39
ADHTT ........................................................................................................................................ 5 A DIHYDROTESTOSTERONE BY TMS 11/14/2016: Reference Ranges ARBVM .......................................................................................................................................................... ARBOVIRUS AB PANEL, IGM 11/21/2016: 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, CSF 11/21/2016: Delete: This test is being discontinued. UQARS ..................................................................................................................................................................... ARSENIC, URINE 24HR 11/7/2016: Department,Reference Ranges URAS .................................................................................................................................................................. ARSENIC, URINE RANDOM 11/7/2016: Department,Reference Ranges AKJD ................................................................................................................................... ASHKENAZI JEWISH DISEASES, 16 GENES 11/14/2016: Test Name,Synonyms,Refrigerated,Frozen -20c,Unacceptable Condition,CPT Codes,Test Schedule,Turnaround Time,Method,Reference Ranges,Notes,Please Note AKJDCF ...................................................................................................................................... ASHKENAZI JEWISH PANEL WITH CF 11/14/2016: Synonyms,Unacceptable Condition,CPT Codes,Test Schedule,Turnaround Time,Method,Reference Ranges,Compliance Remarks,Notes LYMECF ............................................................................................................................................ B. BURGDORFERI AB (LYME), CSF 11/14/2016: Synonyms,Test Schedule,Method,Reference Ranges,Compliance Remarks,Notes ICBFP3 .................................................................................................................................................. BIRD FANCIERS PROFILE PNL III 12/27/2016: CPT Codes,Reference Ranges,Please Note,Other,Fees BRCASQ .................................................................................................................................................... BRCA1/BRCA2 SEQ DEL/DUP 10/18/2016: CPT Codes,Please Note UQCD ........................................................................................................................................................................ CADMIUM, URINE 24HR 11/7/2016: Department,Reference Ranges URCD ................................................................................................................................................................ CADMIUM, URINE RANDOM 11/7/2016: Department,Reference Ranges CATEUR ....................................................................................................................................... CATECHOLAMINES, URINE RANDOM 11/7/2016: Department,Reference Ranges CEBPAM ................................................................................................................................................. CEBPA MUTATION DETECTION 11/14/2016: CPT Codes,Please Note UQCR .................................................................................................................................................................... CHROMIUM, URINE 24HR 11/7/2016: Department,Reference Ranges URCR ............................................................................................................................................................. CHROMIUM, URINE RANDOM 11/7/2016: Department,Reference Ranges UQCO .......................................................................................................................................................................... COBALT, URINE 24HR 11/7/2016: Department,Reference Ranges URCO .................................................................................................................................................................. COBALT, URINE RANDOM 11/7/2016: Department,Reference Ranges UQCOP ...................................................................................................................................................................... COPPER, URINE 24HR 11/7/2016: Department,Reference Ranges URCOP ............................................................................................................................................................... COPPER, URINE RANDOM 11/7/2016: Department,Reference Ranges CUMB12 ................................................................................................................................................... CORDSTAT 12 DRUG SCR PNL 12/27/2016: Other CUM12A (CUMB12A) .................................................................................................................................... CORDSTAT 12 SCR W/ALC 12/27/2016: Other CUMB13 ................................................................................................................................................... CORDSTAT 13 DRUG SCR PNL 12/27/2016: Other Test Change Alert #450 November 28, 2016 Summary Of Changes page: 1

Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

  • Upload
    others

  • View
    4

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

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.

UQARS ..................................................................................................................................................................... ARSENIC, URINE 24HR11/7/2016: Department,Reference Ranges

URAS .................................................................................................................................................................. ARSENIC, URINE RANDOM11/7/2016: Department,Reference Ranges

AKJD ................................................................................................................................... ASHKENAZI JEWISH DISEASES, 16 GENES11/14/2016: Test Name,Synonyms,Refrigerated,Frozen -20c,Unacceptable Condition,CPT Codes,Test Schedule,TurnaroundTime,Method,Reference Ranges,Notes,Please Note

AKJDCF ...................................................................................................................................... ASHKENAZI JEWISH PANEL WITH CF11/14/2016: Synonyms,Unacceptable Condition,CPT Codes,Test Schedule,Turnaround Time,Method,Reference Ranges,ComplianceRemarks,Notes

LYMECF ............................................................................................................................................ B. BURGDORFERI AB (LYME), CSF11/14/2016: Synonyms,Test Schedule,Method,Reference Ranges,Compliance Remarks,Notes

ICBFP3 .................................................................................................................................................. BIRD FANCIERS PROFILE PNL III12/27/2016: CPT Codes,Reference Ranges,Please Note,Other,Fees

BRCASQ .................................................................................................................................................... BRCA1/BRCA2 SEQ DEL/DUP10/18/2016: CPT Codes,Please Note

UQCD ........................................................................................................................................................................ CADMIUM, URINE 24HR11/7/2016: Department,Reference Ranges

URCD ................................................................................................................................................................ CADMIUM, URINE RANDOM11/7/2016: Department,Reference Ranges

CATEUR ....................................................................................................................................... CATECHOLAMINES, URINE RANDOM11/7/2016: Department,Reference Ranges

CEBPAM ................................................................................................................................................. CEBPA MUTATION DETECTION11/14/2016: CPT Codes,Please Note

UQCR .................................................................................................................................................................... CHROMIUM, URINE 24HR11/7/2016: Department,Reference Ranges

URCR ............................................................................................................................................................. CHROMIUM, URINE RANDOM11/7/2016: Department,Reference Ranges

UQCO .......................................................................................................................................................................... COBALT, URINE 24HR11/7/2016: Department,Reference Ranges

URCO .................................................................................................................................................................. COBALT, URINE RANDOM11/7/2016: Department,Reference Ranges

UQCOP ...................................................................................................................................................................... COPPER, URINE 24HR11/7/2016: Department,Reference Ranges

URCOP ............................................................................................................................................................... COPPER, URINE RANDOM11/7/2016: Department,Reference Ranges

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

Test Change Alert #450 November 28, 2016

Summary Of Changes

page: 1

Page 2: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

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.

CUDIBA ............................................................................................................................................... CUTANEOUS BIOPSY (DIRECT IF)11/7/2016: Synonyms,Container Type,Store and Transport,Specimen Type,Specimen Processing,Unacceptable Condition,CPTCodes,Method,Notes

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.

UQPB ................................................................................................................................................................................ LEAD, URINE 24HR11/7/2016: Department,Reference Ranges

Test Change Alert #450 November 28, 2016

Summary Of Changes

page: 2

Page 3: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

UPB ............................................................................................................................................................................. LEAD, URINE RANDOM11/7/2016: Department,Reference Ranges

LSRA ................................................................................................................................................... LECITHIN/SPHINGOMYELIN RATIO11/14/2016: Delete: This test is being discontinued.

UQMN ................................................................................................................................................................ MANGANESE, URINE 24HR11/7/2016: Department,Reference Ranges

URMN ......................................................................................................................................................... MANGANESE, URINE RANDOM11/7/2016: Department,Reference Ranges

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.

UQHG ...................................................................................................................................................................... MERCURY, URINE 24HR11/7/2016: Department,Reference Ranges

URMER ........................................................................................................................................................... MERCURY, URINE RANDOM11/7/2016: Department,Reference Ranges

METAUR ......................................................................................................................................... METANEPHRINES, URINE RANDOM11/7/2016: Department,Reference Ranges

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.

URNI ....................................................................................................................................................................... NICKEL, URINE RANDOM11/7/2016: Department,Reference Ranges

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.

Test Change Alert #450 November 28, 2016

Summary Of Changes

page: 3

Page 4: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

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

PSHPV ....................................................................................................................................................... PRIMARY HRHPV W/PAP RFLX11/21/2016: Synonyms,Container Type,Supply Item Number,Collection Procedure,Room Temp,Refrigerated,Unacceptable Condition

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.

COUMA ................................................................................................................................................. WARFARIN, SERUM OR PLASMA10/19/2016: Synonyms,Specimen Processing,Frozen -20c,Unacceptable Condition,Alternate Specimens,CPT Codes,TestSchedule,Turnaround Time,Method,Please Note

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.

UQZN .................................................................................................................................................................................. ZINC, URINE 24HR11/7/2016: Department,Reference Ranges

URZN ........................................................................................................................................................................... ZINC, URINE RANDOM11/7/2016: Department,Reference Ranges

Test Change Alert #450 November 28, 2016

Summary Of Changes

page: 4

Page 5: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

5 A DIHYDROTESTOSTERONE BY TMSTest Code ADHTT

Billing Code ADHTTEffective 11/14/2016

ReferenceRanges

Title Gender Descriptor Ranges Units

5-a-Dihydrotestosterone,LC-MS/MS

Male Premature 100.0-530.0 pg/mL

Full Term 50.0-600.0

1 week-6 months 120.0-850.0

7 months-9 years 0.0-49.9

ReferenceRanges

continued

10-19 years 0.0-533.0

20+ years 106.0-719.0

Tanner Stage I 1.0-47.6

Tanner Stage II 3.5-397.9

ReferenceRanges

continued

Tanner Stage III 14.8-574.6

Tanner Stage IV and V 44.9-511.8

Female Premature 20.0-130.0

Full Term 20.0-150.0

ReferenceRanges

continued

1 week-9 years 0.0-49.9

10-19 years 50.0-170.0

20+ years 24.0-208.0

Tanner Stage I 1.0-64.3

ReferenceRanges

continued

Tanner Stage II 5.5-95.9

Tanner Stage III 11.4-158.3

Tanner Stage IV and V 18.7-193.8

ARBOVIRUS AB PANEL, IGMTest Code ARBVM

Billing Code ARBVMEffective 11/21/2016

Delete This test is being discontinued.

ARBOVIRUS AB PNL, IGM, CSF (IFA)Test Code ARBMSF

Billing Code ARBMSFEffective 11/21/2016

Delete This test is being discontinued.

ARBOVIRUS ANTIBODY PANEL, IGG & IGM, CSFTest Code ARBOSF

Billing Code ARBOSFEffective 11/21/2016

Delete This test is being discontinued.

Test Change Alert #450 November 28, 2016

The following tables reflect revisions only; other existing data remain unchanged.

page: 5

Page 6: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

ARSENIC, URINE 24HRTest Code UQARS

Billing Code UQARSEffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Gender Ranges Units

Collection Period h

Total Volume mL

Arsenic, Urine 0.0-35.0 (based on biologicalexposure index)

ug/L

Arsenic, Urine (24 hour) 0.0-50.0 ug/24h

ReferenceRanges

continued

Arsenic: Creatinine Ratio < = 30.0 ug/gCR

Creatinine, Urine Male 1.0-2.4 g/24h

Female 0.7-1.6

ReferenceRanges

continued

ARSENIC, URINE RANDOMTest Code URAS

Billing Code URASEffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Descriptor Ranges Units

Arsenic, Urine 0.0-35.0 (based on biologicalexposure index)

ug/L

Creatinine, Urine Male 39-259 mg/dL

Female 28-217

Arsenic: Creatinine Ratio < = 30.0 ug/gCR

ReferenceRanges

continued

Test Change Alert #450 November 28, 2016

The following tables reflect revisions only; other existing data remain unchanged.

page: 6

Page 7: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

ASHKENAZI JEWISH DISEASES, 16 GENESTest Code AKJD

Billing Code AKJDEffective 11/14/2016

Synonyms AJ Panel; Bloom Syndrome; Canavan; Familial Disautonomia; Gaucher; Mucolipidosis; Niemann Pick; Tay-Sachs

Refrigerated 2 weeks

Frozen -20c 1 month

UnacceptableCondition

Plasma or serum. Specimens collected in sodium heparin or lithium heparin tubes.

CPT Codes 81209, 81200, 81260, 81242, 81251, 81290, 81330, 81255, 81205, 81250, 81400, 81401, 81479

Test Schedule Tue, Fri

Turnaround Time 6-10 days

Method Polymerase Chain Reaction/Fluorescence Monitoring

ReferenceRanges

Title Ranges

AJP Gene 1 Negative

AJP Gene 2 Negative

AJP Specimen Whole Blood

Ashkenazi Jewish Panel See below

ReferenceRanges

continued

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.

page: 7

Page 8: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

ASHKENAZI JEWISH PANEL WITH CFTest Code AKJDCF

Billing Code AKJDCFEffective 11/14/2016

Synonyms AJ Panel; Bloom Syndrome; Canavan; Familial Disautonomia; Gaucher; Mucolipidosis; Niemann Pick; Tay-Sachs;Cystic Fibrosis

UnacceptableCondition

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.

CPT Codes 81220, 81209, 81200, 81260, 81242, 81251, 81290, 81330, 81255, 81205, 81250, 81400, 81401, 81479

Test Schedule Mon, Tue, Wed, Fri

Turnaround Time 6-10 days

Method Polymerase Chain Reaction/Fluorescence Monitoring

ReferenceRanges

Title Ranges

AJP Gene 1 Negative

AJP Gene 2 Negative

AJP Specimen Whole blood

Ashkenazi Jewish Panel See below

ReferenceRanges

continued

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.

Notes

AJ mutations included in panel: ABCC8: p.F1388del(c.4163_4165del), p.V187D(c.560T>A), c.3992-9G>A; BLM:p.Y738Lfs(c.2207_2212delinsTAGATTC); ASPA: c.433-2A>G, p.Y231X(c.693C>A), p.E285A(c.854A>C),p.A305E(c.914C>A); IKBKAP: p.R696P(c.2087G>C), c.2204+6T>C; FANCC: p.D23Ifs(c.67delG), c.456+4A>T; GBA:p.L29Afs(c.84dupG), c.115+1G>A, p.N409S(c.1226A>G), c.1263_1317del55, p.V433L(c.1297G>T),p.D448H(c.1342G>C), p.L483P(c.1448T>C), p.R535H(c.1604G>A); G6PC: p.Q27Rfs(c.79delC),p.Y128Tfs(c.379_380dupTA), p.R83H(c.248G>A), p.R83C(c.247C>T), p.G188R(c.562G>C), p.!242X(c.724C>T),p.Q347X(c.1039C>T), p.G270V(c.809G>T), p.F327del(c.979_981delTTC); TMEM216: p.R73L(c.218G>T); DLD:p.Y35X(c.104dupA), p.G229C(c.685G>T); BCKDHB: p.R183P(c.548G>C), p.G278S(c.832G>A), p.E372X(c.1114G>T);MCOLN1: c.406-2A>G, g.511_6493del; NEB: exon 55 del(p.R2478_D2512del); SMPD1: p.L304P(c.911T>C),p.F333Sfs(c.996delC), p.R498L(c.1493G>T), p.R610del(c.1829_1831delGCC); HEXA: 7.6 kb del, p.G269S(c.805G>A),c.1073+1G>A, p.Y427Ifs(c.1274-1277dupTATC), c.1421+1G>C, Pseudodeficiency alleles p.R247W(c.739C>T),p.R249W(c.745C>T); PCDH15: p.R245X(c.733C>T); CLRN1: p.N48K(c.144T>G)

CF Mutations included in panel: 394delTT (c.262_263delTT); 406-1G>A (c.274-1G>A); 621+1G>T* (c.489+1G>T);711+1G>T* (c.579+1G>T); 935delA (c.803delA); 1078delT (c.948delT); 1677delTA (c.1545_1546delTA); 1717-1G>A*(c.1585-1G>A); 1898+1G>A* (c.1766+1G>A); 1898+5G>T (c.1766+5G>T); 2055del9>A (c.1923_1931del9insA);2143delT (c.2012delT); 2183AA>G (c.2051_2052delAAinsG); 2184delA* (c.2052delA); 2307insA (c.2175_2176insA);2789+5G>A* (c.2657+5G>A); 3120+1G>A* (c.2988+1G>A); 3199del6 (c.3067_3072delATAGTG); 3659delC*(c.3528delC); 3791delC (c.3659delC); 3849+10kbC>T* (c.3717+12191C>T); 3876delA (c.3744delA); 3905insT(c.3773_3774insT); A455E* (c.1364C>A); A559T (c.1675G>A); CFTRdele2,3 (c.54-5940_273+10250del21kb); D1152H(c.3454G>C); E60X (c.178G>T); F508del*b (c.1521_1523delCTT); G178R (c.532G>A); G330X (c.988G>T); G542X*(c.1624G>T); G551D* (c.1652G>A); G85E* (c.254G>A); I507del* (c.1519_1521delATC); K710X (c.2128A>T); L206W(c.617T>G); M1101K (c.3302T>A); N1303K* (c.3909C>G); Q493X (c.1477C>T); Q890X (c.2668C>T); R1066C(c.3196C>T); R1158X (c.3472C>T); R1162X* (c.3484C>T); R117H*c (c.350G>A); R334W* (c.1000C>T); R347H(c.1040G>A); R347P* (c.1040G>C); R553X* (c.1657C>T); R560T* (c.1679G>C); R75X (c.223C>T); S1196X(c.3587C>G); S1255X (c.3764C>A); S549N (c.1646G>A); S549R(T>G) (c.1647T>G); V520F (c.1558G>T); W1089X(c.3266G>A); W1282X* (c.3846G>A); Y1092X (c.3276C>A or G); Y122X (c.366T>A)

Test Change Alert #450 November 28, 2016

The following tables reflect revisions only; other existing data remain unchanged.

page: 8

Page 9: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

B. BURGDORFERI AB (LYME), CSFTest Code LYMECF

Billing Code LYMECFEffective 11/14/2016

Synonyms Borrelia burgdorferi Antibodies, Total by ELISA, CSF; Lyme Antibodies, Total; Lyme Disease, Lyme Disease AbCSF, ELISA

Test Schedule Daily

Method Semi-Quantitative Enzyme-Linked Immunosorbent Assay

ReferenceRanges

Title Descriptor Ranges Units

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.

page: 9

Page 10: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

BIRD FANCIERS PROFILE PNL IIITest Code ICBFP3

Billing Code ICBFP3Effective 12/27/2016

CPT Codes 82785, 86003 x 3, 86331 x 12

ReferenceRanges

Title Descriptor Ranges Units

IgE 1-11 months 0-12 IU/mL

1 year 0-15

2 years 1-29

3 years 4-35

ReferenceRanges

continued

4 years 2-33

5 years 8-56

6 years 3-95

7 years 2-88

ReferenceRanges

continued

8 years 5-71

9 years 3-88

10 years 7-110

11-14 years 7-111

ReferenceRanges

continued

15-19 years 6-96

20-30 years 4-59

31-51 years 5-79

51-80 years 3-48

ReferenceRanges

continued

Chicken Feathers IgE < 0.35 kU/L

Parrot Australian (Budgerigar)Droppings IgE

< 0.35 kU/L

Parrot Australian (Budgerigar)Feathers IgE

< 0.35 kU/L

Canary Droppings GelDiffusion

Negative

ReferenceRanges

continued

Chicken Serum Gel Diffusion Negative

Cockatiel Droppings GelDiffusion

Negative

Finch Droppings Gel Diffusion Negative

Parakeet Droppings GelDiffusion

Negative

ReferenceRanges

continued

Parakeet Serum Gel Diffusion Negative

Parrot Droppings Gel Diffusion Negative

Parrot Serum Gel Diffusion Negative

Pigeon/Dove Droppings GelDiffusion

Negative

ReferenceRanges

continued

Pigeon/Dove Serum GelDiffusion

Negative

Aspergillus fumigatus Mix GelDiffusion

Negative

Aureobasidium pullulans GelDiffusion

Negative

Please Note Please refer to the IMB for important update information.

Other Previous CPT Codes: 82785, 86003 x 5, 86331 x 12

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.

page: 10

Page 11: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

BRCA1/BRCA2 SEQ DEL/DUPTest Code BRCASQ

Billing Code BRCASQEffective 10/18/2016

CPT Codes 81162

Please Note Previous CPT Codes: 81211, 81213

CADMIUM, URINE 24HRTest Code UQCD

Billing Code UQCDEffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Gender Ranges Units

Collection Period h

Total Volume mL

Cadmium, Urine 0.0-2.6 ug/L

Cadmium, Urine (24 hour) 0.0-3.3 ug/24h

ReferenceRanges

continued

Cadmium per gram of creatinine 0.0-3.0 ug/gCR

Creatinine, Urine (24 hour) Male 1.0-2.4 g/24h

Female 0.7-1.6

ReferenceRanges

continued

CADMIUM, URINE RANDOMTest Code URCD

Billing Code URCDEffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Descriptor Ranges Units

Cadmium, Urine 0.0-2.6 ug/L

Creatinine, Urine Male 39-259 mg/dL

Female 28-217

Cadmium, Urine 0.0-3.0 ug/gCr

ReferenceRanges

continued

Test Change Alert #450 November 28, 2016

The following tables reflect revisions only; other existing data remain unchanged.

page: 11

Page 12: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

CATECHOLAMINES, URINE RANDOMTest Code CATEUR

Billing Code CATEUREffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Descriptor Ranges Units

Creatinine, Urine Male 39-259 mg/dL

Female 28-217

Epinephrine, Urine Random No reference range established ug/L

Epinephrine (Calculation) 0-1 years 0-375 ug/gCr

ReferenceRanges

continued

2-4 years 0-82

5-10 years 0-93

11+ years 9-58

Norepinephrine, Urine Random No reference range established ug/L

ReferenceRanges

continued

Norepinephrine (Calculation) 0-1 year 25-310 ug/gCr

2-4 years 25-390

5-10 years 27-108

11+ years 4-105

ReferenceRanges

continued

Dopamine, Urine Random No reference range established ug/L

Dopamine (Calculation) 0-1 year 240-1290 ug/gCr

2-4 years 80-1220

5-10 years 220-720

ReferenceRanges

continued

11+ years 120-450

Please note: A 24-hr urine collection is the preferred specimen. These reference ranges for random urine collections are based onliterature review.

CEBPA MUTATION DETECTIONTest Code CEBPAM

Billing Code CEBPAMEffective 11/14/2016

CPT Codes 81218

Please Note Previous CPT Code(s): 81479

CHROMIUM, URINE 24HRTest Code UQCR

Billing Code UQCREffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Gender Ranges Units

Collection Period h

Volume mL

Creatinine, Urine Male 1.0-2.4 g/24h

Female 0.7-1.6

ReferenceRanges

continued

Chromium, Urine 0.0-5.0 ug/L

Chromium, Urine 0.0-6.0 ug/d

Chromium, Urine No reference range ug/gCR

Test Change Alert #450 November 28, 2016

The following tables reflect revisions only; other existing data remain unchanged.

page: 12

Page 13: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

CHROMIUM, URINE RANDOMTest Code URCR

Billing Code URCREffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Descriptor Ranges Units

Creatinine, Urine Male 39-259 mg/dL

Female 28-217

Chromium, Urine 0.0-5.0 ug/L

Chromium, Urine No reference range ug/gCr

ReferenceRanges

continued

COBALT, URINE 24HRTest Code UQCO

Billing Code UQCOEffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Gender Ranges Units

Collection Period h

Cobalt, Urine 0.1-2.0 ug/L

Cobalt, Urine (24 hour) 0.1-2.0 ug/24h

Creatinine, Urine Male 1.0-2.4 g/24h

ReferenceRanges

continued

Female 0.7-1.6

Cobalt, Urine-ratio to CRT No reference interval ug/gCRT

COBALT, URINE RANDOMTest Code URCO

Billing Code URCOEffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Descriptor Ranges Units

Cobalt, Urine 0.1-2.0 ug/L

Creatinine, Urine Male 39-259 mg/dL

Female 28-217

Cobalt, Creatinine Ratio No reference interval ug/gCRT

ReferenceRanges

continued

Test Change Alert #450 November 28, 2016

The following tables reflect revisions only; other existing data remain unchanged.

page: 13

Page 14: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

COPPER, URINE 24HRTest Code UQCOP

Billing Code UQCOPEffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Gender Ranges Units

Collection Period h

Total Volume mL

Creatinine, Urine Male 1.0-2.4 g/24h

Female 0.7-1.6

ReferenceRanges

continued

Copper, Urine 0.2-8.0 ug/dL

Copper, Urine (24 hour) 3-50 ug/d

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.

page: 14

Page 15: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

CORDSTAT 13 SCR W/ALCTest Code CUM13A

Billing Code CUM13AEffective 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 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.

page: 15

Page 16: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

CUTANEOUS BIOPSY (DIRECT IF)Test Code CUDIBA

Billing Code CUDIBAEffective 11/7/2016

Synonyms

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.

page: 16

Page 17: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

DIAZEPAM AND NORDIAZEPAMTest Code DIANO

Billing Code DIANOEffective 12/27/2016

Synonyms Diastat; Diazemuls; Diazepam and Metabolite; Nordiazepam; Stesolid; T-Quil; Tranxene; Valium; Valrelase; Zetran

Container Type Gray top tube (potassium oxalate/sodium fluoride)

Supply ItemNumber

7357 or 1396

Store andTransport

Refrigerated

Specimen Type Plasma

Preferred Volume 2 mL

EmergencyMinimum Volume

1 mL

Patient Prep Timing of specimen collection: Pre-dose (trough) draw - At steady state concentration

SpecimenProcessing

Separate plasma or serum from cells ASAP or within 2 hours of collection and transfer to a standard PAML aliquottube.

Room Temp 1 week

Refrigerated 2 weeks

Frozen -20c 3 years (avoid repeated freeze/thaw cycles)

UnacceptableCondition

Gel separator tubes; plasma or whole blood collected in light blue (sodium citrate); hemolyzed specimens

AlternateSpecimens

Red top tube (plain), green (sodium heparin), lavender (K2 or K3EDTA) or pink (K2EDTA)

ReferenceLaboratory

ARUP

Reference labTest Code

90076

CPT Codes 80346 (HCPCS G0480)

Test Schedule Tue, Fri

Turnaround Time 2-5 days

Method Quantitative Liquid Chromatography/Tandem Mass Spectrometry

ReferenceRanges

Title Descriptor Ranges Units

Diazepam Based on normal dosageamounts

200-1000 ng/mL

Nordiazepam Based on normal dosageamounts

100-1500 ng/mL

Toxic > 2500

Interpretive Data: Adverse effects may include drowsiness, fatigue, ataxia, and muscle weakness.

ReferenceRanges

continuedNotes Ordering Recommendation: Optimize drug therapy and monitor patient adherence.

New New Test - Replaces DIAZ

Fees Fees for this test are being adjusted. Please contact your Sales Representative or Client Services for feeinformation.

DIAZEPAM AND NORDIAZEPAMTest Code DIAZ

Billing Code VALIUMEffective 12/27/2016

Delete This test is being discontinued. Use the ordercode DIANO to order this test.

Test Change Alert #450 November 28, 2016

The following tables reflect revisions only; other existing data remain unchanged.

page: 17

Page 18: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

EASTERN EQUINE AB PANEL, CSFTest Code EEECSF

Billing Code EEECSFEffective 11/21/2016

Delete This test is being discontinued.

EASTERN EQUINE AB, IGGTest Code EEEGAB

Billing Code EEEGABEffective 11/21/2016

Delete This test is being discontinued.

EASTERN EQUINE AB, IGG, CSFTest Code EQEGCF

Billing Code EQEGCFEffective 11/21/2016

Delete This test is being discontinued.

EASTERN EQUINE AB, IGMTest Code EEEMAB

Billing Code EEEMABEffective 11/21/2016

Delete This test is being discontinued.

EASTERN EQUINE AB, IGM, CSFTest Code EEEMCF

Billing Code EEEMCFEffective 11/21/2016

Delete This test is being discontinued.

EASTERN EQUINE ENCEPHALITIS ABTest Code EEEAB

Billing Code EEEABEffective 11/21/2016

Delete This test is being discontinued.

Test Change Alert #450 November 28, 2016

The following tables reflect revisions only; other existing data remain unchanged.

page: 18

Page 19: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

EPI PROCOLONTest Code EPICOL

Billing Code EPICOLEffective 11/14/2016

Synonyms ColoVantage; Ms9; Septin 9; Septin 9 methylation

Container Type Lavender top tube (EDTA)

Supply ItemNumber

1657

Store andTransport

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.

page: 19

Page 20: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

HEAVY METAL 3, URINE 24HRTest Code UHMQ3

Billing Code UHMQ3Effective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Gender Ranges Units

Collection Period h

Total Volume mL

Creatinine, Urine Male 1.0-2.4 g/24h

Female 0.7-1.6

ReferenceRanges

continued

Aresenic, Urine 0.0-35.0 (based on biologicalexposure index)

ug/L

Aresenic, Urine (24 hour) 0.0-50.0 ug/24h

Aresenic: Creatinine Ratio < = 30 ug/gCR

Mercury, Urine 0.0-10.0 ug/L

ReferenceRanges

continued

Mercury, Urine (24 hour) 0.0-15.0 ug/24h

Mercury: Creatinine Ratio < = 35.0 ug/gCR

Lead, Urine 0.0-23.0 ug/L

Lead, Urine (24 hour) 0.0-31.0 ug/24h

ReferenceRanges

continued

Lead: Creatinine Ratio < = 5.0 ug/gCR

HEAVY METAL 3, URINE RANDOMTest Code UHMR3

Billing Code UHMR3Effective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Descriptor Ranges Units

Mercury, Urine 0.0-10.0 ug/L

Mercury: Creatinine Ratio < = 35.0 ug/gCR

Arsenic, Urine 0.0-35.0 (based on biologicalexposure index)

ug/L

Arsenic: Creatinine Ratio < = 30.0 ug/gCR

ReferenceRanges

continued

Lead, Urine 0.0-23.0 ug/L

Lead: Creatinine Ratio < = 5.0 ug/gCR

Creatinine, Urine Male 39-259 mg/dL

Female 28-217

ReferenceRanges

continued

Test Change Alert #450 November 28, 2016

The following tables reflect revisions only; other existing data remain unchanged.

page: 20

Page 21: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

HEAVY METAL 4, URINE 24HRTest Code UHMQ4

Billing Code UHMQ4Effective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Gender Ranges Units

Collection Period h

Total Volume mL

Mercury, Urine 0.0-10.0 ug/L

Mercury, Urine 0.0-15.0 ug/24h

ReferenceRanges

continued

Mercury: Creatinine Ratio < = 35.0 ug/gCR

Creatinine, Urine (24 hour) Male 1.0-2.4 g/24h

Female 0.7-1.6

Lead, Urine 0.0-23.0 ug/L

ReferenceRanges

continued

Lead, Urine (24 hour) 0.0-31.0 ug/24h

Lead: Creatinine Ratio < = 5.0 ug/gCR

Aresenic, Urine 0.0-35.0 (based on biologicalexposure index)

ug/L

Aresenic, Urine (24 hour) 0.0-50.0 ug/24h

ReferenceRanges

continued

Aresenic: Creatinine Ratio < = 30 ug/gCR

Cadmium, Urine 0.0-2.6 ug/L

Cadmium, Urine (24 hour) 0.0-3.3 ug/24h

Cadmium per gram of creatinine 0.0-3.0 ug/gCR

ReferenceRanges

continued

HEAVY METAL 4, URINE RANDOMTest Code UHMR4

Billing Code UHMR4Effective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Descriptor Ranges Units

Mercury, Urine 0.0-10.0 ug/L

Mercury: Creatinine Ratio < = 35.0 ug/gCR

Arsenic, Urine 0.0-35.0 (based on biologicalexposure index)

ug/L

Arsenic: Creatinine Ratio < = 30.0 ug/gCR

ReferenceRanges

continued

Lead, Urine 0.0-23.0 ug/L

Lead: Creatinine Ratio < = 5.0 ug/gCR

Creatinine, Urine Male 39-259 mg/dL

Female 28-217

ReferenceRanges

continued

Cadmium, Urine 0.0-2.6 ug/L

Cadmium, Urine 0.0-3.0 ug/gCR

HNPCC LYNCH SYN (MSH2) SQUENCETest Code MSH2A

Billing Code MSH2AEffective 10/19/2016

Required PatientInfo

Patient History for HNPCC/Lynch Syndrome Testing

Test Change Alert #450 November 28, 2016

The following tables reflect revisions only; other existing data remain unchanged.

page: 21

Page 22: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

HNPCC LYNCH SYN (MSH6) SQUENCETest Code MSH6AR

Billing Code MSH6AREffective 10/19/2016

Required PatientInfo

Patient History for HNPCC/Lynch Syndrome Testing

JAK2 (RFLX MPL W515 MUTATION)Test Code JAKMPL

Billing Code JAKMPLEffective 12/27/2016

Delete This test is being discontinued.

LEAD, URINE 24HRTest Code UQPB

Billing Code UQPBEffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Gender Ranges Units

Collection Period h

Total Volume mL

Lead, Urine 0.0-23.0 ug/L

Lead, Urine (24 hour) 0.0-31.0 ug/24h

ReferenceRanges

continued

Lead: Creatinine Ratio < = 5.0 ug/gCR

Creatinine, Urine Male 1.0-2.4 g/24h

Female 0.7-1.6

ReferenceRanges

continued

LEAD, URINE RANDOMTest Code UPB

Billing Code UPBEffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Descriptor Ranges Units

Lead, Urine 0.0-23.0 ug/L

Creatinine, Urine Male 39-259 mg/dL

Female 28-217

Lead: Creatinine Ratio < 5.0 ug/gCR

ReferenceRanges

continued

LECITHIN/SPHINGOMYELIN RATIOTest Code LSRA

Billing Code LSRAEffective 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.

page: 22

Page 23: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

MANGANESE, URINE 24HRTest Code UQMN

Billing Code UQMNEffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Gender Ranges Units

Collection Period h

Volume mL

Creatinine, Urine Male 1.0-2.4 g/24h

Female 0.7-1.6

ReferenceRanges

continued

Manganese, Urine 0.0-2.0 ug/L

Manganese, Urine (24 hour) 0.0-2.0 ug/24h

Manganese, Urine No reference range ug/gCRT

MANGANESE, URINE RANDOMTest Code URMN

Billing Code URMNEffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Descriptor Ranges Units

Creatinine, Urine Male 39-259 mg/dL

Female 28-217

Manganese, Urine 0.0-2.0 ug/L

Manganese, Urine No reference range ug/gCRT

ReferenceRanges

continued

MECONIUM 12 DRUG + ALCTest Code MEC12A

Billing Code MEC12AEffective 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 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.

page: 23

Page 24: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

MECONIUM 13 DRUG SCREENTest Code MEC13

Billing Code MEC13Effective 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 + 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.

page: 24

Page 25: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

MENINGOENCEPH COMP PANEL RFLXTest Code MECPN

Billing Code MECPNEffective 11/21/2016

Delete This test is being discontinued.

MERCURY, URINE 24HRTest Code UQHG

Billing Code UQHGEffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Gender Ranges Units

Collection Period h

Total Volume mL

Mercury, Urine 0.0-10.0 ug/L

Mercury, Urine (24 hour) 0.0-15.0 ug/24h

ReferenceRanges

continued

Mercury: Creatinine Ratio < = 35.0 ug/gCR

Creatinine, Urine Male 1.0-2.4 g/24h

Female 0.7-1.6

ReferenceRanges

continued

MERCURY, URINE RANDOMTest Code URMER

Billing Code URMEREffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Descriptor Ranges Units

Creatinine, Urine Male 39-259 mg/dL

Female 28-217

Mercury, Urine 0.0-10.0 ug/L

Mercury: Creatinine Ratio < = 35.0 ug/gCR

ReferenceRanges

continued

Test Change Alert #450 November 28, 2016

The following tables reflect revisions only; other existing data remain unchanged.

page: 25

Page 26: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

METANEPHRINES, URINE RANDOMTest Code METAUR

Billing Code METAUREffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Descriptor Ranges Units

Creatinine, Urine Male 39-259 mg/dL

Female 28-217

Metanephrine, Urine Random No reference range established mg/L

Metanephrine, Urine Random 3-8 years 47-240 ug/gCr

ReferenceRanges

continued

9-12 years 40-220

13-17 years 33-145

Adults 31-140

Normetanephrine No reference range established mg/dL

ReferenceRanges

continued

Normetanephrine 3-8 years 62-705 ug/gCr

9-12 years 81-583

13-17 years 95-375

Adults 47-310

ReferenceRanges

continued

Total Metanephrines No reference range established mg/dL

Patients on Buspirone therapy will show falsely elevated metanephrine levels.

ReferenceRanges

continued

Please note: A 24-hr urine collection is the preferred specimen. These reference ranges for random urine collections are based onliterature review.

Test Change Alert #450 November 28, 2016

The following tables reflect revisions only; other existing data remain unchanged.

page: 26

Page 27: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

MICROARRAY, POC TISSUE FRESH OR FFPETest Code SNPPOC

Billing Code SNPPOCEffective 10/24/2016

SynonymsaCGH; CGH; SNP; Array; Affymetrix; LOH; ROH; CNV; Copy Number; Deletion; Duplication; Micro Array; CytoscanHD; POC; Tissue; Products of Conception; CMA (Chromosome Microarray Assay), Formalin Fixed ParaffinEmbedded, FFPE

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.

Store andTransport

Fresh Tissue or POC: Ambient (room temperature)

FFPE Samples: Refrigerated preferred. Ambient (room temperature) acceptable

Extracted DNA: Ambient (room temperature)

Specimen Type

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

Refrigerated Fresh Tissue or POC: 3 days; FFPE Samples: Indefinitely; Extracted DNA: 3 weeks

Frozen -20c Fresh Tissue or POC: Unacceptable; FFPE Samples: Indefinitely; Extracted DNA: 6 months

Frozen -70c Fresh Tissue or POC: Unacceptable; FFPE Samples: Unacceptable; Extracted DNA: 6 months

UnacceptableCondition

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.

page: 27

Page 28: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

NICKEL, URINE RANDOMTest Code URNI

Billing Code URNIEffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Descriptor Ranges Units

Creatinine, Urine Male 39-259 mg/dL

Female 28-217

Nickel, Urine < 6.0 ug/L

Nickel, Urine < 6.0 ug/gCR

ReferenceRanges

continued

ONCOFISH CERVICALTest Code FONCOI

Billing Code FONCOIEffective 11/2/2016

Delete This test is being discontinued.

ONCOFISH CERVICAL ASCUS RFLXTest Code FONCAR

Billing Code FONCAREffective 11/2/2016

Delete This test is being discontinued.

ONCOFISH CERVICAL BILL ONLYTest Code BONCOI

Billing Code BONCOIEffective 11/2/2016

Delete This Bill Only code is being discontinued.

ONCOFISH CERVICAL LSIL RFLXTest Code FONCOR

Billing Code FONCOREffective 11/2/2016

Delete This test is being discontinued.

P50 (HEMOXIMETRY)Test Code OD50HO

Billing Code OD50HOEffective 11/2/2016

Delete This test is being discontinued.

Test Change Alert #450 November 28, 2016

The following tables reflect revisions only; other existing data remain unchanged.

page: 28

Page 29: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

PARANEOPLASTIC AUTOANTIBODY EVALUATION, SERUM RFLXTest Code PAVAL

Billing Code PAVALEffective 12/27/2016

Synonyms Paraneoplastic Autoantibody Evaluation, Serum; Paraneoplastic Autoantibody Eval, S

Container Type Red top tube (plain)

Supply ItemNumber

1372

Store andTransport

Refrigerated

Specimen Type Serum

Preferred Volume 4 mL

EmergencyMinimum Volume

2 mL

SpecimenProcessing

Separate serum from cells and transfer to a standard PAML aliquot tube.

Required PatientInfo

Include relevant clinical information, name, phone number, mailing address, and e-mail address (if applicable) ofordering physician.

Room Temp 3 days

Refrigerated 28 days

Frozen -20c 28 days

UnacceptableCondition

Gross Hemolysis, Lipemia, Icterus

AlternateSpecimens

Serum separator tube (gold, brick, SST, or corvac)

ReferenceLaboratory

MAYO

Reference labTest Code

PAVAL

CPT Codes 83519 x 5, 83520, 86255 x 9

Test Schedule Varies by test

Turnaround Time 12-17 days

Method Indirect Immunofluorescence Assay; Enzyme Immunoassay; Radioimmunoassay; Western Blot; Cell-bindingAssay; Fluorescence-Activated Cell Sorting Assay (FACS)

ReferenceRanges

Title Results Units

ANNA-1, S < 1:240 titer

Reflex Added

ANNA-2, S < 1:240 titer

ANNA-3, S < 1:240 titer

ReferenceRanges

continued

AGNA-1, S < 1:240 titer

PCA-1, S < 1:240 titer

PCA-2, S < 1:240 titer

PCA-Tr, S < 1:240 titer

ReferenceRanges

continued

Amphiphysin Ab, S < 1:240 titer

CRMP-5-IgG, S < 1:240 titer

Striational (Striated Muscle) Ab, S < 1:120 titer

P/Q-Type Calcium Channel Ab < = 0.02 nmol/L

ReferenceRanges

continued

N-Type Calcium Channel Ab < = 0.03 nmol/L

ACh Receptor (Muscle) Binding Ab < = 0.02 nmol/L

AChR Ganglionic Neuronal Ab, S < = 0.02 nmol/L

Neuronal (V-G) K+ Channel Ab, S < = 0.02 nmol/L

ReferenceRanges

continued

Test Change Alert #450 November 28, 2016

The following tables reflect revisions only; other existing data remain unchanged.

page: 29

Page 30: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

PARANEOPLASTIC AUTOANTIBODY EVALUATION, SERUM RFLX

ClinicalSignificance

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.

page: 30

Page 31: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

PARANEOPLASTIC AUTOANTIBODY EVALUATION, SERUM RFLX

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.

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.

page: 31

Page 32: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

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.

page: 32

Page 33: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

PARANEOPLASTIC AUTOANTIBODY EVALUATION, SPINAL FLUID RFLXTest Code PAVSF

Billing Code PAVSFEffective 12/27/2016

Synonyms Paraneoplas Autoantibody Eval, CSF

Container Type CSF sterile plastic tube

Supply ItemNumber

7211

Store andTransport

Refrigerated

Specimen Type CSF

Preferred Volume 4 mL

EmergencyMinimum Volume

2 mL

Required PatientInfo

Relevant clinical information, name, phone number, mailing address, and e-mail address (if applicable) of orderingphysician.

Room Temp 3 days

Refrigerated 28 days

Frozen -20c 28 days

UnacceptableCondition

Gross Hemolysis, Lipema, Icterus

ReferenceLaboratory

MAYO

Reference labTest Code

PAC1

CPT Codes 86255 x 9

Test Schedule Varies by test

Turnaround Time 5-9 days

Method Indirect Immunofluorescence Assay; Western Blot; Radioimmunoassay; Cell-Binding Assay; Fluorescence-Activated Cell Sorting Assay (FACS)

ReferenceRanges

Title Results Units

ANNA-1, CSF < 1:2 titer

Reflex Added

ANNA-2, CSF < 1:2 titer

ANNA-3, CSF < 1:2 titer

ReferenceRanges

continued

AGNA-1, CSF < 1:2 titer

PCA-1, CSF < 1:2 titer

PCA-2, CSF < 1:2 titer

PCA-Tr, CSF < 1:2 titer

ReferenceRanges

continued

Amphiphysin Ab, CSF < 1:2 titer

CRMP-5-IgG, CSF < 1:2 titer

ClinicalSignificance

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.

page: 33

Page 34: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

PARANEOPLASTIC AUTOANTIBODY EVALUATION, SPINAL FLUID RFLXCompliance

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.

page: 34

Page 35: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

PRIMARY HRHPV W/PAP RFLXTest Code PSHPV

Billing Code PSHPVEffective 11/21/2016

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

PROCOLLAGEN TYPE I PROPEPTIDETest Code PRTNP

Billing Code PRTNPEffective 9/27/2016

Synonyms FPINT; P1NP; PINP; Procollagen; Procollagen Propeptide; Procollagen Type 1 Intact N-Terminal Propeptide

ReferenceRanges

Title Gender Descriptor Ranges Units

Procollagen I Intact N-Terminal Propeptide

Male 22-105 ug/L

Female Premenopausal 20-101

Postmenopausal 16-96

RHEUMATOID FACTOR, IGA/IGG/IGMTest Code RHFAGM

Billing Code RHFAGMEffective 11/7/2016

UnacceptableCondition

Gross hemolysis; grossly lipemic; grossly icteric; heat treated samples; serum separator tube

Reference labTest Code

19705

Method Immunoassay

SEPTIN 9, METHYLATED DNA (PCR)Test Code SEPT9

Billing Code SEPT9Effective 11/14/2016

Delete This test is being discontinued. Use the ordercode EPICOL to order this test.

ST LOUIS ENCEPH AB, CSF (IFA)Test Code SLEVSF

Billing Code SLEVSFEffective 11/21/2016

Delete This test is being discontinued.

Test Change Alert #450 November 28, 2016

The following tables reflect revisions only; other existing data remain unchanged.

page: 35

Page 36: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

ST LOUIS ENCEPH AB, IGG, CSFTest Code ENSTLG

Billing Code ENSTLGEffective 11/21/2016

Delete This test is being discontinued.

ST LOUIS ENCEPH AB, IGG, IGMTest Code SLVAB

Billing Code SLVABEffective 11/21/2016

Delete This test is being discontinued.

ST LOUIS ENCEPH AB, IGMTest Code SLVM

Billing Code SLVMEffective 11/21/2016

Delete This test is being discontinued.

ST LOUIS ENCEPH AB, IGM, CSFTest Code ENSTLM

Billing Code ENSTLMEffective 11/21/2016

Delete This test is being discontinued.

ST LOUIS ENCEPHALITIS ABTest Code ENCSTL

Billing Code ENC.STLOUISEffective 11/21/2016

Delete This test is being discontinued.

THYROID STIM IMMUNOGLOBULINSTest Code TSIA

Billing Code TSIAEffective 1/31/2017

Delete This test is being discontinued. Use the ordercode TSIAB to order this test.

Test Change Alert #450 November 28, 2016

The following tables reflect revisions only; other existing data remain unchanged.

page: 36

Page 37: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

THYROID STIMULATING IMMUNOGLOBULINTest Code TSIAB

Billing Code TSIABEffective 12/27/2016

Synonyms Thyroid Stim Immunoglobulin; TSI; TSIG

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.

page: 37

Page 38: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

WARFARIN, SERUM OR PLASMATest Code COUMA

Billing Code COUMAEffective 10/19/2016

Synonyms Warfarin Quantitative; Anticoagulants, Oral; Coumadin; Jantoven; Panwarfarin; Sodium Warfarin

SpecimenProcessing

Separate serum or plasma from cells and transfer to a standard PAML aliquot tube.

Frozen -20c 3 months

UnacceptableCondition

Polymer gel separation tube (SST or PST)

AlternateSpecimens

Lavender top tube (EDTA) or pink top tube (K2EDTA)

CPT Codes 80375 (HCPCS G0480)

Test Schedule Mon

Turnaround Time 4-10 days

Method Quantitative High Performance Liquid Chromatography

Please Note Previous CPT Codes: 80299

WESTERN EQUINE AB, IGGTest Code ENCW

Billing Code ENC.WESTEffective 11/21/2016

Delete This test is being discontinued.

WESTERN EQUINE AB, IGG,IGM CSFTest Code WEEGMC

Billing Code WEEGMCEffective 11/21/2016

Delete This test is being discontinued.

ZINC, URINE 24HRTest Code UQZN

Billing Code UQZNEffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Gender Ranges Units

Volume mL

Collection Period h

Creatinine, Urine Male 1.0-2.4 g/24h

Female 0.7-1.6

ReferenceRanges

continued

Zinc, Urine 15.0-120.0 ug/dL

Zinc, Urine (24 hour) 150.0-1200.0 ug/24h

Zinc, Urine ug/gCRT No reference interval ug/gCRT

Test Change Alert #450 November 28, 2016

The following tables reflect revisions only; other existing data remain unchanged.

page: 38

Page 39: Summary Of Changes - PAML...disorders, including ABCC8-related hyperinsulinism, Bloom syndrome, Canavan disease, familial dysautonomia, Fanconi anemia group c, Gaucher disease, glycogen

PAML Web Test Directory Link

ZINC, URINE RANDOMTest Code URZN

Billing Code URZNEffective 11/7/2016

Department Separation Science, Chemistry

ReferenceRanges

Title Descriptor Ranges Units

Zinc, Urine 15.0-120.0 ug/dL

Creatinine, Urine Male 39-259 mg/dL

Female 28-217

Zinc, Creatinine Ratio No reference interval ug/gCRT

ReferenceRanges

continued

Test Change Alert #450 November 28, 2016

The following tables reflect revisions only; other existing data remain unchanged.

page: 39