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  • Clozapine

    Creatinine, Serum or Plasma Ordering Recommendation Screening test to evaluate kidney function. Methodology Quantitative Enzymatic Assay Performed Mon-Sat Reported Within 24 Hours New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Collect: Plasma separator tube or serum separator tube. Specimen Preparation: Allow serum tube to clot completely at room temperature. Separate serum or plasma from cells within 2 hours of collection. Transfer 1 mL serum or plasma to a standard transport tube. (Min: 0.2 mL) Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Specimens obtained through catheters used to infuse hyperalimentation fluid. Specimens with potassium oxalate/sodium fluoride, citrate, or EDTA as anticoagulants. Remarks: Stability: After separation from cells: Ambient: 1 week; Refrigerated: 1 week; Frozen: 3 months Reference Interval By Report Interpretive Data Note Assay interference (negative) may be observed when high concentrations of N-acetylcysteine (NAC) are present. Negative interference has also been reported with NAPQI (an acetaminophen metabolite) but only with concentrations at or above those expected during acetaminophen overdose. CPT Code 82565 Components Component Test Code Component Chart Name LOINC 0020025 Creatinine, Serum or Plasma 2160-0 3004293 UH EGFR Aliases Blood Creatinine Serum Creatinine

  • Clozapine

    Clozapine and Metabolites, Serum or Plasma, Quantitative Ordering Recommendation Optimize drug therapy and monitor patient adherence. Methodology Quantitative Liquid Chromatography-Tandem Mass Spectrometry Performed Mon-Sat Reported 1-5 Days New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Timing of specimen collection: Predose(trough) draw - at steady -state concentration. Collect: Plain red. Also acceptable: Lavender (K2 or K3EDTA) or pink (K2EDTA). Specimen Preparation: Separate serum or plasma from cells within 2 hours of collection. Transfer 1 mL serum or plasma to a standard transport tube.(Min: 0.5 mL) Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Whole blood. Gel separator tubes, light blue (citrate), or yellow (SPS or ACD solution). Remarks: Stability: After separation from cells: Ambient: 24 hours; Refrigerated: 1 week; Frozen: 3 months Reference Interval Therapeutic Range Not well established Toxic Level Total Clozapine and Metabolites: Greater than or equal to 1500 ng/mL Interpretive Data Therapeutic ranges are not well established. Clozapine is metabolized to norclozapine and clozapine-N-oxide. Clozapine concentrations between 100 and 700 ng/mL may correlate more with clinical response; however, nonresponsiveness may also occur within this range. For refractory schizophrenia, clozapine concentrations greater than 350 ng/mL are suggested to achieve a therapeutic response. Toxicity: Adverse effects to clozapine therapy may include tachycardia, drowsiness, hypotension, and seizures. Therapeutic and toxic ranges are not well established in children. Note CPT Code 80159 Components Component Test Code Component Chart Name LOINC 2013458 Clozapine, S/P, Quant 6896-5 2013459 Norclozapine, S/P, Quant 10992-6 2013460 Clozapine-N-Oxide, S/P, Quant 85497-6 2013461 Total Clozapine and Metabolites 12375-2 Aliases Clopine Clozaril Denzapine FazaClo Versacloz Zaponex

  • Carbamazepine, Free and Total, Serum or Plasma

    Carbamazepine, Free and Total, Serum or Plasma Ordering Recommendation Optimize drug therapy and monitor patient adherence. Methodology Quantitative Enzyme Multiplied Immunoassay Technique Performed Mon-Sat Reported 1-5 Days New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Collect: Serum Pre-dose (Trough) Draw - At a Steady State Concentration in Plain Red. Specimen Preparation: Separate from cells ASAP or within 2 hours of collection. Transfer 2 mL serum to a Standard Transport Tube. (Min: 1 mL) Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Whole Blood, Citrated Plasma. Tubes that contain liquid anticoagulant.or Serum separator tube (SST). Remarks: Stability: Ambient: 5 days; Refrigerated: 5 days; Frozen: 3 months Reference Interval Test Number Components Reference Interval Total Carbamazepine Free Carbamazepine Therapeutic Range: 4.0-12.0 µg/mL Toxic Range: Greater than 15 µg/mL Therapeutic Range: 1.0-3.0 µg/mL Toxic Range: Greater than 3.8 µg/mL Percent Free Carbamazepine 8.0-35.0% Interpretive Data The therapeutic range is based on serum pre-dose (trough) draw at steady-state concentration. Free carbamazepine may be important to monitor in patients with altered or unpredictable protein binding capacity. Carbamazepine is also subject to drug-drug interactions due to displacement of protein binding and extensive metabolism. Cross-reactivity with metabolites may account for differences in carbamazepine among analytical methods. Calculating percent free attempts to minimize differences in assay cross-reactivity and may be useful in dose optimization. A rare adverse drug reaction to carbamazepine therapy includes Stevens-Johnson syndrome or toxic epidermal necrolysis. Patients of Asian ancestry with the presence of the HLA-B*15:02 have an increased risk for this carbamazepine-induced life-threatening reaction. Pharmacogenetic testing for HLA-B*15:02 is recommended for patients at risk for carbamazepine hypersensitivity prior to treatment. This information has been included in the FDA-approved label for carbamazepine (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm) and guideline from the Clinical Pharmacogenetics Implementation Consortium (https://www.pharmgkb.org/guidelines). A combination of therapeutic drug monitoring with HLA-B*15:02 pharmacogenetics genotyping may benefit patients who are at increased risk for developing carbamazepine-induced adverse events due to rare genotypes other than HLA-B*15:02 variant allele. Note CPT Code 80156; 80157 Components Component Test Code Component Chart Name LOINC 2011768 Free Carbamazepine 3433-0 2011769 Percent Free Carbamazepine 32852-6 2011770 Total Carbamazepine 3432-2 Aliases Atretol Biston Calesin Carbamazepin, Free Carbatrol Epimaz Epitol Epitrol Equetro Finlepsin Free Carbamazepine Free Tegretol Protein Free Carbamazepine Sirtal Tegretol, Free Telesmin

  • Urea Nitrogen, Serum or Plasma (BUN)

    Ammonia, Plasma Ordering Recommendation Screening test to evaluate kidney function. Methodology Enzymatic Assay Performed Mon-Sat Reported Within 24 hours New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Collect: Green (sodium or lithium heparin). Collect on ice. Specimen Preparation: Allow specimen to clot completely at room temperature. Separate serum or plasma from cells ASAP or within 2 hours of collection. Transfer 1 mL serum or plasma to a Standard Transport Tube. (Min: 0.2 mL) Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Specimens containing sodium fluoride. Remarks: Stability: After separation from cells: Ambient: 1 week; Refrigerated: 1 week; Frozen: 1 year Reference Interval Refer to Report Interpretive Data Note CPT Code 84520 Components Component Test Code Component Chart Name LOINC 0020023 Urea Nitrogen, Serum or Plasma 3094-0 Aliases Urea Nitrogen Clearance Blood Urea Nitrogen BUN

  • Ammonia

    Ammonia, Plasma Ordering Recommendation Evaluate status of existing liver disease. Monitor treatment in patients with inborn errors of metabolism. Methodology Enzymatic Assay Performed Mon-Sat Reported Within 24 hours New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Collect: Green (sodium or lithium heparin). Collect on ice. Specimen Preparation: Separate plasma from cells and freeze within 15 minutes of draw time. Specimens need to be spun in a refrigerated centrifuge. Transfer 2 mL plasma to a standard Transport Tube. (Min: 0.25 mL) Storage/Transport Temperature: CRITICAL FROZEN. Separate specimens must be submitted when multiple tests are ordered. Unacceptable Conditions: Serum or blood. Non-frozen specimens. Specimens containing oxalate or citrate Remarks: Stability: After separation from cells: Ambient: Unacceptable; Refrigerated: 2 hours; Frozen: 3 weeks (do not thaw) Reference Interval 0-14 days 95 µmol/L or less 15 days-6 years 68 µmol/L or less Greater than 6 years 72 µmol/L or less Interpretive Data Note CPT Code 82140 Components Component Test Code Component Chart Name LOINC 0020043 Ammonia, Plasma 16362-6 Aliases NH3 Plasma ammonia level

  • Tryptase

    SARS-CoV-2 (COVID-19) Ordering Recommendation Use to detect the novel coronavirus (SARS-CoV-2). Mnemonic Methodology Qualitative Nucleic Acid Amplification (NAA) Performed Mon-Sat Reported 1-2 days New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Collect: Nasopharyngeal swab, oropharyngeal swab, nasal swab, or saliva. To ensure the highest quality results, a nasopharyngeal swab is recommended. Specimen Preparation: Nasopharyngeal swab: Place in viral transport media Liquid Amies, or saline (minimum volume 1.2mL). Place each specimen in an individually sealed bag. Oropharyngeal or nasal swab: Place in viral transport media Liquid Amies, or saline (minimum volume 1.2mL). Swab Collection Kit. Place each specimen in an individually sealed bag. Saliva: Transport in COVID-19 Saliva Collection Tube Storage/Transport Temperature: Frozen. Unacceptable Conditions: Undiluted saliva. Saliva submitted in anything other than a Saliva Collection Tube. Swabs not in media. Wood swabs, calcium alginate swabs. Media with guanidine-containing materials, 'molecular media' that indicates inactivation of pathogens and preservation of RNA/DNA, charcoal media. Specimens sent in tubes with pop-top lids/caps. Specimens in glass tubes. Remarks: Stability: Swabs: Ambient: Unacceptable; Refrigerated: 2 days; Frozen: 1 month Saliva: Ambient: 5 days; Refrigerated: 5 days, Frozen: 5 days Reference Interval Interpretive Data This test should be ordered for the detection of the 2019 novel coronavirus SARS-CoV-2 in individuals who meet SARS-CoV-2 clinical and/or epidemiological criteria. The Coronavirus SARS-CoV-2 (COVID-19) by nucleic acid amplification test is for in vitro diagnostic use under the FDA Emergency Use Authorization (EUA) for U.S. laboratories certified under CLIA to perform high complexity tests. Not Detected results do not rule out the presence of PCR inhibitors in the patient specimen or assay-specific nucleic acid in concentrations below the level of detection by the assay. Detected results are indicative of the presence of SARS-CoV-2 RNA. Due to the complexity of nucleic acid amplification methodologies, there may be a risk of false-positive results. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Reliable results are dependent on adequate specimen collection, transport, storage, and handling. Compliance Category: Depends on Specimen/Source/Method Note CPT Code 87635 Components Component Chart Name SARS-CoV-2 Source Component Test Code 3002639 LOINC 31208-2 3002640 SARS-CoV-2 by NAA 94500-6 Aliases 2019-nCoV Coronavirus disease - 2019 COVID-19 COVID-19 Illness COVID-2019 SARS-CoV-2

  • ACTH by Immunochemistry

    ACTH by Immunohistochemistry Ordering Recommendation Mnemonic Methodology Immunohistochemistry Performed Mon-Sat Reported 1-3 days New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Formalin fix (10 percent neutral buffered formalin) and paraffin embed specimen (cells must be prepared into a cellblock). Protect paraffin block and/or slides from excessive heat. Transport tissue block or 5 unstained (3- to 5-micron thick sections), positively charged slides in a tissue transport kit Collect: Tissue or Cells Specimen Preparation: After drawing blood into an EDTA tube, label it with the patient's details. Keep the specimen at room temperature (15-30°C) if transporting within a few hours. For longer transport, place it in a biohazard bag within a cooler with ice packs, maintaining 2-8°C. Deliver it to the lab within 24 hours. Storage/Transport Temperature: Room temperature or refrigerated. Ship in cooled container during summer months. Unacceptable Conditions: Specimens submitted with non-representative tissue type. Depleted specimens. Remarks: Stability: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable Reference Interval Components Available Separately Reference Interval Interpretive Data Note This test is performed as a stain and return (technical) service only. CPT Code 88342 Components Component Test Code 2003428 2003429 Component Chart Name ACTH by IHC LOINC ACTH Reference Number 94736-6 Aliases ACTH ACTH Antibody Staining ACTH by IHC

  • Allergens, Food, Common Adult Food IgE | CDL

    Allergens, Food, Common Adult Food IgE Ordering Recommendation Mnemonic FOOD ADULT Performed Sat-Sun Methodology Quantitative ImmunoCAP Fluorescent Enzyme Immunoassay Reported 1-3 Days New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Multiple patient encounters should be avoided. Collect: Serum separator tube. Multiple specimen tubes should be avoided. Specimen Preparation: Separate serum from cells ASAP or within 2 hours of collection. Transfer 2.25 mL serum to a Standard Transport Tube. (Min: 1.04 mL) Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Hemolyzed, icteric, or lipemic specimens. Remarks: Stability: After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year Reference Interval Test Number Components Reference Interval Immunoglobulin E Age Reference Interval (kU/L) 0-5 months 13 or less 6-12 months 34 or less 1-2 years 97 or less 3 years 199 or less 4-6 years 307 or less 7-8 years 403 or less 9-12 years 696 or less 13-15 years 629 or less 16-17 years 537 or less 18 years and older 214 or less Less than or equal to 0.34 kU/L Less than or equal to 0.34 kU/L Allergen, Food, Egg White IgE Allergen, Food, Milk (Cow) IgE Less than or equal to 0.34 kU/L Less than or equal to 0.34 kU/L Less than or equal to 0.34 kU/L Less than or equal to 0.34 kU/L Allergen, Food, Peanut IgE Allergen, Food, Shrimp IgE Allergen, Food, Soybean IgE Allergen, Food, Wheat IgE Less than or equal to 0.34 kU/L Less than or equal to 0.34 kU/L Allergen, Food, Codfish IgE Allergen, Food, Corn IgE Less than or equal to 0.34 kU/L Less than or equal to 0.34 kU/L Allergen, Food, Walnut (Juglans spp) IgE Allergen, Food, Clam IgE Less than or equal to 0.34 kU/L Allergen, Food, Scallop IgE Reference Interval Allergen results of 0.10-0.34 kU/L are intended for specialist use as the clinical relevance is undetermined. Even though increasing ranges are reflective of increasing concentrations of allergen-specific IgE, these concentrations may not correlate with the degree of clinical response or skin testing results when challenged with a specific allergen. The correlation of allergy laboratory results with clinical history and in vivo reactivity to specific allergens is essential. A negative test may not rule out clinical allergy or even anaphylaxis. Reporting Range (reported in kU) Class Scoring Probability of IgE Mediated Clinical Reactionported in kU) Less than 0.10 No significant level detected 0 0.10-0.34 Clinical relevance undetermined 0/1 0.35-0.70 Low 1 0.71-3.50 3.51-17.50 Moderate High 2 3 17.51-50.00 Very High 4 50.01-100.00 Very High 5 Greater than 100.00 Very High 6 Compliance Category: FDA Note Allergens included in this panel: Clam, Egg White, Codfish/Whitefish, Corn, Milk (Cow's), Peanut, Shrimp, Scallop, Soybean, Walnut, Wheat, and IgE Serum Total CPT Code 86003 x11; 82785 Components Component Test Code Component Chart Name LOINC 19113-0 Allergen, Food, Egg White IgE Allergen, Food, Peanut IgE Allergen, Food, Shrimp IgE Allergen, Food, Milk (Cow) IgE 6106-9 7258-7 6206-7 6246-3 Immunoglobulin E 0050345 0055013 0055020 0055024 0055030 Allergen, Food, Soybean IgE Allergen, Food, Wheat IgE 6248-9 6276-0 0055031 0055034 Allergen, Food, Codfish IgE Allergen, Interp, Immunocap Score IgE 6082-2 33536-4 0055036 0055041 Allergen, Food, Corn IgE Allergen, Food, Walnut (Juglans spp) IgE 6087-1 33536-4 0055078 0055209 Allergen, Food, Clam IgE Allergen, Food, Scallop IgE 6076-4 7691-9 0099488 0099495

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  • Basic Metabolic Panel

    Basic Metabolic Panel Ordering Recommendation Methodology Quantitative Ion-Selective Electrode/Quantitative Enzymatic Assay/Quantitative Spectrophotometry Performed Mon-Sat Reported Within 24 hours New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Collect: Plasma separator tube, or serum separator tube SST Specimen Preparation: Allow serum tube to clot completely at room temperature. Separate serum or plasma from cells ASAP within 30 minutes of collection. Transfer 1 mL serum or plasma to a Standard Transport Tube. (Min: 0.3 mL) Storage/Transport Temperature: Specimens collected in EDTA, citrate, or oxalate. Unacceptable Conditions: EDTA, citrate, oxalate, or sodium fluoride/potassium oxalate. Remarks: Stability: After separation from cells: Ambient: Calcium and CO2: 4 hours, All others: 24 hours; Refrigerated: 1 week; Frozen: 2 weeks Reference Interval Components Available Separately Reference Interval By report (reports may vary based on instrumentation) Interpretive Data Note his panel includes: Calcium, Serum or Plasma (0020027), Carbon Dioxide, Serum or Plasma (0020004), Chloride, Serum or Plasma (0020003), Creatinine, Serum or Plasma (0020025), Glucose, Serum or Plasma (0020024), Potassium, Plasma or Serum (0020002), Sodium, Plasma or Serum (0020001), and Urea Nitrogen, Serum or Plasma (0020023). CPT Code 80048 Components Component Test Code Component Chart Name LOINC 0020001 Sodium, Serum or Plasma 2951-2 0020002 Potassium, Serum or Plasma 2823-3 0020003 Chloride, Serum or Plasma 2075-0 0020004 Potassium, Serum or Plasma 2028-9 0020023 Urea Nitrogen, Serum or Plasma 3094-0 0020024 Glucose, Serum or Plasma 2345-7 0020025 Creatinine, Serum or Plasma 2160-0 0020027 0020396 Calcium, Serum or Plasma Anion Gap 17861-6 33037-3 3004293 UH EGFR Aliases C12 Chem 12 Chemistry Panel Chemistry Screen CMP SMA 12 SMA 20 SMAC

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