AUGUST 2020 - Wardelab

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TEST DIRECTORY UPDATEAUGUST 2020Update NotesUpdate SummaryNew Test Activation8/25/2020CRMWS - "Collapsin Response-Mediator Protein-IgG, Western Blot,Ser"New Test Activation8/25/2020CSHCP - "Cashew Nut IgE Component Panel"New Test Activation8/25/2020DULOX - "Duloxetine, Serum"New Test Activation8/25/2020EGUCT - "Ethyl Glucuronide, Umbilical Cord Tissue, Qualitative"New Test Activation8/25/2020FUKAU - "Ustekinumab and Anti-Ustek Antibody, Serum"New Test Activation8/25/2020HZLCP - "Hazelnut IgE Component Panel"New Test Activation8/25/2020MGPMD - "MGMT Promoter Methylation Detection"New Test Activation7/28/2020UCOPE - "Clin Urine Expanded Opioid Confirm"New Test Activation8/25/2020WLNCP - "Walnut IgE Component Panel"Update Existing Test8/17/2020ASPCF - "Aspergillus Ab by CF"Update Existing Test8/17/2020CHROA - " Chromogranin A, Serum"Update Existing Test8/17/2020FAPIA - "Fungal Antibodies (ID)"Update Existing Test6/11/2020FMP3 - "MyoMarker 3 Profile"Update Existing Test8/17/2020HISID - "Histoplasma Abs (ID)"Update Existing Test8/17/2020HPIDA - "Histoplasma Abs (CF/ID)"Update Existing Test7/21/2020ULEGA - "Legionella Urinary Antigen"Inactivate Test With Replacement7/13/2020HGRIT - "HIV-1 Genotype (RTI, PI, Integrase Inhibitors)" replaced byHIVTO - "HIV-1 Genotype (RTI, PI, Integrase Inhibitors)"Inactivate Test With Replacement8/17/2020TULGM - "F.tularensis Antibody,IgG/IgM" replaced by FTGMR "Francisella tularensis Ab, IgG/M w/ Reflex to Agglutination"LAST EDITED: 2020-07-13PAGE 1 OF 16

TEST DIRECTORY UPDATEAUGUST 2020New Test ActivationEffective DateNameCodeCPT Code(s)8/25/2020Collapsin Response-Mediator Protein-IgG, Western Blot, SerCRMWS84182NotesSpecimen RequirementsDraw blood in a red-top tube. Centrifuge, remove serum from cells and send 1.5 mL serum (1.0Specimen Required mL minimum) refrigerated in a screw-capped plastic vial.Rejection CriteriaStabilityGross hemolysis, gross lipemia, gross icterusRoom temperature: 72 hours; Refrigerated: 28 days; Frozen: 28 daysPerforming InformationMethodologyReference RangePerformed DaysTurnaround TimeChemiluminescenceNegativeMonday - Thursday7-12 daysPerforming LaboratoryMayo Clinic LaboratoriesInterface InformationLegacy Code¹CRMWSInterface Order Code3800119Result CodeNameLOINC CodeCollapsin Response-Mediator Protein-IgG,380011947401-5Western Blot, SerLAST EDITED: 2020-07-13AOE/Prompt²NoPAGE 2 OF 16

rpt chKEY FORLAB:L - LOW,RESULTS:H - HIGH, AB - ABNORMAL, C - CRITICAL, . - NOT TESTEDBWX000000000W WLABORATORY REPORTB51300001EXAMPLE, REPORTWX0000003039M 12/05/1988 31 YExample Client, XYZ1231234 Warde RoadAnn Arbor MI 48108SwitcherSwitcherSwitcherSwitcherrpt ch labB51300001000Referral TestingCollected: 07/13/2020 09:35Test NameResultCollapsin Response-Mediator Protein-IgG,Western Blot, 20Units09:35SiteMMRL-------------------ADDITIONAL INFORMATION------------------This test was developed and its performance characteristicsdetermined by Mayo Clinic in a manner consistent with CLIArequirements. This test has not been cleared or approved bythe U.S. Food and Drug Administration.Test Performed by:Mayo Clinic Laboratories - Rochester Main Campus200 First Street SW, Rochester, MN 55905Lab Director: William G. Morice M.D. Ph.D.; CLIA# 24D0404292Performing Site:MMRL: MAYO MEDICAL REFERENCE LAB 3050 Superior Drive NW Rochester MN 55901LAB: L - LOW, H - HIGH, AB - ABNORMAL, C - CRITICAL, . - NOT TESTEDB513000010WX0000003039Printed D&T: 07/13/20 09:36Ordered By:CLIENT CLIENTWX00000000001595William G. Finn, M.D. - Medical DirectorForm: MM RL1PAGE 1 OF 1LAB:

TEST DIRECTORY UPDATEAUGUST 2020New Test ActivationEffective DateNameCodeCPT Code(s)8/25/2020Cashew Nut IgE Component PanelCSHCP86008NotesSpecimen RequirementsDraw blood in a SST. Centrifuge, remove serum from cells and send 1.0 mL serum (0.5 mLSpecimen Required minimum) refrigerated in a screw-capped plastic vial.Alternate SpecimenStabilitySerum: Red-topRoom temperature: Unacceptable; Refrigerated: 7 days; Frozen: 14 daysPerforming InformationMethodologyReference RangePerformed DaysTurnaround TimePerforming LaboratoryInterface InformationLegacy Code¹Interface Order CodeResult Code300010530001063069000LAST EDITED: 2020-07-13Fluorescent Enzyme ImmunoassaySee reportMonday - Friday1 - 3 daysWarde Medical LaboratoryNameAna o 3 (f443)Ana o 3 ClassAllergy InterpretationCSHCP3000079LOINC Code82539-882540-6Not availableAOE/Prompt²NoNoNoPAGE 3 OF 16

rpt chKEY FORLAB:L - LOW,RESULTS:H - HIGH, AB - ABNORMAL, C - CRITICAL, . - NOT TESTEDBWX000000000W WLABORATORY REPORTB51300001EXAMPLE, REPORTWX0000003039M 12/05/1988 31 YExample Client, XYZ1231234 Warde RoadAnn Arbor MI 48108SwitcherSwitcherSwitcherSwitcherrpt ch labB51300001100Allergy Testing - PanelsCollected: 07/12/2020 09:37Test :37SiteLAB:Cashew Nut IgE Component PanelAna o 3 (f443)Ana o 3 Class 0.10CLASS 0 0.10kU/L---------- 0.100.10 - 0.340.35 - 0.690.70 - 3.493.50 - 17.417.5 - 49.950.0 - 100.0 100.0WMRLWMRLSensitization to Ana 03 may indicate an increasedrisk of systemic allergic response upon exposureto cashew. Patients may be allergic to othernuts, such as pistachio, walnut, and peanut.Reactivity to whole cashew with negative Ana 03results may be explained by sensitization toother cashew nut storage proteins or lipidtransfer protein, pollen proteins, orcross-reacting carbohydrate determinants.Allergy InterpretationSee BelowCLASS----00/1123456kU/LWMRLLevel of AllergenSpecific IgE Antibody--------------------UndetectableVery Low LevelLow LevelModerate LevelHigh LevelVery High LevelVery High LevelVery High LevelPerforming Site:WMRL: WARDE MEDICAL LABORATORY 300 West Textile Road Ann Arbor MI 48108LAB: L - LOW, H - HIGH, AB - ABNORMAL, C - CRITICAL, . - NOT TESTEDB513000011WX0000003039Printed D&T: 07/13/20 09:37Ordered By:CLIENT CLIENTWX00000000001595William G. Finn, M.D. - Medical DirectorForm: MM RL1PAGE 1 OF 1

TEST DIRECTORY UPDATEAUGUST 2020New Test ActivationEffective DateNameCodeCPT Code(s)8/25/2020Duloxetine, SerumDULOX80332 (G0480)NotesSpecimen RequirementsDraw blood in a red-top tube. Centrifuge, remove serum from cells and send 1.0 mL serum (0.5mL minimum) refrigerated in a screw-capped plastic vial. Serum requires light protection at roomSpecimen Requiredtemperature.Alternate SpecimenRejection CriteriaStabilityPlasma: Lavender EDTA. Plasma requires light protection at room temperature.Polymer gel separation tube (SST or PST).Room temperature: 30 days; Refrigerated: 30 days; Frozen: 12 monthsPerforming InformationMethodologyReference RangePerformed DaysTurnaround TimeHigh Performance LIquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS)Duloxetine Reporting Limit: 3 ng/mLVaries10 daysPerforming LaboratoryInterface InformationLegacy Code¹Interface Order CodeResult CodeName3300034Duloxetine, SerumLAST EDITED: 2020-07-13NMS LabsDULOX3300034LOINC Code46227-5AOE/Prompt²NoPAGE 4 OF 16

rpt chKEY FORLAB:L - LOW,RESULTS:H - HIGH, AB - ABNORMAL, C - CRITICAL, . - NOT TESTEDBWX000000000W WLABORATORY REPORTB51300000EXAMPLE, REPORTWX0000003039M 12/05/1988 31 YExample Client, XYZ1231234 Warde RoadAnn Arbor MI 48108SwitcherSwitcherSwitcherSwitcherrpt ch labB51300000000Referral TestingCollected: 07/10/2020 12:00Test NameResultDuloxetine, Siteng/mLNMRLReporting Limit: 3.0 ng/mLSynonym(s): Cymbalta(R)Steady-state trough plasma concentrations after5 days of oral therapy were:20 mg twice daily: 4 to 22 ng/mL30 mg twice daily: 8 to 48 ng/mL40 mg twice daily: 12 to 60 ng/mL.Analysis by High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS)This test was developed and its performancecharacteristics determined by NMS Labs. It has notbeen cleared or approved by the US Food and DrugAdministration.Testing performed at NMS Labs, Inc.200 Welsh RoadHorsham, PA 19044-2208CLIA 39D0197898LAB: L - LOW, H - HIGH, AB - ABNORMAL, C - CRITICAL, . - NOT TESTEDB513000000WX0000003039Printed D&T: 07/13/20 08:59Ordered By:CLIENT CLIENTWX00000000001595William G. Finn, M.D. - Medical DirectorForm: MM RL1PAGE 1 OF 1LAB:

TEST DIRECTORY UPDATEAUGUST 2020New Test ActivationEffective DateNameCodeCPT Code(s)8/25/2020Ethyl Glucuronide, Umbilical Cord Tissue, QualitativeEGUCT80321 (G0480)NotesSpecimen RequirementsCollect at least 8 inches of Umbilical Cord. Ensure no ethanol-containing personal care productsare used or nearby during collection. Drain and discard any blood. Rinse the exterior of the cordSpecimen Requiredsegment with normal saline or water. Pat the cord dry and send in a urine collection cup.Rejection CriteriaStabilityPerforming InformationMethodologyReference RangePerformed DaysTurnaround TimeCords soaking in blood or other fluid. Formalin fixed or decomposed tissue.Room temperature: 1 week; Refrigerated: 3 weeks; Frozen: 1 yearQualitative Liquid Chromatography/Tandem Mass SpectrometryEthyl Glucuronide cutoff: 5 ng/gTuesday, Thursday, Saturday2 - 6 daysPerforming LaboratoryARUP Reference LaboratoryInterface InformationLegacy Code¹EGUCTInterface Order Code3600177Result CodeNameLOINC CodeAOE/Prompt²Ethyl Glucuronide, Umbilical Cord Tissue,3600177Not availableNoQualitativeLAST EDITED: 2020-07-13PAGE 5 OF 16

rpt chKEY FORLAB:L - LOW,RESULTS:H - HIGH, AB - ABNORMAL, C - CRITICAL, . - NOT TESTEDBWX000000000W WLABORATORY REPORTB51300000EXAMPLE, REPORTWX0000003039M 12/05/1988 31 YExample Client, XYZ1231234 Warde RoadAnn Arbor MI 48108SwitcherSwitcherSwitcherSwitcherrpt ch labB51300000100Referral TestingCollected: 07/11/2020 11:12Test NameResultEthyl Glucuronide, Umbilical Cord Tissue,QualitativeNot sSiteCutoff 5ng/gARRLINTERPRETIVE INFORMATION: Ethyl Glucuronide, Umbilical CordTissue, QualitativeMethodology: Qualitative Liquid Chromatography-Tandem MassSpectrometryThis test is designed to detect and document exposure thatoccurred during approximately the last trimester of a fullterm pregnancy, to ethyl glucuronide, a common ethanol(alcohol) metabolite. Alternative testing is available todetect other drug exposures. The pattern and frequency ofalcohol used by the mother cannot be determined by thistest. A negative result does not exclude the possibilitythat a mother used alcohol during pregnancy. Detection ofalcohol in umbilical cord tissue depends on extent ofmaternal use, as well as stability, unique characteristicsof alcohol deposition in umbilical cord tissue, and theperformance of the analytical method. Detection of alcoholin umbilical cord tissue does not insinuate impairment andmay not affect outcomes for the infant. Interpretivequestions should be directed to the laboratory.Caution must be used when collecting specimen to ensure noethanol-containing personal care products (i.e., handsanitizers, wipes, mouthwash) are used directly on thespecimen or nearby during collection.See Compliance Statement B: aruplab.com/CSPerformed By: ARUP Laboratories500 Chipeta WaySalt Lake City, UT 84108Laboratory Director: Julio C. Delgado, MD, MSPerforming Site:ARRL: ARUP REFERENCE LAB 500 Chipeta Way Salt Lake City UT 841081221LAB: L - LOW, H - HIGH, AB - ABNORMAL, C - CRITICAL, . - NOT TESTEDB513000001WX0000003039Printed D&T: 07/13/20 09:02Ordered By:CLIENT CLIENTWX00000000001595William G. Finn, M.D. - Medical DirectorForm: MM RL1PAGE 1 OF 1LAB:

TEST DIRECTORY UPDATEAUGUST 2020New Test ActivationEffective DateNameCodeCPT Code(s)8/25/2020Ustekinumab and Anti-Ustek Antibody, SerumFUKAU80299 (Ustekinumab); 82397 (Antibody)NotesSpecimen RequirementsDraw blood in a plain red-top tube. Centrifuge, separate serum from cells and send 3.0 mL serumSpecimen Required (1.0 mL minimum) frozen in a screw-capped plastic vial.Rejection CriteriaStabilityGross hemolysis, Gross lipemia, Gross icterusRoom temperature: 14 days; Refrigerated: 14 days; Frozen: 14 daysPerforming InformationMethodologyReference RangePerformed DaysTurnaround TimeElectrochemiluminescence immuoassay (ECLIA)By reportWednesday12 - 17 daysPerforming LaboratoryInterface InformationLegacy Code¹Interface Order CodeResult CodeName3800117Ustekinumab3800118Anti-Ustekinumab AbLAST EDITED: 2020-07-13Mayo Clinic LaboratoriesFUKAU3800115LOINC Code87408-188992-3AOE/Prompt²NoNoPAGE 6 OF 16

rpt chKEY FORLAB:L - LOW,RESULTS:H - HIGH, AB - ABNORMAL, C - CRITICAL, . - NOT TESTEDBWX000000000W WLABORATORY REPORTB51300000EXAMPLE, REPORTWX0000003039M 12/05/1988 31 YExample Client, XYZ1231234 Warde RoadAnn Arbor MI 48108SwitcherSwitcherSwitcherSwitcherrpt ch labB51300000200Referral TestingCollected: 07/10/2020 07:00Test :03SiteLAB:Ustekinumab and Anti-Ustek Ab, SerumUstekinumabAnti-Ustekinumab Ab5.51.5ug/mLng/mLMMRLMMRLTest Performed by:Esoterix Endocrinology4301 Lost Hills RoadCalabasas Hills, CA 91301Performing Site:MMRL: MAYO MEDICAL REFERENCE LAB 3050 Superior Drive NW Rochester MN 55901LAB: L - LOW, H - HIGH, AB - ABNORMAL, C - CRITICAL, . - NOT TESTEDB513000002WX0000003039Printed D&T: 07/13/20 09:05Ordered By:CLIENT CLIENTWX00000000001595William G. Finn, M.D. - Medical DirectorForm: MM RL1PAGE 1 OF 1

TEST DIRECTORY UPDATEAUGUST 2020New Test ActivationEffective DateNameCodeCPT Code(s)8/25/2020Hazelnut IgE Component PanelHZLCP86008 x 4NotesSpecimen RequirementsDraw blood in a SST. Centrifuge, remove serum from cells, and send 1.0 mL serum (0.5 mLSpecimen Required minimum) refrigerated in a screw-capped plastic vial.Alternate SpecimenStabilitySerum: Red-topRoom temperature: Unacceptable; Refrigerated: 7 days; Frozen: 14 daysPerforming InformationMethodologyReference RangePerformed DaysTurnaround TimePerforming LaboratoryInterface InformationLegacy Code¹Interface Order CodeResult 13230001333069000LAST EDITED: 2020-07-13Fluorescent Enzyme ImmunoassaySee reportMonday - Friday1 - 3 daysWarde Medical LaboratoryNameCor a 1 (f428)Cor a 1 ClassCor a 8 (f425)Cor a 8 ClassCor a 9 (f440)Cor a 9 ClassCor a 14 (f439)Cor a 14 ClassAllergy InterpretationHZLCP3000077LOINC 8-282569-5Not availableAOE/Prompt²NoNoNoNoNoNoNoNoNoPAGE 7 OF 16

rpt chKEY FORLAB:L - LOW,RESULTS:H - HIGH, AB - ABNORMAL, C - CRITICAL, . - NOT TESTEDBWX000000000W WLABORATORY REPORTB51300000EXAMPLE, REPORTWX0000003039M 12/05/1988 31 YExample Client, XYZ1231234 Warde RoadAnn Arbor MI 48108SwitcherSwitcherSwitcherSwitcherrpt ch labB51300000300Allergy Testing - PanelsCollected: 07/13/2020 09:06Test :06SiteLAB:Hazelnut IgE Component PanelCor a 1 (f428)Cor a 1 ClassCor a 8 (f425)Cor a 8 ClassCor a 9 (f440)Cor a 9 ClassCor a 14 (f439)Cor a 14 Class 0.10CLASS 0 0.10CLASS 0 0.10CLASS 0 0.10CLASS 0 0.10kU/L---------- 0.100.10 - 0.340.35 - 0.690.70 - 3.493.50 - 17.417.5 - 49.950.0 - 100.0 100.0WMRLWMRL 0.10kU/LWMRLWMRL 0.10kU/LWMRLWMRL 0.10kU/LWMRLWMRLSensitization to Cor a 9 and Cor a 14 may indicatean increased risk of systemic allergic responseupon exposure to hazelnut. Patients may beallergic to peanuts and other tree nuts(walnut and Brazil nut). Sensitization toCor a 1 alone is typically associated with localreactions. Cor a 1 may be associated withcross-reactivity and sensitization to birch pollen.Sensitization to Cor a 8 is associated with systemicallergic reactions or local oral symptoms as well assymptoms to other lipid transfer protein containingfood such as peach, lettuce, peanut, walnut, andcherry. Reactivity to whole hazelnut withoutreactivity to hazelnut components may be explainedby sensitization to other hazelnut storage proteins,cross reactivity with pollen proteins, orcross-reactive carbohydrates.Allergy InterpretationSee BelowCLASS----00/1123456kU/LWMRLLevel of AllergenSpecific IgE Antibody--------------------UndetectableVery Low LevelLow LevelModerate LevelHigh LevelVery High LevelVery High LevelVery High LevelPerforming Site:WMRL: WARDE MEDICAL LABORATORY 300 West Textile Road Ann Arbor MI 48108LAB: L - LOW, H - HIGH, AB - ABNORMAL, C - CRITICAL, . - NOT TESTEDB513000003WX0000003039Printed D&T: 07/13/20 09:07Ordered By:CLIENT CLIENTWX00000000001595William G. Finn, M.D. - Medical DirectorForm: MM RL1PAGE 1 OF 1

TEST DIRECTORY UPDATEAUGUST 2020New Test ActivationEffective DateNameCodeCPT Code(s)8/25/2020MGMT Promoter Methylation DetectionMGPMD81287, 88381NotesSpecimen RequirementsTumor Tissue: Formalin fix (10% neutral buffered formalin) and paraffin embed tissue. ProtectSpecimen Required from excessive heat. Transport tissue block and 5 unstained 5 micron slides.Specimens fixed in alternative fixativesHeavy metal fixatives (B-4 or B-5)Rejection Criteria Decalcified specimensLess than 25% tumorStabilityPerforming InformationMethodologyReference RangePerformed DaysTurnaround TimeRoom temperature: Indefinitely; Refrigerated: Indefinitely; Frozen: UnacceptablePolymerase Chain Reaction/MassARRAY/MAL-DI-TOFBy reportDNA Isolation: Sunday - Saturday; Assay: Varies10 - 14 daysPerforming LaboratoryARUP Reference LaboratoryInterface InformationLegacy Code¹MGPMDInterface Order Code3600174Result CodeNameLOINC CodeAOE/Prompt²3600175Block ID57723-9NoMGMT Promoter Methylation Dection360017660252-4NoResultLAST EDITED: 2020-07-13PAGE 8 OF 16

rpt chKEY FORLAB:L - LOW,RESULTS:H - HIGH, AB - ABNORMAL, C - CRITICAL, . - NOT TESTEDBWX000000000W WLABORATORY REPORTB51300000EXAMPLE, REPORTWX0000003039M 12/05/1988 31 YExample Client, XYZ1231234 Warde RoadAnn Arbor MI 48108SwitcherSwitcherSwitcherSwitcherrpt ch labB51300000400Referral TestingCollected: 07/13/2020 09:08Test :08SiteLAB:MGMT Promoter Methylation DectionBlock IDTEST9876Performed By: ARUP Laboratories500 Chipeta WaySalt Lake City, UT 84108Laboratory Director: Julio C. Delgado, MD, MSMGMT Promoter Methylation Dection ResultDetectedARRLABARRLMGMT promoter methylation was detected.This result has been reviewed and approved by GeorgiosDeftereos, M.D.INTERPRETIVE INFORMATION: MGMT Promoter MethylationDetectionCHARACTERISTICS: This assay is designed to detect MGMTpromoter methylation. MGMT promoter methylation status is aprognostic biomarker in patients with high grade gliomasand is useful in treatment decisions. For specifictreatment recommendations please refer to NCCN ClinicalPractice Guidelines in Oncology for Central Nervous SystemCancers (www.nccn.org).METHODOLOGY: Genomic DNA is isolated frommicroscopically-guided dissection of tumor tissue.Bisulfite conversion and subsequent polymerase chainreaction (PCR) amplification of region of interest isfollowed by enzymatic cleavage at thymine residues. Theresulting fragments, which differ in molecular mass basedon CpG site methylation status, are analyzed by MassARRAYmatrix-assisted laser desorption/ionization (MALDI)time-of-flight (TOF) mass spectrometry to determine CpGmethylation status. Methylation status of MGMT promoter CpGsites 72-83 and 86-89 is evaluated. Total methylation iscalculated as an average across listed CpG sites. Totalmethylation of 0-9 percent is reported as "Not detected"10-29 percent as "Low level" and equal or more than 30percent as "Detected".LIMITATIONS: Methylation at locations other than thoselisted above will not be detected.ANALYTICAL SENSITIVITY: 5 percent methylation.CLINICAL DISCLAIMER: Results of this test must always beinterpreted within the clinical context and other relevantLAB: L - LOW, H - HIGH, AB - ABNORMAL, C - CRITICAL, . - NOT TESTEDB513000004WX0000003039Printed D&T: 07/13/20 09:11Ordered By:CLIENT CLIENTWX00000000001595William G. Finn, M.D. - Medical DirectorForm: MM RL1PAGE 1 OF 2

rpt chKEY FORLAB:L - LOW,RESULTS:H - HIGH, AB - ABNORMAL, C - CRITICAL, . - NOT TESTEDBWX000000000W WLABORATORY REPORTB51300000EXAMPLE, REPORTWX0000003039M 12/05/1988 31 YExample Client, XYZ1231234 Warde RoadAnn Arbor MI 48108SwitcherSwitcherSwitcherSwitcherrpt ch labB51300000400Referral TestingCollected: 07/13/2020 09:08Test NameResultFlagRef-Rangesinterpreted within the clinical context and other relevantdata and should not be used alone for a diagnosis ofmalignancy.Received:07/13/2020Units09:08SiteTest developed and characteristics determined by ARUPLaboratories. See Compliance Statement B: aruplab.com/CSPerforming Site:ARRL: ARUP REFERENCE LAB 500 Chipeta Way Salt Lake City UT 841081221LAB: L - LOW, H - HIGH, AB - ABNORMAL, C - CRITICAL, . - NOT TESTEDB513000004WX0000003039Printed D&T: 07/13/20 09:11Ordered By:CLIENT CLIENTWX00000000001595William G. Finn, M.D. - Medical DirectorForm: MM RL1PAGE 2 OF 2

TEST DIRECTORY UPDATEAUGUST 2020New Test ActivationEffective DateNameCode7/28/2020Clin Urine Expanded Opioid ConfirmUCOPE80361, 80365 (Opiates); 80348, 80362 (Buprenorphine & Metabolite);CPT Code(s) 80354 (Fentanyl & Metabolite); 80373 (Tramadol & Metabolite) (G0480)NotesSpecimen RequirementsCollect random urine. Mix well and send 20.0 mL urine (4.0 mL) refrigerated in a screwSpecimen Required capped plastic urine container.Rejection CriteriaStabilityUrine with preservative, vacutainer cupRoom temperature: 48 hours; Refrigerated: 14 days; Frozen: 14 daysPerforming InformationMethodologyLiquid Chromatography - Tandem Mass SpectrometryConfirmation (LC/MS/MS) Decision LimitsFentanyl1 ng/mLNorfentanyl1 ng/mLMorphine25 ng/mLCodeine25 ng/mLHydrocodone25 ng/mLHydromorphone25 ng/mLOxycodone25 ng/mLOxymorphone25 ng/mLNaloxone5 ng/mLBuprenorphine5 ng/mLNorbuprenorphine5 ng/mLTramadol5 ng/mL5 ng/mLO-desmethyltramadolReference RangePerformed DaysTurnaround TimePerforming LaboratoryInterface InformationLegacy Code¹Interface Order CodeResult Code30008123000813300081430008153000816LAST EDITED: 2020-07-13Sunday - Friday4 daysWarde Medical drocodoneUCOPE3000811LOINC �NoNoNoNoNoPAGE 9 OF 16

TEST DIRECTORY UPDATEAUGUST 823300082430008253000826LAST EDITED: NoNoNoNoNoNoNoNoPAGE 10 OF 16

LABORATORY REPORTExample Client, XYZ1231234 Warde RoadAnn Arbor MI 48108EXAMPLE, REPORTWX0000003039 M 12/05/1988Collected:06/30/2020 13:04Received: 06/30/2020 13:04Clinical Urine Expanded Opioid ConfirmTest RLNorfentanyl35ng/mLWMRLMorphine1256The morphine/codeine in this urine could haveresulted from eating foods containing poppy on (LC/MS/MS) Decision Lng/mLng/mLng/mLng/mLng/mLng/mLng/mLAdulterant Decision Limit:General Oxidants200 ug/mLThe adulterant assay tests for General Oxidants,LAB: L - LOW, H - HIGH, AB - ABNORMAL, C - CRITICAL,B430000007Ordered By: CLIENT rinted D&T: 6/30/2020 1:12 PMplaceholder1 OF 2William G. Finn, M.D. - Medical Director

LABORATORY REPORTExample Client, XYZ1231234 Warde RoadAnn Arbor MI 48108EXAMPLE, REPORTWX0000003039 M 12/05/1988Test NameResultFlagThe adulterant assay tests for General Oxidants,including Chromates and Nitrites. Adulterants aresubstances either ingested or added directly to aurine specimen to prevent the detection of drug use.Ref-RangesUnitsSiteIf applicable, any drug confirmation testing reportedhere was developed and the performance characteristicsdetermined by Warde Medical Laboratory. Thisconfirmation testing has not been cleared or approvedby the FDA. The laboratory is regulated under CLIA asqualified to perform high-complexity testing. This testis used for patient testing purposes. It should not beregarded as investigational or for research.Performing Site:WMRL: Warde Medical Laboratory 300 West Textile Road Ann Arbor MI 48108 (800)876-6522LAB: L - LOW, H - HIGH, AB - ABNORMAL, C - CRITICAL,B430000007Ordered By: CLIENT rinted D&T: 6/30/2020 1:12 PMplaceholder2 OF 2William G. Finn, M.D. - Medical Director

TEST DIRECTORY UPDATEAUGUST 2020New Test ActivationEffective DateNameCodeCPT Code(s)8/25/2020Walnut IgE Component PanelWLNCP86008 x 2NotesSpecimen RequirementsDraw blood in a SST. Centrifuge, remove serum from cells, and send 1.0 mL serum (0.5 mLSpecimen Required minimum) refrigerated in a screw-capped plastic vial.Alternate SpecimenStabilitySerum: Red-topRoom temperature: Unacceptable; Refrigerated: 7 days; Frozen: 14 daysPerforming InformationMethodologyReference RangePerformed DaysTurnaround TimePerforming LaboratoryInterface InformationLegacy Code¹Interface Order CodeResult Code30001163000117300011830001193069000LAST EDITED: 2020-07-13Fluorescent Enzyme ImmunoassayBy reportMonday - Friday1 - 3 daysWarde Medical LaboratoryNameJug r 1 (f441)Jug r 1 ClassJug r 3 (f442)Jug r 3 ClassAllergy InterpretationWLNCP3000078LOINC Code81790-882545-581789-081790-8Not availableAOE/Prompt²NoNoNoNoNoPAGE 11 OF 16

rpt chKEY FORLAB:L - LOW,RESULTS:H - HIGH, AB - ABNORMAL, C - CRITICAL, . - NOT TESTEDBWX000000000W WLABORATORY REPORTB51300000EXAMPLE, REPORTWX0000003039M 12/05/1988 31 YExample Client, XYZ1231234 Warde RoadAnn Arbor MI 48108SwitcherSwitcherSwitcherSwitcherrpt ch labB51300000500Allergy Testing - PanelsCollected: 07/13/2020 09:12Test :12SiteLAB:Walnut IgE Component PanelJug r 1 (f441)Jug r 1 ClassJug r 3 (f442)Jug r 3 Class 0.10CLASS 0 0.10CLASS 0 0.10kU/L---------- 0.100.10 - 0.340.35 - 0.690.70 - 3.493.50 - 17.417.5 - 49.950.0 - 100.0 100.0WMRLWMRL 0.10kU/LWMRLWMRLSensitization to Jug r 1 may indicate anincreased risk of systemic allergic responseupon exposure to walnut. Patients may beallergic to other nuts or seeds, includingpecan, hazelnut, and cashew. Sensitizationto Jug r 3 has been associated with bothsystemic and local reactions. Patients mayreact to other lipid transfer proteincontaining foods, such as peach, other nuts,apple, or grapes. Reactivity to whole walnutwith negative Jug r 1 and Jug r 3 results maybe explained by sensitization to other walnutstorage proteins, cross reactivity with pollenproteins, or cross-reactive carbohydrates.Allergy InterpretationSee BelowCLASS----00/1123456kU/LWMRLLevel of AllergenSpecific IgE Antibody--------------------UndetectableVery Low LevelLow LevelModerate LevelHigh LevelVery High LevelVery High LevelVery High LevelPerforming Site:WMRL: WARDE MEDICAL LABORATORY 300 West Textile Road Ann Arbor MI 48108LAB: L - LOW, H - HIGH, AB - ABNORMAL, C - CRITICAL, . - NOT TESTEDB513000005WX0000003039Printed D&T: 07/13/20 09:12Ordered By:CLIENT CLIENTWX00000000001595William G. Finn, M.D. - Medical DirectorForm: MM RL1PAGE 1 OF 1

TEST DIRECTORY UPDATEAUGUST 2020Update Existing TestEffective Date8/17/2020NameAspergillus Ab by CFCodeASPCFInterface Order Code3680160Legacy CodeASPABCFARPNotesMinimum volume changesRequired Testing ChangesDraw blood in a SST. Centrifuge, separate serum from cells within 2 hours, and send 1.0 mL serumSpecimen Required (0.4 mL minimum) refrigerated in a screw-capped plastic vial.Update Existing TestEffective Date8/17/2020NameChromogranin ACodeCHROAInterface Order Code3420100Legacy CodeCHROMAQNotesRequired Testing ChangesNameChromogranin A, SerumDraw blood in a plain red-top tube. Centrifuge, separate and send 1.0 mL serum (0.5 mLSpecimen Required minimum) frozen in a screw-capped plastic vial.Alternate SpecimenStabilityMethodologyReference RangePerformed DaysResult Code3420100LAST EDITED: 2020-07-13Serum: SSTRoom temperature: 48 hours; Refrigerated: 3 days; Frozen: 4 weeksImmunofluorescence assay0 - 103 ng/mLMonday, Wednesday, Friday, SundayNameChromogranin A, SerumLOINC Code9811-1AOE/Prompt²NoPAGE 12 OF 16

TEST DIRECTORY UPDATEAUGUST 2020Update Existing TestEffective DateNameCodeInterface Order CodeLegacy CodeNotesRequired Testing Changes4 - 7 daysTurnaround TimeUpdate Existing TestEffective DateNameCodeInterface Order CodeLegacy CodeNotes8/17/2020Fungal Antibodies (ID)FAPIA3682945FAPIDARPTurnaround changes6/11/2020MyoMarker Panel 3FMP33800044FMP3Methodology Changes and Resulting name changes.Required Testing ChangesNameMyoMarker 3 ProfileMethodologyEnzyme-linked Immunosorbent Assay (ELISA)Result CodeNameLOINC CodeAOE/Prompt²3800045Anti-Jo-1 Ab35333-43800046Anti-PL-7 Ab33772-53800047Anti-PL-12 Ab33771-73800048Anti-EJ Ab45149-23800049Anti-OJ Ab45152-63800050Anti-SRP Ab33921-83800051Anti-MI-2 Ab18485-33800052Anti-TIF1 Gamma Ab88739-83800053MDA-5 Ab (CADM-140)88725-73800054Anti-NXP-2 (P140) Ab82425-03800055Anti-PM/Scl-100 Ab61120-23800056Anti-U3 RNP (Fibrillarin)49963-23800057Anti-U2 RNP Ab68549-53800058Anti-U1-RNP Ab57662-93800059Anti-Ku Ab18484-63800060Anti-SS-A 52 kD Ab, IgG56549-9LAST EDITED: 2020-07-13NoNoNoNoNoNoNoNoNoNoNoNoNoNoNoNoPAGE 13 OF 16

TEST DIRECTORY UPDATEAUGUST 2020Update Existing TestEffective Date8/17/2020NameHistoplasma Abs (ID)CodeHISIDInterface Order Code3680860Legacy CodeHISABIDARPNotesMinimum volume and turnaround changesRequired Testing ChangesDraw blood in a SST. Centrifuge, separate serum from cells within 2 hours and send 0.5 mL serumSpecimen Required (0.2 mL minimum) refrigerated in a screw-capped plastic vial.Turnaround Time4 - 7 daysUpdate Existing TestEffective Date8/17/2020NameHistoplasma Abs (CF/ID)CodeHPIDAInterface Order Code3683110Legacy CodeHISTABCFIDNotesMinimum volume and turnaro

Ana o 3 (f443) 0.10 0.10 kU/L WMRL Ana o 3 Class CLASS 0 WMRL Sensitization to Ana 03 may indicate an increased risk of systemic allergic response upon exposure to cashew. Patients may be allergic to other nuts, such as pistachio, walnut, and peanut. Reactivity to whole cashew with negative Ana

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