LA NEWSLETTER
ABHORIZONS
FOR CLIENTS
Volume XVII, Nº 4 — April 2017
New Procedures
Methicillin-Resistant Staphylococcus aureus/
Methicillin-Susceptible Staphylococcus aureus Colonization
Screening Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183074
CPT Call client services.
Synonyms MRSA/MSSA
Test Includes Culture for isolation of Staphylococcus aureus and drug
susceptibility testing (additional charge)
Use Screen for methicillin-resistant Staphylococcus aureus (MRSA) and/
or methicillin-susceptible Staphylococcus aureus (MSSA) colonization of
patients prior to surgery, or staff in health care settings
Limitations This test is not intended to establish diagnosis of MRSA/MSSA
infection.
Methodology Conventional culture
Specimen Nasal (preferred) or other site swab
Volume One swab
Container Bacterial culture transport swab with media
Collection
Nares: Insert swab into one anterior naris. Apply slight pressure to the
nostril and rotate swab to sample the inside surface. Insert the same
swab into the other naris and repeat. Place swab into swab transport
tube.
Other Sites: Collect as appropriate using the bacterial culture swab
transport.
Storage Instructions Maintain specimen at room temperature.
Causes for Rejection Specimen received without proper identification;
inappropriate specimen transport device; unlabeled specimen or name
discrepancy between request label; specimen received after prolonged
delay (usually more than 72 hours); expired transport device
Special Instructions This test is intended only for screening for MRSA/
MSSA colonization only and is not intended to diagnose MRSA/MSSA
infection. For culture and isolation of other potential pathogens as Upper
Respiratory Culture [008342] or other test appropriate for specimens
source should be ordered.
References
Baron E. The Detection, Significance, and Rational for Control of Methicillin-resistant
Staphylococcus aureus, Clinical Microbiology Newsletter, Vol. 14, No. 17, New York, NY:
Elsevier Science Publishing Co, 1992.
Edmiston CE Jr, Ledeboer NA, Buchan BW, Spencer M, Seabrook GR, Leaper D. Is Staphylococcal Screening and Suppression an Effective Interventional Strategy for Reduction of
Surgical Site Infection? Surgical Infections. 2016 Apr;17(2):158-166. PubMed 26836053
Murray PR, Baron EJ, Jorgensen JH, et al. Manual of Clinical Microbiology, 9th ed., Washington, DC: ASM Press, 2007.
Remel Spectra MRSA [package insert]. Lenexa, KS: Revised April 16, 2013.
RAS/RAF Pathway Mutation Profile (KRAS and NRAS reflex to
BRAF) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 481468
CPT 81275; 81276; 81311; 81479; 88381
Synonyms BRAF; KRAS; NRAS
Use KRAS and NRAS are guanosine triphosphate (GTP)-binding proteins
involved in downstream receptor signaling, which is critical for cell proliferation, survival and differentiation. Mutations in the KRAS and NRAS
oncogene are frequently found in human cancers. They are common in
pancreatic, colorectal, lung, bile duct, and thyroid cancer, as well as in
melanomas. BRAF is an important member of the mitogen-activated protein kinase (MAPK) pathway that influences cell proliferation. Mutations
in the BRAF oncogene are frequently found in human cancers, such as
melanoma, colorectal cancer, lung cancer, ovarian cancer, thyroid cancer,
and hairy cell leukemia. This assay detects KRAS and NRAS mutations in
exons 2, 3, and 4, BRAF V600 mutations, allowing the determination of
drug response.
Limitations This assay is able to detect 5% mutation in a background of
wild-type DNA.
This test was developed, and its performance characteristics determined,
by LabCorp. It has not been cleared or approved by the US Food and
Drug Administration (FDA).
Methodology SNaPshot Multiplex PCR (primer extension-based method)
Specimen Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides
Volume Formalin-fixed, paraffin-embedded (FFPE) tissue block or eight
unstained slides and one matching H&E-stained slide at 5 μM
Minimum Volume Four unstained slides at 5 μM and one matching H&Estained slide
Container Formalin-fixed, paraffin-embedded (FFPE) tissue blocks or
slides
Storage Instructions Room temperature
Causes for Rejection Tumor block containing insufficient tumor tissue;
broken or stained slides
Special Instructions Provide a copy of the pathology report; the RAS/
RAF test will be delayed if the pathology report is not received. Direct any
questions regarding this test to customer service at 1-800-345-4363.
References
NCCN Clinical Practice Guidelines in Oncology: Colon Cancer v2. 2017.
NCCN Clinical Practice Guidelines in Oncology: Rectal Cancer v2. 2017.
Synthetic Cannabinoids (K2, Spice), Screen with Reflexed
Confirmation, Qualitative, Urine . . . . . . . . . . . . . . . . . . . 701106
CPT 80307
Synonyms K2; Spice
Test Includes Qualitative synthetic cannabinoid analysis includes metabolites of the following: AB-CHMINACA, AB-FUBINACA, AB-PINACA, FAB-PINACA, ADBICA, 5F-ADBICA, ADB-PINACA, 5F-ADB-PINACA, AKB-48,
5CI-AKB-48, 5F-AKB-48, AM2201, AM694, BB-22, BB-22 hydroxyquinolines,
JWH-018, JWH-073, JWH-122, JWH-250, MAB-CHMINACA, MAM-2201,
PB-22, PB-22 hydroxyquinolines, 5F-PB-22, 5F-PB-22 hydroxyquinolines,
UR-144, XLR-11
Use Detect use of synthetic cannabinoid drugs
These new/revised publications are now available:
•
•
•
•
HCV Menu for Complete Care Decisions flyer (L10589)
Microbiology Specimen Collection and Transport Guide (L1196)
Women’s Health Service Spectrum Brochure (L12799)
Chlamydia, Gonorrhea, and Trichomonas Flyer (L4675)
Please ask your LabCorp service representative for these titles.
Volume XVII, Nº 4
LabHorizons
Limitations This test was developed and its performance characteristics
determined by LabCorp. It has not been cleared or approved by the Food
and Drug Administration.
Methodology Initial presumptive testing by liquid chromatography
tandem mass spectrometry (LC/MS-MS) at a testing threshold of 1.0 ng/
mL; presumptive positives confirmed by definitive liquid chromatography tandem mass spectrometry (LC/MS-MS) at a testing threshold of 1.0
ng/mL.
Specimen Urine (random)
Volume 10 mL
Minimum Volume 1 mL
Container Plastic urine container without preservative
Storage Instructions Submission/transport (<3 days): Room Temperature. For storage beyond three days, specimen should be refrigerated or
frozen.
Causes for Rejection Urine in preservative tube
April 2017
lone; Salvinorin; and metabolites of the following Synthetic Cannabinoids: AB-CHMINACA, AB-FUBINACA, AB-PINACA, F-AB-PINACA,
ADBICA, 5F-ADBICA, ADB-PINACA, 5F-ADB-PINACA, AKB-48, 5CI-AKB-48,
5F-AKB-48, AM2201, AM694, BB-22, BB-22 hydroxyquinolines, JWH-018,
JWH-073, JWH-122, JWH-250, MAB-CHMINACA, MAM-2201, PB-22, PB-22
hydroxyquinolines, 5F-PB-22, 5F-PB-22 hydroxyquinolines, UR-144, XLR11
Use Detect use of synthetic/designer drugs, including synthetic cannabinoids, methcathinone, cathinone, mephedrone, MDPV, methylone, and
salvinorin.
Methodology Liquid chromatography/tandem mass spectrometry (LC/
MS-MS)
Specimen Urine (random) or spot urine collection, without preservative
Volume 10 mL
Minimum Volume 1 mL
Container Urine transer tube without preservative
Collection Random
Storage Instructions Ambient temperature is acceptable for shipping
and/or short-term storage (up to three days); specimen also may be
refrigerated or frozen.
Synthetic Designer Drug Profile . . . . . . . . . . . . . . . . . . . 701110
CPT 80307; 80371
Test Includes Methcathinone; Cathinone; Mephedrone; MDPV; Methy-
Special notice
Revised CMS Advance Beneficiary Notice of Noncoverage (ABN)
for Medicare Beneficiaries
The Centers for Medicare and Medicaid Services (CMS) has released the latest version of the ABN with an effective use date of June 21, 2017.
This will replace the 03/11 version. There are no changes to the form itself; however, the form now incorporates an expiration date of 03/2020
and language has been added to inform beneficiaries of their rights to CMS nondiscrimination practices and how to request an ABN in an alternative format.
LabCorp connectivity products are being updated to generate an ABN that reflects these revisions. For clients who do not use LabCorp’s connectivity products, LabCorp is in the process of printing the latest version of the ABN. Paper copies will be available through routine distribution
channels.
For more information about ABN, visit the ABN section of the CMS website:
https://www.cms.gov/Medicare/Medicare-General-Information/BNI/ABN.html.
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Volume XVII, Nº 4
LabHorizons
April 2017
Updates to the Directory of Services and Interpretive Guide (DoS)
Test Name
Nº
Field/Change (Only fields that change are included here.)
α2-Macroglobulin, Quantitative
122135
Minimum Volume 0.2 mL (adult), 0.1 mL (pediatric)
Anti-Müllerian Hormone (AMH) (Endocrine
Sciences)
500183
Stability
Temperature
Period
Room temperature
1 day
Refrigerated
14 days
Frozen
14 days
Freeze/thaw cycles
Stable x6
Antithrombin (AT) Antigen (Immunologic)
015057
Limitations Added “This test was developed, and its performance characteristics determined, by LabCorp. It has
not been cleared or approved by the US Food and Drug Administration (FDA).” [Additional statements already
on Test Menu remain.]
Bupropion and Hydroxybupropion, Serum or
Plasma
811083
Methodology Liquid chromatography with tandem mass spectrometry (LC/MS-MS)
Container Red-top (no additive) tube or green-top (heparin) tube. Gel-barrier tubes are not recommended.
Storage/Transport: Custom “Transfer for Bupropion Analysis” tube containing Sodium Citrate Monobasic
(PeopleSoft N° 116538)
Collection Centrifuge within 30 minutes of collection. Transfer separated serum or plasma to the “Transfer for
Bupropion Analysis” tube containing sodium citrate monobasic (white powder). Mix well. Freeze.
Chlamydia trachomatis Antibodies, IgM
096149
Reference Interval Negative: <0.8; Borderline: 0.8−1.0; Positive: >1.0
Catecholamines, Fractionated, Plasma
084152
Storage Instructions Freeze. After centrifugation, the plasma can be stored up to two hours at room temperature. Sample can be kept for up to two weeks at -20°C.
Factor VIII Chromogenic Activity
500192
Volume 1 mL
Minimum Volume 0.5 mL
Stability
Temperature
Period
Room temperature
4 hours
Refrigerated
4 hours
Frozen
2 weeks
Freeze/thaw cycles
Stable x2
Factor X, Chromogenic
117904
Limitations Added “This test was developed, and its performance characteristics determined, by LabCorp. It has
not been cleared or approved by the US Food and Drug Administration (FDA).” [Additional statements already
on Test Menu remain.]
Fungus Culture With Reflex to Rapid Identification
188573
Container Sterile screw-capped container for fluid or tissue, green-top (sodium heparin) tube, blood culture
bottle, bacterial swab
Heparin-dependent Platelet Antibody (Serotonin
Release Assay)
150018
Container Gel-barrier or red top tube
Hepatitis C Virus (HCV) Antibody Cascade to
Quantitative PCR and Genotyping
144127
Use Diagnosis and management of hepatitis C virus (HCV) infection. A positive antibody test will reflex to a
quantitative PCR assay. When the quantitative viral load is >1000 IU/ml an additional reflex to genotyping will
occur.
Hepatitis Profile V (Hepatitis A Profile)
028928
Special Instructions This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is
recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients
should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.
Hereditary Hemochromatosis, DNA Analysis
511345
Limitations Added “This test was developed, and its performance characteristics determined, by LabCorp. It has
not been cleared or approved by the US Food and Drug Administration (FDA).” [Additional statements already
on Test Menu remain.]
Histopathology
500918*
Methodology See individual test components.
Volume Entire specimen; paraffin embedded (FFPE) tissue block(s) or slide(s) sectioned from FFPE tissue
block(s) at 4-5 microns
Inheritest® Gene-specific Sequencing, NGS
451910
Use This test is available for partner testing when a carrier is identified through universal carrier screening
(Inheritest® Comprehensive, NGS [451950] or Inheritest® Ashkenazi Jewish Carrier Screening, NGS [451920] or
Inheritest® Society-guided Screening, NGS [451960]).
Lithium
007708
Reference Interval Therapeutic: 0.6−1.2 mmol/L
Mutation-specific Sequencing, Prenatal
481385
Use This test is available for partner testing when a carrier is identified through universal carrier screening
(Inheritest® Comprehensive, NGS [451950] or Inheritest® Ashkenazi Jewish Carrier Screening, NGS [451920] or
Inheritest® Society-guided Screening, NGS [451960] or Inheritest® Gene-specific Sequencing, NGS [451910]).
Note: Please consult the online Directory of Services and Interpretive Guide at https://www.labcorp.com/tests for the most current test information.
* Test number is for tracking purposes only; additional test numbers may be entered on receipt of specimen[s] at the test facility.
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Volume XVII, Nº 4
LabHorizons
Test Name
Nº
April 2017
Field/Change (Only fields that change are included here.)
Mutation-specific Sequencing, Whole Blood
451382
Use This test is available for family testing when a mutation has been specifically identified through universal
carrier screening (Inheritest® Gene-specific Sequencing, NGS [451910]; Inheritest® Ashkenazi Jewish Carrier
Screening Panel, NGS [451920]; Inheritest® Comprehensive Panel, NGS [451950]; or Inheritest® Society-guided
Screening Panel, NGS [451960]); or VistaSeqSM Hereditary Cancer Panel [481220] or VistaSeqSM Hereditary
Cancer Panel Without BRCA [481240]); or through GeneSeq: Cardio testing. (See links to tests in Related Information).
Plasminogen Activator Inhibitor 1 (PAI-1) 4G/5G
Polymorphism
500309
Additional Information Deep vein thrombosis (DVT) and coronary artery disease (CAD) are associated with
increased PAI-1 levels. Elevated PAI-1 levels may help predict risk of reinfarction in survivors of myocardial
infarction, particularly in young individuals. PAI-1 levels tend to be lower in individuals with 4G/5G or 5G/5G
genotype compared to a 4G/4G genotype.
Protein Electrophoresis, Cerebrospinal Fluid
002246
Minimum Volume 1.2 mL
Protein S, Free
164519
Limitations This test was developed, and its performance characteristics determined, by LabCorp. It has not
been cleared or approved by the US Food and Drug Administration (FDA).
Renal Function Panel
322777
Container Gel-barrier tube is preferred. Red-top tube or green-top (heparin) tube is acceptable.
Susceptibility Testing, Anaerobic Bacteria
180349
Limitations CLSI recommendations limit microbroth dilution methodology to the Bacteroides fragilis group.
Anaerobic organisms other than the B. fragilis group will be reported with MIC values only without interpretive
standards. Anaerobic infections are frequently mixed involving aerobic and anaerobic flora, thus, the predictive
value of an anaerobic susceptibility test for a successful clinical outcome may be limited by the complexity of
the clinical infection.
von Willebrand Factor (vWF) Antigen
086280
Limitations Added “This test was developed, and its performance characteristics determined, by LabCorp. It has
not been cleared or approved by the US Food and Drug Administration (FDA).” [Additional statements already
on Test Menu remain.]
Note: Please consult the online Directory of Services and Interpretive Guide at https://www.labcorp.com/tests for the most current test information.
Deleted Procedures
Deleted Tests
Test Nº
LabCorp Offers
Test Nº
Cannabinoids (THC), Synthetic, Screen and Confirmation, Urine
790742
Synthetic Cannabinoids (K2, Spice), Screen with Reflexed Confirmation,
Qualitative, Urine
Coccidioides Antibodies, Quantitative, DID
164301
Contact your LabCorp representative for testing options.
Coccidioides Antibody, CF
139172
Contact your LabCorp representative for testing options.
Coccidioides Antibody, ID
139171
Contact your LabCorp representative for testing options.
Coccidioides immitis Antibodies
138396
Contact your LabCorp representative for testing options.
Inheritest® Carrier Screen
451381
Inheritest® Comprehensive Panel, NGS
451950
Inheritest® Select Carrier Screen
451394
Inheritest® Ashkenazi Jewish Carrier Screening Panel, NGS
451920
701106
CPT Code Updates
Test Name
Test Nº
CPT(s)
Celiac HLA DQ Association With Reflex to Celiac Antibodies tTG IgA/IgG With
DGP IgA/IgG Pos/Neg Combination Screen
164031
81377; 81383
GeneSeq®: Cardio Familial Cardiomyopathy Profile
451422
81403; 81404(x2); 81405(x12); 81406(x11); 81407(x4); 81408; 81479
The CPT codes listed are in accordance with the current edition of Current Procedural Terminology, a publication of the American Medical Association. CPT codes are provided for the
convenience of our clients; however, correct coding often varies from one carrier to another. Consequently, the codes presented here are intended as general guidelines and should not
be used without confirming with the applicable payer that their use is appropriate in each case.
LOINC® Map. The Logical Observation Identifiers Names and Codes (LOINC®) corresponding to the individual LabCorp published assays is updated on a regular basis at www.labcorp.com.
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