Medical Necessity Documentation:
Client Notes:
Minimum Required Order & Billing information
All specimens and requisitions must be labeled at the time of collection with at least two patient identifiers, which must also be indicated on the requisition.
• Tubes must be labeled with at least a minimum of two patient identifiers. A single tube of serum (containing a minimum of 0.5 mL of sample volume) may be submitted for use for both assays.
• Two patient identifiers (e.g., full name and DOB, medical record number, or social security number)
• Patient gender
• Patient date of birth
• Name and address of physician or facility ordering the test
• Ordering Physician name
• Date/Time of specimen collection
• Type of L-asparaginase drug administered, if known
• Test(s) requested (Asparaginase Activity, or Asparaginase Panel)
• Provide complete instructions for direct bill including address and contact information
Patient Preparation:
Specimen Requirements:
2.0 mL Serum from a Red Top Tube in a Plastic Vial
Collection Instructions:
Separate serum from RBCs within 2 hours, freeze/refrigerate serum immediately
No samples will be processed after 3 pm Monday through Friday
Minimum Volume:
0.5 mL Serum
Transport & Storage: Temperature/Stability:
1 day Ambient
3 days Refrigerated
30 days Frozen
Only 3 Freeze/Thaw cycles
Freeze prior to transport
Rejection Criteria:
Gross hemolysis; gross lipemia; icteremia (activity assay).
Reference Range:
Physician established therapeutic range.
Critical Ranges:
Test Comments:
Methodology:
Spectrophotometry/absorbance-based enzyme-coupled kinetic reaction
Clinical Significance:
Used to monitor Asparaginase therapy for sufficient enzyme activity, to assess silent inactivation by patient sensitization (activity assay). To assess if a patient is producing antibodies against asparaginase (antibody assay).
Asparaginase is an enzyme produced by some plants, animals, and bacteria that hydrolyzes the amino acid asparagine to aspartic acid. It is commonly produced in native forms from Escherichia coli or Erwinia chrysanthemi and has a molecular weight of 138-141 kDa. PEG-modified E.coli has a MW of 145 kDa.
Documentation:
Results are reported in IU/mL (activity assay). Traditional antigen-capture ELISA assay. Results are reported as positive or negative for antibodies (antibody assay).
Custom Panel:
No
PRODUCTION SCHEDULE
Turn Around Time:
1 day
Departments:
Sites Performed:
Granger Genetics
PHL Test Code:
MSOT
Alternate Test Names:
L-Asparaginase
Included Tests:
Asparaginase Activity; Asparaginase Antibody
CPT Coding:
82657 for the activity assay (If drug administered is not specified then results will be reported for Oncaspar, Erwinaze and Rylaze which warrants 3 units, 82657*3). Assay is 83516