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HelpTest Code LABLASP L-Asparaginase Assay
Additional Codes
|
Test Name in EPIC |
EPIC Test Code |
Test ID |
|---|---|---|
| L-Asparaginase Assay | LABLASP | L-ASP |
Useful For/Utility
The assay is intended to help physicians identify patients experiencing “silent inactivation” and/or rapid clearance so as to ensure that adequate asparaginase activity is present during treatment.
Methodology
Laboratory developed test-enzyme activity
Clinical Information
https://www.nextmolecular.com/asparaginase
The L-asparaginase assay is a laboratory developed test (LDT) to determine the enzyme activity of L-asparaginase in patients who have been treated with Elspar®/Kidrolase®, Oncaspar®, or Erwinaze®. This assay has been validated and is performed in our CLIA certified laboratory to monitor the asparaginase activity level during a patient’s treatment.
L-asparaginase is a high molecular weight enzyme which often induces an immune response in a significant percentage of treated patients. (2) There are two forms of hypersensitivity seen in clinical practice. Clinical hypersensitivity ranges from a mild local injection site reaction to full blown anaphylaxis.(3) Since asparaginase derived from E. coli is frequently used as first treatment, patients who develop a reaction are switched to Erwinaze (derived from Erwinia chrysanthemi) to continue their treatment because of the lack of cross-reactivity of anti-E. coli antibodies to Erwinaze.(4)
The second form of hypersensitivity is when antibodies are formed, but the patients do not experience any clinical signs of hypersensitivity. Even though there are no outward symptoms, these antibodies can either inactivate the enzyme or enhance the metabolism of asparaginase such that the patient may not have adequate serum or plasma activity levels to achieve an anti-leukemic effect (often referred to as “silent inactivation” or “silent hypersensitivity”).(5)
As a result, hypersensitivity to L-asparaginase is a clinically relevant issue regardless of the source from which the drug is prepared.(3)
Specimen Requirements
Use Kit supplied by Next Bio
Or
Red top plain; Serum SST or Purple top EDTA
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FOR SERUM collection, draw about 2 mL blood in plain red top tubes or into a serum separator tubes (SST). • Leave the stopper intact throughout collection and centrifugation. • If using an SST tube, invert the tube gently five times as specified in the manufactures instructions • Allow blood to clot at room temperature for a minimum of 30, but not longer than 60 minutes. • Centrifuge the tube at approximately 3,000 rpm for 15 minutes. • Remove stopper avoid contaminating the serum with red cells • Using a disposable pipette, transfer a portion of the serum sample into a suitably pre- labeled specimen shipping tube. o Make sure to transfer at least 0.3 mL (300 µL) of serum into specimen shipping tube. • Record the sample date and time of collection on the sample submission form as well as the time and date of the last asparaginase administration .• FOR PLASMA collection, at each sample draw point, collect 2 mL whole blood into a lavender-capped (K2 EDTA) Vacutainer ® Blood Collection tube (note: heparinized plasma is also acceptable) • Invert the tube gently 4 times to mix the blood with the EDTA (no longer than one minute after drawing the sample). • Place the tube on ice immediately after mixing (no longer than one minute after gently mixing the blood with the EDTA) • Centrifuge the tube immediately (within 15 minutes after blood collection), in a refrigerated centrifuge at a speed of approximately 3,000 rpm for 5 minutes. • Using the disposable pipette, transfer a portion of the plasma fraction (within 30 minutes of centrifugation) into a suitably pre-labeled specimen shipping tube. o Make sure to transfer at least 0.3mL (300 µL) of plasma into specimen shipping tube. • Record the sample date and time of collection on the sample submission form as well as the time and date of the last asparaginase administration
• Ship the samples by overnight express mail to NEXT Molecular Analytics Sample Submission Form • The Sample Submission Form is included in the Sample Collection kit, and can also be downloaded from our web site (www.nextmolecular.com), and is available upon request • Complete a sample collection form for each patient at each blood draw. o IMPORTANT: IT IS IMPORTANT TO NOTE THE MATRIX (SERUM OR PLASMA) ON THE SAMPLE SUBMISSION FORM, AND MOREOVER, TO INDICATE THE TYPE OF PLASMA SAMPLE (EDTA•plasma; Heparin•plasma) • Enter the Patient and Billing information, as requested. • To bill the patient’s insurance, you MUST Indicate the diagnosis code(s) (ICD-10) and the submission form MUST bear the signature of the health care provider. • Enter the sample collection date and time. Indicate pre- or post-treatment sample. • If applicable enter the date and time of the last L-asparaginase administration. o It is preferable that the type of asparaginase (Oncaspar, Asparlas, Kidrolase, Erwinaze, Elspar) that was administered is indicated, but this information is not absolutely required. • Note Special circumstances/errors – clearly indicate if any of the following occurred: o Specimen hemolyzed during processing o Any unusual appearance or occurrence during processing |
Specimen Transport Temperature
Sample Shipment
• Place the sample shipment tubes in the long pouch of the bio hazard sample bag. Seal the
pouch (see Figure 1).
• Place the sample collection form in the outer pocket of the bio hazard sample bag.
• Place the bio hazard bag into one half of the shipping container against the foam
cushion.
• Place the frozen gel pack in the second half of the shipping container, against a foam
cushion. (Note that the gel packs should be put in the freezer at least 24 hours ahead of
use).
• Close the two halves of the shipping container, and place the shipping container in the
outer mailing sleeve. Close the outer mailing sleeve.
• Samples should be sent Monday through Thursday to NEXT Molecular Analytics by
overnight express mail. If necessary, samples may be stored refrigerated up to 5 days
before shipment.
• Complete an airbill and affix to the outer mailing sleeve, or place the shipping container in
an express mail container, or place the shipping container within a larger box.
Day(s) Test Set Up
Assay results are routinely returned on the same day as the
sample is received.
Performing Laboratory
NEXT Molecular Analytics
Clinical Testing Services
Suite 101
11601 Ironbridge Rd.
Chester, VA 23831
Phone: 844-812-7415
Test Classification and CPT Coding
82657
Reference Values
The test was run using a mentof for quantitation of L-asparaginase enzyme activity in clinical samples. The expected reference interval is 0 IU/mL. This test was developed and its performance characteristics determined by NEXT Bio Research Services, LLC. It has not been cleared or approved by the US Food and
Drug Adminstration
Test Performed at NEXT Bio Research Services , LLC