1. health and fitness
2. disease
3. aids and hiv

LA NEWSLETTER
ABHORIZONS
FOR CLIENTS
Volume XIV, Nº 10 –11 — October – November 2014
New Procedures
Androsterone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 504005
CPT 82160.
Special Instructions Note: This test is not the same as Androstenedione.
(See 004705 and 500152.)
Specimen Serum, frozen
Volume 1 mL
Minimum Volume 0.4 mL (Note: This volume does not allow for repeat testing.)
Container Red-top tube only; do not use gel-barrier tube
Collection Centrifuge and separate serum immediately. Freeze and submit serum in a plastic transport tube.
Storage Instructions Freeze. Stable at room temperature for nine hours.
Stable refrigerated and frozen for seven days. Freeze/thaw cycles stable x6.
Causes for Rejection Sample received thawed; gross hemolysis
Use Androsterone is a major metabolite of testosterone and androstenedione
along with the enantiomer etiocholanolone. Androsterone is also part of the
“backdoor pathway” from allopregnanolone to dihydrotestosterone, which
has importance in certain disease states. Androsterone is one of a few steroids
with neutral activity that interact with γ-aminobutyric acid (GABA) receptors.
Limitations Results of this test are for investigational purposes only. The performance characteristics of this assay have been determined by LabCorp. The
result should not be used as a diagnostic procedure without confirmation of the
diagnosis by another medically established diagnostic product or procedure.
Methodology High-pressure liquid chromatography (HPLC)/tandem mass
spectrometry (MS-MS)
References
Kaminski RM, Marini H, Kim WJ, Rogawski MA. Anticonvulsant activity of androsterone
and etiocholamolone. Epilepsia. 2005 Jun; 46(6):819-827. PubMed 15946323
Calreticulin (CALR) Mutation Analysis . . . . . . . . . 489450
CPT Call client services.
Specimen Whole blood or bone marrow
Volume 3-5 mL whole blood or 1-2 mL bone marrow
Minimum Volume 3 mL whole blood or 1 mL bone marrow
Container Lavender-top (EDTA) tube or green-top (sodium heparin) tube
Special Instructions Please direct any questions regarding this test to customer service at 800-345-4363.
Collection Ship specimen at room temperature. Specimen should arrive in the
laboratory within 48 hours of collection. If specimen is to be stored prior to
shipment, store at 2°C to 8°C. Indicate date and time of collection on the test
request form.
Storage Instructions Refrigerate. Stable for 72 hours at room temperature
or refrigerated.
Causes for Rejection Sample greater than 72 hours old; clotted blood.
Use The calcium-binding endoplasmic reticulin chaperone protein, calreticulin
(CALR), is somatically mutated in approximately 70% of patients with JAK2negative essential thrombocythemia (ET) and 60% to 88% of patients with
JAK2-negative primary myelofibrosis. Only a minority of patients (approximately 8%) with myelodysplasia has mutations in the CALR gene. CALR
mutations are rarely detected in patients with de novo acute myeloid leukemia,
chronic myelogenous leukemia, lymphoid leukemia, or solid tumors. CALR
mutations are not detected in polycythemia and appear to be mutually exclusive with JAK2 mutations and MPL mutations.
The majority of mutational changes involve a variety of insertion or deletion
mutations in exon 9 of the calreticulin gene: approximately 53% of all CALR
mutations are a 52 bp deletion, while the second most prevalent mutation (approximately 32%) contains a 5 bp insertion. The remaining mutations consist
of mostly deletions ranging from 1 bp to 52 bp and 1 or 2 insertion mutations.
The detection of a CALR gene mutation aids in the specific diagnosis of a
myeloproliferative neoplasm, and help distinguish this clonal disease from a
benign reactive more indolent disease course with a lower thrombotic risk and
longer overall survival (relative to those with a JAK2 mutation).
Limitations This PCR assay is capable of detecting a mutant cell population
with a sensitivity of 5 mutant cells per 100 normal cells. A negative result
does not exclude the presence of a myeloproliferative disorder or other neoplastic process.
Methodology Polymerase chain reaction (PCR); capillary electrophoresis
References
Klampfl T, Gisslinger H, Harutyunyan AS, et al. Somatic mutations of calreticulin in myeloproliferative neoplasms. N Engl J Med. 2013 Dec; 369(25):2379-2390. PubMed 24325356
Nangalia J, Massie CE, Baxter EJ, et al. Somatic CALR mutations in myeloproliferative
neoplasms with nonmutated JAK2. N Engl J Med. 2013 Dec; 369(25):2391-2405. PubMed
24325359
c-MET Oncology FISH . . . . . . . . . . . . . . . . . . . . . . . . . . 510890
CPT Call client services.
Synonyms Adenocarcinoma; Non–Small-cell Lung Cancer
Specimen FNA, formalin-fixed paraffin blocks are also acceptable.
Volume Five slides (4- to 5-micron thick sections)
Minimum Volume Two slides (4- to 5-micron thick sections)
Container Paraffin block
Collection Transport to the test facility at room temperature.
Storage Instructions Maintain specimen at room temperature.
Causes for Rejection Broken or dirty slides; excessive cellular debris or
stained slides; decalcified bone cores; absence of tumor or quantity not sufficient for analysis
Use Confirmation/identification of cancer-related alterations (for lung cancer).
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). The FDA has determined that such clearance or
approval is not necessary. Results of this test are for investigational purposes
only. The result should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product
or procedure.
Methodology Fluorescence in situ hybridization (FISH)
The following new/revised publications are now available:
• GenoSure ArchiveSM Cell-associated viral DNA assay for HIV-1 protease, reverse
transcriptase, and integrase inhibitors (L13457)
• Women’s Health Program: Pap Tests and Services (L9014)
Please ask your LabCorp service representative for these titles.
Volume XIV, Nº 10 – 11
LabHorizons
References
October – November 2014
A number of tests to determine free cortisol have been devised. The free
fraction depends on the concentrations of the binding proteins and cortisol,
and, thus, may be calculated based on these factors. Free cortisol is best
measured by equilibrium dialysis. Structure-function observations favor a
direct measure of free cortisol. There are polymorphic forms of transcortin that
affect cortisol binding, and glycosylation affects cortisol binding to transcortin.
The Cortisol, Free, Equilibrium Dialysis and LC/MS-MS assay provides a
specific direct test.
References
Lennerz JK, Kwak EL, Ackerman A, et al. MET amplification identifies a small and aggressive subgroup of esophagogastric adenocarcinoma with evidence of responsiveness to crizotinib. J Clin Oncol. 2011 Dec 20; 29(36):4803-4810. PubMed 22042947
CML FISH Reflex to JAK2V617F Mutation Analysis, Quali­
tative, With Reflex to CALR Mutation Analysis, JAK2
Exon 12 Mutation Analysis and MLP Mutation Analysis
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .511595
le Roux CW, Sivakumaran S, Alaghband-Zadeh J, Dhillo W, Kong WM, Wheeler M. Free
cortisol index as a surrogate marker for serum free cortisol. Ann Clin Biochem. 2002; 39(Pt
4):406-408. PubMed 12117446
Lentjes EG, M, Romijn F, Maassen RJ, de Graaf I, Gautier P, Moolenaar AJ. Free cortisol
in serum assayed by temperature-controlled ultrafiltration before fluorescence polarization
immunoassay. Clin Chem. 1993 Dec; 39(12):2518-2521. PubMed 8252724
Hamrahian AH, Oseni TS, Arafah BM. Measurements of serum free cortisol in critically ill
patients. N Engl J Med. 2004 Apr 15; 350(16):1629-1638. PubMed 15084695
Hill LA, Vassiliadi DA, Simard M, Pavlaki A, Perogamvros I, Hadjidakis D, Hammond GL.
Two different corticosteroid-binding globulin variants that lack cortisol-binding activity in a
Greek woman. J Clin Endocrinol Metab. 2012 Nov; 97(11):4260-4267. PubMed 22948765
Lin HY, Underhill C, Lei JH, Helander-Claesson A, Lee HY, Gardill BR, Muller YA, Wang H,
Hammond GL. High frequency of SERPINA6 polymorphisms that reduce plasma corticosteroidbinding globulin activity in Chinese subjects. J Clin Endocrinol Metab. 2012 Apr; 97(4): E678686. PubMed 22337907
Avvakumov GV, Warmels-Rodenhiser S, Hammond GL. Glycosylation of human
corticosteroid-binding globulin at aspargine 238 is necessary for steroid binding. J Biol Chem.
1993 Jan 15; 268(2):862-866. PubMed 8419363
Bartanusz V, Corneille MG, Sordo S, Gildea M, Michalek JE, Nair PV, Stewart RM, Jezova
DJ. Diurnal salivary cortisol measurement in the neurosurgical-surgical intensive care unit in
critically ill acute trauma patients. Clin Neurosci. 2014 Jul 22; .pii:S0967-5868(14)00309-9.
PubMed 25065844
Bendel S, Karlsson S, Pettil V, Loisa P, Varpula M, Ruokonen E. Free cortisol in sepsis and
septic shock. Finnsepsis Study Group. Anesth Analg. 2008 Jun; 106(6):1813-1819. PubMed
18499615
Arafah BM, Nishiyama FJ, Tlaygeh H, Hejal RJ. Measurement of salivary cortisol
concentration in the assessment of adrenal function in critically ill subjects: A surrogate marker
of the circulating free cortisol. Clin Endocrinol Metab. 2007 Aug; 92(8):2965-2971. PubMed
17535998
CPT Call client services. If reflex testing is performed, concomitant CPT
codes/charges will apply.
Synonyms Philadelphia Chromosome
Special Instructions Please direct any questions regarding this test to oncology
customer service at 800-345-4363.
Specimen Bone marrow or peripheral blood
Volume Bone marrow: 2 mL in pediatric green-top (heparin) tube; peripheral
blood: 3 mL in pediatric green-top (heparin) tube
Container Pediatric green-top (heparin) tube
Collection Submit at room temperature using Leukemia/Lymphoma Specimen
Transport Kit (supplied by LabCorp). Specimens should arrive in the laboratory
within 48 hours of collection. Indicate the date and time of collection on the
test request form.
Storage Instructions Maintain specimen at room temperature.
Use Confirm the diagnosis of CML; establish the chronic phase karyotype for
comparison with blast crisis alterations; monitor residual disease
Methodology Cytogenetics; fluorescence in situ hybridization (FISH)
Cortisol, Free, Equilibrium Dialysis and LC/MS-MS . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 504020
CPT 82530
Specimen Serum, frozen
Volume 1.6 mL
Minimum Volume 0.8 mL (Note: This volume does not allow for repeat
testing.)
Container Red-top tube or gel-barrier tube
Collection Separate within two hours of venipuncture. Transfer specimen to a
plastic transport tube before freezing.
Storage Instructions Freeze. Stable at room temperature or refrigerated for
seven days. Stable frozen for six months. Freeze/thaw cycles stable x6.
Causes for Rejection Hemolysis, icteric, lipemic
Use Cortisol is the primary glucocorticoid in humans, affecting glucose control,
inflammation, and response to stress.
Limitations Results of this test are for investigational purposes only. The
performance characteristics of this assay have been determined by LabCorp.
The result should not be used as a diagnostic procedure without confirmation of
the diagnosis by another medically established diagnostic product or procedure.
Methodology Equilibrium dialysis and high-pressure liquid chromatography
(HPLC) with tandem mass spectrometry.
Additional Information Cortisol stimulates gluconeogenesis in the liver and
reduces insulin secretion while increasing glucagon release by the pancreas.
This increases blood glucose levels. Cortisol is also involved in inhibiting
inflammatory responses and maintaining blood pressure by potentiating effects
on norepinephrine.
Most of circulating cortisol is bound to protein, primarily transcortin
(corticosteroid-binding globulin [CBG]) and albumin. The free hormone
hypothesis suggests that the unbound, or free, cortisol is the active fraction, and
that this fraction is the most important clinically. Total serum cortisol may be
an adequate measure of cortisol activity except when the levels of the binding
proteins are abnormal such as in liver disease or acute illness.
A study published in the New England Journal of Medicine demonstrates
the utility of measurements of free cortisol in critically ill patients. Patients
with critical illness increase cortisol secretion; however, this is best observed
when free cortisol levels are measured. In the study, 40% of patients with
hypoproteinemia had low levels of total cortisol even though their adrenal
function was adequate as demonstrated by robust response to ACTH. Similar
results were obtained when salivary cortisol was used as a marker for adrenal
sufficiency during illness.
Diabetes Autoimmune Profile . . . . . . . . . . . . . . . . . . . 504050
CPT Call client services.
Specimen Serum, frozen
Volume 1.5 mL
Minimum Volume 0.5 mL (Note: This volume does not allow for repeat
testing.)
Container Red-top tube or gel-barrier tube
Collection Transfer specimen to a plastic transport tube before freezing. To
avoid delays in turnaround time when requesting multiple test on frozen
samples, please submit separate frozen specimens for each test requested.
Storage Instructions Freeze. Stable at room temperature or refrigerated for
one day. Stable frozen for seven days. Freeze/thaw cycles: stable x3
Causes for Rejection Gross hemolysis, lipemic specimen, EDTA plasma
Use Diabetes autoantibodies assessment is helpful in identifying and managing
patients at risk for development of type 1 diabetes. Published positivity rates for
diabetes autoantibodies in new-onset type 1 diabetes patients listed below are
based on the combined analysis of GAD-65, ICA 512, insulin antibodies, and
ZnT8 antibodies. The combined analysis has a 98% autoimmunity detection
rate, with 1.8% diabetic individuals remaining as autoantibody-negative. fewer
than 3% of type 2 diabetics have positive antibodies.1
Positive rate in new-onset type 1 diabetes patients:
• GAD-65 antibodies = 68% positive
• ICA 512 antibodies = 72% positive
• Insulin antibodies = 55% positive
• ZnT8 antibodies = 63% positive
An increase in the number of positive antibodies is associated with a higher
likelihood of type 1 diabetes.
Methodology Enzyme-linked immunosorbent assay (ELISA), radioimmuno­
precipitation
Footnotes
1. Wenzlau JM, Juhl K, Yu L, et al. The cation efflux transporter ZnT8 (Slc30A8) is a major
autoantigen in human type 1 diabetes. Proc Natl Acad Sci U S A. 2007 Oct 23; 104(43):1704017045. PubMed 17942684
2
Volume XIV, Nº 10 – 11
LabHorizons
Dihydrotestosterone (DHT), Free, LCMS/Dialysis . . 504026
Hurt C. Transmitted resistance to HIV integrase strand-transfer inhibitors: Right on schedule.
Antivir Ther. 2011; 16(2):137-140. PubMed 21447861
CPT Call client services.
Synonyms Free 5-α-dihydrotestoterone; Free dihydrotestosterone
Specimen Serum (preferred) or plasma, frozen
Volume 3 mL
Minimum Volume 1.2 mL (Note: This volume does not allow for repeat
testing.)
Container Red-top tube, gel-barrier tube, or green-top (heparin) tube
Collection Separate serum or plasma from cells within four hours of collection.
Send serum or plasma in a plastic transport tube. Transfer specimen to a
plastic transport tube before freezing. To avoid delays in turnaround time
when requesting multiple test on frozen samples, please submit separate frozen
specimens for each test requested.
Storage Instructions Freeze. Stable at room temperature, refrigerated, or
frozen for 14 days. Freeze/thaw cycles: stable x6
Causes for Rejection EDTA plasma, grossly hemolyzed, ecteric or lipemic
sample
Use Dihydrotestosterone measurment is used to diagnose 5a-reductase
deficiency and for the evaluation of androgen utilization. Dihydrotestosterone
is produced by the reduction of testosterone by 5α-reductase in the target
organs. Circulating dihydrotestosterone is tightly bound to sex hormonebinding globulin. The free fraction represents the dihydrotestosterone
available to act on tissues.
Limitations This test was developed and the performance characteristics were
validated by LabCorp. It has not been cleared or approved by the US Food and
Drug Administration (FDA).
Methodology Equilibrium dialysis, high-performance liquid chromatography/
tandem mass spectrometry (HPLC/MS-MS)
Human Immunodeficiency Virus 1 (HIV-1) DNA Sequen­
cing Protease − Reverse Transcriptase . . . . . . . . . 551730
CPT Call client services.
Synonyms Cell-associated Viral DNA; HIV-1 Genotype; Resistance Analysis
Specimen Whole blood, frozen
Volume 4 mL
Collection Collect specimen in lavender-top (EDTA) tube. Do not centrifuge. Ship frozen. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for
each test requested.
Storage Instructions Freeze.
Causes for Rejection Quantity not sufficient for analysis; heparinized plasma; non-frozen specimen
Use Detect resistance of HIV-1 to protease and reverse transcriptase inhibitors
in cell-associated viral DNA.
Limitations This procedure should be used for patients with documented
HIV-1 infection and undetectable viral load or low level viremia.
Methodology Polymerase chain reaction (PCR) amplification and next generation DNA sequencing
References
Panel on Antiretroviral Guidelines for Adults and Adolescents—A Working Group of the Office of AIDS Research Advisory Council (OARAC). Guidelines for the Use of Antiretroviral
Agents in HIV-1-Infected Adults and Adolescents. Washington, DC: Department of Health and
Human Services; May 1, 2014.
Günthard HF, Aberg JA, Eron JJ, et al. Antiretroviral treatment of adult HIV infection: 2014
recommendations of the International Antiviral Society-USA Panel. JAMA. 2014 Jul 23-30;
312(4):410-425. PubMed 25038359
Heroin Metabolite (6-AM), Screen Only, Urine . . . 701875
Human Immunodeficiency Virus 1 (HIV-1) GenoSure
ArchiveSM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 551776
CPT Call client services.
Special Instructions This assay is designed for pain management. It is not
intended for workplace testing and does not comply with state regulatory
workplace testing programs.
Specimen Urine
Volume 20 mL
Container Plastic urine container
Storage Instructions Maintain specimen at room temperature. Stability: If
arrival at lab will extend beyond seven days, refrigerate.
Use Detect heroin and 6-acetylmorphine
Methodology Immunoassay (IA)
CPT Call client services.
Synonyms Cell-associated Viral DNA; HIV-1 Genotype; Resistance Analysis
Specimen Whole blood, frozen
Volume 4 mL
Container Lavender-top (EDTA) tube
Collection Collect specimen in lavender-top (EDTA) tube. Do not centrifuge. Ship frozen. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for
each test requested.
Storage Instructions Freeze.
Causes for Rejection Quantity not sufficient for analysis; heparinized plasma; nonfrozen specimen
Use Detect resistance of HIV-1 to protease, reverse transcriptase, and integrase inhibitors in cell-associated viral DNA.
Limitations This procedure should be used for patients with documented
HIV-1 infection and undetectable viral load or low level viremia.
Methodology Polymerase chain reaction (PCR) amplification and next generation DNA sequencing
References
Human Immunodeficiency Virus 1 (HIV-1) DNA Sequen­
cing Integrase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 551965
CPT Call client services.
Synonyms Cell-associated Viral DNA; HIV-1 Genotype; Resistance Analysis
Specimen Whole blood, frozen
Volume 4 mL
Collection Collect specimen in lavender-top (EDTA) tube. Do not centrifuge. Ship frozen. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for
each test requested.
Storage Instructions Freeze.
Causes for Rejection Quantity not sufficient for analysis; heparinized plasma; non-frozen specimen
Use Detect resistance of HIV-1 to integrase inhibitors in cell-associated viral
DNA.
Limitations This procedure should be used for patients with documented
HIV-1 infection and undetectable viral load or low level viremia.
Methodology Polymerase chain reaction (PCR) amplification and next generation DNA sequencing
References
Panel on Antiretroviral Guidelines for Adults and Adolescents—A Working Group of the Office of AIDS Research Advisory Council (OARAC). Guidelines for the Use of Antiretroviral
Agents in HIV-1-Infected Adults and Adolescents. Washington, DC: Department of Health and
Human Services; May 1, 2014.
Günthard HF, Aberg JA, Eron JJ, et al. Antiretroviral treatment of adult HIV infection: 2014
recommendations of the International Antiviral Society-USA Panel. JAMA. 2014 Jul 23-30;
312(4):410-425. PubMed 25038359
October – November 2014
Panel on Antiretroviral Guidelines for Adults and Adolescents—A Working Group of the Office of AIDS Research Advisory Council (OARAC). Guidelines for the Use of Antiretroviral
Agents in HIV-1-Infected Adults and Adolescents. Washington, DC: Department of Health and
Human Services; May 1, 2014.
Günthard HF, Aberg JA, Eron JJ, et al. Antiretroviral treatment of adult HIV infection: 2014
recommendations of the International Antiviral Society-USA Panel. JAMA. 2014 Jul 23-30;
312(4):410-425. PubMed 25038359
Hurt C. Transmitted resistance to HIV integrase strand-transfer inhibitors: Right on schedule.
Antivir Ther. 2011; 16(2):137-140. PubMed 21447861
Human Immunodeficiency Virus 1 (HIV-1) GenoSure
ArchiveSM Plus Trofile® DNA . . . . . . . . . . . . . . . . 552020
CPT Call client services.
Synonyms Cell-associated Viral DNA; HIV-1 Genotype; Resistance Analysis
Specimen Whole blood, frozen
Volume 8 mL
Container Lavender-top (EDTA)
3
Volume XIV, Nº 10 – 11
LabHorizons
Collection Collect specimen in two lavender-top (EDTA) tubes. Do not centrifuge. Ship frozen. To avoid delays in turnaround time when requesting
multiple tests on frozen samples, please submit separate frozen specimens
for each test requested.
Storage Instructions Freeze.
Causes for Rejection Quantity not sufficient for analysis; heparinized plasma; nonfrozen specimen
Use Detect resistance of HIV-1 to protease, reverse transcriptase, and integrase inhibitors (GenoSure ArchiveSM) and detect HIV-1 coreceptor tropism
(Trofile® DNA) in cell-associated viral DNA; determine eligibility for CCR5
antagonist therapy, such as maraviroc (Selzentry®).
Limitations This procedure should be used for patients with documented
HIV-1 infection and undetectable viral load or low level viremia.
Methodology GenoSure ArchiveSM: Polymerase chain reaction (PCR) amplification and next generation DNA sequencing; Trofile® DNA: Polymerase
chain reaction (PCR) amplification and viral culture
References
October – November 2014
mutations are rarely detected in patients with de novo acute myeloid leukemia, chronic myelogenous leukemia, lymphoid leukemia, or solid tumors.
CALR mutations are not detected in polycythemia and appear to be mutually
exclusive with JAK2 mutations and MPL mutations.
JAK2 exon 12 mutation status is associated with erythrocytosis and atypical
marrow morphology. Mutation analysis may be used to differentiate reactive
conditions from malignant erythrocytosis. JAK2 exon 12 mutations appear
to be specific to polycythemia vera (PV) or idiopathic erythrocytosis.
MPL(myeloproliferative leukemia virus oncogene homology) belongs to
the hematopoietin superfamily and enables its ligand thrombopoietin, to
facilitate both global hematopoiesis and megakaryocyte growth and differentiation. MPL W515 mutations are present in patients with primary myelofibrosis (PMF) and essential thrombocythemia (ET) at a frequency of
approximately 5% and 1%, respectively. The S505 mutation is detected in
patients with hereditary thrombocythemia.
Limitations This assay has a sensitivity of approximately 5% for the detection of cells containing the JAK2 mutations and CALR mutations, 10% to
20% for MPL mutations in a background of nonmutant cells.
Methodology Allele-specific polymerase chain reaction (PCR); capillary
electrophoresis; Sanger sequencing
References
Panel on Antiretroviral Guidelines for Adults and Adolescents—A Working Group of the Office of AIDS Research Advisory Council (OARAC). Guidelines for the Use of Antiretroviral
Agents in HIV-1-Infected Adults and Adolescents. Washington, DC: Department of Health and
Human Services; May 1, 2014.
Günthard HF, Aberg JA, Eron JJ, et al. Antiretroviral treatment of adult HIV infection: 2014
recommendations of the International Antiviral Society-USA Panel. JAMA. 2014 Jul 23-30;
312(4):410-425. PubMed 25038359
Hurt C. Transmitted resistance to HIV integrase strand-transfer inhibitors: Right on schedule.
Antivir Ther. 2011; 16(2):137-140. PubMed 21447861
Whitcomb JM, Huang W, Fransen S, et al. Development and characterization of a novel
single-cycle recombinant-virus assay to determine human immunodeficiency virus type 1 coreceptor tropism. Antimicrob Agents Chemother. 2007 Feb; 51(2):566-575. PubMed 17116663
Baxter EJ, Scott LM, Campbell PJ, et al. Acquired mutation of the the tyrosine kinase JAK2
in human myeloproliferative disorders. Lancet. 2005 Mar 19-25; 365(9464):1054-1061.
PubMed 15781101
James C, Ugo V, LeCouédic JP, et al. A unique clonal JAK2 mutation leading to constitutive signalling causes polycythaemia vera. Nature. 2005; 434(7037):1144-1148. PubMed
15793561
Jones AV, Kreil S, Zoi K, et al. Widespread occurrence of the JAK2V617F mutation in chronic
myeloproliferative disorders. Blood. 2005; 106(6):2162-2168. PubMed 15920007
Kilpivaara O, Levine RL. JAK2 and MPL mutations in myeloproliferative neoplasms: Discovery and science. Leukemia. 2008 Oct; 22(10):1813-1817. PubMed 18754026
Klampfl T, Gisslinger H, Harutyunyan AS, et al. Somatic mutations of calreticulin in myeloproliferative neoplasms. N Engl J Med. 2013 Dec; 369(25):2379-2390. PubMed 24325356
Kralovics R, Passamonti F, Buser AS, et al. A gain-of-function mutation of JAK2 in myeloproliferative disorders. N Engl J Med. 2005 Apr 28; 352(17):1779-1790. PubMed 15858187
Liu K, Martini M, Rocca B, et al. Evidence for a founder effect of the MPL-S505N mutation in eight Italian pedigrees with hereditary thrombocythemia. Haematologica. 2009 Oct;
94(10):1368-1374. PubMed 19608689
Nangalia J, Massie CE, Baxter EL, et al. Somatic CALR mutations in myeloproliferative
neoplasms with nonmutated JAK2. N Engl J Med. 2013 Dec; 369(25):2391-2405. PubMed
24325359
Pardanani AD, Levine RL, Lasho T, et al. MPL515 mutations in myeloproliferative and
other myeloid disorders: A study of 1182 patients. Blood. 2006 Nov 15; 108(10):3472-3476.
PubMed 16868251
Tefferi A, Gilliland DG. The JAK2 V617F tyrosine kinase mutation in myeloproliferative
disorders: Status report and immediate implications for disease classification and diagnosis.
Mayo Clin Proc. 2005; 80(7):947-958. PubMed 16007902
JAK2V617F Mutation Analysis, Qualitative, with Reflex to
CALR Mutation Analysis, JAK2 Exon 12 Mutation Analysis and MPL Mutation Analysis . . . . . . . . . . . . . .489395
CPT Call client services. If reflex testing is performed, concomitant CPT
codes/charges will apply.
Synonyms CALR Mutation Analysis; JAK2 Exon 12 Mutation Detection;
Janus Kinase 2 V617F Mutation Detection; MPL Mutation Analysis
Special Instructions Please direct any questions regarding this test to customer service at 800-345-4363.
Specimen Whole blood or bone marrow
Volume 3-5 mL whole blood or 1-2 mL bone marrow
Minimum Volume 3 mL whole blood or 1 mL bone marrow
Container Lavender-top (EDTA) tube or green-top (sodium heparin) tube
Collection Submit at room temperature. Specimens should arrive in the laboratory within 48 hours of collection. Indicate date and time of collection on
the test request form.
Storage Instructions Refrigerate. Ship specimen at room temperature.
Specimen should arrive in the laboratory within 48 hours of collection. If
specimen is to be stored prior to shipment, store at 2°C to 8°C. Indicate date
and time of collection on the test request form.
Causes for Rejection Sample greater than 72 hours old; clotted blood
Use This test will assess for the JAK2V617F (exon 14) mutation first and will
reflex to CALR mutation analysis, JAK2 exon 12 mutation analysis and MPL
mutation analysis when the JAK2V617F mutation is negative.
The JAK2V617F (exon 14) mutation analysis can be used in conjunction with
bone marrow histology and cytogenetic analysis to assist in the diagnosis of
myeloproliferative neoplasms (MPN). The JAK2V617F mutation is found in
almost all patients with polycythemia vera (PV) and in nearly one-half of
those with idiopathic myelofibrosis (IMF) and with essential thrombocythemia (ET).
The calcium-binding endoplasmic reticulin chaperone protein, calreticulin (CALR), is somatically mutated in approximately 70% of patients with
JAK2-negative essential thrombocythemia (ET) and 60% to 88% of patients
with JAK2-negative primary myelofibrosis. Only a minority of patients (approximately 8%) with myelodysplasia has mutations in CALR gene. CALR
ZnT8 Antibodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 503995
CPT 86341
Synonyms Zinc Transporter 8 Autoantibodies
Specimen Serum (preferred) or plasma (heparin)
Volume 0.5 mL
Minimum Volume 0.2 mL (Note: This volume does not allow for repeat
testing.)
Container Red-top tube, gel-barrier tube, or green-top (heparin) tube
Collection Serum or plasma must be separated from cells within 45 minutes
of venipuncture. Transfer separated serum or plasma to a plastic transport
tube. To avoid dealys in turnaround time when requesting multiple tests on
frozen samples, please submit separate frozen specimens for each test requested.
Storage Instructions Freeze. Stable at room temperature, refrigerated, or
frozen for seven days. Freeze/thaw cycles: stable x6
Causes for Rejection Gross hemolysis, lipemic specimen, EDTA plasma
Use Detects zinc transporter 8 autoantibodies, an autoimmune diabetes marker that is instrumental in the diagnosis of new-onset type 1 diabetes
Methodology Enzyme-linked immunosorbent assay (ELISA)
4
Volume XIV, Nº 10 – 11
LabHorizons
October – November 2014
Ebola Virus Disease (EVD)
not submit specimens to LabCorp for any testing (eg, CBC, malaria,
routine chemistry, serology, blood culture) from patients suspected for
EVD until results for EVD laboratory testing are completed by the CDC
or other public health agency and EVD has been ruled out.
EVD is an infection of public health significance. If you are either considering a diagnosis of EVD, or if you are seeking to rule out EVD in
a patient, then you should first consult the Centers for Disease Control
and Prevention (CDC) EVD criteria to assess the patient for consistent
symptoms and stated risk factors. If the patient is then suspected of
having EVD, contact your state public health laboratory for further instructions. Specimens from the patient for diagnostic testing for Ebola
virus would then be collected and sent by you to a specified laboratory
as directed by the public health laboratory.
For CDC EVD criteria, visit the CDC website at:
http://www.cdc.gov/vhf/ebola/hcp/case-definition.html.
For additional EVD information, visit the
American Society for Microbiology
website at: https://www.asm.org/images/PSAB/Ebola9-10-14.pdf.
LabCorp does not collect or process specimens from patients suspected
of having EVD. LabCorp does not test specimens to rule out EVD. Do
Methodology Change for Cryptococcus Antigen Effective January 5, 2015
Effective January 5, 2015, testing for Cryptococcus antigen will be
performed using the lateral flow immunochromographic methodology.
The new methodology detects both C gattii and C neoformans but does
not differentiate between the two species. Positive results are reflexed
to titers and billed at an additional charge.
As the new methodology employs different antibodies, LabCorp will
offer a rebaseline test at no charge. The rebaseline test will be available
for a period of 90 days after the discontinuation of the current assays.
Please refer to the table below for relevant test numbers.
Clients who currently receive results though an electronic interface (ie,
EMR), must update the tests in their respective systems. Please direct
any questions to your local LabCorp service representative.
Additionally, following the College of American Pathologists’
guidelines,1 CSF samples submitted for initial diagnosis that test
positive must have a fungal (mycology) culture performed. If a fungal
culture has not been requested on a CSF sample and the screen is
positive, a fungal culture will be performed at no additional charge.
____________________
1. College of American Pathologists. Immunology Checklist. Northfield, Ill: CAP; April 21, 2014: IMM.41840; page 35.
New Assay (Available January 5, 2015)
New Test Nº
CPT(s)
Discontinued Test Nº
CPT(s)
Cryptococcus Antigen
183025
87899
006551
87899
Cryptococcus Antigen
183060
Cryptococcus Antigen, Cerebrospinal Fluid.
183016
87899
160747
87899
Cryptococcus Antigen, Cerebrospinal Fluid
183048
5
Rebaseline Assays (Available Until April 3, 2015)
Rebaseline Test Nº
Volume XIV, Nº 10 – 11
LabHorizons
October – November 2014
Uq pdates to the Directory of Services and Interpretive Guide (DoS)
Test Name
Nº
Field/Change (Only fields that change are included here.)
Aldosterone:Renin Ratio
004354
Volume 1 mL serum and 1 mL plasma
Minimum Volume 0.5 mL serum and 0.8 mL plasma (Note: This volume does not allow for repeat testing.)
Androsterone
504005
Specimen Serum (preferred) or EDTA plasma, frozen
Container Red-top tube (Do not use gel-barrier tube.) or lavender-top (EDTA) tube
Special Instructions: Note: This test is not the same as Androstenedione. (See 004705 and 500152.)
Collection Centrifuge and separate serum or plasma immediately. Freeze. Send serum or plasma in a plastic transport
tube
Antidepressant Drug Profile, Whole Blood
791490
Volume 7 mL whole blood or 3 mL serum or plasma
Bordetella pertussis Antibodies, IgG
161745
Reference Interval
• Negative: <0.95 index
• Equivocal: 0.95 - 1.04 index
• Positive: >1.04 index
Calprotectin, Fecal
123255
Storage Instructions Stool specimens should be received by the laboratory within 10 days of collection. Samples are
stable for four days before testing at 2°C to 8°C. Freeze at -20°C if samples will not be tested within four days. Temperature should not exceed 30°C during shipment.
Causes for Rejection Serum or plasma received; stool contaminated with urine; sample outside of the container; specimen older than 10 days of collection before tested; samples taken from diapers unless portion taken has not been in
contact with diaper material; preserved stool received
Use An in vitro diagnostic to aid in the diagnosis of inflammatory bowel disease (IBD), Crohn’s disease, and ulcerative
colitis, and to differentiate IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory
findings.
Limitations
• False-negative results could occur in patients who have granulocytopenia due to bone marrow depression.
• Some patients who are taking NSAIDs will have elevations in their fecal calprotectin levels.
• Results may not be clinically applicable to children younger than two years old, who have mildly increased calprotectin levels.
• Patients with IBD fluctuate between active (inflammatory) and inactive stages of the disease. These stages must be
considered when using the calprotectin test.
• The use of proton pump inhibitors (PPIs), colitis, and diverticular disease may also lead to elevated calprotectin
levels. Patients affected by untreated celiac disease may occasionally show elevated calprotectin values.
• Other intestinal ailments, including many gastrointestinal infections and colorectal cancer, can result in elevated levels of calprotectin. These specimens will test positive with this test. Consequently, a diagnosis of active IBD cannot
be established solely on the basis of a positive result with this test.
• Fecal calprotectin is an indicator of neutrophilic presence in the stool and is not specific for IBD.
Methodology Quantitative enzyme-linked immunosorbent assay (ELISA)
Additional Information Various types of organic disease in the gastrointestinal tract will cause damage to the intestinal
lining (mucosa layer). Such damage may vary from increased permeability of the mucosa to inflammation, which may
be toxic or chemotactic (ie, they stimulate leukocytes, in particular polymorphonuclear granulocytes [PMNs] to migrate
into the gut lumen where they release their contents, including antimicrobial substances like calprotectin). This protein
constitutes about 60% of total proteins in the cytoplasm of PMN and can be estimated in small, random stool samples
even after storage for seven days at ambient temperature. The concentration of calprotectin in stool reflects the number
of PMNs migrating into the gut lumen.
Calprotectin is a calcium- and zinc-binding protein produced by PMNs, monocytes, and squamous epithelial cells,
except those in normal skin. After binding calcium, it can resist degradation by leukocytic and bacterial enzymes. By
competing with different enzymes for limited local amounts of zinc, calprotectin may inhibit many zinc-dependent
enzymes and thereby kill microörganism or animal and human cells in culture.
Calprotectin can be detected even in small (<1 g) random stool samples. Furthermore, organic diseases of the bowel
give a strong fecal calprotectin signal (ie, elevations are often five to several thousand times the upper reference in
healthy individuals indicating intestinal inflammation). Patients with organic or functional abdominal disorders may
have similar symptoms, and clinical examination alone may not be sufficient to support a specific diagnosis. Additionally, the calprotectin test has been demonstrated to be a marker of inflammatory bowel disease in both children and
adult patients.
Inflammatory bowel disease (IBD) (eg, ulcerative colitis and Crohn’s disease), may appear from early childhood to late
adulthood, and the diagnosis is often delayed due to vague symptoms or reluctance to perform endoscopy and biopsy.
Cortisol
004051
Storage Instructions Room temperature.
Cortisol, ACTH Stimulation
140761
Cortisol, AM
104018
Cortisol, AM & PM
104000
Cortisol, PM
104026
Creatine
002402
Volume 1 mL
Minimum Volume 0.5 mL
D-Dimer
115188
Volume 2 mL
Minimum Volume 1 mL
Reference Interval 0.00-0.49 mg/L FEU
Dextromethorphan (DM) and Metabolite, Quantitative, Urine
790340
Storage Instructions Refrigerated; stable for two weeks. Stable at room temperature for five days. Stable frozen for
six months.
Ecarin Clotting Time (ECT)
500190
Reference Interval 20.1−24.1 seconds
Note: For the most current test information, please consult the online Directory of Services and Interpretive Guide at https://www.labcorp.com/wps/portal/provider/testmenu.
6
Volume XIV, Nº 10 – 11
LabHorizons
October – November 2014
Uq pdates to the Directory of Services and Interpretive Guide (DoS)
Test Name
Estriol, Serum
Nº
004614
Field/Change (Only fields that change are included here.)
Reference Interval
Gestational Week
Median (ng/mL)
Central 95% Range (ng/mL)
27
4.6
2.6-7.1
28
4.7
2.6-7.8
29
5.0
2.6-8.6
30
5.5
2.7-9.6
31
6.1
2.9-11.0
32
6.9
3.2-12.7
33
8.0
3.4 to > 13.3
34
9.3
3.7 to > 13.3
35
11.3
4.3 to > 13.3
36
> 13.3
5.3 to > 13.3
37
> 13.3
6.2 to > 13.3
38
> 13.3
7.4 to > 13.3
39
> 13.3
8.1 to > 13.3
40
> 13.3
8.5 to > 13.3
Hemoglobin, Sickle Cell, Prenatal, DNA
451391
Volume 12 mL amniotic fluid or 20 mg CVS and 5 mL blood per parental sample
Minimum Volume 10 mL amniotic fluid or 10 mg CVS and 2 mL blood per parental sample.
Hepatitis Be Antigen
006619
Container Gel-barrier tube or lavender-top (EDTA) tube
Storage Instructions Refrigerate. Samples can be stored at 2°C to 8°C for seven days or at -20°C for one year. Stable
for three freeze/thaw cycles.
Causes for Rejection Non-EDTA plasma specimen; heat-inactivated specimens; cord blood; cadaver specimens; or body
fluids other than serum or EDTA plasma
Use The HBe assay is intended for use as an aid in the diagnosis of patients with hepatitis B viral infections, when used
in conjunction with results from other HBV marker assays.
Limitations Assay performance characteristics have not been established for (1) children younger than 17 years of age,
(2) pregnant women, or (3) populations of immunocompromised or immunosuppressed patients.
Methodology Immunochemiluminometric assay (ICMA)
Hepatitis B Virus (HBV) DNA, Quantitative Real-time PCR With
Reflex to HBV Genotype
551722
Use This test quantitates HBV DNA in serum or plasma with reflex to HBV genotype if ≥ 500 IU/mL is detected.
Limitations The quantitative test has a range of 20 IU/mL to 170,000,000 IU/mL. The genotype assay is only triggered
when the quantitative test result is ≥500 IU/mL.
Hepatitis B Virus (HBV) DNA, Quantitative Real-time PCR With
Reflex to HBV Genotype Plus Drug Resistance
551735
Use This test quantitates HBV DNA in serum or plasma with reflex to HBV genotype and drug resistance testing if ≥ 500
IU/mL is detected.
Limitations The quantitative test has a range of 20 IU/mL to 170,000,000 IU/mL. The genotype assay is only triggered
when the quantitative test result is ≥ 500 IU/mL.
Hepatitis B Virus (HBV) Genotype
551710
Collection Centrifuge sample within six hours of collection, transfer plasma/serum to a polypropylene screw-cap tube
and freeze. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate
frozen specimens for each test requested.
Limitations This assay may not be successful when the HBV viral load is <500 IU/mL.
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). The FDA has determined that such clearance or approval is not
necessary.
Hepatitis B Virus (HBV) Genotyping Plus Drug Resistance
551750
Collection Centrifuge sample within six hours of collection, transfer plasma/serum to a polypropylene screw-cap tube
and freeze. To avoid delays in turnaround time, when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.
Limitations This assay may not be successful when the HBV viral load is < 500 IU/mL.
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). The FDA has determined that such clearance or approval is
not necessary.
Hepatitis C Virus (HCV) Genotyping With 1a Subtype Reflex to
Hepatitis C Virus (HCV) GenoSure® NS3/4A
550555
Volume 3.0 mL
Minimum Volume 2.0 mL
Collection Collect specimen in two PPT™ tubes, gel-barrier tubes, yellow-top (ACD) tubes, or lavender-top (EDTA)
tubes. Do not use green-top (heparin) tubes. Centrifuge specimen within six hours of collection, remove serum/plasma,
and transfer specimen to polypropylene screw-capped tubes, and freeze. Specimens drawn into PPT™s need to be centrifuged within six hours and frozen. Ship frozen. To avoid delays in turnaround time when requesting multiple tests on
frozen samples, please submit separate frozen specimens for each test requested.
Use Genotyping of the six major HCV types and their most common subtypes. Assessment of drug susceptibility by
nucleic acid sequencing of a patient’s hepatitis C virus (HCV) to the NS3/4A protease inhibitors. Detects Q80K polymorphism.
Hepatitis C Virus (HCV), Quantitative, Real-time PCR
(Graphical)
550070
Use Determine the number of international units (IU) of hepatitis C virus (HCV) RNA per milliliter in serum or plasma
in known HCV-positive patients
HER-2/CEP17, FISH
483248
HER-2/CEP17, FISH With Reflex to HERmark® if FISH
Equivocal
483410
Causes for Rejection Fixative other than neutral buffered formalin; quantity not sufficient for analysis; tumor other
than breast tumor
Note: For the most current test information, please consult the online Directory of Services and Interpretive Guide at https://www.labcorp.com/wps/portal/provider/testmenu.
7
Volume XIV, Nº 10 – 11
LabHorizons
October – November 2014
Uq pdates to the Directory of Services and Interpretive Guide (DoS)
Nº
Field/Change (Only fields that change are included here.)
HER-2 Immunohistochemistry (IHC), Breast With Reflex to
FISH if 0, 1+, or 2+ by IHC
Test Name
483320
Collection Specimen should be fixed in 10% neutral-buffered formalin. Fixation time should be between 6 and 72 hours
according to ASCO/CAP guidelines; however, the package insert indicates optimum fixation time between 18 and 24
hours.
Causes for Rejection Tumor other than breast tumor
HER-2 Immunohistochemistry (IHC) Breast With Reflex to FISH
if 2+ by IHC
483289
Collection Specimen should be fixed in 10% neutral-buffered formalin. Fixation time should be between 6 and 72 hours
according to ASCO/CAP guidelines; however, the package insert indicates optimum fixation time between 18 and 24
hours.
Causes for Rejection Tumor other than breast tumor
HER-2 Immunohistochemistry (IHC), Gastric With Reflex to
FISH if 2+ by IHC
483360
Collection FFPE tissue, preserved in 10% neutral buffered formalin, fixed for 18 to 24 hours. ASCO/CAP 2013 guidelines recommend fixation time between 6 and 72 hours for breast tissue; however, special ASCO/CAP guidelines have
not been established for gastric cancer samples.
Causes for Rejection Tumor other than gastric tumor
HER-2 Immunohistochemistry (IHC) With Reflex to FISH if 2+
by IHC With Reflex to HERmark® if FISH Equivocal
483200
Collection Specimen should be fixed in 10% neutral-buffered formalin. Fixation time should be between 6 and 72 hours
according to ASCO/CAP guidelines; however, the package insert indicates optimum fixation time between 18 and 24
hours.
Causes for Rejection Tumor other than breast tumor
HER-2 Immunohistochemistry (IHC) With Reflex to HERmark®
if 2+ by IHC
480845
Collection Specimen should be fixed in 10% neutral-buffered formalin. Fixation time should be between 6 and 72 hours
according to ASCO/CAP guidelines; however, the package insert indicates optimum fixation time between 18 and 24
hours.
Causes for Rejection Tumor other than breast tumor
HER-2/neu IHC, Breast Paraffin
480376
Collection Specimen should be fixed in 10% neutral-buffered formalin. Fixation time should be between six and 72
hours according to ASCO/CAP guidelines; however, the package insert indicates optimum fixation time between 18
and 24 hours.
Causes for Rejection Tumor other than breast tumor
HER-2/neu Immunohistochemistry (IHC), Gastric Paraffin
480226
Collection FFPE tissue, preserved in 10% neutral buffered formalin, fixed for 18 to 24 hours. ASCO/CAP 2013 guidelines recommend fixation time between 6 and 72 hours for breast tissue; however, special ASCO/CAP guidelines have
not been established for gastric cancer samples.
Causes for Rejection Tumor other than gastric tumor
HER-2/neu FISH, G stric, Paraffin
483340
Causes for Rejection Fixative other than neutral buffered formalin; quantity not sufficient for analysis; tumor other
t an gastric tumor
Hereditary Angioedema (HAE)
123020
Specimen Serum, frozen and room temperature
Volume Two aliquots: 0.5 mL frozen, 2 mL at room temperature
Minimum Volume Two aliquots: 0.1 mL frozen, 1 mL at room temperature
Collection Collect sample on ice. Separate serum from cells in a refrigerated centrifuge. If a refrigerated centrifuge is
not available, chill centrifuge tube carriers before centrifuging. Transfer aliquots of serum to each of two plastic transport tubes. Freeze the required 0.5 mL frozen aliquot immediately at -20°C.
Storage Instructions Frozen sample should not be stored at room temperature (15°C to 30°C) for longer than six hours.
Required room temperature samples are stable for three days, frozen samples for 14 days.
Causes for Rejection Plasma specimen; specimen not drawn on ice; stored specimen not frozen; gross bacterial contamination; excess lipemia; hemolysis; separate specimens not received (room temperature and frozen)
Limitations Rheumatoid factors (>200 IU/mL) significantly increase the apparent C4 concentration. This profile is not
intended for the diagnoses of estrogen-dependent, estrogen-associated, drug-induced, or idiopathic angioedema. Also
note that patients taking anabolic steroids may have falsely elevated C4 values thus limiting the effectiveness of the
profile’s logic. Consider retesting the patient after discontinuation of anabolic steroids.
Immunofixation (IFE)
001685
Volume 2 mL
Lactate Dehydrogenase (LD) Isoenzymes
001842
Volume 2 mL
Lactic Acid Dehydrogenase (LD)
001115
Reference Interval
a
h
Age
Male (IU/L)
Female (IU/L)
1 – 7 d
123 – 237
123 – 237
8 – 30 d
126 – 331
130 – 275
1 – 11 m
143 – 381
128 – 376
1 – 3 y
195 – 361
192 – 352
4 – 6 y
180 – 313
180 – 311
7 – 9 y
166 – 291
166 – 290
10 – 12 y
155 – 280
135 – 260
13 – 15 y
126 – 244
118 – 215
16 – 17 y
118 – 222
114 – 209
>17 y
121 – 224
119 – 226
Note: For the most current test information, please consult the online Directory of Services and Interpretive Guide at https://www.labcorp.com/wps/portal/provider/testmenu.
8
Volume XIV, Nº 10 – 11
LabHorizons
October – November 2014
Uq pdates to the Directory of Services and Interpretive Guide (DoS)
Nº
Field/Change (Only fields that change are included here.)
Lipid Cascade With Reflex to Lipoprotein Particle Assessment
by NMR
Test Name
361946
Storage Instructions Room temperature: Gel-barrier tube, green-top (heparin) tube, or lavender-top (EDTA) tube.
Stable at room temperature for six hours or refrigerated for 10 days. Frozen is not acceptable. Refrigerate: NMR LipoTube (black-and-yellow-top tube) or serum transport tube. Do not freeze sample, and do not store at room temperature.
Stable refrigerated for six days and room temperature is not acceptable. Frozen is not acceptable.
Lipoprotein Phenotyping Profile
235036
Volume 2 mL
Metabolic Syndrome Profile
335884
Collection Separate serum or plasma from cells within 45 minutes of collection. Label gray-top tube as plasma.
Limitations This profile should not be performed on patients who have, in the preceding three months, suffered a myocardial infarction or similar traumatic episode, including acute infection or inflammation.
Multiple Myeloma Profile, FISH
510325
Special Instructions Indicate pertinent clinical diagnosis and previous cytogenetics studies on the test request form. If
insufficient plasma cells available, the following probe priority will be followed: Previous abnormality, p53, FGFR3/
IGH, MAF/IGH, 13q14, 1p/1q. CCND1/IGH, 7/9/15 aneuploidy probes.
Oncology Therapeutic Panel (IntelliGENSM)
489600
Use IntelliGENSM is a next-generation sequencing (NGS) panel that contains ~2,600 mutations within 50 common oncogenes and tumor suppressor genes. The information provided in this analysis may assist in making cancer treatment
decisions involving target therapies and other therapeutic indications related to the molecular alterations detected in the
tumor sample.
Methodology IntelliGENSM is an NGS “hot-spot” panel that contains a single pool of 207 primer pairs used to perform
multiplex PCR for preparation of amplicon libraries from genomic “hot-spot” regions frequently mutated in human
cancer genes. It covers ~2,600 COSMIC mutations within 50 common oncogenes and tumor suppressor genes.
Pigweed, Common
602484
Minimum Volume 0.1 mL
Renin Activity and Aldosterone
000703
Volume 1.0 mL serum and 1.0 mL plasma
Minimum Volume 0.5 mL serum and 0.8 mL plasma (Note: This volume does not allow for repeat testing.)
Renin Activity, Plasma
002006
Volume 1.0 mL
Minimum Volume 0.8 mL (Note: This volume does not allow for repeat testing.)
Respiratory Syncytial Virus (RSV), Immunoassay
014548
Limitations A positive result may occur in the absence of viable virus. In the event of a negative result, infection due
to RSV cannot be ruled out because the antigen present may be below the detection limit of the test. A negative test
is presumptive, and it is recommended by the assay manufacturer that these results be confirmed by another method.
SCN1A Family-targeted Sequencing
511274
Container Lavender-top (EDTA) tube or yellow-top (ACD) tube
SCN1A Sequencing, Full Gene
511236
Serotonin
120204
Minimum Volume 1.0 mL
Sodium, 24-Hour Urine
003178
Container Plastic urine container without preservative
Thyroid-stimulating Hormone (TSH)
004259
Reference Interval
Age
μIU/mL
0–6 d
0.700–15.200
7 d–3 mo
0.720–11.000
3 mo 1 d – 12 mo
0.730–8.350
1y–5y
0.700–5.970
6–10 y
0.600–4.840
>10 y
0.450–4.500
Vitamin A
017509
Volume 1.0 mL
Vitamin B6, Plasma
004655
Minimum Volume 1.0 mL
Vitamin C
001479
Volume 1.0 mL
Minimum Volume 0.5 mL
Vitamin E
081000
Volume 1.0 mL
Note: For the most current test information, please consult the online Directory of Services and Interpretive Guide at https://www.labcorp.com/wps/portal/provider/testmenu.
9
Volume XIV, Nº 10 – 11
LabHorizons
October – November 2014
CPT Code Updates
Test Name
Nº
CPT(s)
Chromosome Analysis, Amniotic Fluid
052040
Contact CPT coding department at 800-222-7566, ext 6-8400.
Chromosome Analysis, Amniotic Fluid With Reflex to SNP Microarray (Reveal®)
052104
Contact CPT coding department at 800-222-7566, ext 6-8400.
Chromosome Analysis, Blood (Constitutional)
511035
Contact CPT coding department at 800-222-7566, ext 6-8400.
Chromosome Analysis, Blood (Constitutional) With Reflex for Y Deletion Analysis
511075
Call client services.
Chromosome Analysis, Chorionic Villi Biopsy
510988
Contact CPT coding department at 800-222-7566, ext 6-8400.
Chromosome Analysis, High Resolution
052215
Contact CPT coding department at 800-222-7566, ext 6-8400.
Chromosome Analysis, Leukemia/Lymphoma
510999
Call client services.
Chromosome Analysis, Prenatal Cordocentesis and Fetal Hemoglobin
511025
Contact CPT coding department at 800-222-7566, ext 6-8400..
Chromosome Analysis, Products of Conception (POC) With Reflex to SNP Microarray
(Reveal®)
052065
Contact CPT coding department at 800-222-7566, ext 6-8400.
Chromosome Analysis, Tissue Biopsies (Products of Conception, Skin)
052052
Contact CPT coding department at 800-222-7566, ext 6-8400.
Chromosome Analysis With Reflex to SNP Microarray−Pediatric (Reveal®)
052045
Contact CPT coding department at 800-222-7566, ext 6-8400.
Chromosome Five-cell Count Plus Microarray (Reveal ), Amniotic Fluid
511590
81229. If additional testing is performed, concomitant CPT codes/charges will
apply.
Chromosome Five-cell Count Plus Microarray (Reveal®), CVS
511555
81229. If additional testing is performed, concomitant CPT codes/charges will
apply.
510770
Contact CPT coding department at 800-222-7566, ext 6-8400.
®
Microdeletion Syndromes, FISH
Multiple Myeloma Profile, FISH
510325
Call client services.
Prenatal Aneuploid Evaluation, Amniotic Fluid, FISH
510365
Contact CPT coding department at 800-222-7566, ext 6-8400.
Prenatal Aneuploid Evaluation, Chorionic Villus Sampling, FISH
510960
Contact CPT coding department at 800-222-7566, ext 6-8400.
SNP Microarray, Whole Blood (Reveal )
511535
81229. If additional testing is performed, concomitant CPT codes/charges will
apply.
®
Deleted Procedures
Deleted Tests
Test Nº
LabCorp Offers
Test Nº
Androstenedione, Ultrasensitive
503859
Androstenedione LCMS (Endocrine Sciences)
500152
CML FISH Reflex to Qualitative JAK2V617F Mutation Analysis
510980
CML FISH Reflex to Qualitative JAK2V617F Reflex to JAK2 Exon 12 Mutation Analysis
510970
CML FISH Reflex to JAK2V617F Mutation Analysis, Qualitative, With Reflex
to CALR Mutation Analysis, JAK2 Exon 12 Mutation Analysis and MLP
Mutation Analysis
511595
DHEA-Sulfate, Ultrasensitive
503895
DHEA-Sulfate (Endocrine Sciences)
500161
Growth Hormone, Urine 24 Hour
500330
No replacement is available.
Human Immunodeficiency Virus 1/O/2 (HIV-1/O/2) Antibody With Reflex to NAA
083850
HIV-1/O/2 Antigen/Antibody Preliminary Test With Cascade Reflex to
Supplementary Testing
083935
JAK2V617F Mutation Analysis, Qualitative, With Reflex to JAK2 Exon 12 Mutation
Analysis
489230
JAK2
Mutation Analysis, Qualitative, with Reflex to JAK2 Exon 12 Mutation
Analysis and MPL Mutation Analysis
489395
489370
JAK2V617F Mutation Analysis, Qualitative, With Reflex to CALR Mutation
Analysis, JAK2 Exon 12 Mutation Analysis and MPL Mutation Analysis
Testosterone, Ultrasensitive
503888
V617F
No replacement is available.
The CPT codes included in this publication are in accordance with Current Procedural Terminology, a publication of the American Medical
Association. CPT codes are provided here for the convenience of our clients; however, correct coding often varies from one carrier to another,
and LabCorp may bill specific carriers using codes other than those shown. Clients who bill for services should verify the codes with the applicable payor to confirm that their use is appropriate in each case.
©2014 Laboratory Corporation of America® Holdings All Rights Reserved. L13628-1114-1
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