The Glucarpidase assays are laboratory developed tests (LDT) to determine the presence of antibodies against the drug Glucarpidase. There is an antibody screening assay and a neutralizing antibody assay.
An account does not need to be set up prior to sending samples to Granger Genetics. Download the requisition form from our website, https://www.grangergenetics.com/AsparaginaseRequisitionForm, and enter the required information (marked with an *). Indicate how the report should be sent, whether it be via fax or by web portal. Please note that the Billing Information section, including the phone number, is required when sending samples for the first time. This information is required to set up the account and additionally allows Granger Genetics to contact the facility if there are any questions or missing information.
If there are any additional questions about this process or need to submit other pertinent account information, i.e. email address or additional non-billing phone numbers to the facility, send an email to clientservices@grangergenetics.com.
The screening assay reports if a patient’s sample contains antibodies against Glucarpidase. Samples containing antibodies will be reported as positive along with the concentration (ng/mL) of the antibodies that are present. Samples without antibodies will be reported as negative along with the concentration (ng/mL) of the antibodies that are present. Please note that a negative sample may still show an antibody concentration result, but that value will be below the target value for considering a sample as positive.
Only samples that are deemed positive by the screening assay will be reflexed to the neutralizing assay. Samples will only be reported as positive or negative for the neutralizing assay.
There are two ways to set up a web portal account.
- Fill out the web portal delivery option at the bottom of the requisition form
- Send an email to clientservices@grangergenetics.com requesting access to the web portal. Include the following information in the email:
- Facility name or Physician Name
- If this is for a Physician, then we need their NPI number
- Contact name
- Phone number
- Email address
There are two web portal account types.
- Facility-based access: This account allows a designated administrator to access all reports sent to that facility.
- Physician Access: This account allows the physician to access all reports ordered by them, regardless of the facility.
If the NPI number is not given at time of registration the account will be set up as a Facility based account.
- The Glucarpidase Screening Assay is $300
- The Glucarpidase Neutralizing assay is $200 (in addition to the Screening Assay charge of $300)
Glucarpidase Screening Assay
- The CPT Code for ordering the screening assay is 83516.
Glucarpidase Neutralizing Antibody Assay
- The CPT Code for ordering the neutralizing assay is 83520.
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.
Right from our website using the links below.
Glucarpidase Requisition Form Supply Order Form Laboratory Manual
No. You can use supplies you already have on hand. Blood should 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 Screening Assay samples are reported within five hours of receipt. All Screening Assay samples are reported on the same day or within one business day of receipt. If any samples require the Neutralizing Antibody Assay then results will be reported within two business days.
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, sample must be collected at least two weeks after injection.
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