreathTek UBT can be administered the following day. Additional kits can be obtained by contacting Client Services at 800.628.6816 or 216.444.5755. Clinical Information: A result greater than or equal to 2.4 Delta Over Baseline (DOB) is interpreted as diagnostically positive indicating the presence of urease associated with H pylori. A negative result does not rule out the possibility of H pylori infection. If clinical signs are suggestive of H pylori infection, retest with a new sample or an alternate method. Clinical Limitation: The BreathTek UBT must be stored per package insert. Do not use past the stated expiration date.
Helicobacter HPYBRP 88834 Special Information: This test is for pediatric patients age 3-17 9/1/16 pylori Breath Test, years; safety and effectiveness have not been assessed in children Pediatric below the age of three. Collection of breath samples should be performed by trained healthcare personnel only; per instructions in collection kit. Gender, age, height and weight are required. Please indicate this information on the test requisition. Phenylketonurics: Contains Phenylalanine. Hypersensitivity: Patients who are hypersensitive to mannitol, citric acid, or Aspartame should avoid taking the drug solution as the drug solution contains these ingredients. Risk of Aspiration: Use with caution in patients with difficulty in swallowing or who may be at high risk for aspiration due to medical or physical conditions. Pregnancy/ Lactation: The safety of the BreathTek UBT kit during pregnancy and lactation is not established. If particulate matter is visible in the reconstituted Pranactin-Citric solution after thorough mixing, the solution should not be used. Fast at least 1 hour prior to administering the BreathTek UBT. Patient should not have taken antibiotics, proton pump inhibitors or bismuth preparations within 2 weeks prior to administering the BreathTek UBT. The effect of histamine 2-receptor antagonists may reduce urease activity on urea breath tests. They may be discontinued for 24-48 hours before the BreathTek UBT. Use of Antacids does not appear to affect the accuracy of the BreathTek UBT. Do not use any straw other than the straw provided in the kit. If repeat testing is needed, BreathTek UBT can be administered the following day. Additional kits can be obtained by contacting Client Services at 800.628.6816 or 216.444.5755. (continued on page 14)
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 13 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Helicobacter Clinical Information: A result greater than or equal to pylori Breath Test, 10.0 µg/min UHR (Urea Hydrolysis Rate) is interpreted as Pediatric diagnostically positive indicating the presence of urease associated (continued from with H pylori. A negative result does not rule out the possibility page 13) of H pylori infection. If clinical signs are suggestive of H pylori infection, retest with a new sample or an alternate method. Clinical Limitation: The BreathTek UBT must be stored per package insert. Do not use past the stated expiration date. Specimen Requirement: Submit one baseline (blue) and one post dose (pink) breath sample bag; Ambient Reference Range: 3–17 Years: < 10.0 UHR
Her-2-Neu Serum HER2S 81391 Specimen Requirement: 1 mL serum from a serum separator (gold) Effective tube; Minimum: 0.3 mL; Frozen immediately *OR* 1 mL serum from a red top tube with no additive; Minimum: 0.3 mL; Frozen Days Performed: Wednesday (every 2nd and 4th week per month) Reported: 8–22 days
IDH1/IDH2 IDH12 88044 Test Name: Previously IDH1 and IDH2 Mutation Analysis, exon 4 9/1/16 Mutation, Blood/ Bone marrow
Ketorolac KETOR 80422 Special Information: This test is New York State approved. 9/1/16 Clinical Information: Used for therapeutic drug monitoring. Reporting limit: 0.2 mcg/mL. Specimen Requirement: 1 mL serum from a red top tube with no additive; Do not use serum separator tubes; Protect specimen from light; Centrifuge and aliquot ASAP; Minimum: 0.4 mL; Refrigerated *OR* 1 mL plasma from an EDTA lavender top tube; Do not use plasma separator tubes; Protect specimen from light; Separate plasma from cells ASAP; Minimum: 0.4 mL; Refrigerated Days Performed: Tuesday, Thursday Reported: 5–10 days
Lactate LD6 83615 Clinical Information: For patient population 0-17 years of age: 10/26/16 Dehydrogenase Reference ranges for this patient’s age group have not been established. These reference ranges reflect verified or established ranges for the adult population. Interpret these ranges with caution using the clinical context and additional reference resources. Specimen Requirement: 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Submit in original tube or aliquot specimen into CCL aliquot tube; Centrifuge and refrigerate Stability: Ambient: 7 days Refrigerated: 4 days Frozen: 6 weeks Reference Range: Male 0–99 Years: 135–225 U/L Female 0–99 Years: 135–214 U/L
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 14 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Lactate BFLDH 77071 Clinical Limitation: In connection with certain diseases (e.g. 9/8/16 Dehydrogenase, hepatopathy, diseases of skeletal muscles, malignant tumors), the Body Fluid LDH-4 and LDH-5 isoenzyme portions are increased and unstable in cooled and frozen samples; this may lead to an incorrect LDH value in samples collected from patients suffering from such diseases. Clinical Information: Pleural fluids: Pleural fluid lactate dehydrogenase (LDH) measurements may be useful for classifying pleural effusions as exudates. A ratio of pleural fluid LDH to a concurrent serum LDH > 0.6 is suggestive of an exudate. Peritoneal fluids: Ascitic fluid LDH measurements may aid in characterizing secondary peritonitis and should be interpreted along with other clinical and laboratory information. Synovial fluids: Synovial fluid LDH measurements may be useful as an inflammatory marker for various arthritic conditions and should be interpreted along with other clinical and laboratory information. References: 1. CLSI. Analysis of Body Fluids in Clinical Chemistry; Approved Guideline. CLSI document C49-A. Wayne, PA: Clinical Laboratory Standards Institute; 2007. 2. Block DR, Algeciras-Schimnich A. Body fluid analysis: clinical utility and applicability of published studies to guide interpretation of today’s laboratory testing in serous fluids. Crit Rev Clin Lab Sci, 2013;50(4-5):107-124. 3. Pejovic M, Stankovic A, Mitrovic DR. Lactate dehydrogenase activity and its isoenzymes in serum and synovial fluid of patients with rheumatoid arthritis and osteoarthritis. J Rheumatol. 1992;19:529-533. Specimen Requirement: 1 mL body fluid in asterile container; Minimum: 0.5 mL; Viscous specimens will be rejected; Indicate source of fluid; Ambient Stability: Ambient: 7 days Refrigerated: 4 days Frozen: 6 weeks Reference Range: Refer to Clinical Information
Lindane LIND 81731 Special Information: This test is New York State approved. 9/1/16 Clinical Information: Exposure monitoring; Category: pesticide. Reporting limit: 1.0 ppb. Specimen Requirement: 3 mL serum from a red top tube with no additive; Minimum: 1.2 mL; Do not use serum separator tubes; Centrifuge and aliquot ASAP; Refrigerated *OR* 3 mL plasma from an EDTA lavender top tube; Minimum: 1.2 mL; Do not use plasma separator tubes; Collect two EDTA lavender top tubes; Separate plasma from cells ASAP; Refrigerated Days Performed: Thursday Reported: 3–11 days
Lipase LIPA 83690 Specimen Requirement: 1 mL plasma from a lithium heparin (light 9/8/16 green) plasma separator tube (PST); Minimum: 0.4 mL; Submit in original tube or aliquot specimen into CCL aliquot tube; Centrifuge and refrigerate *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Centrifuge and refrigerate Stability: Ambient: 1 week Refrigerated: 1 week Frozen: 1 year Reference Range: 0–99 Years: 16–61 U/L
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 15 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Lipase, Fluid FLIP 77632 Clinical Information: Pleural fluids: Lipase measurement in pleural 9/8/16 fluid, in conjunction with amylase measurement, is considered a useful test for determining the cause of pleural effusions. Peritoneal fluids and drainage fluids: Pancreatic damage causes extravasation of lipase from the exocrine cells into the peritoneal space. In cases of pancreatitis, fluid lipase concentration can be several-fold times higher in fluid of pancreatic origin compared to concurrent serum lipase values. Pancreatic cyst fluid: Pancreatic cyst fluid lipase may aid in the differentiation of pancreatic cyst lesions and should be interpreted along with other clinical and laboratory information. References: 1. CLSI. Analysis of Body Fluids in Clinical Chemistry; Approved Guideline. CLSI document C49-A. Wayne, PA: Clinical Laboratory Standards Institute; 2007. 2. Boot C. A review of pancreatic cyst fluid analysis in the differential diagnosis of pancreatic cyst lesions. Ann Clin Biochem OnlineFirst 2013;0:1-16. Specimen Requirement: 1 mL body fluid in asterile container; Minimum: 0.5 mL; Indicate fluid type/source; Viscous specimens will be rejected; Refrigerated Stability: Ambient: 1 week Refrigerated: 1 week Frozen: 1 year Reference Range: Refer to Clinical Information
Lyme Antibodies, LYMEGM 50156 Clinical Limitation: Grossly hemolyzed, icteric or lipemic samples 10/26/16 IgG, IgM as well as samples containing particulate matter or exhibiting obvious microbial contamination should not be tested. The results are not by themselves diagnostic and should be considered in association with the second step Western Blot and other clinical data and symptoms. This assay should not be used for general population screening. It should be used only for patients with signs and symptoms consistent with Lyme disease. Potential assay interference due to circulating antibodies against Human Ehrlichiosis and Tick Borne Relapsing Fever has been found. Clinical Information: Qualitative test for the presence of IgG and IgM antibodies to Borrelia burgdorferi, the causative agent of Lyme disease. Positive or equivocal results will automatically reflex to Western Blot for confirmation. Specimen Requirement: 0.5 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Refrigerated Stability: Ambient: 48 hours Refrigerated: 5 days Frozen: 15 days at minus 20 °C or below (Avoid multiple freeze/ thaw cycles) Methodology: Chemiluminescence Immunoassay (CLIA) Reference Range: Negative
Megaloblastic ANEMIA 82935 Specimen Requirement: 1 mL serum from a red top tube with no Effective Anemia Panel additive; Minimum: 0.2 mL; Remove serum from cells within 1 immediately hour of collection and freeze ASAP; Indicate serum on the label; Frozen *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.2 mL; Remove serum from cells within 1 hour of collection and freeze ASAP; Indicate serum on the label; Frozen *OR* 1 mL plasma in a sodium or lithium heparin green top tube; Minimum: 0.2 mL; Remove plasma from cells within 1 hour of collection and freeze ASAP; Indicate plasma on the label; Frozen Stability: Ambient: 24 hours Refrigerated: 30 days Frozen: Indefinitely Days Performed: Monday, Wednesday Reported: 4–15 days
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 16 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Mephenytoin & MEPNOR 75053 Special Information: This test is New York State approved. 9/1/16 Normephenytoin Clinical Information: Monitor concentration of medication for optimal level. Suggested therapeutic range for combined plasma Mephenytoin and Normephenytoin concentrations during chronic therapy: 25–40 µg/mL. Reporting limit: Mephenytoin: 0.5 µg/mL and Normephenytoin: 0.5 µg/mL. Specimen Requirement: 2 mL serum from a red top tube with no additive; Do not use serum separator tubes; Separate serum from cells ASAP; Minimum: 0.7 mL; Refrigerated *OR* 2 mL plasma from an EDTA lavender top tube; Do not use plasma separator tubes; Separate plasma from cells ASAP; Minimum: 0.7 mL; Refrigerated Days Performed: Monday, Wednesday, Friday Reported: 4–8 days
Myasthenia Gravis MYGRAV 82922 For Interfaced Clients Only: Test build may need to be modified Effective Evaluation, Adult Includes: immediately Acetylcholine Receptor (Muscle) Binding Ab Acetylcholine Receptor (Muscle) Modulating Ab Striational (Striated Muscle) Ab MG Lambert-Eaton Interpretation, S Special Information: Hemolysis is unacceptable for AChR Modulating Antibody. Reflex Algorithm: If AChR modulating antibodies are ≥90% and Striational antibodies are ≥1:120, AChR Ganglionic Neuronal Antibody, Glutamic Acid Decarboxylase Ab, Neuronal Voltage-gated K+ Channel (VGKC) Autoantibody and CRMP-5-IgG Western blot will be performed at an additional charge. Patient should have no general anesthetic or muscle- relaxant drugs in the 24 hours prior to sample collection. Clinical Information: Initial evaluation of patients aged 20 or older with symptoms and signs of acquired myasthenia gravis (MG). Bone marrow transplant recipients with suspected graft-versus-host disease, particularly if weakness has appeared. Confirming that a recently acquired neurological disorder has an autoimmune basis (e.g., MG). Providing a quantitative baseline for future comparisons in monitoring a patient's clinical course and the response to immunomodulatory treatment. Specimen Requirement: 3 mL serum from a red top tube with no additive; To ensure adequate specimen volume, collect 2 red top tubes; Patient should have no general anesthetic or muscle relaxant drugs in the previous 24 hours; Minimum: 2 mL; Refrigerated *OR* 3 mL serum from a serum separator (gold) tube; To ensure adequate specimen volume, collect 2 gold top tubes; Patient should have no general anesthetic or muscle relaxant drugs in the previous 24 hours; Minimum: 2 mL; Refrigerated Days Performed: Monday–Sunday Reported: 5–8 days
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 17 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Myasthenia Gravis/ LAMBRT 83027 For Interfaced Clients Only: Test build may need to be modified Effective Lambert-Eaton Includes: immediately Syndrome ACh Receptor (Muscle) Binding Ab & Modulating Ab Calcium Channel Binding Ab, P/Q & N-Type Striational (Striated muscle) Ab MG Lambert-Eaton Interpretation, S Clinical Information: Confirming the autoimmune basis of a defect in neuromuscular transmission (e.g., myasthenia gravis [MG], Lambert-Eaton syndrome [LES]). Distinguishing LES from two recognized autoimmune forms of MG. Raising the index of suspicion for cancer, particularly primary lung carcinoma (N-type calcium channel antibody). Providing a quantitative autoantibody baseline for future comparisons in monitoring a patient's clinical course and response to immunomodulatory treatment. This evaluation is recommended for patients presenting with an acquired defect of neuromuscular transmission in whom the differential diagnosis includes Lambert-Eaton syndrome (LES). It is not recommended for patients with a past history of, or risk factors for, lung cancer and/or concurrent neurological symptoms/ signs not attributable to LES; for those situations, order PAVAL/ Paraneoplastic Autoantibody Evaluation, Serum. Testing for muscle-specific receptor tyrosine kinase (MuSK) is indicated when all tests are negative. Specimen Requirement: 3 mL serum from a red top tube with no additive; Patient should have no general anesthetic or muscle- relaxant drugs in the previous 24 hours; Minimum: 2 mL; Refrigerated *OR* 3 mL serum from a serum separator (gold) tube; Patient should have no general anesthetic or muscle-relaxant drugs in the previous 24 hours; Minimum: 2 mL; Refrigerated Days Performed: Monday–Sunday Reported: 5–8 days
Mycoplasma MYCIGA 89483 Days Performed: Monday 9/1/16 pneumoniae IgA Reported: 6–22 days
Neoencephalitis CEPHAL 82188 Reference Range: Effective Paraneoplastic anti-CV2: Negative immediately Profile with Recombx anti-Hu: Negative anti-Ma: Negative anti-Ta: Negative Amphiphysin: Negative VGKC Antibodies: < 112 pmol/L GAD Antibodies: 0–99 Years: Negative: < 1:600 pmol/L 0–99 Years: Borderline: 1:100–1:1200 pmol/L 0–99 Years: Positive: > 1:1200 pmol/L NMDA Receptor (NRI): Negative CASPR2: Negative LGI1: Negative
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 18 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Neuromyelitis FNMOA4 89630 Test Name: Previously NMO/Aquaporin-4-IgG Cell Binding Assay, Effective Optica (NMO)/ CSF immediately Aquaporin-4-IgG Special Information: This is a reflex test from Paraneoplastic FACS Assay, CSF Autoantibody Evaluation in CSF and will be performed at an additional cost, if indicated. It is also orderable alone. Include relevant clinical information, name, phone number, mailing address, and e-mail address (if applicable) of ordering physician. Reflex algorithm: When the results of this assay require further evaluation, NMOTC/Neuromyelitis Optica (NMO)/Aquaporin-4-IgG Fluorescence-Activated Cell Sorting (FACS) Titer Assay, Spinal Fluid will be performed at an additional charge. Clinical Information: Useful for the diagnosis of a neuromyelitis optica spectrum disorder (NMOSD), diagnosis of autoimmune AQP4 channelopathy, distinguishing NMOSD from multiple sclerosis early in the course of disease. Methodology: Fluorescent Activated Cell Sorting Assay (FACS) Days Performed: Monday, Tuesday, Thursday Reported: 5–9 days
Neuromyelitis NMOA4 89628 Test Name: Previously NMO/Aquaporin 4 IgG, Cell Binding Assay Effective Optica (NMO)/ Special Information: Include relevant clinical information, name, immediately Aquaporin-4-IgG phone number, mailing address and e-mail address (if applicable) FACS Assay, Serum of ordering physician. Reflex Algorithm: When the results of this assay require further evaluation, NMOTS/Neuromyelitis Optica (NMO)/Aquaporin-4-IgG Fluorescence-Activated Cell Sorting (FACS) Titer Assay, Serum will be performed at an additional charge. This test is also a reflex test for Paraneoplastic Autoantibody Evaluation, Serum. Clinical Information: Useful for diagnosis of neuromyelitis optica spectrum disorder (NMOSD), diagnosis of autoimmune AQP4 channelopathy, distinguishing NMOSD from multiple sclerosis early in the course of disease. Specimen Requirement: 4 mL serum from a serum separator (gold) tube; Please include the physician's name, address and telephone number with the specimen; Collect 2 specimen tubes to ensure adequate specimen volume; Minimum: 2 mL; Refrigerated *OR* 4 mL serum from a red top tube with no additive; Please include the physician's name, address and telephone number with the specimen; Collect 2 specimen tubes to ensure adequate specimen volume; Minimum: 2 mL; Refrigerated Methodology: Fluorescent Activated Cell Sorting Assay (FACS) Days Performed: Monday, Tuesday, Thursday Reported: 6–10 days
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 19 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Paraneoplastic PARCSF 87937 For Interfaced Clients Only: Test build may need to be modified Effective Autoantibody Includes: immediately Evaluation, CSF Anti-Neuronal Nuclear Ab Type 1 Anti-Neuronal Nuclear Ab Type 2 Anti-Neuronal Nuclear Ab Type 3 Purkinje Cell Cytoplasmic Ab Type 1 Purkinje Cell Cytoplasmic Ab Type 2 Purkinje Cell Cytoplasmic Ab Type Tr Amphiphysin Ab CRMP-5 IgG Anti-Glial Nuclear Ab Type 1 Paraneoplastic Interpretation, CSF Reflex tests added Special Information: Include name, phone number, mailing address, and email address (if applicable) of ordering physician. Reflex algorithm: If indirect immunofluorescence assay (IFA) (ANN1C, ANN2C,ANN3C, PCA1C, PCA2C, PCTRC, AMPHC, CRMC, AGN1C) is indeterminate, then paraneoplastic autoantibody Western blot is performed at an additional charge. If IFA pattern suggests NMO/AQP4-IgG, then NMO/AQP4-IgG FACS is performed at an additional charge. If NMO/AQP4-IgG FACS screen assay is positive, then NMO/AQP4-IgG FACS titration assay is performed at an additional charge. If IFA patterns suggest CRMP-5-IgG, then CRMP-5-IgG Western blot is performed at an additional charge. If IFA patterns suggest GAD65 antibody, then GAD65 antibody radioimmunoassay is performed at an additional charge. If IFA patterns suggest neuronal voltage-gated potassium channel-complex autoantibody, then VGKC-complex antibody IPA is performed at an additional charge. If IFA patterns suggest amphiphysin antibody, then amphiphysin Western blot is performed at an additional charge. If IFA patterns suggest NMDA-R, then NMDA-R antibody CBA and/or NMDA-R titer is performed at an additional charge. If IFA pattern suggests AMPA-R, then AMPA-R antibody CBA and/or AMPA-R titer is performed at an additional charge. If IFA pattern suggests GABA-B-R, then GABA-B-R antibody CBA and/or GABA-B-R titer is performed at an additional charge. In patients with a history of tobacco use or other lung cancer risk, or if thymoma is suspected, PAVAL/Paraneoplastic Autoantibody Evaluation, Serum is also recommended. Clinical Information: Aids in the diagnosis of paraneoplastic neurological autoimmune disorders related to carcinoma of lung, breast, ovary, thymoma, or Hodgkin lymphoma. Methodology: Cell Binding Assay (CBA), if indicated Fluorescent Activated Cell Sorting Assay (FACS) Immunoprecipitation Indirect Immunofluorescence Assay (IFA) Radioimmunoassay (RIA) Western Blot (WB), if indicated Days Performed: Monday–Sunday Reported: 5–7 days CPT: 86255 x 9
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 20 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Paraneoplastic PARNEO 82929 Special Information: Reflex Algorithm: If IFA (ANN1S, ANN2S, Effective Autoantibody ANN3S, PCABP, PCAB2, PCATR, AMPHS, CRMS, AGN1S) patterns immediately Evaluation, Serum are indeterminate, paraneoplastic autoantibody Western blot is performed at an additional charge. If client requests or if IFA patterns suggest CRMP-5-IgG, CRMP-5-IgG Western blot is performed at an additional charge. If IFA pattern suggests NMO/AQP4-IgG, NMO/ AQP4-IgG FACS is performed at an additional charge. If the results of NMO/AQP4-IgG FACS assay require further evaluation, then NMO/AQP4-IgG FACS titration assay will be performed at an additional charge. If IFA patterns suggest amphiphysin antibody, amphiphysin Western blot is performed at an additional charge. If IFA patterns suggest GAD65 antibody, GAD65 antibody radioimmunoassay is performed at an additional charge. If IFA pattern suggests NMDA-R, NMDA-R Ab CBA and/or NMDA-R Ab, IF Titer Assay is performed at an additional charge. If IFA pattern suggests AMPA-R, AMPA-R Ab CBA and/or AMPA-R Ab, IF Titer Assay is performed at an additional charge. If IFA patterns suggest GABA-B-R, GABA-B-R Ab CBA and/or GABA-B-R Ab, IF Titer Assay is performed at an additional charge. If ACh receptor binding antibody is > 0.02, ACh receptor modulating antibodies and CRMP-5-IgG Western blot are performed at an additional charge. CRMP-5-IgG Western blot is also performed by specific request for more sensitive detection of CRMP-5-IgG. Testing should be requested in cases of subacute basal ganglionic disorders (chorea, Parkinsonism), cranial neuropathies (especially loss of vision, taste, or smell) and myelopathies. Specimen Requirement: 4 mL serum from a serum separator (gold) tube; Collect 2 specimen tubes to ensure adequate specimen volume; Minimum: 2 mL; Refrigerated *OR* 4 mL serum from a red top tube with no additive; Collect 2 specimen tubes to ensure adequate specimen volume; Minimum: 2 mL; Refrigerated Methodology: Cell Binding Assay (CBA), if indicated Enzyme Immunoassay (EIA) Fluorescent Activated Cell Sorting Assay (FACS) IFA Titer Assay, if indicated Indirect Immunofluorescence Assay (IFA) Radioimmunoassay (RIA) Western Blot (WB), if indicated CPT: 83519 x 5, 83520 x 1, 86255 x 9
PDGFRB PDGFRB 87770 Specimen Requirement: 5 mL whole blood in an EDTA lavender 9/22/16 Rearrangement by top tube; Refrigerated FISH *OR* 3 mL bone marrow in an EDTA lavender top tube; Refrigerated *OR* 5 mL whole blood in a sodium heparin green top tube; Refrigerated *OR* 3 mL bone marrow in a sodium heparin green top tube; Refrigerated
Potassium K1 81422 Special Information: Hemolysis will falsely increase values. Grossly 9/8/16 hemolyzed specimens will be rejected. Clinical Information: For patient population 0-17 years of age: Reference ranges for this patient’s age group have not been established. These reference ranges reflect verified or established ranges for the adult population. Interpret these ranges with caution using the clinical context and additional reference resources. Specimen Requirement: 1 mL plasma from a lithium heparin (light green) plasma separator tube (PST); Minimum: 0.4 mL; Submit in original tube or aliquot specimen into CCL aliquot tube; Centrifuge and refrigerate *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Centrifuge and refrigerate Stability: Ambient: 14 days Refrigerated: 14 days Frozen: Stable Reference Range: 0–99 Years: 3.7–5.1 mmol/L
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 21 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Prealbumin PREALB 32108 Stability: 9/8/16 Ambient: Unacceptable Refrigerated: After separation from cells: 3 days Frozen: After separation from cells: 6 months Reference Range: 17–36 mg/dL
Protein, Body Fluid BFPROT 37541 Special Information: Indicate body fluid type/source. 9/8/16 Clinical Information: Serous fluids: Effusions are the accumulation of clinically detected fluid in any of the serous cavities. Effusions are further separated into transudates and exudates, which aid in determining the etiology of the effusion. Transudate: Body fluid total protein measurement < 3.0 g/dL. A ratio of serous fluid total protein to a concurrent serum total protein < 0.5 indicates a transudate. Exudate: Body fluid total protein measurement greater than or equal to 3.0 g/dL. A ratio of serous fluid total protein to a concurrent serum total protein greater than or equal to 0.5 indicates an exudate. Reference: 1. CLSI. Analysis of Body Fluids in Clinical Chemistry; Approved Guideline. CLSI document C49-A. Wayne, PA: Clinical Laboratory Standards Institute; 2007. Specimen Requirement: 2 mL body fluid in asterile container; Minimum: 0.4 mL; Viscous specimens will be rejected; Indicate source of fluid; Refrigerated Stability: Ambient: Unacceptable Refrigerated: 4 weeks Frozen: 24 weeks Reference Range: Refer to report
Protein, Total TP 84155 Clinical Information: A pediatric reference range table will be 9/8/16 appended to all pediatric results. Specimen Requirement: 1 mL plasma from a lithium heparin (light green) plasma separator tube (PST); Minimum: 0.4 mL; Submit in original tube or aliquot specimen into CCL aliquot tube; Centrifuge and refrigerate *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Centrifuge and refrigerate Stability: Ambient: Unacceptable Refrigerated: 4 weeks Frozen: 24 weeks Reference Range: 18–99 Years: 6.3–8.0 g/dL
Sodium NA 84295 Clinical Information: For patient population 0-17 years of age: 9/8/16 Reference ranges for this patient’s age group have not been established. These reference ranges reflect verified or established ranges for the adult population. Interpret these ranges with caution using the clinical context and additional reference resources. Specimen Requirement: 1 mL plasma in a lithium heparin (light green) plasma separator tube (PST); Minimum: 0.4 mL; Submit in original tube or aliquot specimen into CCL aliquot tube; Centrifuge and refrigerate *OR* 1 mL serum from a serum separator (gold) tube; Minimum: 0.4 mL; Centrifuge and refrigerate Stability: Ambient: 14 days Refrigerated: 14 days Frozen: Stable Reference Range: 0–99 Years: 136–144 mmol/L
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 22 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Supersaturation SSAT24 90238 Reference Range: Effective Profile, 24 Hour Calcium Oxalate Crystal immediately Urine 0–99 Years: Reference Mean = 1.77 DG Brushite Crystal 0–99 Years: Reference Mean = 0.21 DG Hydroxyapatite Crystal 0–99 Years: Reference Mean = 3.96 DG Uric Acid Crystal 0–99 Years: Reference Mean = 1.04 DG Sodium Urate Crystal 0–99 Years: Reference Mean = 1.76 DG Sodium, Urine 16–99 Years: 41–227 mmol/24 hr 0–15 Years: Not established Potassium, Urine 16–99 Years: 17–77 mmol/24 hr 0–15 Years: Not established Calcium, Urine Male: 18–83 Years: < 250 mg/24 hrs Female: 18–83 Years: < 200 mg/24 hrs 0–17 Years: Not established 84–99 Years: Not established Magnesium, Urine 0–17 Years: Not established 84–99 Years: Not established 18–83 Years: 51–269 mg/24 hrs Chloride, Urine 16–99 Years: 40–224 mmol/24 hr 0–15 Years: Not established Phosphorus, Urine 0–99 Years: < 1100 mg/24 hrs Sulfate, Urine 0–99 Years: 7–47 mmol/24 hr Citrate Excretion, Urine Refer to report Oxalate, U mmol/spec 0–99 Years: 0.11–0.46 mmol/24 hr Oxalate, U mg/spec 0–99 Years: 9.7–40.5 mg/24 hrs pH, Urine 0–99 Years: 4.5–8.0 Uric Acid, Urine 0–99 Years: < 750 (*Diet dependent) mg/24 hrs Creatinine, Urine 0–17 Years: Not established 84–99 Years: Not established Male: 18–83 Years: 955–2936 mg/24 hrs Male: 18–83 Years: Creatinine Excretion: 13–29 Female: 18–83 Years: 601–1689 mg/24 hrs Female: 18–83 Years: Creatinine Excretion: 9–26 Osmolality, Urine 0–11 Months: 50–750 mOsm/kg 1–99 Years: 150–1150 mOsm/kg Ammonium, 24 Hr, Ur 0–17 Years: Not established 18–77 Years: 15–56 mg/24 hrs 78–99 Years: Not established Urea Nitrogen 0–99 Years: 5.0–16.0 mg/24 hrs Protein Catabolic Rate, Ur 0–99 Years: 56–125 g/24 hour
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 23 Test Changes (Cont.)
Test Name Order Code Billing Code Change Effective Date
Urea Nitrogen, Fluid FLUN 77793 Special Information: Indicate body fluid/source on the requisition. 9/8/16 Clinical Information: Serous fluids: Urea Nitrogen measurement in peritoneal or drainage fluids is a useful test for detecting the presence of urine leaking through a defect in the urinary tract. A ratio of peritoneal drainage fluid urea nitrogen to a concurrent serum blood urea nitrogen > 1.0 indicates possible urine extravasation. Dialysate fluids: Urea Nitrogen measurement in dialysate fluid may be used in calculations to determine the adequacy of the dialysis regimen. The calculations are dependent upon various factors beyond the available laboratory data. References: 1. CLSI. Analysis of Body Fluids in Clinical Chemistry; Approved Guideline. CLSI document C49-A. Wayne, PA: Clinical Laboratory Standards Institute; 2007. 2. Wang J H, Kung, Y H, King, T M, et al. Measurement of peritoneal fluid urea nitrogen and creatinine levels is useful to detect iatrogenic urinary tract leakage in colorectal surgery. Journal of the Chinese Medical Association. 2015;78:283-286. 3. National Kidney Foundation. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for 2006 Updates: Hemodialysis Adequacy, Peritoneal Dialysis Adequacy and Vascular Access. Am J Kidney Dis 48:S1-S322, 2006 (suppl 1). Specimen Requirement: 1 mL body fluid in a sterile container; Minimum: 0.5 mL; Viscous specimens will be rejected; Indicate source of fluid; Refrigerated Stability: Ambient: 7 days Refrigerated: 7 days Frozen: 1 year Reference Range: Refer to Clinical Information
Vitamin A VITA 84590 Specimen Requirement: 2 mL plasma from an EDTA lavender top 9/13/16 tube; Protect specimen from light; Minimum: 0.5 mL; Frozen *OR* 2 mL serum from a serum separator (gold) tube; Protect specimen from light; Minimum: 0.5 mL; Frozen
Vitamin B2 VITB2 83756 Special Information: Critical frozen. Specimens received at room 9/12/16 temperature or refrigerated will be rejected. Pour plasma into an amber transport tube (preferred) or transport tube wrapped in aluminum foil to protect from light. Separate specimens must be submitted when multiple tests are requested. Patient preparation: Overnight fasting is required. Avoidance of vitamin supplements for 24 hours prior to collection is preferred. Methodology: Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)
Vitamin E EVIT 84446 Specimen Requirement: 2 mL plasma from an EDTA lavender top 9/13/16 tube; Protect from direct sunlight exposure; Minimum: 0.7 mL; Frozen *OR* 2 mL serum from a serum separator (gold) tube; Protect from direct sunlight exposure; Minimum: 0.7 mL; Frozen
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 24 New Tests
Test Name Order Code Billing Code Change Effective Date
Bird Fanciers BFPP1 Includes: 11/30/16 Precipitin Panel I Canary Droppings Gel Diffusion Chicken Serum Gel Diffusion Cockatiel Droppings Gel Diffusion Finch Droppings Gel Diffusion Parakeet Droppings Gel Diffusion Parakeet Serum Gel Diffusion Parrot Droppings Gel Diffusion Parrot Serum Gel Diffusion Pigeon/Dove Droppings Gel Diffusion Pigeon/Dove Serum Gel Diffusion Clinical Information: For patients who have both precipitating antibody specific for bird antigens and the symptoms and the clinical findings for pneumonitis, a diagnosis of bird fancier's lung disease may be appropriate. It is important to recognize that a positive serology alone cannot be used to establish the diagnosis of Hypersensitivity Pneumonitis (HP) or Bird Fancier's Lung without the appropriate clinical findings and exposure history. In patients who lack the symptoms of HP but who have precipitating antibody (usually IgG), the serology can be taken to document significant exposure to bird antigens. Although the gel diffusion methods may be less sensitive than new methods, such as the ELISA tests for these bird antigens, it may be more specific. Specimen Requirement: 1 mL serum from a serum separator (gold) tube; Minimum: 0.5 mL; Ambient *OR* 1 mL serum from a red top tube with no additive; Minimum: 0.5 mL; Ambient Stability: Ambient: 4 weeks Refrigerated: 4 weeks Frozen: 4 weeks Methodology: Ouchterlony Gel Immunodiffusion Reference Range: Negative Days Performed: Tuesday, Friday Reported: 4–6 days CPT: 86331 x 10 Price: $280.00 (non-discountable)
Catecholamines URCAT2 Special Information: Drugs and medications may affect results 10/26/16 Fractionated by LC- and should be discontinued for at least 72 hours prior to specimen MS/MS, Urine Free collection, if possible. Catecholamines are not stable above pH 7. The pH of such specimens must be adjusted by the addition of 6M HCl acid or sulfamic acid prior to transport. A pH less than 2 can cause assay interference. Record total volume and collection time interval on transport tube and test request form. Specimen preservation can be extended to 1 month refrigerated by performing one of the following: Option 1: Transfer a 4 mL aliquot (Min: 2.5 mL) to an ARUP Standard Transport Tube. Adjust pH to 2.0-4.0 with 6M HCl. Option 2: Transfer a 4 mL aliquot (Min: 2.5 mL) to an ARUP Standard Transport Tube containing 20 mg sulfamic acid (ARUP Supply #48098), available by contacting Client Services at 800.628.6816 or 216.444.5755 (Min: 2.5 mL). This test is New York DOH approved.
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9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 25 New Tests (Cont.)
Test Name Order Code Billing Code Change Effective Date
Catecholamines Clinical Information: Not a first-line test for suspected Fractionated by LC- catecholamine-secreting neuroendocrine tumors MS/MS, Urine Free (pheochromocytoma or neuroblastoma). The optimal specimen for (continued from this testing is a 24-hour urine collection. Mass per day calculations page 25) are not reported for patients younger than 4 years of age and for the following specimen types: a random collection, a collection with duration of less than 20 hours, a collection with duration of greater than 28 hours, or a collection with total volume less than 400 mL (if 18 years of age or older) or greater than 5000 mL (all ages). Ratios to creatinine may be useful for these evaluations. Smaller increases in catecholamine concentrations (less than two times the upper limit) usually are the result of physiological stimuli, drugs, or improper specimen collection. Significant elevation of one or more catecholamines (three or more times the upper reference limit) is associated with an increased probability of a neuroendocrine tumor. Secreting neuroendocrine tumors are typically associated with catecholamine concentrations several times higher than the upper reference intervals. Large elevations can be seen in life-threatening illnesses and drug interferences. Common reasons for slight and moderate elevations include intense physical activity, emotional and physical stress, drug interferences, and improper specimen collection. Medications which may physiologically interfere with catecholamines and metabolites include amphetamines and amphetamine-like compounds, appetite suppressants, bromocriptine, buspirone, caffeine, carbidopa-levodopa (Sinemet), clonidine, dexamethasone, diuretics (in doses sufficient to deplete sodium), ethanol, isoproterenol, methyldopa (Aldomet), MAO inhibitors, nicotine, nose drops, propafenone (Rythmol), reserpine, theophylline, tricyclic antidepressants, and vasodilators. The effects of some drugs on catecholamine results may not be predictable. References: 1) Optimal collection and storage conditions for catecholamine measurements in human plasma and urine (Clinical Chemistry 1993; 39:2503-8); 2) Effect of urine pH, storage time, and temperature on stability of catecholamines, cortisol, and creatinine (Clinical Chemistry 1998; 44:1759-62). Specimen Requirement: 4 mL 24-hour urine (well-mixed) in a clean container; Drugs and medications may affect results and should be discontinued for at least 72 hours prior to specimen collection; Refrigerate during collection; pH urine to > 2 and < 7 with 6M HCl acid before transport; Record total volume and collection time interval on sample and test request form; Minimum: 2.5 mL; Refrigerated *OR* 4 mL random urine in a clean container; Drugs and medications may affect results and should be discontinued for at least 72 hours prior to specimen collection; pH urine to > 2 and < 7 with 6M HCl acid before transport; Record volume on sample and test request form; Minimum: 2.5 mL; Refrigerated Stability: Ambient: Unacceptable Refrigerated: 1 week (unpreserved); NOTE: For longer stability, see special information Frozen: 6 months (preserved) Methodology: High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS)
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9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 26 New Tests (Cont.)
Test Name Order Code Billing Code Change Effective Date
Catecholamines Reference Range: Fractionated by LC- Dopamine: 24-Hour Urine MS/MS, Urine Free 0–3 Years: Not Established (continued from 4–6 Years: 95–221 µg/d page 26) 7–12 Years: 76–371 µg/d 13–17 Years: 137–393 µg/d 18–69 Years: 77–324 µg/d 70–99 Years: 56–272 µg/d Epinephrine: 24-Hour Urine 0–3 Years: Not Established 4–17 Years: 1–9 µg/d 18–69 Years: 1–7 µg/d 70–99 Years: 1–5 µg/d Norepinephrine: 24-Hour Urine 0–3 Years: Not Established 4–12 Years: 6–45 µg/d 13–17 Years: 15–57 µg/d 18–69 Years: 16–71 µg/d 70–99 Years: 11–60 µg/d Creatinine: 24-Hour Urine Male 3–8 Years: 140–700 mg/d 9–12 Years: 300–1300 mg/d 13–17 Years: 500–2300 mg/d 18–50 Years: 1000–2500 mg/d 51–80 Years: 800–2100 mg/d 81–99 Years: 600–2000 mg/d Female 3–8 Years: 140–700 mg/d 9–12 Years: 300–1300 mg/d 13–17 Years: 400–1600 mg/d 18–50 Years: 700–1600 mg/d 51–80 Years: 500–1400 mg/d 81–99 Years: 400–1300 mg/d Dopamine: Random Urine, Ratio-to-Creatinine (CRT) 0–11 Months: 240–1290 µg/g crt 1–3 Years: 80–1220 µg/g crt 4–10 Years: 220–720 µg/g crt 11–17 Years: 120–450 µg/g crt 18–99 Years: 0–250 µg/g crt Epinephrine: Random Urine, Ratio-to-Creatinine (CRT) 0–11 Months: 0–380 µg/g crt 1–3 Years: 0–82 µg/g crt 4–10 Years: 5–93 µg/g crt 11–17 Years: 3–58 µg/g crt 18–99 Years: 0–20 µg/g crt Norepinephrine: Random Urine, Ratio-to-Creatinine (CRT) 0–11 Months: 25–310 µg/g crt 1–3 Years: 25–290 µg/g crt 4–10 Years: 27–110 µg/g crt 11–17 Years: 4–105 µg/g crt 18–99 Years: 0–45 µg/g crt Days Performed: Sunday–Saturday Reported: 2–5 days CPT: 82384 x 1 Price: $43.00 (non-discountable)
Human HPVHRS This test was previously documented in the 2016 August 10/11/16 Papillomavirus (HPV) Technical Update. DNA Detection with Price: $129.00 Genotyping 16,18, High-Risk Types by PCR, Sure Path
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 27 New Tests (Cont.)
Test Name Order Code Billing Code Change Effective Date
RBC Folate FOLRBC Special Information: One specimen should be submitted frozen for 10/26/16 folate testing and the other specimen should be kept refrigerated for hematocrit testing. Do NOT freeze both specimens. A recent hematocrit value can be submitted in place of the refrigerated specimen. Specimen Requirement: 1 mL whole blood in an EDTA lavender top tube; Minimum: 0.5 mL; Frozen *AND* 3 mL whole blood in an EDTA lavender top tube; Minimum: 1 mL; A minimum volume of 0.5 mL is also acceptable if collected in a microtainer; Refrigerated *OR* 1 mL whole blood in an EDTA lavender top tube; Recent hematocrit value must be submitted; Minimum: 0.5 mL; Frozen Stability: Ambient: 3 hours Refrigerated: 4 days Frozen: 2 months Methodology: Immunochemiluminometric Assay (ICMA) Days Performed: Monday–Saturday Reported: 2–3 days CPT: 82747 X 1 Price: $71.00
Fee Reductions
Test Name Order Code Billing Code List Fee CPT Code Effective Date
Albumin, Fluid FLALB 77789 $18.00 82040 9/8/16
Lyme Antibodies, IgG, IgM LYMEGM 50156 $95.00 86618 10/26/16
Discontinued Tests
Test Name Order Code Billing Code Test Information Effective Date
Catecholamines, UCAT24 83904 This test will no longer be available. Suggest ordering 10/26/16 Urine 24 Hour Catecholamines Fractionated by LC-MS/MS, Urine Free
Catecholamines, URCAT 83689 This test will no longer be available. Suggest ordering 10/26/16 Urine Random Catecholamines Fractionated by LC-MS/MS, Urine Free
Folate, RBC RBCFOL 22601 This test will no longer be available. Suggest ordering RBC Folate. 10/26/16
High Resolution HIRES 88436 This test will no longer be available. 9/8/16 Respirometry, Fibroblasts
9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 28