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ADHTT ........................................................................................................................................ 5 A DIHYDROTESTOSTERONE BY TMS11/14/2016: Reference Ranges
ARBVM .......................................................................................................................................................... ARBOVIRUS AB PANEL, IGM11/21/2016: Delete: This test is being discontinued.
ARBMSF ....................................................................................................................................... ARBOVIRUS AB PNL, IGM, CSF (IFA)11/21/2016: Delete: This test is being discontinued.
ARBOSF ................................................................................................................ ARBOVIRUS ANTIBODY PANEL, IGG & IGM, CSF11/21/2016: Delete: This test is being discontinued.
CUMB12 ................................................................................................................................................... CORDSTAT 12 DRUG SCR PNL12/27/2016: Other
CUM12A (CUMB12A).................................................................................................................................... CORDSTAT 12 SCR W/ALC12/27/2016: Other
CUMB13 ................................................................................................................................................... CORDSTAT 13 DRUG SCR PNL12/27/2016: Other
CUM13A .......................................................................................................................................................... CORDSTAT 13 SCR W/ALC 12/27/2016: Other
CUMB5 ........................................................................................................................................................ CORDSTAT 5 DRUG SCR PNL12/27/2016: Other
CUMB5A .................................................................................................................................................... CORDSTAT 5 SCREEN W/ALC12/27/2016: Other
CUMB7 ........................................................................................................................................................ CORDSTAT 7 DRUG SCR PNL12/27/2016: Other
CUMB9 ........................................................................................................................................................ CORDSTAT 9 DRUG SCR PNL12/27/2016: Other
CRTUQ (CREATINE-U) ...................................................................................................................................... CREATINE, URINE 24HR11/8/2016: Delete: This test is being discontinued.
DIANO ...................................................................................................................................................... DIAZEPAM AND NORDIAZEPAM12/27/2016: New: New Test - Replaces DIAZ
DIAZ (VALIUM)....................................................................................................................................... DIAZEPAM AND NORDIAZEPAM12/27/2016: Delete: This test is being discontinued. Use the ordercode DIANO to order this test.
EEECSF ............................................................................................................................................ EASTERN EQUINE AB PANEL, CSF11/21/2016: Delete: This test is being discontinued.
EEEGAB .......................................................................................................................................................... EASTERN EQUINE AB, IGG11/21/2016: Delete: This test is being discontinued.
EQEGCF ................................................................................................................................................ EASTERN EQUINE AB, IGG, CSF11/21/2016: Delete: This test is being discontinued.
EEEMAB ......................................................................................................................................................... EASTERN EQUINE AB, IGM11/21/2016: Delete: This test is being discontinued.
EEEMCF ................................................................................................................................................ EASTERN EQUINE AB, IGM, CSF11/21/2016: Delete: This test is being discontinued.
EEEAB ......................................................................................................................................... EASTERN EQUINE ENCEPHALITIS AB11/21/2016: Delete: This test is being discontinued.
EPICOL .................................................................................................................................................................................. EPI PROCOLON11/14/2016: New: New Test - Replaces SEPT9
UHMQ3 ....................................................................................................................................................... HEAVY METAL 3, URINE 24HR11/7/2016: Department,Reference Ranges
UHMR3 ................................................................................................................................................ HEAVY METAL 3, URINE RANDOM11/7/2016: Department,Reference Ranges
UHMQ4 ....................................................................................................................................................... HEAVY METAL 4, URINE 24HR11/7/2016: Department,Reference Ranges
UHMR4 ................................................................................................................................................ HEAVY METAL 4, URINE RANDOM11/7/2016: Department,Reference Ranges
MSH2A ....................................................................................................................................... HNPCC LYNCH SYN (MSH2) SQUENCE10/19/2016: Required Patient Info
MSH6AR .................................................................................................................................... HNPCC LYNCH SYN (MSH6) SQUENCE10/19/2016: Required Patient Info
JAKMPL ........................................................................................................................................... JAK2 (RFLX MPL W515 MUTATION)12/27/2016: Delete: This test is being discontinued.
LSRA ................................................................................................................................................... LECITHIN/SPHINGOMYELIN RATIO11/14/2016: Delete: This test is being discontinued.
MEC12A ......................................................................................................................................................... MECONIUM 12 DRUG + ALC12/27/2016: Other
MEC12 ........................................................................................................................................................ MECONIUM 12 DRUG SCREEN12/27/2016: Other
MEC13A ......................................................................................................................................................... MECONIUM 13 DRUG + ALC12/27/2016: Other
MEC13 ........................................................................................................................................................ MECONIUM 13 DRUG SCREEN12/27/2016: Other
MEC5A ............................................................................................................................................................... MECONIUM 5 DRUG + ALC12/27/2016: Other
MEC5 .............................................................................................................................................................. MECONIUM 5 DRUG SCREEN12/27/2016: Other
MEC7 ................................................................................................................................................................... MECONIUM 7 DRUG SCRN12/27/2016: Other
MEC7A ...................................................................................................................................... MECONIUM 7 DRUG SCRN + ALCOHOL12/27/2016: Other
MEC9SC ...................................................................................................................................................... MECONIUM 9 DRUG SCREEN12/27/2016: Other
MECPN ...................................................................................................................................... MENINGOENCEPH COMP PANEL RFLX11/21/2016: Delete: This test is being discontinued.
SNPPOC ...................................................................................................................... MICROARRAY, POC TISSUE FRESH OR FFPE10/24/2016: Synonyms,Container Type,Store and Transport,Specimen Type,Preferred Volume,Emergency Minimum Volume,CollectionProcedure,Room Temp,Refrigerated,Frozen -20c,Frozen -70c,Unacceptable Condition,Turnaround Time
MPL515 ................................................................................................................................................. MPL W515 MUTATION ANALYSIS12/27/2016: Delete: This test is being discontinued.
FONCOI ..................................................................................................................................................................... ONCOFISH CERVICAL11/2/2016: Delete: This test is being discontinued.
FONCAR ........................................................................................................................................ ONCOFISH CERVICAL ASCUS RFLX11/2/2016: Delete: This test is being discontinued.
BONCOI .............................................................................................................................................. ONCOFISH CERVICAL BILL ONLY11/2/2016: Delete: This Bill Only code is being discontinued.
FONCOR ............................................................................................................................................. ONCOFISH CERVICAL LSIL RFLX11/2/2016: Delete: This test is being discontinued.
OD50HO ...................................................................................................................................................................... P50 (HEMOXIMETRY)11/2/2016: Delete: This test is being discontinued.
PAVAL .................................................................................... PARANEOPLASTIC AUTOANTIBODY EVALUATION, SERUM RFLX12/27/2016: New
PAVSF ....................................................................... PARANEOPLASTIC AUTOANTIBODY EVALUATION, SPINAL FLUID RFLX12/27/2016: New
PRTNP .......................................................................................................................................... PROCOLLAGEN TYPE I PROPEPTIDE9/27/2016: Synonyms,Reference Ranges
RHFAGM ...................................................................................................................................... RHEUMATOID FACTOR, IGA/IGG/IGM11/7/2016: Unacceptable Condition,Reference lab Test Code,Method
SEPT9 .............................................................................................................................................. SEPTIN 9, METHYLATED DNA (PCR)11/14/2016: Delete: This test is being discontinued. Use the ordercode EPICOL to order this test.
SLEVSF ................................................................................................................................................ ST LOUIS ENCEPH AB, CSF (IFA)11/21/2016: Delete: This test is being discontinued.
ENSTLG ................................................................................................................................................ ST LOUIS ENCEPH AB, IGG, CSF11/21/2016: Delete: This test is being discontinued.
SLVAB .................................................................................................................................................... ST LOUIS ENCEPH AB, IGG, IGM11/21/2016: Delete: This test is being discontinued.
SLVM ................................................................................................................................................................. ST LOUIS ENCEPH AB, IGM11/21/2016: Delete: This test is being discontinued.
ENSTLM ............................................................................................................................................... ST LOUIS ENCEPH AB, IGM, CSF11/21/2016: Delete: This test is being discontinued.
ENCSTL (ENC.STLOUIS) ........................................................................................................................ ST LOUIS ENCEPHALITIS AB11/21/2016: Delete: This test is being discontinued.
TSIA .................................................................................................................................................. THYROID STIM IMMUNOGLOBULINS1/31/2017: Delete: This test is being discontinued. Use the ordercode TSIAB to order this test.
TSIAB ............................................................................................................................... THYROID STIMULATING IMMUNOGLOBULIN12/27/2016: New: New Test - Replaces TSIA
TRYP (TRYPSN)............................................................................................................................. TRYPSIN-LIKE IMMUNOREACTIVITY11/14/2016: Delete: This test is being discontinued.
ENCW (ENC.WEST)...................................................................................................................................... WESTERN EQUINE AB, IGG11/21/2016: Delete: This test is being discontinued.
WEEGMC ..................................................................................................................................... WESTERN EQUINE AB, IGG,IGM CSF11/21/2016: Delete: This test is being discontinued.
Interpretive Data: This targeted panel detects 51 variants common in the Ashkenazi Jewish population associated with 16disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconianemia group c, Gaucher disease, glycogen storage disease 1A, Joubert syndrome type 2, lipoamide dehydrogenase deficiency,maple syrup urine disease type 1B, mucolipidosis type IV, NEB-related nemaline myopathy, Niemann-Pick disease type C, Tay-Sachs disease, Usher syndrome type 1F and type 3.
Notes
Ordering Recommendation: Preferred gene panel for carrier screening in individuals of Ashkenazi Jewish descent.
Cystic fibrosis (CF) carrier testing is NOT included as part of this panel. Please order Cystic Fibrosis to assess CFcarrier status.
Please Note Counseling and informed consent are recommended for genetic testing. Consent forms are available online.
Test Change Alert #450 November 28, 2016
The following tables reflect revisions only; other existing data remain unchanged.
Specimens collected in sodium heparin or lithium heparin tubes. Heparinized whole blood, plasma, serum, grosslyhemolyzed specimens, frozen specimens, specimens over 5 days old and specimens in leaky containers. Alsospecimens not received in the original collection tubes.
Cystic Fibrosis Carrier Screen or Diagnosis, Interpretation andComments
Interpretive Data: This targeted panel detects 51 variants common in the Ashkenazi Jewish population associated with 16disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconianemia group c, Gaucher disease, glycogen storage disease 1A, Joubert syndrome type 2, lipoamide dehydrogenase deficiency,maple syrup urine disease type 1B, mucolipidosis type IV, NEB-related nemaline myopathy, Niemann-Pick disease type C, Tay-Sachs disease, Usher syndrome type 1F and type 3.
ComplianceRemarks
ARUP Testing: The performance characteristics of this test were validated by ARUP Laboratories. The U.S. Foodand Drug Administration (FDA) has not approved or cleared this test; however, FDA approval or clearance iscurrently not required for clinical use of this test. The results are not intended to be used as the sole means forclinical diagnosis or patient management decisions. ARUP is authorized under Clinical Laboratory ImprovementAmendments (CLIA) and by all states to perform high-complexity testing.
Lyme (B. burgdorferi) Ab, CSF Negative-Antibody to B.burgdorferi not detected
0.99 or less LIV
Equivocal-Repeat testing in 10-14days may be helpful
1.00-1.20
Positive-Probable presence ofantibody to B. burgdorferidetected
1.21 or more
ReferenceRanges
continued
Interpretive Data: The detection of antibodies to B. burgdorferi in cerebrospinal fluid may indicate central nervous systeminfection. However, consideration must be given to possible contamination by blood or transfer of serum antibodies across theblood-brain barrier.
Current CDC recommendations for the serologic diagnosis of Lyme disease are to screen with a polyvalent ELISA test andconfirm equivocal and positive results with immunoblot. Both IgM and IgG immunoblots should be performed on samples lessthan 4 weeks after appearance of erythema migrans. Only IgG immunoblot should be performed on samples greater than 4weeks after the disease onset. IgM immunoblot in the chronic stage is not recommended and does not aid in the diagnosis ofneuroborreliosis or chronic Lyme disease. Please submit requests for appropriate immunoblot testing within 10 days.
ComplianceRemarks
This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Foodand Drug Administration has not approved or cleared this test; however, FDA clearance or approval is notcurrently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosisor patient management decisions.
Notes
Ordering Recommendation: Use in conjunction with positive serologic testing for the workup of suspected acuteLyme neuroborreliosis. Do not order in the absence of clinical symptoms.
Once this test is performed, if:a) Negative - no further testing is done.b) Positive or equivocal - Immunoblot testing will be performed on the original sample upon receiving a request.Sample will be held for 30 days only.
Test Change Alert #450 November 28, 2016
The following tables reflect revisions only; other existing data remain unchanged.
Copper, Creatinine Ratio No Reference Interval ug/gCR
COPPER, URINE RANDOMTest Code URCOP
Billing Code URCOPEffective 11/7/2016
Department Separation Science, Chemistry
ReferenceRanges
Title Descriptor Ranges Units
Creatinine, Urine Male 39-259 mg/dL
Female 28-217
Copper, Urine 0.2-8.0 ug/dL
Copper, Creatinine Ratio No Reference Interval ug/gCR
ReferenceRanges
continued
CORDSTAT 12 DRUG SCR PNLTest Code CUMB12
Billing Code CUMB12Effective 12/27/2016
OtherPlacement of the tamper seal and completion of the custody and control form must be performed at the hospitalwhere the specimen is collected. Failure to complete the Chain of Custody form correctly or improper sealing ofthe sample will lead to rejection.
CORDSTAT 12 SCR W/ALCTest Code CUM12A
Billing Code CUMB12AEffective 12/27/2016
OtherPlacement of the tamper seal and completion of the custody and control form must be performed at the hospitalwhere the specimen is collected. Failure to complete the Chain of Custody form correctly or improper sealing ofthe sample will lead to rejection.
CORDSTAT 13 DRUG SCR PNLTest Code CUMB13
Billing Code CUMB13Effective 12/27/2016
OtherPlacement of the tamper seal and completion of the custody and control form must be performed at the hospitalwhere the specimen is collected. Failure to complete the Chain of Custody form correctly or improper sealing ofthe sample will lead to rejection.
Test Change Alert #450 November 28, 2016
The following tables reflect revisions only; other existing data remain unchanged.
OtherPlacement of the tamper seal and completion of the custody and control form must be performed at the hospitalwhere the specimen is collected. Failure to complete the Chain of Custody form correctly or improper sealing ofthe sample will lead to rejection.
CORDSTAT 5 DRUG SCR PNLTest Code CUMB5
Billing Code CUMB5Effective 12/27/2016
OtherPlacement of the tamper seal and completion of the custody and control form must be performed at the hospitalwhere the specimen is collected. Failure to complete the Chain of Custody form correctly or improper sealing ofthe sample will lead to rejection.
CORDSTAT 5 SCREEN W/ALCTest Code CUMB5A
Billing Code CUMB5AEffective 12/27/2016
OtherPlacement of the tamper seal and completion of the custody and control form must be performed at the hospitalwhere the specimen is collected. Failure to complete the Chain of Custody form correctly or improper sealing ofthe sample will lead to rejection.
CORDSTAT 7 DRUG SCR PNLTest Code CUMB7
Billing Code CUMB7Effective 12/27/2016
OtherPlacement of the tamper seal and completion of the custody and control form must be performed at the hospitalwhere the specimen is collected. Failure to complete the Chain of Custody form correctly or improper sealing ofthe sample will lead to rejection.
CORDSTAT 9 DRUG SCR PNLTest Code CUMB9
Billing Code CUMB9Effective 12/27/2016
OtherPlacement of the tamper seal and completion of the custody and control form must be performed at the hospitalwhere the specimen is collected. Failure to complete the Chain of Custody form correctly or improper sealing ofthe sample will lead to rejection.
CREATINE, URINE 24HRTest Code CRTUQ
Billing Code CREATINE-UEffective 11/8/2016
Delete This test is being discontinued.
Test Change Alert #450 November 28, 2016
The following tables reflect revisions only; other existing data remain unchanged.
Cutaneous Direct Immunofluorescence, Biopsy; Bullous Disease; Chronic Bullous Disease; CutaneousHerpetiformis; Dermatitis Herpetiformis; Lichen Planus and Lichenoid; Linear IgA Bullous, Tissue; LupusErythematous, Tissue; Pemphigoid, Tissue; Pemphigus; Porphyria and Pseudoporphyria, Tissue; SkinImmunofluorescence; Urticaria; Urticarial Pemphigoid; Urticarial Vasculitis; Vasculitis
Container Type Michel's Media or Zeus tissue fixative
Store andTransport
Room temperature; also acceptable: refrigerated
Specimen Type Tissue: skin, mucosa (oral, conjunctival, genital, esophageal), other epithelium (gastrointestinal, respiratory,urinary)
SpecimenProcessing
Transport tissue (optimal 4-6 mm) in Michel's medium. Also acceptable: Zeus tissue fixative.
UnacceptableCondition
Formalin-fixed tissue; solid organs or solid organ tissue
CPT Codes 88346, 88350 x 4
Method Direct Immunofluorescence
Notes
Ordering Recommendation:
-Order concurrently with serum antibody testing and fixed tissue histopathology for assessment of patient withpruritic, urticarial, blistering and/or erosive disorders, including possible pemphigoid and pemphigoid variants,pemphigus and pemphigus subtypes, dermatitis herpetiformis, epidermolysis bullous acquisita, porphyria, andpseudoporphyria.
-Order concurrently with fixed tissue histopathology for assessment of patient with inflammatory, immune-mediated cutaneous disease, including possible lupus and lupus variants, vasculitis, drug reactions, lichen planusand lichenoid reactions.
Test Change Alert #450 November 28, 2016
The following tables reflect revisions only; other existing data remain unchanged.
Frozen - Separate samples must be submitted when multiple tests are ordered.
Specimen Type Plasma
EmergencyMinimum Volume
3.5 mL plasma (see note below)
CollectionProcedure
Collect a minimum of 10 mL whole blood. Blood collection tubes should be allowed to complete the evacuated fill.
SpecimenProcessing
Plasma preparation should be performed ASAP or within 4 hours of collection. Centrifuge for 12 min at 1350 ± 150 rcf.Transfer the plasma to a 15 mL conical tube and centrifuge for an additional 12 minutes at 1350 ± 150 rcf. Ensure aminimum of 3.5 mL of plasma is obtained following centrifugation. Transfer entire plasma aliquot to a cryovial tubeor any freezable specimen transport tube.
Room Temp Unacceptable
Refrigerated 3 days
Frozen -20c 2 weeks
UnacceptableCondition
Serum, stool, or whole blood. Hemolyzed specimens.
ReferenceLaboratory
ARUP
Reference labTest Code
2013906
CPT Codes 81401 x 1
Test Schedule Sun, Wed
Turnaround Time 8-10 days
Method Polymerase Chain Reaction
ReferenceRanges
Title Ranges
Methylated Septin 9 Not Detected
Notes
Ordering Recommendation: The Epi proColon test is indicated to screen adults of either sex, 50 years or older,defined as average risk for CRC, who have been offered and have a history of not completing CRC screening.Tests that are available and recommended in the USPSTF 2008 CRC screening guidelines should be offered anddeclined prior to offering the Epi proColon test. Patients with a positive Epi proColon test result should be referredfor diagnostic colonoscopy. The Epi proColon test results should be used in combination with physician'sassessment and individual risk factors in guiding patient management.
This test is not intended to replace a colonoscopy. NOT recommended for pregnant women because of a potentialfor false-positive results in these individuals.
Accurate test performance requires following the specimen preparation instructions. Minimum volume of 3.5 mL isrequired for testing without repeats. If a repeat is necessary, an additional specimen will be requested.
New New Test - Replaces SEPT9
Fees Fees for this test are being adjusted. Please contact your Sales Representative or Client Services for feeinformation.
Test Change Alert #450 November 28, 2016
The following tables reflect revisions only; other existing data remain unchanged.
OtherPlacement of the tamper seal and completion of the custody and control form must be performed at the hospitalwhere the specimen is collected. Failure to complete the Chain of Custody form correctly or improper sealing ofthe sample will lead to rejection.
MECONIUM 12 DRUG SCREENTest Code MEC12
Billing Code MEC12Effective 12/27/2016
OtherPlacement of the tamper seal and completion of the custody and control form must be performed at the hospitalwhere the specimen is collected. Failure to complete the Chain of Custody form correctly or improper sealing ofthe sample will lead to rejection.
MECONIUM 13 DRUG + ALCTest Code MEC13A
Billing Code MEC13AEffective 12/27/2016
OtherPlacement of the tamper seal and completion of the custody and control form must be performed at the hospitalwhere the specimen is collected. Failure to complete the Chain of Custody form correctly or improper sealing ofthe sample will lead to rejection.
Test Change Alert #450 November 28, 2016
The following tables reflect revisions only; other existing data remain unchanged.
OtherPlacement of the tamper seal and completion of the custody and control form must be performed at the hospitalwhere the specimen is collected. Failure to complete the Chain of Custody form correctly or improper sealing ofthe sample will lead to rejection.
MECONIUM 5 DRUG + ALCTest Code MEC5A
Billing Code MEC5AEffective 12/27/2016
OtherPlacement of the tamper seal and completion of the custody and control form must be performed at the hospitalwhere the specimen is collected. Failure to complete the Chain of Custody form correctly or improper sealing ofthe sample will lead to rejection.
MECONIUM 5 DRUG SCREENTest Code MEC5
Billing Code MEC5Effective 12/27/2016
OtherPlacement of the tamper seal and completion of the custody and control form must be performed at the hospitalwhere the specimen is collected. Failure to complete the Chain of Custody form correctly or improper sealing ofthe sample will lead to rejection.
MECONIUM 7 DRUG SCRNTest Code MEC7
Billing Code MEC7Effective 12/27/2016
OtherPlacement of the tamper seal and completion of the custody and control form must be performed at the hospitalwhere the specimen is collected. Failure to complete the Chain of Custody form correctly or improper sealing ofthe sample will lead to rejection.
MECONIUM 7 DRUG SCRN + ALCOHOLTest Code MEC7A
Billing Code MEC7AEffective 12/27/2016
OtherPlacement of the tamper seal and completion of the custody and control form must be performed at the hospitalwhere the specimen is collected. Failure to complete the Chain of Custody form correctly or improper sealing ofthe sample will lead to rejection.
MECONIUM 9 DRUG SCREENTest Code MEC9SC
Billing Code MEC9SCEffective 12/27/2016
OtherPlacement of the tamper seal and completion of the custody and control form must be performed at the hospitalwhere the specimen is collected. Failure to complete the Chain of Custody form correctly or improper sealing ofthe sample will lead to rejection.
Test Change Alert #450 November 28, 2016
The following tables reflect revisions only; other existing data remain unchanged.
Container Type Fresh Tissue or POC: Tissue transport tube or sterile saline; FFPE Samples: 2 mL microfuge tubes or FFPE slides;Extracted DNA: 2 mL microfuge tubes.
Fresh Tissue or POC: Tissue biopsy in sterile tube with tissue culture media containing antibiotics (preferred);FFPE Samples: Tissue embedded in paraffin; Extracted DNA: Genomic DNA at a concentration of > 12 ng/uL,extracted from products of conception or solid tissue/skin samples. Provide quantification paperwork withrequisition, if possible.
Preferred VolumeFresh Tissue or POC: 5 mm3; FFPE Samples: Two 2 mL microfuge tubes each containing 5 8-micron FFPEsections, OR 10 slides, each with 8-micron unstained sections; Extracted DNA: 20 uL. DNA must pass QC filtersfor a successful run.
EmergencyMinimum Volume
Fresh Tissue or POC: 5 mm3; FFPE Samples: One 2 mL microfuge tube containing 5 8-micron FFPE sections, OR 5slides, each with 8-micron unstained sections; Extracted DNA: 15 uL. DNA must pass QC filters for a successfulrun.
CollectionProcedure
Fresh Tissue or POC: Keep as sterile as possible.
Room Temp Fresh Tissue or POC: 2 days; FFPE Samples: Indefinitely; Extracted DNA: 3 days
Fresh Tissue or POC: Frozen, placed in formalin or fixative of any kind, or grossly contaminated with bateriaand/or fungus. If sample is fixed at any point, the only testing available is FFPE processing.
FFPE Samples: Decalcified specimens; specimens fixed or processed in alternative fixatives or heavy metalfixativesExtracted DNA: Poor quality DNA, insufficient DNA volume or concentration.
Turnaround Time Fresh Tissue or POC: 8-11 days; FFPE Samples: 2-3 weeks; Extracted DNA from fresh tissue/POC: 8-11 days;Extracted DNA from FFPE tissue: 2-3 weeks
MPL W515 MUTATION ANALYSISTest Code MPL515
Billing Code MPL515Effective 12/27/2016
Delete This test is being discontinued.
Test Change Alert #450 November 28, 2016
The following tables reflect revisions only; other existing data remain unchanged.
Paraneoplastic autoimmune neurological disorders reflect a patient's humoral and cellular immune responses tocancer. The cancer may be new or recurrent, is usually limited in metastatic volume, and is often occult bystandard imaging procedures. Autoantibodies specific for onconeural proteins found in the plasma membrane,cytoplasm, and nucleus of neurons, glia, or muscle are generated in this immune response and serve asserological markers of paraneoplastic autoimmunity. Cancers recognized in this context most commonly aresmall-cell lung carcinoma, thymoma, ovarian (or related mullerian) carcinoma, breast carcinoma, and Hodgkinlymphoma. Pertinent childhood neoplasms recognized thus far include neuroblastoma, thymoma, Hodgkinlymphoma, and chondroblastoma. An individual patient's autoantibody profile can predict a specific neoplasm with90% certainty, but not the neurological syndrome.
Four classes of autoantibodies are recognized in this evaluation:
-Neuronal nuclear (ANNA-1, ANNA-2, ANNA-3)
-Anti-glial/neuronal nuclear (AGNA-1; also known as Sox1)
-Neuronal and muscle cytoplasmic (PCA-1, PCA-2, PCA-Tr, CRMP-5, amphiphysin, and striational)
-Plasma membrane cation channel, calcium channels, P/Q-type and N-type calcium channel, dendrotoxin-sensitivepotassium channels, and neuronal (ganglionic) and muscle nicotinic acetylcholine receptors (AChR). Theseautoantibodies are potential effectors of neurological dysfunction.
Seropositive patients usually present with subacute neurological symptoms and signs such as encephalopathy;cerebellar ataxia; myelopathy; radiculopathy; plexopathy; or sensory, sensorimotor, or autoimmune neuropathy,with or without a neuromuscular transmission disorder: Lambert-Eaton syndrome, myasthenia gravis, orneuromuscular hyperexcitability. Initial signs may be subtle, but a subacute multifocal and progressive syndromeusually evolves. Sensorimotor neuropathy and cerebellar ataxia are common presentations, but the clinical picturein some patients is dominated by striking gastrointestinal dysmotility, limbic encephalopathy, basal ganglionitis,or cranial neuropathy (especially loss of vision, hearing, smell, or taste).
Cancer risk factors include past or family history of cancer, history of smoking, or social or environmentalexposure to carcinogens. Early diagnosis and treatment of the neoplasm favor less neurological morbidity andoffer the best hope for survival.
ComplianceRemarks
This test was developed and its performance characteristics determined by Laboratory Medicine and Pathology,Mayo Clinic. This test has not been cleared or approved by the U.S. Food and Drug Administration.
Test Change Alert #450 November 28, 2016
The following tables reflect revisions only; other existing data remain unchanged.
CRMP-5-IgG Western blot is also performed by specific request for more sensitive detection of CRMP-5-IgG.Testing should be requested in cases of subacute basal ganglionic disorders (chorea, Parkinsonism), cranialneuropathies (especially loss of vision, taste, or smell) and myelopathies.
This test should not be requested for patients who have recently received radioisotopes, therapeutically ordiagnostically, because of potential assay interference. The specific waiting period before specimen collection willdepend on the isotope administered, the dose given, and the clearance rate in the individual patient. Specimenswill be screened for radioactivity prior to analysis. Radioactive specimens received in the laboratory will be held 1week and assayed if sufficiently decayed, or canceled if radioactivity remains.
Cautions: Negative results do not exclude cancer.This evaluation does not include Ma2 autoantibody (alias: MaTa). Ma2 autoantibody has been described in patientswith brainstem and limbic encephalitis in the context of testicular germ cell neoplasms. Scrotal ultrasound isadvisable in men who present with unexplained subacute encephalitis. N-methyl-D-asparate receptor antibodieshave been reported in women with paraneoplastic encephalitis related to ovarian teratoma.
Useful For:Serological evaluation of patients who present with a subacute neurological disorder of undetermined etiology,especially those with known risk factors for cancer.
Directing a focused search for cancer.
Investigating neurological symptoms that appear in the course of, or after, cancer therapy, and are not explainableby metastasis.
Differentiating autoimmune neuropathies from neurotoxic effects of chemotherapy.
Monitoring the immune response of seropositive patients in the course of cancer therapy.
Detecting early evidence of cancer recurrence in previously seropositive patients.
Forms: If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:
General Request Form (T239) (http://www.mayomedicallaboratories.com/it-mmfiles/general-request-form.pdf)Neurology Test Request Form-General (T732) (http://www.mayomedicallaboratories.com/it-mmfiles/neurology-request-form.pdf)
Reflex Testing
Reflex Condition Reflex Test Name Reflex CPT codes Reflex Billing Codes
If IFA patterns suggest GAD65antibody
GAD65 Ab Assay, S 86341 XGD65S
If IFA (ANN1S, ANN2S, ANN3S,PCABP, PCAB2, PCATR,AMPHS, CRMS, AGN1S)patterns are indeterminate
Paraneoplastic AutoantibodyWBlot, S
84182 XWBN
If client requests or if IFApatterns suggest CRMP-5-IgG
CRMP-5-IgG Western Blot, S 84182 XCRMWS
If ACh receptor bindingantibody is > 0.02
ACh Receptor (Muscle)Modulating Ab and CRMP-5-IgG Western Blot, S
83519 & 84182 XARMO and XCRMWS
Reflex Testingcontinued
If IFA patterns suggestamphiphysin antibody
Amphiphysin Western Blot, S 84182 XABLOT
If IFA pattern suggest NMDA-R NMDA-R Ab CBA, S and/orNMDA-R Ab IF Titer Assay, S
86255 and/or 86256 XNMDCS or XNMDIS
If IFA pattern suggest AMPA-R AMPA-R Ab CBA, S and/orAMPA-R Ab IF Titer Assay, S
86255 and/or 86256 XAMPCS or XAMPIS
If IFA pattern suggest GABA-B-R
GABA-B-R Ab CBA, S and/orGABA-B-R Ab IF Titer Assay, S
86255 and/or 86256 XGABCS or XGABIS
If IFA pattern suggestNMO/AQP4-IgG
NMO/AQP4-IgG FACS, S 86255 XMOFS
If NMO/AQP4-IgG FACS screenassay is positive
NMO/AQP4 FACS TitrationAssay, S
86256 XNMOTS
New New Test
Test Change Alert #450 November 28, 2016
The following tables reflect revisions only; other existing data remain unchanged.
PARANEOPLASTIC AUTOANTIBODY EVALUATION, SERUM RFLXPlease Note This test may reflex to additional tests depending upon the results of this test. An additional fee will be added if the
reflex test is necessary.
Test Change Alert #450 November 28, 2016
The following tables reflect revisions only; other existing data remain unchanged.
Several antineuronal and glial autoantibodies are recognized clinically as markers of a patient's immune responseto specific cancers (paraneoplastic autoantibodies). Seropositive patients present with neurologic symptoms andsigns in >90% of cases. The cancers are most commonly small-cell lung carcinoma, ovarian (or related mullerian)carcinoma, breast carcinoma, thymoma, or Hodgkin lymphoma. The cancers may be new or recurrent, are usuallylimited in metastatic volume, and are often occult by standard imaging procedures. Detection of the informativemarker autoantibodies allows early diagnosis and treatment of the cancer, which may lessen neurologicalmorbidity and improve survival.
Serum is the preferred specimen for paraneoplastic autoantibodies. However, cerebrospinal fluid (CSF) results aresometimes positive when serum results are negative (especially for CRMP-5 and other inflammatory centralnervous system autoimmunity). Additionally, CSF is more readily interpretable because it generally lacks theinterfering nonorgan-specific antibodies that are common in serum of patients with cancer. Because neurologiststypically perform spinal taps in these patients, we recommend that CSF be submitted with serum, either forsimultaneous testing or to be held for testing only if serum is negative.
Test Change Alert #450 November 28, 2016
The following tables reflect revisions only; other existing data remain unchanged.
RemarksThis test was developed and its performance characteristics determined by Mayo Clinic in a manner consistentwith CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.
Notes
CRMP-5-IgG Western blot is also performed by specific request for more sensitive detection of CRMP-5-IgG.Testing should be requested in cases of subacute basal ganglionic disorders (chorea, Parkinsonism), cranialneuropathies (especially loss of vision, taste, or smell), and myelopathies.
In patients with a history of tobacco use or other lung cancer risk, or if thymoma is suspected,PAVAL/Paraneoplastic Autoantibody Evaluation, Serum is also recommended.
Useful For: Aids in the diagnosis of paraneoplastic neurological autoimmune disorders related to carcinoma oflung, breast, ovary, thymoma, or Hodgkin lymphoma.
Forms: If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:
General Request Form (T239) (http://www.mayomedicallaboratories.com/it-mmfiles/general-request-form.pdf)Neurology Test Request Form (T732) (http://www.mayomedicallaboratories.com/it-mmfiles/neurology-request-form.pdf)
Reflex Testing
Reflex Condition Reflex Test Name Reflex CPT codes Reflex Billing Codes
If indirect immunofluorescenceassay (ANN1C, ANN2C,ANN3C, PCA1C, PCA2C,PCTRC, AMPHC, CRMC,AGN1C) is indeterminate
Paraneoplastic AutoantibodyWBlot, CSF
84182 XWBNC
If IFA pattern suggestNMO/AQP4-IgG
NMO/AQP4-IgG FACS CSF 86255 XNMOFC
If NMO/AQP4-IgG FACS screenassay is positive
NMO/AQP4-IgG FACS TitrationAssay, CSF
86256 XNMOTC
If IFA patterns suggest CRMP-5-IgG
CRMP-5-IgG Western Blot, CSF 84182 XCRMWC
Reflex Testingcontinued
If IFA patterns suggest GAD65antibody
GAD65 Ab Assay, CSF 86341 XGD65C
If IFA patterns suggestneuronal voltage-gatedpotassium channel-complexautoantibody
VGKC-complex Ab IPA, CSF 83519 XVGKCC
If IFA patterns suggestamphiphysin antibody
Amphiphysin Western Blot,CSF
84182 XABLTC
If IFA pattern suggest NMDA-R NMDA-R Ab CBA, CSF, and/orNMDA-R Ab IF Titer Assay,CSF
86255 and/or 86256 XNMDCC and/or XNMDIC
If IFA pattern suggest AMPA-R AMPA-R Ab CBA, CSF and/orAMPA-R Ab IF Titer Assay, CSF
86255 and/or 86256 XAMPCC and/or XAMPIC
If IFA pattern suggest GABA-B-R
GABA-B-R Ab CBA, CSF and/orGABA-B-R Ab IF Titer Assay,CSF
86255 and/or 86256 XGABCC and/or XGABIC
New New Test
Please Note This test may reflex to additional tests depending upon the results of this test. An additional fee will be added if thereflex test is necessary.
Test Change Alert #450 November 28, 2016
The following tables reflect revisions only; other existing data remain unchanged.
Synonyms Human Papilloma Virus; HPV; Molecular; Cervical Cancer; High Risk; ThinPrep; PAP; Liquid-based Pap; HPV HighRisk; HPV Genotype 16/18
Container Type ThinPrep®
Supply ItemNumber
1852K, 1639K
CollectionProcedure
Cervical and endocervical samples collected using ThinPrep® liquid-based cytology specimen transport media.
Room Temp 3 months
Refrigerated 3 months
UnacceptableCondition
Samples on male patients; SurePath® specimens; Digene Cervical Sampler; Samples in EIA transport media;Cervical biopsies; samples with wooden shafted swabs
Container Type Serum separator tube (gold, brick, SST, or corvac)
Supply ItemNumber
1467
Store andTransport
Refrigerated
Specimen Type Serum
Preferred Volume 1.0 mL
EmergencyMinimum Volume
0.5 mL
SpecimenProcessing
Separate serum from cells and transfer to a standard PAML aliquot tube.
Room Temp 1 day
Refrigerated 1 week
Frozen -20c 1 year
UnacceptableCondition
Hemolysis; room temperature specimens; short drawn K2-EDTA tubes
AlternateSpecimens
Lithium Heparin, K2-EDTA
Department Immunochemistry
ReferenceLaboratory
PAML
CPT Codes 84445
Test Schedule Mon-Sat
Turnaround Time 1-4 days
Method ICMA
ReferenceRanges
Title Ranges Units
Thyroid Stim Immunoglobulin < 0.10 IU/L
ClinicalSignificance
Graves' disease (GD) is an autoimmune disorder caused by the presence of thyroid-stimulating immunoglobulins(TSI) that bind to the TSH receptor on the thyroid cells and stimulate the uncontrolled production of thyroidhormones. Detecting the presence of TSI in the blood is a powerful diagnostic tool for the diagnosis of GD. TSImeasurements are also used to monitor the response to GD therapy and for predicting remission or relapse,confirming Graves' ophthalmopathy, and predicting neonatal thyroid hyperthyroidism. Incorporating the TSI assayinto existing diagnostic algorithms has been shown to reduce overall direct costs of GD diagnosis by up to 43%,with the net cost of misdiagnosis reduced by up to 85%. The IMMULITE 2000 TSI assay utilizes recombinant humanTSH receptors (hTSHR) for specific detection of thyroid stimulating autoantibodies.
NotesResults of > 0.10 IU/L indicate detection of thyroid stimulating autoantibodies and should be used in conjunctionwith other clinical and laboratory findings to aid in the diagnosis of patients suspected of having Graves' disease(GD). Short drawn K2-EDTA plasma samples may result in under-recovery of IMMULITE 2000 TSI results.
New New Test - Replaces TSIA
TRYPSIN-LIKE IMMUNOREACTIVITYTest Code TRYP
Billing Code TRYPSNEffective 11/14/2016
Delete This test is being discontinued.
Test Change Alert #450 November 28, 2016
The following tables reflect revisions only; other existing data remain unchanged.