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Rituximab and Anti-Rituximab Antibody, DoseASSURE™ RTX
CPT:
80299; 82397
Synonyms
- Anti-CD20
- Biologics
- Biopharmaceutical
- DoseASSURE
- Rituxan®
Special Instructions
This test includes Serial Monitoring.
Expected Turnaround Time
12 - 16 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Information
Related Documents
Specimen Requirements
Specimen
Serum
Volume
3 mL
Minimum Volume
1 mL (Note: This volume does not allow for repeat testing.)
Container
Gel-barrier tube, red-top tube, or serum transfer tube
Collection
Serum must be separated from cells within 45 minutes of venipuncture. Submit serum in a plastic transport tube. To avoid delays in turnaround time when requesting multiple test on frozen samples, please submit separate frozen specimens for each test requested.
Storage Instructions
Refrigerate or freeze
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 7 days |
Refrigerated | 14 days |
Frozen | 14 days |
Freeze/thaw cycles | Stable x6 |
Causes for Rejection
Gross hemolysis; gross lipemia; icteric specimen
Test Details
Use
Therapeutic monitoring of rituximab and antidrug antibody development for individuals with non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), and rheumatoid arthritis. This test provides rituximab drug concentration as well as the level of anti-rituximab antibodies.
Limitations
Failure of rituximab therapy may not always be due to the presence of anti-rituximab antibodies. Conversely, the absence of anti-rituximab antibodies does not guarantee positive response to treatment.
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
High serum biotin concentrations in patients taking biotin supplements may cause an interference in this assay. Patients may be advised to stop biotin consumption at least 72 hours prior to sample collection.
Methodology
Electrochemiluminescence immunoassay (ECLIA); chemiluminescence immunoassay (CLIA)
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 504355 | Rituximab Drug + Antibody | 504356 | Rituximab Drug Concentration | ug/mL | 82467-2 | |
| 504355 | Rituximab Drug + Antibody | 504357 | Anti-Rituximab Antibody Level | ng/mL | 82466-4 |
| Reflex Table for Anti-Rituximab Antibody Level | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 504108 | Serial Monitoring | 000000 | Serial Monitoring | N/A | |
| Reflex Table for Anti-Rituximab Antibody Level | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 504108 | Serial Monitoring | 511958 | 80563-0 | ||
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CPT Statement/Profile Statement
The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf