Parkview Health Laboratory: Test Directory

Medicare Medical Necessity Restrictions May Apply

Medical Necessity Documentation: For acceptable narrative descriptions and ICD-9 information see Addendum C

Specimen Requirements: 4.0 mL Whole Blood in a Green Top Tube - Na Heparin
and
3.0 mL Whole Blood in a Lavender Top Tube - EDTA

Collection Instructions:

Specimens collected with Lithium Heparin tubes will be rejected

Temperature & Stability: EDTA: 24 hours Ambient
Na Heparin: 48 hours Ambient

Reference Range: Refer to Interpretive Results

Test Comments:

The specimen is processed by whole blood lysis and stained with monoclonal antibodies using a direct immunofluorescence method. The cells are separated by Flow Cytometry based on light scatter characteristics and the percentages of cells positive within the blast subpopulation are reported five to ten thousand cells are analyzed for each marker.

Methodology: Flow Cytometry

Clinical Significance:

Useful for distinguishing acute lympoblastic leukemia from acute myelogenous leukemia and phenotypic subtyping of acute leukemias

Documentation:

This test was developed and the performance characteristics determined by Parkview Health Laboratories. This test has not been cleared by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing.

Custom Panel: No

Turn Around Time: 48 to 72 hours

Days Performed: Monday, Tuesday, Wednesday, Thursday, Friday, Saturday

Sites Performed: Parkview Hospital

PHL Test Code: FACUT

Alternate Test Names: Flow Cytometry Acute Phase

Included Tests: CBC [Automated Differential; Hematocrit (Hct); Hemoglobin (Hgb); Mean Corpuscular Hemoglobin (MCH); Mean Corpuscular Hemoglobin Concentration (MCHC); Mean Corpuscular Volume (MCV); Platelet (PLT); Red Blood Cell Count (RBC); Red Cell Distribution Width Standard Deviation (RDWSD); Red Cell Distribution Width Coefficient Variation (RDWCV); White Blood Cell Count (WBC)]; CD2; CD3; CD4; CD5; CD7; CD8; CD10; CD11b; CD13; CD14; CD19; CD20; CD23; CD33; CD34;CD38; CD45; CD56; CD117; HLA-DR; Surface Kappa; Surface Lambda

CPT Coding: 88184, 88185 x 20

Parkview Laboratory: Test Directory

Acute Leukemia Panel

PRODUCTION SCHEDULE