LabCorp and its Specialty Testing Group, a fully integrated portfolio of specialty and esoteric testing laboratories.
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Peripheral blood or bone marrow
10-20 mL peripheral blood or 2-3 mL bone marrow aspirate
1 mL whole blood or 1 mL bone marrow
Lavender-top (EDTA) tube or green-top (heparin) tube
Ship specimen with an ice pack. Specimen should arrive in the laboratory within 5-7 days 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 request form.
Specimen does not meet collection criteria: frozen whole blood, marrow, or cell pellet; leaking tube; clotted blood or marrow; grossly hemolyzed specimen, or otherwise visably degraded; contamination by another specimen; specimens containing suspicious foreign material
More than 10% of patients with B-CLL have a dysfunctional p53 gene. Patients may have p53 mutations, a p53 deletion, or both. Mutations and deletions in p53 predict poor survival in B-CLL patients (median survival 6-31 months) versus those patients without p53 abnormalities (median survival of patients with normal karyotype >100 months). Several studies have demonstrated that alkylating agents, purine analogs and some monoclonal therapies are ineffective in treating CLL patients with p53 mutations and/or deletions. Finally, chemotherapy can cause p53 gene alterations, can exhibit new alterations of p53.
The assay can detect a mutation present in at least 20% of a B-cell-enriched sample. False positive or negative results may occur for reasons that include genetic variants, blood transfusions, or somatic heterogeneity of the tissue sample.
This test was developed and its performance characteristics determined by Esoterix Genetic Laboratories, LLC. It has not been cleared by the Food and Drug Administration.
Samples are enriched for B-cells. Susequently, DNA is isolated from the samples and amplified by polymerase chain reaction (PCR). Exons 5-9 and the flanking intronic regions (-6 and +15) of the TP53 gene are analyzed by bi-directional direct DNA sequencing using capillary gel electrophoresis and fluorescence detection.
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