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Certolizumab and Anti-Certolizumab Antibody, DoseASSURE™ CTZ

CPT 80299; 82397
Synonyms
  • Anti-TNF
  • Anti-TNF drug
  • Biologic drug level and anti-drug antibody
  • Biologic monitoring
  • Cimzia
  • DoseASSURE
  • Immunogenicity testing
  • therapeutic drug monitoring (TDM)
  • TNF inhibitor

Test Details

Methodology

Electrochemiluminescence Immunoassay (ECLIA); Surface Plasmon Resonance

Result Turnaround Time

8 - 15 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.

Test Includes

This test includes serial monitoring.

Use

Provides certolizumab drug concentration and anti-certolizumab antibodies in order to optimize treatment and facilitate clinical decision-making. This assay may be helpful in any patient on certolizumab therapy for Crohn's disease, psoriasis, or other autoimmune condition.

Limitations

As with other biologics, the optimal certolizumab concentration depends upon patient-specific factors including co-morbidities, disease, and desired therapeutic endpoint.

Trough blood collection (just before the next dose) is suitable because target ranges and therapeutic cut-offs are established by clinical studies that typically evaluate trough concentrations.

Therefore, the timing of specimen collection should be considered when interpreting drug concentrations. Drug half-life should be factored in when evaluating non-trough concentrations.

Adequate drug trough levels do not guarantee clinical efficacy since primary non-response can be due to mechanistic failure.

Lack of clinical response may be due to inadequate drug exposure, immunogenicity or mechanistic mismatch. Positive anti-certolizumab antibodies should be interpreted in the context of the concomitant free certolizumab drug level.

References

Cimzia® [package insert]. Smyrna, GA: UCB Inc; 2016.
Jani M, Isaacs JD, Morgan AW, et al. High frequency of antidrug antibodies and association of random drug levels with efficacy in certolizumab pegol-treated patients with rheumatoid arthritis: results from the BRAGGSS cohort. Ann Rheum Dis. 2017 Jan;76(1):208-213.27245864
Ramos GP, Al-Bawardy B, Willrich M, et al. Certolizumab Trough Levels And Antibodies In Inflammatory Bowel Disease: A Single-Center Experience. Gastroenterology. 2018 May;154(6):S826-S827.10.1016/S0016-5085(18)32819-1
Sandborn W, Feagan B, Parker G, Bosny P-L, Lee S. The Relationship Between Plasma Concentrations of Certolizumab Pegol and Clinical Efficacy: Results from the PRECiSE 2 Trial. Inflamm Bowel Dis. 2012 Dec;18:S23.10.1097/00054725-201212001-00057
Vande Casteele N, Herfarth H, Katz J, Falck-Ytter Y, Singh S. American Gastroenterological Association Institute Technical Review on the Role of Therapeutic Drug Monitoring in the Management of Inflammatory Bowel Diseases. Gastroenterology. 2017 Sep;153(3):835-857.e6.28774547
Vermeire S, Gils A, Accossato P, Lula S, Marren A. Immunogenicity of biologics in inflammatory bowel disease. Therap Adv Gastroenterol. 2018 Jan 21;11:1756283X17750355.29383030

Specimen Requirements

Specimen

Serum

Volume

2 mL

Minimum Volume

600 µL

Container

Red-top tube, serum from red-top tube, serum from a gel tube, or serum transfer tube

Collection Instructions

Allow a minimum clotting time of 30 to 60 minutes with serum separation within 2 hours of collection. Send serum in a plastic transport tube. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.

Stability Requirements

Temperature

Period

Room temperature

18 hours

Refrigerated

14 days

Frozen

14 days

Freeze/thaw cycles

Stable x6

Storage Instructions

Refrigerate or freeze.

Causes for Rejection

Gross hemolysis; gross lipemia; incorrect specimen type

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
504627 Certolizumab Drug + Antibody 87404-0 504628 Certolizumab DRUG Level ug/mL 87404-0
504627 Certolizumab Drug + Antibody 87404-0 504629 Anti-Certolizumab Ab Level ng/mL 101724-3
Order Code504627
Order Code NameCertolizumab Drug + Antibody
Order Loinc87404-0
Result Code504628
Result Code NameCertolizumab DRUG Level
UofMug/mL
Result LOINC87404-0
Order Code504627
Order Code NameCertolizumab Drug + Antibody
Order Loinc87404-0
Result Code504629
Result Code NameAnti-Certolizumab Ab Level
UofMng/mL
Result LOINC101724-3
Reflex Table for Anti-Certolizumab Ab Level
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 506001 Serial Monitoring 000000 Serial Monitoring N/A
Reflex 1
Order Code506001
Order NameSerial Monitoring
Result Code000000
Result NameSerial Monitoring
UofM
Result LOINCN/A
Reflex Table for Anti-Certolizumab Ab Level
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 506001 Serial Monitoring 511958 PDF 80563-0
Reflex 1
Order Code506001
Order NameSerial Monitoring
Result Code511958
Result NamePDF
UofM
Result LOINC80563-0