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.
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.
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. |
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. 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. |
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
References
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 Code | 504627 | |||||
| Order Code Name | Certolizumab Drug + Antibody | |||||
| Order Loinc | 87404-0 | |||||
| Result Code | 504628 | |||||
| Result Code Name | Certolizumab DRUG Level | |||||
| UofM | ug/mL | |||||
| Result LOINC | 87404-0 | |||||
| Order Code | 504627 | |||||
| Order Code Name | Certolizumab Drug + Antibody | |||||
| Order Loinc | 87404-0 | |||||
| Result Code | 504629 | |||||
| Result Code Name | Anti-Certolizumab Ab Level | |||||
| UofM | ng/mL | |||||
| Result LOINC | 101724-3 |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 506001 | Serial Monitoring | 000000 | Serial Monitoring | N/A | |
| Reflex 1 | ||||||
| Order Code | 506001 | |||||
| Order Name | Serial Monitoring | |||||
| Result Code | 000000 | |||||
| Result Name | Serial Monitoring | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 506001 | Serial Monitoring | 511958 | 80563-0 | ||
| Reflex 1 | ||||||
| Order Code | 506001 | |||||
| Order Name | Serial Monitoring | |||||
| Result Code | 511958 | |||||
| Result Name | ||||||
| UofM | ||||||
| Result LOINC | 80563-0 | |||||