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.
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.
- 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