Cleveland Clinic Laboratories

Technical Update • November 2015

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

Special Information Test Discontinued Reference Range

Name Change Component(s) Methodology Test Update Billing Code Order Code New Test Stability Page # CPT Summary of Changes Fee by Test Name

3 14-3-3 Protein, CSF 3 Alcohol, Blood Confirmation 4 Antimony, Urine 4 Arsenic, Fractionated Urine 4 Arsenic, Urine 24 Hour 4 Barbiturates Confirmation, Urine 5 Buprenorphine and Metabolites, Confirm/Qt, Serum/Plasma 21 CA199, Fluid 5 Calpain 3 DNA Sequencing Test 6 CEA, Fluid 5 Celiac Associated HLA-DQ genotyping 5 Celiac Gluten Free Panel 6 Chlamydia trachomatis Culture 6 Clorazepate 20 Cortisol 7 Cortisol, Free Serum 7 Cortisol, Plasma 8 Coxiella Burnetii IgG Antibodies 8 Creutzfeldt-Jacob Disease 8 Cysticercus IgG Ab, CSF 9 Cysticercus IgG Ab, Serum

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Special Information Test Discontinued Reference Range

Name Change Component(s) Methodology Test Update Billing Code Order Code New Test Stability Page # CPT Summary of Changes Fee by Test Name

9, 20 Cyto P450 2C19 – 9 Variants 10 Dexamethasone 10 Diazepam & Metabolite 10 Digitoxin 10 Disopyramide (Norpace) 11, Estrogen, Fractionated Blood 12 12 Estrone 12 Ethosuximide 13 Ethylene Glycol 13 FBN1 Gene Sequencing Analysis 19 FISH for BCL6, Blood or Bone Marrow 13 FISH for IgH/BCL2, Blood or Bone Marrow 13, FISH for IgH/CCND1, Blood or Bone Marrow 20 19 FISH for MYC (8q24), Blood or Bone Marrow 14 Fructosamine 14 Glucose Screen, Pregnancy 20 Group A Streptococcus by PCR 14 Hemoglobin, Plasma 14 Homovanillic Acid, Urine 14 Interleukin 28B Associated Variants, 2 SNPs 14 JAK2 Exon 12–15 Sequencing 14 Leukotriene E4, Urine 15 Librium & Metabolite 15, Loxapine 20 20 Nitrogen, Total, Feces 16 Platelet Antibody Detection 16 Polychlorinated Biphenyls Quantitative, Serum or Plasma 16 Prostate Cancer Biomarker 16, Sialic Acid, CSF 20 21 Strep Group A DNA Probe 17 Synthetic Cannabinoid Metabolite, Screen with Confirmation 17 Syphilis IgG with Confirmation 17 Torch Antibodies, IgG & IgM 17 Treponema Pallidum Antibody, IgG 17 Vanillylmandelic Acid (VMA) & Homovanillic Acid (HVA), Urine 17 Varicella Zoster by PCR 18, Warfarin Sensitivity Genotyping 20

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Test Name Order Code Billing Code Change Effective Date

14-3-3 Protein, CSF PR1433 90158 Special Information: Specimens that have not been kept 11/5/15 refrigerated, or which have been tested for other analytes previously, may give a false-positive result. Hemolyzed specimens will give a false positive result. The test will be canceled if there is any level of hemolysis present. Clinical Information: This 14-3-3 assay is a quantitative assay. All other assays are currently based on qualitative or semiquantitative assessment of 14-3-3 Western blots of CSF specimens. Results of diagnostic 14-3-3 studies performed in other laboratories, therefore, cannot be compared directly with these 14-3-3 test results. However, the published literature suggests comparable sensitivity and specificity ranges between this assay and Western blot assays. Regardless of the method used, measurement of 14-3-3 protein in CSF should not be relied upon exclusively to establish the diagnosis of Creutzfeldt-Jakob disease (CJD). Increased concentrations of 14-3-3 protein in CSF have been described in a variety of central nervous system (CNS) diseases other than CJD that are associated with relative rapid (days to months, rather than months to years) destruction of significant amounts of CNS neuronal tissue. Published examples include: infectious encephalitides, transverse myelitis, stroke, intracerebral and subarachnoid hemorrhage, rapidly progressive vascular dementia, various metabolic and anoxic encephalopathy's, severe acute CNS episodes of multiple sclerosis, cerebral vasculitides and angiopathies, mitochondrial encephalomyelopathies, CNS storage diseases, widespread or rapidly growing primary or secondary CNS and leptomeningeal tumors, and, rarely, Alzheimer disease and other primary dementias. Specimen Requirement: 1 mL cerebrospinal fluid (CSF) in a sterile container; Obtain aliquot from second collection vial; Minimum: 0.6 mL; Place on ice after collection; Centrifuge to remove red cells and transfer an aliquot into a plastic tube. Immediately place on ice; Refrigerated Methodology: Immunochemiluminometric Assay (ICMA) Reference Range: ≤ 2.0 ng/mL Days Performed: Monday, Thursday Reported: 3–7 days

Alcohol, Blood BALCO 79879 Special Information: For medical purposes only. Timing of 12/29/15 Confirmation specimen collection; Dependent upon time of exposure–test upon presentation to hospital Clinical Information: Therapy for methanol intoxication: 100–200 mg/dL Critical: > 250 mg/dL Specimen Requirement: 2 mL serum from a red top tube; Minimum: 0.5 mL; Remove serum from cells ASAP or within 2 hours of collection; Refrigerated *OR* 2 mL plasma from an EDTA lavender top tube; Minimum: 0.5 mL; Remove plasma from cells ASAP or within 2 hours of collection; Refrigerated *OR* 2 mL plasma from a potassium oxalate/sodium fluoride gray top tube; Minimum: 0.5 mL; Remove plasma from cells ASAP or within 2 hours of collection; Refrigerated Days Performed: Sunday–Saturday Reported: 2–3 days

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Test Name Order Code Billing Code Change Effective Date

Antimony, Urine ANTIMU 77009 For Interfaced Clients only: Test build will need to be modified 1/4/16 Includes: Antimony, Urine Specimen Requirement: 5 mL random urine in a metal free, plastic container; Minimum: 0.25 mL; Refrigerated Stability: Ambient: 3 days Refrigerated: 2 weeks Frozen: 180 days Reference Range: < 1.0 ng/mL Days Performed: Sunday–Saturday Reported: 4–5 days

Arsenic, Fractionated UASFR 88171 Special Information: Indicate total volume. Submit a Heavy Metal 11/16/15 Urine requisition with the specimen. Provide all required demographics to meet State Health Department requirements. Urine collected within 48 hours after administration of a gadolinium (Gd) containing contrast media (may occur with MRI studies) or acid preserved urine specimens are not acceptable. Specimens contaminated with blood or fecal material or specimens transported in non-trace element-free transport tubes (with the exception of the original device) are not acceptable

Arsenic, Urine 24 UARSND 30120 Clinical Information: If total arsenic concentration is between 1/5/16 Hour 35-2000 µg/L, then Arsenic, Fractionated, will be added to determine the proportion of organic, inorganic, and methylated forms. Additional charges apply. The ACGIH Biological Exposure Index is 35 µg/L, for the sum of the inorganic and methylated forms of arsenic. If low-level chronic poisoning is suspected, the µg/g CRT ratio may be more sensitive than the total arsenic concentration. It may be appropriate to fractionate specimens with a µg/g CRT ratio >30 µg/g CRT despite a total arsenic concentration <35 µg/L; the laboratory will perform this on request. Special Information: Indicate total volume. Provide all required demographics to meet State Health Department requirements. Patient preparation: Diet, medication, and nutritional supplements may introduce interfering substances. Patients should be encouraged to discontinue nutritional supplements, vitamins, minerals, nonessential over-the-counter medications (upon the advice of their physician), and avoid shellfish and seafood for 48-72 hours. High concentrations of iodine may interfere with elemental testing. Abstinence from iodine-containing medications or contrast agents for at least 1 month prior to collecting specimens for elemental testing is recommended. Urine specimens collected within 48 hours after administration of gadolinium (Gd) contrast media and acid preserved samples are unacceptable. Specimens contaminated with blood or fecal material or specimens transported in a non-trace element transport tube (with the exception of the original device) are unacceptable.

Barbiturates UBARBC 90310 For Interfaced Clients Only: Test build will need to be modified 10/22/15 Confirmation, Urine Clinical Information: Cutoff Concentrations for all analytes: 50 ng/mL. For medical purposes only, not for forensic use. The absence of expected drug(s) and/or drug metabolite(s) may indicate non-compliance, inappropriate timing of specimen collection relative to drug administration, poor drug absorption, diluted/adulterated urine, or limitations of testing. The concentration value must be greater than or equal to the cutoff to be reported as positive.

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Test Name Order Code Billing Code Change Effective Date

Buprenorphine and SBUP 89772 For Interfaced Clients Only: Test build will need to be modified 1/4/16 Metabolites, Confirm/ Special Information: For medical purposes only, not valid for Qt, Serum/Plasma forensic use Clinical Information: Positive Cutoff: 1 ng/mL. The presence of metabolites(s) without parent drug may indicate use of parent drug during the prior week. The absence of expected drug(s) and/ or metabolite(s) may indicate non-compliance, inappropriate timing of specimen collection relative to drug administration, poor drug absorption, or limitations of testing. The concentration value must be greater than or equal to the cutoff to be reported as positive. Includes: Buprenorphine Norbuprenorphine Specimen Requirement: 2 mL serum from a red top tube; Minimum: 1 mL; Do not use serum separator tubes; Remove serum from cells ASAP or within 2 hours of collection; Refrigerated *OR* 2 mL plasma from a potassium oxalate/sodium fluoride gray top tube; Minimum: 1 mL; Remove plasma from cells ASAP or within 2 hours of collection; Refrigerated *OR* 2 mL plasma from a sodium heparin green top tube; Minimum: 1 mL; Do not use plasma separator tubes; Remove plasma from cells ASAP or within 2 hours of collection; Refrigerated *OR* 2 mL plasma from an EDTA lavender top tube; Minimum: 1 mL; Do not use plasma separator tubes; Remove plasma from cells ASAP or within 2 hours of collection; Refrigerated Reference Range: Cutoff Concentrations: Buprenorphine: 1 ng/mL Norbuprenorphine: 1 ng/mL Days Performed: Tuesday, Friday Reported: 2–5 days

Calpain 3 DNA CALP3 83055 For Interfaced Clients Only: Test build will need to be modified 12/23/15 Sequencing Test Specimen Requirement: 4 mL whole blood in an EDTA lavender top tube; Minimum volume: 2 mL; Ambient Stability: Ambient: 7 days Refrigerated: 7 days Frozen: Unacceptable Methodology: DNA Sequencing Polymerase Chain Reaction (PCR) Reference Range: Refer to report Days Performed: Upon receipt Reported: 15–16 days

Celiac Associated CELIA 82969 CPT: 81382x2 11/3/15 HLA-DQ genotyping

Celiac Gluten Free CELGLU 90711 CPT: 81382x2 11/3/15 Panel

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Test Name Order Code Billing Code Change Effective Date

CEA, Fluid CEAFL 77619 For Interfaced Clients Only: Test build will need to be modified 12/29/15 Order Code: Previously FCEA Clinical Information: The Roche CEA electrochemiluminescent immunoassay is used. Results obtained with different assay methods or kits cannot be used interchangeably. Measurements of CEA have been shown to be clinically relevant in the management of patients with colorectal, breast, lung, prostatic, pancreatic, and ovarian carcinomas. Smokers may have slightly elevated levels of CEA. The CEA assay value, regardless of level, should not be interpreted as evidence for the presence or absence of malignant disease and is not recommended for use as a screening procedure to detect the presence of cancer in the general population Specimen Requirement: 1 mL body fluid in a clean container; Minimum: 0.5 mL; Breast milk, salivary fluid, and gastric fluid are unacceptable; Refrigerated Methodology: Electrochemiluminescent Immunoassay (ECLIA) Days Performed: Sunday–Saturday Reported: 2–3 days

Chlamydia CTRACH 83315 Specimen Requirement: Endocervical swab in M4 or Universal 12/3/15 trachomatis Culture Transport Media (UTM); Genital specimens are obtained by inserting a swab for a distance of 2 to 5 cm into the endocervix or urethra to obtain epithelial cells. Place swab immediately into transport media. Place each specimen in an individually sealed bag; Frozen *OR* Swab (Eye, Rectal, or Urethral) in M4 or UTM; Place swab immediately into transport media; Place each specimen in an individually sealed bag; Frozen *OR* Nasopharynx swab in M4 or UTM; On Infants; Place swab immediately into transport media. Place each specimen in an individually sealed bag; Frozen *OR* Peritoneal fluid in M4 or UTM; Place fluid immediately into transport media. Place each specimen in an individually sealed bag; Frozen Days Performed: Sunday–Saturday Reported: 3–4 days

Clorazepate TRANX 75464 Specimen Requirement: 2 mL serum from a red top tube; 11/16/15 Minimum: 1 mL; Do not use serum separator tubes; Separate serum from cells within 2 hours of specimen collection; Refrigerated *OR* 2 mL plasma from an EDTA lavender top tube; Minimum: 1 mL; Do not use plasma separator tubes; Separate plasma from cells within 2 hours of specimen collection; Refrigerated *OR* 2 mL plasma from a sodium heparin green top tube; Minimum: 1 mL; Do not use plasma separator tubes; Separate plasma from cells within 2 hours of specimen collection; Refrigerated Stability: (After separation from cells) Ambient: 1 week Refrigerated: 2 weeks Frozen: 3 years Reference Range: Dose related: 100–1500 ng/mL (based on common dosage amounts) Toxic: > 2500 ng/mL

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Test Name Order Code Billing Code Change Effective Date

Cortisol, Free Serum FRCORT 82971 Specimen Requirement: 1 mL serum from a serum separator tube; 1/4/16 Minimum: 0.6 mL; Recommended collection times are 8-10 a.m. or 4-6 p.m.; Remove serum from cells and freeze within 2 hours of collection; Frozen *OR* 1 mL serum from a red top tube; Minimum: 0.6 mL; Recommended collection times are 8-10 a.m. or 4-6 p.m.; Remove serum from cells and freeze within 2 hours of collection; Frozen *OR* 1 mL plasma from an EDTA lavender top tube; Minimum: 0.6 mL; Recommended collection times are 8-10 a.m. or 4-6 p.m.; Remove plasma from cells and freeze within 2 hours of collection; Frozen Stability: (After separation from cells) Ambient: Unacceptable Refrigerated: 1 week Frozen: 6 months Methodology: Equilibrium Dialysis/Liquid Chromatography– Tandem Mass Spectrometry Reference Range: 0–17 years: Not established ≥ 18 years: 8:00-10:00 a.m.: 0.21–1.04 µg/dL ≥ 18 years: 4:00-6:00 p.m.: 0.10–0.63 µg/dL Days Performed: Sunday, Tuesday, Thursday, Friday Reported: 3–6 days

Cortisol, Plasma PCORT 89351 For Interfaced Clients Only: Test build will need to be modified 10/27/15 Specimen Requirement: 1 mL plasma from a sodium or lithium heparin green top tube; Minimum: 0.3 mL; Separate plasma from cells ASAP and refrigerate; Transport Refrigerated *OR* 1 mL plasma from an EDTA lavender top tube; Minimum: 0.3 mL; Separate plasma from cells ASAP and refrigerate; Transport Refrigerated Stability: Ambient: 1 day Refrigerated: 30 days Frozen: 30 days Methodology: Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS) Reference Range: ≥ 18 years: AM: 4.6–20.6 mcg/dL PM: 1.8–13.6 mcg/dL  Stimulation 30-60 Minutes post 0.25 mg Cosyntropin IV: > 20.0 mcg/dL Pediatric, AM: 1–12 months: 4.6–23.0 mcg/dL 1–5 years: 6.0–25.0 mcg/dL 6–17 years: 4.6–15.0 mcg/dL Pediatric, Stimulation 30-60 Minutes post 0.25 mg Cosyntropin IV: 1–12 months: 32.0–60.0 mcg/dL 1–5 years: 22.0–40.0 mcg/dL 6–17 years: 17.0–28.0 mcg/dL Days Performed: Tuesday, Friday Reported: 2–7 days

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Test Name Order Code Billing Code Change Effective Date

Coxiella Burnetii IgG COXIGG 79536 For Interfaced Clients Only: Test build will need to be modified 1/4/16 Antibodies Specimen Requirement: 1 mL serum from a serum separator tube; Minimum: 0.4 mL; Refrigerated *OR* 1 mL serum from a red top tube; Minimum: 0.4 mL; Refrigerated Stability: Ambient: 2 days Refrigerated: 1 week Frozen: 60 days Reference Range: IgG Phase 1: < 1:16 titer IgG Phase 2: < 1:16 titer Days Performed: Sunday, Wednesday Reported: 2–6 days

Creutzfeldt-Jacob CJD 88751 Clinical Information: If either the 14-3-3 protein or Tau protein 11/19/15 Disease are elevated, confirmatory testing will automatically reflex using real-time quaking induced conversion (RT-QuIC), an assay which detects the presence of PrPSC, the disease-causing agent (Ann Neurol, 2012 Aug; 72(2): 278-285).” Additional cost will apply Special Information: A completed 'Test Request Form' MUST accompany each sample. CSF should be obtained by lumbar puncture. The first 2 mL of CSF that flows from the tap should be discarded. Avoid a bloody tap because RT-QuIC and 14-3-3 protein tests cannot be performed reliably when there is a significant presence of blood in the CSF specimen. Includes: 14-3-3 Protein Tau Protein RT-QuIC, if indicated Specimen Requirement: 5 mL cerebrospinal fluid (CSF) in a clean container; Minimum: 2 mL; Discard first 2 mL of CSF from tap before starting collection. Immediately place sample on ice and freeze within 20 minutes of collection. Avoid a bloody tap; Frozen *AND* (if possible) 100 mL random urine in a clean container; Minimum: 5 mL; Immediately place specimen on ice; A urine sample is requested, but not required, for research purposes only; Frozen Methodology: Enzyme-Linked Immunosorbent Assay (ELISA) Western Blot (WB) Real-time Quaking Induced Conversion (RT-QuIC), if indicated CPT: 84182, 86316

Cysticercus IgG Ab, CYSGCS 80333 Clinical Information: Diagnosis of central nervous system 11/16/15 CSF infections can be accomplished by demonstrating the presence of intrathecally-produced specific antibody. Interpretation of results may be complicated by low antibody levels found in CSF, passive transfer of antibody from blood, and contamination via bloody taps. Specimen Requirement: 1 mL cerebrospinal fluid (CSF) in a clean container; Minimum: 0.2 mL; Refrigerated Days Performed: Monday Reported: 2–9 days

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Test Name Order Code Billing Code Change Effective Date

Cysticercus IgG Ab, CYSGBL 80331 Specimen Requirement: 1 mL serum from a serum separator tube; 11/16/15 Serum Minimum: 0.1 mL; Label specimen as acute or convalescent; Refrigerated *OR* 1 mL serum from a red top tube; Minimum: 0.1 mL; Label specimen as acute or convalescent; Refrigerated Days Performed: Monday Reported: 2–9 days

Cyto P450 2C19–9 2C19PL 88307 For Interfaced Clients Only: Test build will need to be modified 1/4/16 Variants Test Name: Previously Cyto P450 2C19 Genotype Clinical Information: CHARACTERISTICS: The cytochrome P450 (CYP) isozyme 2C19 is involved in the metabolism of many drugs such as Clopidogrel, Phenytoin, Diazepam, R-warfarin, Tamoxifen, some antidepressants, proton pump inhibitors, and antimalarials. Variants of CYP2C19 will influence pharmacokinetics of CYP2C19 substrates, and may predict non-standard dose requirements INHERITANCE: Autosomal recessive. CAUSE: CYP2C19 gene variants result in increased, decreased, or complete deficiency in enzyme activity. VARIANTS TESTED: Decreased function: *9 (rs17884712, c.431G>A); *10 (rs6413438, c.680C>T) Non-functional: *2 (rs4244285, c.681G>A), *3 (rs4986893, c.636G>A), *4 (rs28399504, c.1A>G), *6 (rs72552267, c.395G>A), *7 (rs72558186, c.819+2T>A), *8 (rs41291556, c.358T>C) Increased function: *17 (rs12248560, c.-806C>T) NEGATIVE: No variants detected is predictive of *1 functional alleles and normal enzymatic activity. ALLELE FREQUENCIES: CYP2C19*2: African American 18.3%, Caucasian 14.6%, Middle Eastern 13.2%, Oceanian 54.9%, South Asian 34.4%. CYP2C19*3: African American 0.3%, Caucasian 0.6%, Middle Eastern 2.6%, Oceanian 13.9%, East Asian 8.5%. CYP2C19*17: African American 19.4%, Caucasian 21.5%, Oceanian 2.5%, South Asian 16.5% Other alleles are rare, with allele frequencies of less than 1% in all populations studied. CLINICAL SENSITIVITY: Drug dependent. ANALYTICAL SENSITIVITY & SPECIFICITY: >99% LIMITATIONS: Only the targeted CYP2C19 variants will be detected by this panel. Diagnostic errors can occur due to rare sequence variations. Risk of therapeutic failure or adverse reactions with CYP2C19 substrates may be affected by genetic and non-genetic factors that are not detected by this test. This result does not replace the need for therapeutic drug or clinical monitoring. Includes: CYP2C19 Genotype CYP2C19 Phenotype Stability: Ambient: 72 hours Refrigerated: 2 weeks Frozen: 1 month Methodology: Polymerase Chain Reaction (PCR) Fluorescence Monitoring Days Performed: Monday, Thursday Reported: 6–11 days

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

Dexamethasone DEXA 82965 Specimen Requirement: 1 mL serum from a serum separator tube; 11/16/15 Minimum: 0.5 mL; Collect between 8–10 a.m.; Separate serum from cells within 2 hours of collection; Refrigerated *OR* 1 mL plasma from an EDTA lavender top tube; Minimum: 0.5 mL; Collect between 8–10 a.m.; Separate plasma from cells within 2 hours of collection; Refrigerated *OR* 1 mL plasma from a sodium heparin green top tube; Minimum: 0.5 mL; Collect between 8–10 a.m.; Separate plasma from cells within 2 hours of collection; Refrigerated

Diazepam & DIAZEP 75420 Specimen Requirement: 2 mL serum from a red top tube; 11/16/15 Metabolite Minimum: 1 mL; Do not use serum separator tubes; Separate serum from cells within 2 hours of collection; Refrigerated *OR* 2 mL plasma from an EDTA lavender top tube; Minimum: 1 mL; Do not use plasma separator tubes; Separate plasma from cells within 2 hours of collection; Refrigerated *OR* 2 mL plasma from a sodium heparin green top tube; Minimum: 1 mL; Do not use plasma separator tubes; Separate plasma from cells within 2 hours of collection; Refrigerated Stability: (after separation from cells) Ambient: 1 week Refrigerated: 2 weeks Frozen: 3 years Reference Range: (based on normal dosages) Diazepam: 200–1000 ng/mL Nordiazepam: 100–1500 ng/mL, Critical: > 2500 ng/mL

Digitoxin DIGIT 82640 Reference Range: 10.0–30.0 ng/mL 11/16/15 Toxic: > 45.0 ng/mL

Disopyramide DISOP 34032 Specimen Requirement: 1 mL serum from a red top tube; 11/16/15 (Norpace) Minimum: 0.5 mL; Collect Pre-Dose; Do not use serum separator tubes. Separate serum from cells within 2 hours of collection. Please provide the following information if available: 1.) Dose–List drug amount and include the units of measure 2.) Route–List the route of administration (IV, oral, etc.) 3.) Dose Frequency–Indicate how often the dose is administered (per day, per week, as needed, etc.) 4.) Type of Draw–Indicate the type of blood draw (Peak, Trough, Random, etc.); Refrigerated *OR* 1 mL plasma from an EDTA lavender top tube; Minimum: 0.5 mL; Collect Pre-Dose; Do not use plasma separator tubes. Separate plasma from cells within 2 hours of collection. Please provide the following information if available: 1.) Dose–List drug amount and include the units of measure 2.) Route–List the route of administration (IV, oral, etc.) 3.) Dose Frequency–Indicate how often the dose is administered (per day, per week, as needed, etc.) 4.) Type of Draw–Indicate the type of blood draw (Peak, Trough, Random, etc.); Refrigerated Stability: (after separation from cells) Ambient: 4 days Refrigerated: 1 week Frozen: 2 months Reference Range: 2.0–6.0 µg/mL, Toxic: > 6.0 µg/mL

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

Estrogen, ESTGEN 75491 Reference Range: Effective Fractionated Blood Estradiol (pg/mL) Immediately Male Tanner Stage I: < 12 Tanner Stage II: < 14 Tanner Stage III: 3-44 Tanner Stage IV AND V: 6-44 7-9 years: < 10 10-12 years: < 15 13-15 years: 3-45 16-17 years: 6-43 18-99 years: 14-53 Female Tanner Stage I: < 70 Tanner Stage II: 4-163 Tanner Stage III: 16-337 Tanner Stage IV and V: 4-315 7-9 years: < 45 10-12 years: 3-107 13-15 years: 13-303 16-17 years: 4-323 18–99 years, Early Follicular: 38-123 18–99 years, Late Follicular: 123-485 18–99 years, Luteal: 62-183 18–99 years, Post-Menopausal: 4-27 Estrone (pg/mL) Male Tanner Stage I: < 10 Tanner Stage II: < 15 Tanner Stage III: 3-39 Tanner Stage IV AND V: 4-38 7-9 years: < 10 10-12 years: < 15 13-15 years: 3-38 16-17 years: 3-41 18-99 years: 13-45 Female Tanner Stage I: 35-49 Tanner Stage II: 3-49 Tanner Stage III: 12-143 Tanner Stage IV and V: 7-134 7-9 years: 26-50 10-12 years: 3-50 13-15 years: 12-129 16-17 years: 7-163 18-99 years, Early Follicular: < 183 18-99 years, Late Follicular: 123-304 18-99 years, Luteal: 2-243 18-99 years, Post-Menopausal: 6-41 Total Estrogens: (pg/mL) Male: Tanner Stage I: 3-15 Tanner Stage II: 3-25 Tanner Stage III: 6-76 Tanner Stage IV AND V: 7-77 7-9 years: < 14 10-12 years: 3-25 13-15 years: 6-77 16-17 years: 7-79 18-99 years: 25-85

(continued on page 12)

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

Estrogen, Female: Fractionated Blood Tanner Stage I: 3-106 (continued from Tanner Stage II: 6-206 page 11) Tanner Stage III: 30-426 Tanner Stage IV and V: 12-414 7-9 years: 3-60 10-12 years: 4-142 13-15 years: 20-404 16-17 years: 9-430 18-99 years, Early Follicular: 38-304 18-99 years, Late Follicular: 243-787 18-99 years, Luteal: 62-425 18-99 years, Post-Menopausal: 8-65

Estrone EST 75641 Reference Range: (pg/mL) Effective Male Immediately Tanner Stage I: < 10 Tanner Stage II: < 15 Tanner Stage III: 3-39 Tanner Stage IV AND V: 4-38 7-9 years: < 10 10-12 years: < 15 13-15 years: 3-38 16-17 years: 3-41 18-99 years: 13-45 Female Tanner Stage I: 35-49 Tanner Stage II: 3-49 Tanner Stage III: 12-143 Tanner Stage IV and V: 7-134 7-9 years: 26-50 10-12 years: 3-50 13-15 years: 12-129 16-17 years: 7-163 18-99 years, Early Follicular: < 183 18-99 years, Late Follicular: 123-304 18-99 years, Luteal: 2-243 18-99 years, Post-Menopausal: 6-41

Ethosuximide ETHOS 82692 Special Information: Draw specimen prior to next dose–at steady 11/16/15 state concentration. Please provide the following information if available: 1.) Dose–List drug amount and include the units of measure 2.) Route–List the route of administration (IV, oral, etc.) 3.) Dose Frequency–Indicate how often the dose is administered (per day, per week, as needed, etc.) 4.) Type of Draw–Indicate the type of blood draw (Peak, Trough, Random, etc.) Specimen Requirement: 1 mL serum from a red top tube; Minimum: 0.5 mL; Dosage information is required, see Special Information; Refrigerated *OR* 1 mL plasma from an EDTA lavender top tube; Minimum: 0.5 mL; Dosage information is required, see Special Information; Refrigerated Stability: (after separation from cells) Ambient: 5 days Refrigerated: 1 week Frozen: 2 months

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

Ethylene Glycol ETHYL 77043 Special Information: Detection limit: 5 mg/dL. Potentially toxic: 11/16/15 >20 mg/dL. Toxic concentrations may cause intoxication, CNS depression, metabolic acidosis, renal damage and hypocalcemia. Ethylene glycol is extremely toxic. Ingestion can be fatal if patients do not receive immediate medical treatment. Stability: Ambient: 1 week Refrigerated: 1 week Frozen: 1 month Days Performed: Tuesday, Wednesday, Saturday Reported: 2–5 days

FBN1 Gene FBN1 88568 Specimen Requirement: 4 mL whole blood in an EDTA lavender 1/7/16 Sequencing Analysis top tube; Minimum: 3 mL; Refrigerated Methodology: Sanger Sequencing Days Performed: Monday–Friday Reported: 2–3 weeks

FISH for IgH/BCL2, FSHFCL 81939 Test Name: Previously FISH for IgH/BCL2 12/28/15 Blood or Bone Clinical Information: This assay uses a dual color, dual fusion marrow probe to detect the IGH/BCL2 translocation that is associated with follicular lymphoma and diffuse large B-cell lymphoma. This test should not be used to monitor minimal residual disease. Specimen Requirement: 4 mL bone marrow in an EDTA lavender top tube; Specimens which will not be processed by the laboratory within 72 hours are considered unsatisfactory; Ambient *OR* 4 mL whole blood in an EDTA lavender top tube; Specimens which will not be processed by the laboratory within 72 hours are considered unsatisfactory; Ambient *OR* 4 mL bone marrow in a sodium heparin green top tube; Specimens which will not be processed by the laboratory within 72 hours are considered unsatisfactory; Ambient *OR* 4 mL whole blood in a sodium heparin green top tube; Specimens which will not be processed by the laboratory within 72 hours are considered unsatisfactory; Ambient Days Performed: 3 days per week Reported: 7 days

FISH for IgH/ FSHMCL 81940 Test Name: Previously FISH for IgH/CCND1 12/28/15 CCND1, Blood or Clinical Information: This assay uses a dual color, dual fusion Bone Marrow probe to detect the IGH/CCND1 translocation associated with mantle cell lymphoma. This test should not be used to monitor minimal residual disease. Specimen Requirement: 4 mL bone marrow in an EDTA lavender top tube; Specimens which will not be processed by the laboratory within 72 hours of draw are considered unsatisfactory; Ambient *OR* 4 mL whole blood in an EDTA lavender top tube; Specimens which will not be processed by the laboratory within 72 hours of draw are considered unsatisfactory; Ambient *OR* 4 mL bone marrow in a sodium heparin green top tube; Specimens which will not be processed by the laboratory within 72 hours of draw are considered unsatisfactory; Ambient *OR* 4 mL whole blood in a sodium heparin green top tube; Specimens which will not be processed by the laboratory within 72 hours of draw are considered unsatisfactory; Ambient Days Performed: 3 days per week Reported: 7 days CPT: 88291, 88275, 88271x2

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

Fructosamine FRUCTO 76672 Specimen Requirement: 0.5 mL serum from a serum separator 12/31/15 tube; Minimum: 0.2 mL; Refrigerated *OR* 0.5 mL plasma from a sodium or lithium heparin green top tube; Minimum: 0.2 mL; Refrigerated *OR* 0.5 mL plasma from an EDTA lavender top tube; Minimum: 0.2 mL; Refrigerated

Glucose Screen, GLUC 79121 CPT: 82950 1/4/16 Pregnancy

Hemoglobin, Plasma HGBP 83211 Specimen Requirement: 2 mL plasma from a sodium or lithium 11/16/15 heparin green top tube; Minimum: 0.7 mL; Separate plasma from cells ASAP or within 2 hours of collection; Refrigerated Reference Range: 0.0–9.7 mg/dL Days Performed: Sunday–Saturday Reported: 2–3 days

Homovanillic Acid, UHVA 77385 Clinical Information: Medications which may interfere with 11/16/15 Urine catecholamines and their metabolites include amphetamines and amphetamine-like compounds, appetite suppressants, bromocriptine, buspirone, caffeine, chlorpromazine, clonidine, disulfiram, diuretics (in doses sufficient to deplete sodium), epinephrine, glucagon, guanethidine, histamine, hydrazine derivatives, imipramine, levodopa (L-dopa, Sinemet), lithium, MAO inhibitors, melatonin, methyldopa (Aldomet), morphine, nitroglycerin, nose drops, propafenone (Rythmol), radiographic agents, rauwolfia alkaloids (Reserpine), and vasodilators. The effects of some drugs on catecholamine metabolite results may not be predictable. Methodology: Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS)

Interleukin 28B IL28B 88185 For Interfaced Clients Only: Test build may need to be modified 11/16/15 Associated Variants, Clinical Information: Analytical sensitivity & specificity: 99%. 2 SNPs Limitations: SNPs other than those targeted will not be detected. Mutations in other genes and non-genetic factors that may affect response to Hepatitis C therapy are not detected. For HCV genotypes other than type 1, the usefulness of these SNPs for predicting response to therapy is unknown. Diagnostic errors may occur due to rare sequence variations. Hepatitis C virus is categorized into 6 genotypes and HCV 1 accounts for 75% of U.S. cases. Methodology: Polymerase Chain Reaction (PCR) Single Nucleotide Extension (SNE) CPT: 81400, 81479

JAK2 Exon 12–15 JAKNON 87775 CPT: 81403, G0452 1/5/16 Sequencing

Leukotriene E4, ULTE4 90678 Specimen Requirement: 4 mL urine from a well mixed 24-hour 11/5/15 Urine collection in a clean container; Minimum: 1 mL; No preservatives preferred. Refrigerate during collection. 24-hour volume is required; Refrigerated *OR* 4 mL urine from a random collection in a clean container; Minimum: 1 mL; No preservatives preferred. Refrigerate ASAP; Refrigerated Stability: Ambient: 24 hours Refrigerated: 7 days Frozen: 30 days

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Test Name Order Code Billing Code Change Effective Date

Librium & Metabolite LIBRI 77069 Specimen Requirement: 2 mL serum from a red top tube; 11/16/15 Minimum: 1 mL; Do not use serum separator tubes; Separate serum from cells within 2 hours of collection; Refrigerated *OR* 2 mL plasma from an EDTA lavender top tube; Minimum: 1 mL; Do not use plasma separator tubes; Separate plasma from cells within 2 hours of collection; Refrigerated *OR* 2 mL plasma from a sodium heparin green top tube; Minimum: 1 mL; Do not use plasma separator tubes; Separate plasma from cells within 2 hours of collection; Refrigerated *OR* 2 mL plasma from a potassium oxalate/sodium fluoride gray top tube; Minimum: 1 mL; Separate plasma from cells within 2 hours of collection; Refrigerated Stability: (after separation from cells) Ambient: 1 week Refrigerated: 2 weeks Frozen: 3 years Reference Range: Librium: 500–3,000 ng/mL (based on adult dose 5–100 mg) Critical: > 5,000 ng/mL Nordiazepam: 100–1500 ng/mL (based on normal dosages) Critical: > 2,500 ng/mL

Loxapine LOXAP 75669 For Interfaced Clients Only: Test build may need to be modified 11/24/15 Clinical Information: Reporting limit: 5.0 ng/mL for both Loxapine and 8-Hydroxy-Loxapine Includes: Loxapine 8-Hydroxy-Loxapine Specimen Requirement: 2 mL serum from a red top tube; Minimum: 0.3 mL; Do not use serum separator tubes; Refrigerated *OR* 2 mL plasma from a sodium or lithium heparin green top tube; Minimum: 0.3 mL; Do not use plasma separator tubes; Refrigerated Stability: Ambient: 72 hours Refrigerated: 14 days Frozen: 180 days Methodology: Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS) Reference Range: Loxapine: 5.0–30.0 ng/mL 8-Hydroxy-Loxapine: 20.0–100 ng/mL Days Performed: Sunday–Saturday Reported: 4–9 days CPT: 80342

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

Platelet Antibody PLTDET 86022 Clinical Information: This is the primary test for detection of 11/16/15 Detection platelet-specific antibodies. It is not recommended for the diagnosis of immune thrombocytopenic purpura (ITP). This test will detect both allo and autoantibodies, but will not distinguish between them. Results of this test should be used in conjunction with clinical findings and other serological tests. Antibodies directed to antigens found on platelets are associated with many different clinical situations. Immune thrombocytopenic purpura (ITP) is a destructive thrombocytopenia caused by autoantibodies. Neonatal alloimmune thrombocytopenia (NATP) and post- transfusion purpura (PTP) are diseases where thrombocytopenia is caused by platelet-specific alloantibodies. HLA alloantibodies do not cause thrombocytopenia, but are commonly associated with refractoriness to platelet transfusions. This test is designed to detect antibodies to platelet glycoproteins IIb/IIIa (HPA-1a/1b [P1A1 and P1A2], HPA-3a/3b, and HPA-4a), Ia/IIA (HPA-5a/5b), Ib/IX, and IV. In addition, this test will also detect antibodies to HLA Class 1 antigens (HLA-A-B). Specimen Requirement: 1 mL serum from a red top tube; Minimum: 0.5 mL; Separate serum from cells ASAP. For newborns < 30 days old, collect specimen from the mother; Frozen *OR* 1 mL plasma from an ACD A yellow top tube; Minimum: 0.5 mL; Separate plasma from cells ASAP. For newborns < 30 days old, collect specimen from the mother; Frozen *OR* 1 mL plasma from an EDTA lavender top tube; Minimum: 0.5 mL; Separate plasma from cells ASAP. For newborns < 30 days old, collect specimen from the mother; Frozen *OR* 1 mL serum from a serum separator tube; Minimum: 0.5 mL; Separate serum from cells ASAP. For newborns < 30 days old, collect specimen from the mother; Frozen

Polychlorinated PBPS 89450 Specimen Requirement: 3 mL serum from a red top tube; 11/16/15 Biphenyls Minimum: 1.2 mL; Do not use serum separator tubes. Separate Quantitative, Serum serum from cells within 2 hours of collection; Refrigerated or Plasma *OR* 3 mL plasma from an EDTA lavender top tube; Minimum: 1.2 mL; Do not use plasma separator tubes. Separate plasma from cells within 2 hours of collection; Refrigerated Days Performed: Varies Reported: 6–13 days

Prostate Cancer PCA3 87736 Days Performed: 1 day per week 11/13/15 Biomarker Reported: 7–14 days

Sialic Acid, CSF SIACSF 88642 Specimen Requirement: 1 mL cerebrospinal fluid (CSF) in a clean 10/29/15 container; Minimum: 0.5 mL; Freeze specimen at -80°C; Transport Frozen Methodology: Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS) Reference Range: Free Sialic Acid: 0–6 months: 4–55.0 µMol/L ≥ 6 months: 4–22 µMol/L Total Sialic Acid: 0–6 months: 8–125 µMol/L ≥ 6 months: 8–50 µMol/L Free/Total Ratio: 0.30–0.70 µMol/L CPT: 84275

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Test Name Order Code Billing Code Change Effective Date

Synthetic K2 89621 Includes: 11/23/15 Cannabinoid Synthetic Cannabinoid Screen Metabolite, Screen UR-144 N-pentanoic Acid, if indicated with Confirmation AB-CHMINACA-3-methyl-butanoic Acid, if indicated ADB-PINACA N-pentanoic Acid, if indicated AB-PINACA N-pentanoic Acid, if indicated ADBICA N-pentanoic Acid, if indicated CPT: 80352

Syphilis IgG with SYPHGX 84566 Special Information: 12/29/15 Confirmation Patients > 6 months of age: A weakly reactive or reactive Syphilis IgG (SYPHG) result will be confirmed by RPR at an extra cost. A non-reactive RPR result will have Treponema Pallidum Antibody IgG Confirmation performed at an extra fee. A reactive RPR result will have a RPR quant with titer (RPRQNT) performed at an extra fee. Patients < 6 months of age: A weakly-reactive or reactive SYPHG result will be reported without confirmation. When a Reactive specimen is found, Ohio State law requires completion of an Ohio Department of Health confidential report form.

Torch Antibodies, IgG TORCH 79189 Specimen Requirement: 3 mL serum from serum separator tube(s); 11/24/15 & IgM Allow to clot; Separate serum from cells within two hours of collection; Transfer to THREE aliquot tubes, 1 mL each; Minimum: 2 mL in TWO aliquot tubes with 1 mL each; Refrigerated Methodology: Chemiluminescence Immunoassay (CLIA) Enzyme Immunoassay (EIA) Immunochemiluminometric Assay (ICMA) Days Performed: Monday–Saturday Reported: 2–3 days

Treponema Pallidum FTAABS 86650 Test Name: Previously FTA, Syphilis IgG Confirmation Test 12/29/15 Antibody, IgG

Vanillylmandelic UVAHA 89313 Specimen Requirement: 4 mL well mixed urine from a 24-hour 11/16/15 Acid (VMA) & collection in a clean container; Minimum: 1 mL; Refrigerate during Homovanillic Acid collection. Abstain from medications 72 hours prior to collection; (HVA), Urine Refrigerated *OR* 4 mL random urine in a clean container; Minimum: 1 mL; Abstain from medications 72 hours prior to collection; Refrigerated Methodology: High Performance Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS) Reference Range: VMA, Urine: 18–99 years: 0.0–7.0 mg/d All other Reference Ranges are unchanged Days Performed: Sunday, Tuesday–Saturday Reported: 2–5 days

Varicella Zoster by VZPCR 77127 Specimen Requirement: 1 mL cerebrospinal fluid (CSF) in a sterile 12/3/15 PCR container; Minimum: 0.5 mL; Specimen source is required; Frozen *OR* 1 mL plasma from an EDTA lavender top tube; Minimum: 0.5 mL; Specimen source is required; Frozen *OR* 1 mL serum from a serum separator tube; Minimum: 0.5 mL; Specimen source is required; Frozen *OR* Tissue in a sterile container; Freeze immediately; Specimen source is required; Transport Frozen *OR* Vesicle fluid swab in M4 or UTM; Place into transport media ASAP and freeze; Specimen source is required; Frozen

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Test Name Order Code Billing Code Change Effective Date

Warfarin Sensitivity WARSEN 88301 For Interfaced Clients Only; Test build will need to be modified 1/4/16 Genotyping Clinical Information: CHARACTERISTICS: The cytochrome P450 (CYP) isozyme 2C9 is involved in the metabolism of many drugs such as Warfarin, Phenytoin, Tolbutamide, Glipizide, Ibuprofen, and Phenobarbital. Variants of CYP2C9 will influence pharmacokinetics of CYP2C9 substrates, and may predict non-standard dose requirements. Warfarin sensitivity can lead to a life-threatening overdose event such as excessive bleeding. Genetic variation is recognized to explain a large proportion of variability in warfarin dose requirements. This test may predict individual warfarin sensitivity and non-standard dose requirements. The VKORC1 test should be performed in combination with the CYP2C9 test for application to warfarin dose estimates, such as through www.WarfarinDosing.org. CAUSE: CYP2C9 gene variants result in decreased or complete deficiency in enzyme activity. The VKORC1*2 allele is associated with reduced expression of the Warfarin target, vitamin K epoxide reductase (VKOR), and a reduced dose requirement. CYP2C9 gene variants result in decreased or complete deficiency in enzyme activity that will reduce metabolism and prolong the half- life of Warfarin. VARIANTS TESTED: Decreased function: *2 (rs1799853, c.430C>T) Non-functional: *3 (rs1057910, c.1075A>C).A). VKORC1*2 (rs9923231, c.-1639G>A) ALLELE FREQUENCIES: CYP2C9 *2: Caucasians 13%, Asians <1%, African Americans 3% CYP2C9 *3: Caucasians 7%, Asians 4%, African Americans 2% VKORC1: VKORC1*2: Caucasians 39%, Asians 91%, African Americans 11% CLINICAL SENSITIVITY: CYP2C9: Drug-dependent VKORC1: Approximately 90% of CYP2C9 and VKORC1 variants causing Warfarin sensitivity in Caucasians are detected when both tests are performed. Less characterized in other populations. ANALYTICAL SENSITIVITY & SPECIFICITY: >99% Clinical Information: LIMITATIONS: Only the targeted CYP2C9 or VKORC1 variants will be detected by this panel. Diagnostic errors can occur due to rare sequence variations. Risk of therapeutic failure or adverse reactions with CYP2C9 substrates and/or Warfarin may be affected by genetic and non-genetic factors that are not detected by this test. This result does not replace the need for therapeutic drug or clinical monitoring. Includes: Warfarin Predicted Sensitivity CYP2C9 Genotype CYP2C9 Phenotype VKORC1 Genotype Specimen Requirement: 3 mL whole blood in an EDTA lavender top tube; Refrigerated *OR* 3 mL whole blood in an ACD A or B yellow top tube; Refrigerated Stability: Ambient: 72 hours Refrigerated: 2 weeks Frozen: 1 month Methodology: Polymerase Chain Reaction (PCR) Fluorescence Monitoring Days Performed: Monday, Thursday Reported: 6–11 days

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 18 New Tests

Test Name Order Code Billing Code Test Information Effective Date

FISH for BCL6, BCL6FH 90761 Clinical Information: This assay uses a dual color, break-apart 12/28/15 Blood or Bone probe to detect BCL6 translocations. Marrow Specimen Requirement: 4 mL bone marrow in an EDTA lavender top tube; Specimens which will not be processed by the performing laboratory within 72 hours of draw are considered unsatisfactory; Ambient *OR* 4 mL blood in an EDTA lavender top tube; Specimens which will not be processed by the performing laboratory within 72 hours of draw are considered unsatisfactory; Ambient *OR* 4 mL bone marrow in a sodium heparin green top tube; Specimens which will not be processed by the performing laboratory within 72 hours of draw are considered unsatisfactory; Ambient *OR* 4 mL blood in a sodium heparin green top tube; Specimens which will not be processed by the performing laboratory within 72 hours of draw are considered unsatisfactory; Ambient Stability: Ambient: 24 hours Refrigerated: 24 hours Frozen: Unacceptable Methodology: Fluorescent In-Situ Hybridization (FISH) Days Performed: 3 days per week Reported: 7 days CPT: 88291, 88275, 88271x2 Price: $495.00

FISH for MYC MYCFSH 90762 Clinical Information: This assay uses a dual color, break-apart 12/28/15 (8q24), Blood or probe to detect translocations involving the MYC gene. MYC Bone Marrow translocations are seen in a wide variety of malignant lymphomas including Burkitt lymphoma, diffuse large B-cell lymphoma, and others. Specimen Requirement: 4 mL bone marrow in an EDTA lavender top tube; Specimens which will not be processed by the performing laboratory within 72 hours of draw are considered unsatisfactory; Ambient *OR* 4 mL blood in an EDTA lavender top tube; Specimens which will not be processed by the performing laboratory within 72 hours of draw are considered unsatisfactory; Ambient *OR* 4 mL bone marrow in a sodium heparin green top tube; Specimens which will not be processed by the performing laboratory within 72 hours of draw are considered unsatisfactory; Ambient *OR* 4 mL blood in a sodium heparin green top tube; Specimens which will not be processed by the performing laboratory within 72 hours of draw are considered unsatisfactory; Ambient Stability: Ambient: 24 hours Refrigerated: 24 hours Frozen: Unacceptable Methodology: Fluorescent In-Situ Hybridization (FISH) Days Performed: 3 days per week Reported: 7 days CPT: 88271x2, 88275, 88291 Price: $495.00

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Test Name Order Code Billing Code Test Information Effective Date

Group A GASPCR 90760 Special Information: Calcium alginate swabs, dry swabs, wood 1/12/16 Streptococcus by swabs or swabs received in gel or charcoal preservatives will be PCR rejected. Swabs received greater than 72 hours from collection will be rejected. Specimen Requirement: Throat swab in Amies or Stuart's media without charcoal; Transport Ambient or Refrigerated *OR* Throat ESwab (Copan Liquid Amies Elution Swab); Transport Ambient or Refrigerated Stability: Ambient: 72 hours Refrigerated: 72 hours Frozen: Unacceptable Methodology: Polymerase Chain Reaction (PCR) Reference Range: Negative for Group A Streptococcus Days Performed: Sunday–Saturday Reported: 1–2 days CPT: 87651 Price: $90.00

Fee Increases

Test Name Order Code Billing Code List Fee CPT Code Effective Date

Nitrogen, Total, Feces NITF 90663 $273.00 (non- 84999 11/3/15 discountable)

Sialic Acid, CSF SIACSF 88642 $230.00 (non- 84275 10/29/15 discountable)

Fee Reductions

Test Name Order Code Billing Code List Fee CPT Code Effective Date

Cortisol COR 83533 $61.00 82533 11/2/15

Cyto P450 2C19 – 9 Variants 2C19PL 88307 $218.00 (non- 81225 1/4/16 discountable)

FISH for IgH/CCND1, Blood or Bone Marrow FSHMCL 81940 $495.00 (non- 88291, 12/28/15 discountable) 88275, 88271x2

Loxapine LOXAP 75669 $105.00 (non- 80342 11/24/15 discountable)

Warfarin Sensitivity Genotyping WARSEN 88301 $525.00 81227, 1/4/16 81355

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 20 Discontinued Tests

Test Name Order Code Billing Code Test Information Effective Date

CA199, Fluid FCA199 89330 This test will no longer be available. 12/29/15

Strep Group A DNA STREPA 76571 This test will no longer be available. Suggest ordering Group A 1/12/16 Probe Streptococcus by PCR (GASPCR)

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 21