Technical Update • November 2015

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 1

Technical Update • November 2015

Cleveland Clinic Laboratories

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].

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

Summary of Changes by Test Name

Order CodeBilling Code

Nam

e ChangeN

ew Test

Test DiscontinuedSpecial Inform

ation

Specimen Requirem

entCom

ponent(s)M

ethodologyReference Range

Days Performed/Reported

Stability

CPT

Fee

Test Update

Page #


Summary of Changes by Test Name

9, 20 Cyto P450 2C19 – 9 Variants

10 Dexamethasone

10 Diazepam & Metabolite

10 Digitoxin

10 Disopyramide (Norpace)

11, 12

Estrogen, Fractionated Blood

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, 20

FISH for IgH/CCND1, Blood or Bone Marrow

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, 20

Loxapine

20 Nitrogen, Total, Feces

16 Platelet Antibody Detection

16 Polychlorinated Biphenyls Quantitative, Serum or Plasma

16 Prostate Cancer Biomarker

16, 20

Sialic Acid, CSF

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, 20

Warfarin Sensitivity Genotyping

Test Update

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Order CodeBilling Code

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Test Changes

Test Name Order Code Billing Code Change Effective Date

14-3-3 Protein, CSF PR1433 90158 Special Information: Specimens that have not been kept 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

11/5/15

Alcohol, Blood Confirmation

BALCO 79879 Special Information: For medical purposes only. Timing of 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


12/29/15


Antimony, Urine ANTIMU 77009 For Interfaced Clients only: Test build will need to be modified

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



1/4/16

Arsenic, Fractionated Urine

UASFR 88171 Special Information: Indicate total volume. Submit a Heavy Metal 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

11/16/15

Arsenic, Urine 24 Hour

UARSND 30120 Clinical Information: If total arsenic concentration is between 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.

1/5/16

Barbiturates Confirmation, Urine

UBARBC 90310 For Interfaced Clients Only: Test build will need to be modified

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.

10/22/15

Test Changes (Cont.)




Buprenorphine and Metabolites, Confirm/Qt, Serum/Plasma

SBUP 89772 For Interfaced Clients Only: Test build will need to be modified

Special Information: For medical purposes only, not valid for 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


1/4/16

Calpain 3 DNA Sequencing Test

CALP3 83055 For Interfaced Clients Only: Test build will need to be modified

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


12/23/15

Celiac Associated HLA-DQ genotyping

CELIA 82969 CPT: 81382x2 11/3/15

Celiac Gluten Free Panel

CELGLU 90711 CPT: 81382x2 11/3/15



CEA, Fluid CEAFL 77619 For Interfaced Clients Only: Test build will need to be modified

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)



12/29/15

Chlamydia trachomatis Culture

CTRACH 83315 Specimen Requirement: Endocervical swab in M4 or Universal 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



12/3/15

Clorazepate TRANX 75464 Specimen Requirement: 2 mL serum from a red top tube; 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

11/16/15




Cortisol, Free Serum FRCORT 82971 Specimen Requirement: 1 mL serum from a serum separator 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 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


1/4/16

Cortisol, Plasma PCORT 89351 For Interfaced Clients Only: Test build will need to be modified

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


10/27/15




Coxiella Burnetii IgG Antibodies

COXIGG 79536 For Interfaced Clients Only: Test build will need to be modified

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


1/4/16

Creutzfeldt-Jacob Disease

CJD 88751 Clinical Information: If either the 14-3-3 protein or Tau protein 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

11/19/15

Cysticercus IgG Ab, CSF

CYSGCS 80333 Clinical Information: Diagnosis of central nervous system 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


11/16/15




Cysticercus IgG Ab, Serum

CYSGBL 80331 Specimen Requirement: 1 mL serum from a serum separator tube; 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


11/16/15

Cyto P450 2C19–9 Variants

2C19PL 88307 For Interfaced Clients Only: Test build will need to be modified

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



1/4/16




Dexamethasone DEXA 82965 Specimen Requirement: 1 mL serum from a serum separator tube; 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

11/16/15

Diazepam & Metabolite

DIAZEP 75420 Specimen Requirement: 2 mL serum from a red top tube; 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

11/16/15

Digitoxin DIGIT 82640 Reference Range: 10.0–30.0 ng/mL

Toxic: > 45.0 ng/mL

11/16/15

Disopyramide (Norpace)

DISOP 34032 Specimen Requirement: 1 mL serum from a red top tube; 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:




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

11/16/15




Estrogen, Fractionated Blood

ESTGEN 75491 Reference Range:

Estradiol (pg/mL)

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)


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)

Effective Immediately




Estrogen, Fractionated Blood (continued from page 11)

Female: Tanner Stage I: 3-106 Tanner Stage II: 6-206 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)


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

Effective Immediately

Ethosuximide ETHOS 82692 Special Information: Draw specimen prior to next dose–at steady state concentration. Please provide the following information if available:




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

11/16/15




Ethylene Glycol ETHYL 77043 Special Information: Detection limit: 5 mg/dL. Potentially toxic: >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


11/16/15

FBN1 Gene Sequencing Analysis

FBN1 88568 Specimen Requirement: 4 mL whole blood in an EDTA lavender top tube; Minimum: 3 mL; Refrigerated

Methodology: Sanger Sequencing

Days Performed: Monday–Friday

Reported: 2–3 weeks

1/7/16

FISH for IgH/BCL2, Blood or Bone marrow

FSHFCL 81939 Test Name: Previously FISH for IgH/BCL2

Clinical Information: This assay uses a dual color, dual fusion 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

12/28/15

FISH for IgH/CCND1, Blood or Bone Marrow

FSHMCL 81940 Test Name: Previously FISH for IgH/CCND1

Clinical Information: This assay uses a dual color, dual fusion 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


Reported: 7 days

CPT: 88291, 88275, 88271x2

12/28/15




Fructosamine FRUCTO 76672 Specimen Requirement: 0.5 mL serum from a serum separator 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

12/31/15

Glucose Screen, Pregnancy

GLUC 79121 CPT: 82950 1/4/16

Hemoglobin, Plasma HGBP 83211 Specimen Requirement: 2 mL plasma from a sodium or lithium 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



11/16/15

Homovanillic Acid, Urine

UHVA 77385 Clinical Information: Medications which may interfere with 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.


11/16/15

Interleukin 28B Associated Variants, 2 SNPs

IL28B 88185 For Interfaced Clients Only: Test build may need to be modified

Clinical Information: Analytical sensitivity & specificity: 99%. 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

11/16/15

JAK2 Exon 12–15 Sequencing

JAKNON 87775 CPT: 81403, G0452 1/5/16

Leukotriene E4, Urine

ULTE4 90678 Specimen Requirement: 4 mL urine from a well mixed 24-hour 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

11/5/15




Librium & Metabolite LIBRI 77069 Specimen Requirement: 2 mL serum from a red top tube; 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

11/16/15

Loxapine LOXAP 75669 For Interfaced Clients Only: Test build may need to be modified

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


Reference Range: Loxapine: 5.0–30.0 ng/mL 8-Hydroxy-Loxapine: 20.0–100 ng/mL



CPT: 80342

11/24/15




Platelet Antibody Detection

PLTDET 86022 Clinical Information: This is the primary test for detection of 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

11/16/15

Polychlorinated Biphenyls Quantitative, Serum or Plasma

PBPS 89450 Specimen Requirement: 3 mL serum from a red top tube; Minimum: 1.2 mL; Do not use serum separator tubes. Separate serum from cells within 2 hours of collection; Refrigerated

*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


11/16/15

Prostate Cancer Biomarker

PCA3 87736 Days Performed: 1 day per week


11/13/15

Sialic Acid, CSF SIACSF 88642 Specimen Requirement: 1 mL cerebrospinal fluid (CSF) in a clean container; Minimum: 0.5 mL; Freeze specimen at -80°C; Transport Frozen


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

10/29/15




Synthetic Cannabinoid Metabolite, Screen with Confirmation

K2 89621 Includes: Synthetic Cannabinoid Screen UR-144 N-pentanoic Acid, if indicated 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

11/23/15

Syphilis IgG with Confirmation

SYPHGX 84566 Special Information:

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.

12/29/15

Torch Antibodies, IgG & IgM

TORCH 79189 Specimen Requirement: 3 mL serum from serum separator tube(s); 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


11/24/15

Treponema Pallidum Antibody, IgG

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

Vanillylmandelic Acid (VMA) & Homovanillic Acid (HVA), Urine

UVAHA 89313 Specimen Requirement: 4 mL well mixed urine from a 24-hour collection in a clean container; Minimum: 1 mL; Refrigerate during collection. Abstain from medications 72 hours prior to collection; 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


11/16/15

Varicella Zoster by PCR

VZPCR 77127 Specimen Requirement: 1 mL cerebrospinal fluid (CSF) in a sterile 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

12/3/15




Warfarin Sensitivity Genotyping

WARSEN 88301 For Interfaced Clients Only; Test build will need to be modified

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



1/4/16




New Tests

Test Name Order Code Billing Code Test Information Effective Date

FISH for BCL6, Blood or Bone Marrow

BCL6FH 90761 Clinical Information: This assay uses a dual color, break-apart probe to detect BCL6 translocations.

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)


Reported: 7 days

CPT: 88291, 88275, 88271x2

Price: $495.00

12/28/15

FISH for MYC (8q24), Blood or Bone Marrow

MYCFSH 90762 Clinical Information: This assay uses a dual color, break-apart probe to detect translocations involving the MYC gene. MYC 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


Methodology: Fluorescent In-Situ Hybridization (FISH)


Reported: 7 days

CPT: 88271x2, 88275, 88291

Price: $495.00

12/28/15


New Tests (Cont.)


Group A Streptococcus by PCR

GASPCR 90760 Special Information: Calcium alginate swabs, dry swabs, wood swabs or swabs received in gel or charcoal preservatives will be 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


Methodology: Polymerase Chain Reaction (PCR)

Reference Range: Negative for Group A Streptococcus



CPT: 87651

Price: $90.00

1/12/16

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-discountable)

81225 1/4/16

FISH for IgH/CCND1, Blood or Bone Marrow FSHMCL 81940 $495.00 (non-discountable)

88291, 88275, 88271x2

12/28/15

Loxapine LOXAP 75669 $105.00 (non-discountable)

80342 11/24/15

Warfarin Sensitivity Genotyping WARSEN 88301 $525.00 81227, 81355

1/4/16

Fee Increases

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

Nitrogen, Total, Feces NITF 90663 $273.00 (non-discountable)

84999 11/3/15

Sialic Acid, CSF SIACSF 88642 $230.00 (non-discountable)

84275 10/29/15


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

Strep Group A DNA Probe

STREPA 76571 This test will no longer be available. Suggest ordering Group A Streptococcus by PCR (GASPCR)

1/12/16

Discontinued Tests


Documents

Technical Update • November 2015