The L-asparaginase assays are laboratory developed tests (LDT) to determine the enzyme activity of L-asparaginase or the presence of anti-asparaginase antibodies in patients who have been treated with Asparlas®, Erwinaze®, Oncaspar® or Rylaze®. These assays have been validated and are performed in a CLIA certified high complexity laboratory.
L-asparaginase activity test determines the concentration of drug which can help physicians identify patients experiencing “silent inactivation” as well as to ensure that adequate asparaginase activity is present during asparaginase treatment. The assay is performed using a serum sample obtained from the patient after treatment.
The ELISA antibody assay determines the presence or absence of antibodies to Asparaginase. This test allows clinicians to monitor their patient’s antibody levels in a manner similar to therapeutic drug monitoring as done with the asparaginase activity assay. This assay reports the presence or absence of antibodies to asparaginase in the sample, but it does not distinguish between general antibodies towards asparaginase and neutralizing antibodies.
- The Asparaginase Activity Assay is $520
- The Asparaginase Panel is $520 (includes both activity and antibody results)
Asparaginase Activity Assay
- The CPT Code for ordering any individual Asparaginase Activity Assay (Asparlas, Erwinaze, Oncaspar, Rylaze) is 82657.
Asparaginase Activity Panel
- When the Asparaginase Panel is ordered, antibody detection is performed in addition to the specified activity assay above. In addition to the activity assay CPT code, the CPT Code for antibody detection (83516) should also be included.
Examples
Asparaginase Activity Assay-
- If the drug given is Asparlas, the CPT code would be 82657 because only one result is reported. If there is no drug specified, then four results will be reported and the CPT code would still be 82657.
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- If the drug given is Asparlas and the Panel was ordered, the CPT codes would be 82657 and 83516 because only one assay result and antibody detection are reported. If there is no drug specified, then four results and antibody detection will be reported and the CPT codes would still be 82657 and 83516.
No, we do not bill insurance. We only bill the institution sending in the sample. We do not require that an institution be set up prior to receiving a sample.
Asparaginase Requisition Form Supply Order Form Laboratory Manual
No. You can use supplies you already have on hand, it just needs to be collected in a red-top tube or gel-barrier tube, to separate serum from red blood cells. Please only submit the serum. Each sample needs a minimum of 0.5 mL to perform both assays.
98% of our samples are reported within five hours of receipt. All samples are reported on the same day or within one business day of receipt.
Frozen or refrigerated specimens must be transported in insulated containers surrounded by an ample amount of dry ice (frozen) or frozen cold packs (refrigerated) to keep the specimen at optimal storage condition until arrival to the laboratory. Specimens received internationally must be shipped using dry ice. It is also recommended that samples shipped during the summer months be shipped frozen on dry ice due to the potential exposure to high temperatures during shipment.
Specimen: Serum
Collection: Venous Collection, red‐top tube or gel‐barrier tube, separate serum from RBCs within two hours, freeze/refrigerate serum immediately
Volume: 0.5 – 2 mL
Storage Instructions: Freeze prior to transport. Sample may be refrigerated at 2°C to 8°C
- The Patient’s first and last name or a unique ID code is required
- The second patient identifier may be one of the following:
- Date of birth.
- Other unique patient identifier, e.g. medical record number, social security number.
- Barcode labels can be used if barcode matches the unique identifiers on the printed requisition, including our provided barcode or requisition # where applicable.
- Time and date of collection
Granger Genetics was the company which first validated the asparaginase activity assay in conjunction with the pharmaceutical companies which owned the two drugs tested in the assay.
- In 2016, Granger Genetics performed a major revalidation of the original assay (which is the assay performed by our competitors).
- The science of the assay is the same as our competitor’s assay, but we streamlined the process and introduced some automation techniques which make the assay more robust and therefore reduced human error.
- We also moved our data processing away from an excel spreadsheet to a validated data processing software which reduced the need for human interpretation of the results allowing for another reduction in human error.