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February 2020 Cleveland Clinic Laboratories Technical Update • February 2020 Cleveland Clinic Laboratories is dedicated to keeping you updated and informed about recent testing changes. This Technical Update is provided on a monthly basis to notify you of any changes to the tests in our catalog. Recently changed tests are bolded, and they could include revisions to methodology, reference range, days performed, or CPT code. Deleted tests and new tests are listed separately. For your convenience, tests are listed alphabetically and order codes are provided. To compare the new information with previous test information, refer to the online Test Directory at clevelandcliniclabs. com. Test information is updated in the online Test Directory on the Effective Date stated in the Technical Update. Please update your database as necessary. For additional detail, contact Client Services at 216.444.5755 or 800.628.6816, or via email at [email protected]. Days Performed/Reported Specimen Requirement Component Change(s) Special Information Test Discontinued Reference Range Name Change Test Update Methodology Order Code New Test Stability Page # CPT Summary of Changes Fee by Test Name 3 5' Nucleotidase 3 Acetoacetate 3 AFB Culture Only 3 ALL NGS Panel Bone Marrow 3 ALL NGS Panel Peripheral Blood 3 Aluminum 4 Amylase, Pancreatic 4 Anti IgA Antibody 4 Anti-Platelet Factor 4 4–5 Arsenic, Urine 24 Hr 5 Aspirin/Clopidogrel Resistance (Aggregation) Panel 14 Bence Jones Protein, Qt Free Kappa/Lambda Light Chains 5 Carnitine, Free and Total, Urine by Tandem Mass Spectrometry 5 Chromium, Serum 5 Chromosome Analysis with Reflex AML FISH panel 6 Chromosome Analysis with Reflex MDS FISH 6 Coxsackie B Abs 6 Cryptosporidium & Giardia Antigens by EIA 6 Diltiazem 6 Duchenne/Becker Muscular Dystrophy (DMD) Deletion/Duplication with Reflex to Sequencing 6 Echovirus Antibodies 9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 1 Days Performed/Reported Specimen Requirement Component Change(s) Special Information Test Discontinued Reference Range Name Change Test Update Methodology Order Code New Test Stability Page # CPT Summary of Changes Fee by Test Name 7 F2 Isoprostane/Creatinine Ratio 14 Factor XIII V34L DNA 13 Free Light Chains, Quantitative, Urine 7 Gamma-Hydroxybutyric Acid, Serum 7 Hemoglobin, Plasma 7 Heparin Anti Xa Assay 7 Herpes Simplex IgM, Abs 7 Herpesvirus 6, Qual, Plasma, PCR 7 HSV 1,2 Antibodies, IgG and IgM 7–8 Hydroxylase-21 Antibody 8 Iodine, Urine 14 KIT Mutation Exons 8-11 and 17, Hematologic Neoplasms, Sequencing 8 Leptospira Antibody, IgM by Dot Blot 9 Lipid Associated Sialic Acid 9 Manganese, Serum 9 Methylmalonic Acid Blood 9 Myeloid NGS Panel Bone Marrow 9 Myeloid NGS Panel Peripheral Blood 10 Opiates Confirmation, Quantitation Serum/Plasma 10 PML/RARA RTPCR 10 Protein, Urine Qualitative 10 Pseudocholinesterase, Total, Serum 11 Selenium, Plasma or Serum 11 Strongyloides IgG Abs, Serum 12 Trypanosoma cruzi Antibody, IgM 12 Urinalysis Only 12 Urinalysis with Microscopic 14 Urine Kappa/Lambda Free Light Chains (FLC) with Ratio 12 Varicella Zoster IgG Ab, CSF 14 Williams Syndrome, 7q11.23 Deletion, FISH 14 X-Linked Intellectual Disability (XLID) 9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 2 Test Changes Test Name Order Code Change Effective Date 5' Nucleotidase NUC5P Special Information: Avoid hemolysis. This test is New York DOH approved. 2/18/20 Clinical Information: Determine whether enzyme elevation is due to hepatocellular or cholestatic pattern. Specimen Requirement: 1 mL serum from a serum separator (gold) tube; Minimum: 0.2 mL; Separate serum from cells ASAP or within 2 hours of collection and transfer into a standard aliquot tube; Avoid hemolysis; Refrigerated Days Performed: Sunday–Saturday Reported: 2–4 days Acetoacetate ACETAC Special Information: Serum gel tubes, plasma gel tubes, and specimens received Effective at room temperature are unacceptable. immediately Stability: Ambient: Unacceptable Refrigerated: 4 days Frozen: 4 days (preferred) Days Performed: Monday–Sunday Reported: 9–12 days AFB Culture Only AFCO Special Information: An acid-fast bacilli (AFB) stain will not be performed. Blood Effective cultures for AFB should ideally be drawn prior to administration of antimicrobials. immediately Patient Preparation: For blood cultures, select vein to use. Wipe off venipuncture site using a 70% alcohol pad. Apply Chloraprep to the skin over the selected venipuncture site and apply using up and down and back and forth strokes for a full 30 seconds. Allow the site to dry completely for 30–60 seconds. Swab septum of Isolator tube or Myco/F bottle using 70% alcohol. Draw 10 mL into adult Isolator tube, 1.5 mL into pediatric Isolator tube, or 5 mL if direct draw into the Myco/ F bottle. After inoculation, clean septum with 70% alcohol. Transport to Microbiology laboratory at Cleveland Clinic Laboratories within 4–6 hours is recommended. Do NOT transport glass Myco/F bottles using the pneumatic tube system. ALL NGS Panel Bone ALLMRW Special Information: The following genes are interrogated: ABL1, CBL, CDKN2A, Effective Marrow EED, ETV6, EZH2, FBXW7, FLT3, IKZF1, JAK2, JAK3, KDM6A, KMT2A, KRAS, immediately NOTCH1, NRAS, PAX5, PHF6, PTEN, RUNX1, SH2B3, STAT5B, SUZ12, TET2, TP53, and WT1 ALL NGS Panel ALLPBL Special Information: Genes interrogated on the panel: ABL1, CBL, CDKN2A, Effective Peripheral Blood EED, ETV6, EZH2, FBXW7, FLT3, IKZF1, JAK2, JAK3, KDM6A, KMT2A, KRAS, immediately NOTCH1, NRAS, PAX5, PHF6, PTEN, RUNX1, SH2B3, STAT5B, SUZ12, TET2, TP53, and WT1 Aluminum ALUM Special Information: Diet, medication, and nutritional supplements may introduce 2/18/20 interfering substances. Patient should be encouraged to discontinue nutritional supplements, vitamins, minerals, and non-essential over-the-counter medications (upon the advice of their physician). Unacceptable conditions: Plasma. Specimens that are not separated from the red cells or clot within 2 hours. Specimens collected and/or transported in containers other than specified. This test is New York DOH approved. Clinical Information: Serum aluminum may be useful in the assessment of aluminum toxicity due to dialysis and is the preferred test for routine screening. Serum aluminum > 50.0 µg/L is consistent with overload and may correlate with toxicity. Elevated levels of aluminum in serum should be confirmed with a second specimen due to a high susceptibility of the specimen to collection-related environmental contamination. Stability: Ambient: Indefinitely Refrigerated: Indefinitely Frozen: Indefinitely (If the specimen is drawn and stored in the appropriate container, the trace element values do not change with time) 9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 3 Test Changes (Cont.) Test Name Order Code Change Effective Date Amylase, Pancreatic AMYLPS Special Information: Grossly hemolyzed, grossly lipemic, or grossly icteric 1/28/20 specimens will be rejected. Specimen Requirement: 1 mL serum from a serum separator (gold) tube; Minimum: 0.5 mL; Centrifuge and transfer 1 mL serum into a standard plastic aliquot tube; Refrigerated *OR* 1 mL serum from a plain no additive (red) tube; Minimum: 0.5 mL; Centrifuge and transfer 1 mL serum into a standard plastic aliquot tube; Refrigerated Methodology: Colorimetry Reference Range: 0–23 Months: 0–20 U/L 2–17 Years: 9–35 U/L 18–99 Years: 13–53 U/L Days Performed: Monday–Saturday Reported: 2–5 days Anti IgA Antibody ANTGA Stability: 2/18/20 Ambient: 1 week Refrigerated: 1 week Frozen: 2 weeks Anti-Platelet Factor 4 PLATF4 Reference Range: 3/29/20 Anti-Platelet Factor 4 (0–99 Years): < 0.400 OD PF4 Interpretation: Negative Arsenic, Urine 24 Hr UARSND Special Information: Patient demographics (Heavy Metals) form is required to 2/18/20 meet State Health Department requirements. Indicate total volume. 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. Collection of urine specimens from patients receiving iodinated or gadolinium-based contrast media should be avoided for a minimum of 72 hours post-exposure. Collection from patients with impaired kidney function should be avoided for a minimum of 14 days post contrast media exposure. Urine specimens collected within 72 hours after administration of iodinated or 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-free transport tube (with the exception of the original device) are unacceptable. ARUP studies indicate that refrigeration of urine alone, during and after collection, preserves specimens adequately if tested within 14 days of collection. This test is New York DOH approved. Specimen Requirement: 8 mL 24-hour urine (well-mixed) in a clean container; Minimum: 2 mL; Refrigerate during collection; HEAVY METALS FORM REQUIRED to meet State Health Department requirements; Must collect in a plastic container; Specimen must not come into contact with glass or metal; Patient Prep: Diet, medication, and nutritional supplements may introduce interfering substances; Patients
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