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DEPARTMENT:   CYTOGENETICS

DIRECTOR:  Athena Milatovich Cherry, Ph.D.

NEW TEST

Array Comparative Genomic Hybridization (aCGH)

Test Description and Clinical Indications:  Array comparative genomic hybridization (aCGH) is a new method using existing array technology to detect some chromosomal abnormalities that are too small to be appreciated by high-resolution chromosomal analysis.  Typically, high-resolution chromosomal analysis can detect chromosomal abnormalities of between 5 to 10 Mb in size.  Depending upon the type of array and the spacing of the features on the array, the size of detectable anomalies can be anywhere from a few hundred kilobases of DNA to less than 5 Mb.

Our method utilizes a microarray carrying 44,000 oligonucleotide (Agilent) sequences from known genomic locations at an average spatial resolution of 35 kb of DNA.    Patient and control DNA samples are labeled using different fluorescent tags.  These DNA samples are then hybridized to the array.  The arrays are scanned and the intensities of the fluorescence are plotted as a ratio at each oligonucleotide probe.  These ratios can then be interpreted as representing either a loss or a gain of DNA.  A copy number change is considered only when three or more adjacent oligonucleotides are shown to be duplicated or deleted (with an average size of ~ 100 kb).

Please note:  This array cannot detect polyploidy, balanced chromosomal rearrangements; mosaicism, small duplications or deletions below the resolution of this array or point mutations. Blood on the patient AND his/her parents are requested at the initiation of testing.  This is to confirm by FISH (where possible) any anomalies detected by aCGH, as well as to determine if the difference(s) found are unreported copy number variants (CNV’s).

Array-based Comparative Genome Hybridization, Genetic Dx.

Order Code:CGH GEN

   

Synonyms:

aCGH, CGH, array CGH

Specimen Type:

Peripheral blood Note: blood specimens of both parents at the initiation of testing are also requested. See note in Test Description.

Container Type:

Green-top tube (sodium heparin)

Required Volume:

10 mL 

Minimum Volume (Pediatric):

2 mL

Special Handling:

Room temperature; NoNote: blood specimens of both parents at the initiation of testing are also requested. See note in Test Description.

Methodology:

Array-based comparative genome hybridization 
TAT: 21 days

CPT Codes:

88386 x 4, 83891, 83892 x 2

Report:

Interpretation and report
Causes For Rejection: Improperly labeled specimen, incorrect specimen, hemolyzed or coagulated specimen.

 

NEW TEST

CHIC2 Deletion (or FIP1L1/PDGFRA fusion)

Test Description and Clinical Indications:  Interphase fluorescence in situ hybridization (FISH) is performed using a set of differentially labeled probes specific for three different loci – CHIC2, FIP1L1 and PDGFRA.  Loss of the CHIC2 probe is used as a surrogate for fusion of FIP1L1 and PDGRFA.  CHIC2 deletion (or FIP1L1/PDGFRA fusion) can be observed in individuals with hypereosinophillic syndrome (HES) or systemic mast cell disease (SMCD).  The FIP1L1/PDGFRA fusion creates a novel tyrosine kinase which can be a therapeutic target for imatinib mesylate (or Gleevec).

FISH CHIC2

Order Code:  CGFi CHIC2

   

Synonyms:

FISH, FIP1L1/PDGFRA gene rearrangement; FIP1L1; PDGFRA; deletion 4q12; del(4q12)

Specimen Type:

Whole blood, bone marrow, or other cellular fluid

Container Type:

Green-top tube (sodium heparin), or sterile container for other fluid

Required Volume:

2 mL

Minimum Volume (Pediatric):

1 mL

Special Handling:

Transport at Room Temperature.

Methodology:

Fluorescence in situ hybridization, deletion probes, interphase analysis

TAT:

12-14 days

CPT Codes:

88271 x 3, 88275

Report: Interpretation and report
Causes For Rejection: Improperly labeled specimen, incorrect specimen, hemolyzed or coagulated specimen.

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DEPARTMENT:     FLOW CYTOMETRY / SPECIAL HEMATOLOGY

DIRECTOR:   Daniel Arber, M.D.
DIRECTOR:   Susan Atwater, M.D.

NEW TEST: CD34 Panel, Blood, Bone Marrow and Fluid

Test Description and Clinical Indication: CD34 is a transmembrane glycoprotein found on human myeloid and lymphoid progenitor cells, as well as endothelial progenitor cells.  CD34+ progenitor cells are used in stem cell transplantation to repopulate the bone marrow after myeloablative conditioning.   Prior to transplantation, patients are prepared for stem cell harvesting using G-CSF mobilization, and then peripheral leukocytes are collected by apheresis.  Stem cell enumeration ensures that CD34+ stem cells are present in sufficient numbers to repopulate the bone marrow following storage. 

This assay enumerates CD34+ progenitor cells by flow cytometry using a PE-conjugated class III CD34 reagent antibody, with data analysis using the ISHAGE sequential gating strategy.  This gating strategy selects the population of interest while minimizing interference from debris and nonspecific CD34 reagent binding to non-progenitor cells.

 

CD34 Panel, Blood

Order Code:  CD34

   

Specimen Type:

Whole Blood

Container Type:

Lavender-top tube (EDTA)

Required Volume:

3 mL

Minimum Volume (Pediatric):

1 mL

Special Handling:

Room Temperature, received within 24 hours of collection.

Methodology:

Flow Cytometry, gating ISHAGE

Components:

CD34 % and absolute count

TAT:

24 hours/next day

CPT Codes:

86367

Report:

Reported as CD34% and absolute count

 

CD34 Panel, Bone Marrow

Order Code:  BMCD34

   

Specimen Type:

Bone Marrow

Container Type:

Lavender-top tube (EDTA)

Required Volume:

1 mL

Minimum Volume (Pediatric):

1 mL

Special Handling:

Room Temperature, received within 24 hours of collection.

Methodology:

Flow cytometry, gating ISHAGE

Components:

CD34 % and absolute count

TAT:

24 hours/next day

CPT Codes:

86367

Report:

Reported as CD34% and absolute count 

 

CD34 Panel, Fluid

Order Code:  FCD34

   

Specimen Type:

Apheresis Fluid

Container Type:

Sterile tube or container

Required Volume:

1 mL

Minimum Volume (Pediatric):

1 mL

Special Handling:

Room Temperature, received within 24 hours of collection.

Methodology:

Flow Cytometry, gating ISHAGE

Components:

CD34 % and absolute count

TAT:

24 hours/next day

CPT Codes:

86367

Report:

Reported as CD34% and absolute count 


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DEPARTMENT:     MOLECULAR GENETIC PATHOLOGY

DIRECTOR:   Iris Schrijver, M.D.
DIRECTOR:   James Zehnder, M.D.

NEW TEST

BCR-ABL KINASE DOMAIN MUTATION ANALYSIS

Test Description and Clinical Indications: Translocation of the ABL gene on chromosome 9 to the BCR gene on chromosome 22 creates a chimeric BCR-ABL gene, also known as the Philadelphia Chromosome or t(9:22).  Mutations in the ABL Kinase Domian (KD) of BCR-ABL can occur, both de novo and in treated patients.  Expansion of such a KD mutant clone may be associated with resistance to treatment and with progression to advanced phase disease.  Depending on the specific mutation, such resistance may be overcome by dose escalation of Imatinib or treatment with second-generation tyrosine-kinase inhibitors.  This sequencing assay detects mutations in the ABL Kinase Domain.

BCR-ABL Kinase Domain Mutation Analysis

Order Code:  BCRKDM
   

Synonyms:

ABL Mutation; BCRABL Kinase Domain

Specimen Type:

Whole Blood

Container Type:

Lavender-top tube (EDTA), Light-blue-top tube (sodium citrate), Yellow-top tube Acid Citrate Dextrose Solution A (ACD)

Required Volume:

4 mL

Minimum Volume (Pediatric):

3 mL

Special Handling:

Refrigerate. Ship on wet ice/cold packs.  To be received within 48 hours of collection

Methodology:

RT-PCR followed by sequencing analysis

TAT:

7-14 days

CPT Codes:

83891, 83894, 83898, 83902, 83904 x 4, 83912

Report:

Negative or Positive, with an interpretation and description of the modification.
Causes For Rejection: Heparin

 

NEW TEST

Familial Gastric Cancer

Test Description and Clinical Indications: Familial diffuse gastric and lobular breast cancer predisposition, diagnostic test. The CDH1 gene encodes the cell adhesion protein e-cadherin. E-cadherin germline mutations are associated with both hereditary diffuse gastric cancer and lobular breast cancer. The inheritance pattern is autosomal dominant with incomplete penetrance (~80% for diffuse gastric cancer and ~40% for lobular breast cancer). Mutations are widely distributed throughout the gene, and associated with loss of function of the mutated e-cadherin allele. By the time gastric cancer becomes symptomatic, it is rarely curable. However, a high cure rate (>90% 5 year survival) is possible if the stomach is removed prior to tumor invasion through the gastric wall. Identification of individuals at high risk of developing diffuse gastric cancer, then, affords the opportunity for elective prophylactic gastrectomy. The e-cadherin gene locus (CDH1) is tested for the presence of sequence variants by polymerase chain reaction followed by direct DNA sequencing of the 16 exons as well as surrounding non-coding regions. Because mutations are distributed across all coding exons of the CDH1 gene, an analysis of all exons is recommended. For families with a known mutation, sequencing of a single exon may be appropriate. This is offered separately in our laboratory.

Familial Gastric Cancer

Order Code:  CDH1

   

Synonyms:

CDH1 by Sequencing

Specimen Type:

Whole Blood

Container Type:

Lavender-top tube (EDTA)

Required Volume:

2 mL

Special Handling:

Mix by gentle inversion several times. DO NOT CENTRIFUGE. Transport original tube promptly, at room temperature.

Methodology:

Polymerase Chain Reaction (PCR)

TAT:

14-21 days

CPT Codes:

83891, 83894, 83898 x 9, 83904 x 9, 83912; Site specific testing for a known familial mutation is 83891, 83898, 83894, 83904 x2, 83912.

Report:

Negative or Positive, with an interpretation and description of the modification.

 

DISCONTINUED TEST

FLT3 Gene Analysis Blood, Bone Marrow, Fluid

FLT3 Gene Analysis FLT3, BMFLT3 & FFLT3 tests have been discontinued and replaced with:

NEW TESTS

  • AML Prognosis Assay, Blood, Test Code AMLP   and
  • AML Prognosis Assay, Bone Marrow BMAML

Test Description and Clinical Indications: The FLT3 gene encodes a receptor tyrosine kinase that regulates proliferation and differentiation of hematopoietic stem cells. An internal tandem duplication of the FLT3 gene (FLT3-ITD) has been reported in nearly 25% of patients with AML. A further 7% of AML patients have a mutation of aspartic acid residue 835 (D835) in the activation loop of the second kinase domain, which leads to constitutive activation. Both FLT3 mutations are associated with a poor prognosis. The NPM1 gene encodes nucleophosmin, a nucleolar phoshoprotein that constantly shuttles between the nucleolus and cytoplasm. Insertion mutations in exon 12 of NPM1 occur in approximately one-third of de novo AMLs and confer a favorable prognosis. This assay is based on fluorescent-PCR combined with restriction enzyme digestion, capillary electrophoresis and GeneScan analysis to detect and identify the FLT3-ITD and FLT3-D835 mutations, as well as exon 12 NPM1 insertion mutations, in a single reaction.

AML Prognosis Assay, Blood

Order Code:  AMLP

   

Synonyms:

FLT3-NPM1; FLT3-ITD; FLT3-D835; Tyrosine Kinase; Nucleophosmin

Specimen Type:

Whole Blood

Container Type:

Lavender-top tube (EDTA), Yellow-top tube Acid Citrate Dextrose Solution A (ACD), or Light-blue-top tube (sodium citrate) whole blood

Required Volume:

2 mL whole blood

Minimum Volume (Pediatric):

500 µL whole blood

Special Handling:

Room Temperature

Methodology:

PCR amplification, restriction enzyme digestion, capillary electrophoresis

Components:

FLT3-NPM1; FLT3-ITD; FLT3-D835

TAT:

7-14 days

CPT Codes:

83891, 83892, 83900, 83901, 83909 x 2, 83912

Report:

Negative or Positive, with an interpretation and description of the modification.
Causes For Rejection: Contact with heparin

 

AML Prognosis Assay, Bone Marrow

Order Code:  BMAML

   

Synonyms:

FLT3-NPM1; FLT3-ITD; FLT3-D835; Tyrosine Kinase; Nucleophosmin

Specimen Type:

Bone Marrow Aspirate

Container Type:

Lavender-top tube (EDTA), Yellow-top tube Acid Citrate Dextrose Solution A (ACD), or Light-blue-top tube (sodium citrate)

Required Volume:

1 mL bone marrow aspirate

Minimum Volume (Pediatric):

500 µL bone marrow aspirate

Special Handling:

Room Temperature

Methodology:

PCR amplification, restriction enzyme digestion, capillary electrophoresis

Components:

FLT3-NPM1; FLT3-ITD; FLT3-D835

TAT:

7-14 days

CPT Codes:

83891, 83892, 83900, 83901, 83909 x 2, 83912

Report: Negative or Positive, with an interpretation and description of the modification.
Causes For Rejection: Contact with heparin

 

NEW SPECIMEN TYPE

BCR-ABL, Quantitative, Fluid

Order Code:  FBCRQT

Specimen Type:

Body Fluid

Container Type:

Sterile container

Required Volume:

8 mL

Minimum Volume (Pediatric):

8 mL

Special Handling:

Transport Refrigerated, ship on wet ice/cold packs to be received within 48 hours of collection.

Methodology:

Quantitative RT-PCR

TAT:

7-14 days
CPT Codes: 83891, 83896 x 2, 83898 x 2, 83902, 83912

Report:

The results are expressed as a ratio of the BCR-ABL transcripts versus ABL transcripts


ORDER CODE CHANGE:  From TMSI to TMS see red text.

Microsatellite Instability

Order Code:  TMS

Specimen Type:

Frozen Tissue Frozen, Paraffin Tissue (must include a normal tissue or whole blood sample)

Container Type:

Frozen Tissue in sterile container Paraffin block plus normal tissue or Whole blood in Lavender-top tube (EDTA)

Required Volume:

Tissue, amount varies; Whole blood, 2 mL

Minimum Volume (Pediatric):

Varies

Special Handling:

Transport at Room Temperature

Methodology:

PCR / Fragment Analysis

TAT:

7-14 days

CPT Codes: 83891 x 2, 83900 x 2, 83901 x 6, 83909 x 2, 83912

Report:

Negative or Positive, with an interpretation and description of the assay.


CPT CODE UPDATE:  Changes see red text

Maternal Cell Contamination, tissue

Order Code:  TMCC

   

Specimen Type:

Chorionic villi Tissue & Maternal Blood

Container Type:

Tissue in sterile container; Maternal Blood, Lavender-top tube (EDTA)

Required Volume:

Tissue, amount varies; Maternal Blood, 4 mL

Minimum Volume (Pediatric):

Varies

Special Handling:

Transport at Room Temperature

Methodology:

PCR / Fragment Analysis

TAT:

7-14 days

CPT Codes: 83891, 83900, 83901, 83909, 83912

Report:

Negative or Positive, with an interpretation and description of the assay.


Maternal Cell Contamination

Order Code:  MCC

   

Specimen Type:

Amniotic Fluid plus maternal whole blood sample

Container Type:

Amniotic Fluid in sterile container; Maternal Blood in Lavender-top tube (EDTA)

Required Volume:

Amniotic Fluid 1-5 mL; Maternal whole blood, 4 mL

Special Handling:

Transport at Room Temperature

Methodology:

PCR / Fragment Analysis

TAT:

7-14 days

CPT Codes: 83891, 83900, 83901, 83909, 83912

Report:

Negative or Positive, with an interpretation and description of the assay.

 

Alpha Thalassemia, Amniotic Fluid

Order Code:  FATHAL

   

Specimen Type:

Amniotic Fluid

Container Type:

Sterile container

Required Volume:

8 mL

Minimum Volume (Pediatric):

8 mL

Special Handling:

Transport at Room Temperature

Methodology:

Polymerase Chain Reaction (PCR)

TAT:

7-14 days

CPT Codes: 83891, 83894, 83900, 83901 x 5, 831912, 83896x 2, 83898

Report:

Negative or Positive, with an interpretation and description of the assay.


Alpha Thalassemia, Blood

Order Code:  ATHAL

   

Specimen Type:

Whole Blood

Container Type:

Lavender-top tube (EDTA)

Required Volume:

4 mL

Minimum Volume (Pediatric):

2 mL

Special Handling:

Transport at Room Temperature

Methodology:

Polymerase Chain Reaction (PCR)

TAT:

7-14 days

CPT Codes: 83891, 83894, 83900, 83901 x 5, 83912, 83896 x 2, 83898

Report:

Negative or Positive, with an interpretation and description of the assay.

 

Alpha Thalassemia, Tissue

Order Code:  TATHAL

   

Specimen Type:

Fresh or Frozen Tissue

Container Type:

Fresh Tissue in a sterile saline or RPMI.  Frozen Tissue in Sterile container

Required Volume:

Amount varies

Minimum Volume (Pediatric):

Varies

Special Handling:

Transport Fresh Tissue at Room Temperature, Transport Frozen Tissue Frozen

Methodology:

Polymerase Chain Reaction (PCR)

TAT:

7-14 days

CPT Codes: 83891, 83894, 83900, 83901 x 5, 83912, 83896 x 2, 83898

Report:

Negative or Positive, with an interpretation and description of the assay.

 

TEST VOLUME UPDATE: Change see red text

T(15;17) PML-RAR, Fluid, PCR

Order Code:  FT1517

   

Specimen Type:

Body Fluid

Container Type:

Sterile container

Required Volume:

8 mL

Minimum Volume (Pediatric):

8 mL

Special Handling:

Transport Refrigerated, ship on wet ice/cold packs to be received within 48 hours of collection.

Methodology:

Quantitative RT-PCR

TAT:

7-14 days

CPT Codes:

83891, 83896 x 4, 83898, 83900, 83901, 83902, 83912

Report:

Negative or Positive, with an interpretation and description of the assay.

 

DISCONTINUED TESTS

Solid Tumor Testing: The following 3 tests have been discontinued

  • Alvelor Rhabdomyosarcoma, Tissue       Order Code TARS
  • Ewing’s Sarcoma, Tissue                       Order Code TEWS
  • Synovial Sarcoma, Tissue                      Order Code TSYS

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DEPARTMENT:    SPECIAL COAGULATION

DIRECTOR:   James Zehnder, M.D.

NEW TESTS: Protein C and Protein S Antigen

Test Description and Clinical Indications:

Protein C is a natural anticoagulant produced in the liver. It is vitamin K dependent and requires thrombin and thrombomodulin for activation. Activated protein C in the presence of cofactor protein S inactivates factors Va and VIIIa, thereby limiting coagulation. Patients heterozygous for deficiency of protein C or S may exhibit recurrent venous thrombosis at a young age (peak incidence between ages 15 and 40). Heterozygotes also appear to have an increased risk of coumadin-induced skin necrosis. Patients homozygous for protein C deficiency present with generalized microvascular thrombosis in the neonatal period (purpura fulminanas). Normal neonates have lower levels of protein C than adults. Warfarin therapy will result in low protein C levels. See also Thrombosis screen and Activated Protein C Resistance in the Test Directory at www.stanfordlab.com.

Protein S is a vitamin K-dependent cofactor for activated protein C, which serves to inactivate factors Va and VIIIa. Protein S deficiency is clinically indistinguishable from protein C deficiency, with heterozygous individuals at an increased risk of recurrent venous thrombosis. The assay is useful for evaluation of thrombophilic patients, in particular those who have a family history of thrombosis, thrombosis at a young age (<40 years), recurrent thrombosis or thrombosis at unusual sites (inferior vena cava, mesenteric veins). Normal neonates have lower protein S levels than adults do. Pregnancy normally results in decreased protein S levels. Patients with the factor V Leiden mutation may have artifactually low functional Protein S levels. Protein S is a vitamin K-dependent protein, so  warfarin use will result in low levels.

 

Protein C Antigen, Total

Order Code:  TOTALC

   

Specimen Type:

Platelet Poor Plasma, Frozen (2 aliquots)

Container Type:

Light-blue-top tube (sodium citrate)

Required Volume:

5 mL

Minimum Volume (Pediatric):

Full tube (2.7 mL blood or 1.8 mL blood depending on size of tube used)

Special Handling:

Within 1 hour of collection, centrifuge tube as required to obtain platelet-poor plasma. Aliquot platelet-poor plasma into plastic tubes (minimum 2 aliquots). Freeze immediately. Transport frozen.

Methodology:

Manual method by ELISA

TAT:

5-7 days

CPT Codes:

85302

Report:

%
Causes For Rejection: Clotted, hemolyzed, not received within 1 hour from draw; Hct >55% (must be drawn in special tube obtained from Coagulation Laboratory); improper volume in tube

 

Protein S Antigen, Total

Order Code:  TOTALS

   

Specimen Type:

Plasma

Container Type:

Light-blue-top tube (sodium citrate)

Required Volume:

5 mL

Minimum Volume (Pediatric):

Full tube (2.7 mL blood or 1.8 mL blood depending on size of tube used)

Special Handling:

Within 1 hour of collection, centrifuge tube as required to obtain platelet-poor plasma. Aliquot platelet-poor plasma into plastic tubes (minimum 2 aliquots). Freeze immediately. Transport frozen.

Methodology:

Automated Latex Immunoassay

TAT:

5-7 days

CPT Codes:

85305

Report: %

Causes For Rejection:

Clotted, hemolyzed, not received within 1 hour from draw; Hct >55% (must be drawn in special tube obtained from Coagulation Laboratory); improper volume in tube


 

Protein C and S, Total Combined

Order Code:  CSTOTL

   

Specimen Type:

Plasma

Container Type:

Light-blue-top tube (sodium citrate)

Required Volume:

10 mL

Minimum Volume (Pediatric):

Full tube (2.7 mL blood or 1.8 mL blood depending on size of tube used)

Special Handling:

Within 1 hour of collection, centrifuge tube as required to obtain platelet-poor plasma. Aliquot platelet-poor plasma into plastic tubes (minimum 2 aliquots). Freeze immediately. Transport frozen.

Methodology:

Manual method by ELISA; Automated Latex Immunoassay

Components:

Protein C Antigen, Total; Protein S Antigen, Total

TAT:

5-7 days

CPT Codes:

85302, 85305

Report: %

Causes For Rejection:

Clotted, hemolyzed, not received within 1 hour from draw; Hct >55% (must be drawn in special tube obtained from Coagulation Laboratory); improper volume in tube


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DEPARTMENT:    VIROLOGY

DIRECTOR:   Bruce Patterson, M.D.

CHANGES FOR:

  • Viral Reservoirs
  • Viral Load, HIV Quantitative, PCR, Plasma

SPECIMEN REQUIREMENT CHANGES FOR VIRAL RESERVOIR TESTING

The specimens must be collected in a dedicated Yellow-top tube – Acid Citrate Dextrose (ACD), Solution A.

PPT tubes CAN NO LONGER BE USED for HIV Viral Load samples. We have made this change because BD Diagnostics, the tube manufacturer issued the following notification: “BD PPT tubes should not be used for HIV nucleic acid testing due to medically significant differences in results”.

Changes are in red text.

Viral Reservoirs, (Monocytes)

Order Code:  HVVRM

   

Specimen Type:

Whole Blood

Container Type:

Dedicated Yellow-top tube Acid Citrate Dextrose Solution A (ACD)

Required Volume:

8.5 mL

Minimum Volume (Pediatric):

8.5 mL

Special Handling:

Must draw a dedicated tube. Tube cannot be shared with any other test except HVVRM. DO NOT CENTRIFUGE. Samples must be collected Monday - Wednesday only. Transport immediately (within 24 hours) to lab and keep at Room Temperature.

CPT Codes:

87797, 88184, 88185, 88291

Report: Reference range =<2.4%

Causes For Rejection:

Excessive transport time greater than 48 hours. Incorrect transport/storage temperature. Incorrect tube type or mislabeled sample. White-top plasma preparation tube (PPT) has been discontinued and will be rejected. See note above.

 

Viral Reservoirs, (T-Cell)

Order Code:  HVVRT

   

Specimen Type:

Whole Blood

Container Type:

Dedicated Yellow-top tube Acid Citrate Dextrose Solution A (ACD)

Required Volume:

8.5 mL

Minimum Volume (Pediatric):

8.5 mL

Special Handling:

Must draw a dedicated tube. Tube cannot be shared with any other test except HVVRM. DO NOT CENTRIFUGE. Samples must be collected Monday - Wednesday only. Transport immediately (within 24 hours) to lab and keep at Room Temperature.

CPT Codes:

87797, 88184, 88185, 88291

Report: Reference range =<1.1%

Causes For Rejection:

Excessive transport time greater than 48 hours. Incorrect transport/storage temperature. Incorrect tube type or mislabeled sample. White-top plasma preparation tube (PPT) has been discontinued and will be rejected. See note above.


CHANGES FOR:

  • HIV-I Quantitative, PCR, Plasma
  • HIV Quantitative, PCR, Dilution Protocol (Discontinued Test)

METHODOLOGY CHANGE:

Effective April 1st, Viral Load has changed from a manual method to an automated platform for HIV-I Quantitative, PCR, Plasma. This new automated platform has increased linear range.

  • FDA approved, Ampliprep has an increased linear range of 50-10,000,000 c/mL which is greater than the linear range of the manual method (COBAS Amplicor: 50-100,000 c/mL). 
  • Ampliprep automated method has greater throughput with 48 samples per day vs. 24 on the COBAS Amplicor:
  • Automated extraction is more precise than a manual extraction.
  • Ampliprep has specific sample requirement: Plasma separated from blood collected in a Lavender-top tube is required.

SPECIMEN REQUIRMENT CHANGE: Changes are in red text.

HIV-I Quantitative, PCR, Plasma

Order Code:  HIVQ2

   

Synonyms:

HIV -1 Viral Load, HIV RNA, HIV Ultrasensitive PCR

Specimen Type:

Plasma Note:2-3mLs EDTA plasma required. Test cannot be performed with less than 1mL of plasma.

Container Type:

Dedicated Lavender-top tube (EDTA) ONLY

Required Volume:

6.0 mL Whole blood

Minimum Volume (Pediatric):

3 mL (tube must be full)

Special Handling:

 Centrifuge specimen within 6 hours of collection.
Remove plasma and transfer plasma to a screw-capped PCR aliquot tube. Please label transport tube: EDTA PLASMA. Transport Refrigerated.
If transport is greater than 3 days, Freeze and transport Frozen.
Note: Plasma separated from blood collected in a Lavender-top tube is required.

Methodology:

Real-time PCR

TAT:

5-7 days

CPT Codes:

87536
Report: Linear Range of Assay- 50-10,000,000 copies/mL of plasma. (1.7 to 7.0 log 10)

Causes For Rejection:

Samples containing heparin; delay in transit; EDTA plasma is the only acceptable specimen, all others will be rejected.

 

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