Rituximab and Anti-Rituximab Antibody, DoseASSURE™ RTX

CPT: 80299; 82397
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Synonyms

  • Anti-CD20
  • Biologics
  • Biopharmaceutical
  • DoseASSURE
  • Rituxan®

Special Instructions

This test includes Serial Monitoring.


Expected Turnaround Time

12 - 16 days




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 US Food and Drug Administration (FDA).


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 RTA Conc+RTA Ab 504356 Rituximab Drug Concentration ug/mL 82467-2
504355 RTA Conc+RTA Ab 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 000000 Serial Monitoring 000000 Serial Monitoring N/A

For Providers

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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2019, 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