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HelpTest Code PRZBSO Anser RZB, Prometheus (Risankizumab) (3140)
Additional Codes
Prometheus Test Code: 3140
Useful For
The Anser RZB test is a quantitative therapeutic drug monitoring (TDM) assay that allows healthcare providers to measure and monitor serum risankizumab (RZB) and antibodies-to-risankizumab (ATR) levels at any time during therapy.
***Test is NOT available for Outreach clients, but is available to MMC-Dickinson.***
Synonyms/Keywords
Skyrizi
Specimen Requirements
| Specimen Type | Preferred Container/Tube | Acceptable Container/Tube | Specimen Volume | Specimen Minimum Volume (allows for 1 repeat) |
Pediatric Minimum Volume (no repeat) |
|---|---|---|---|---|---|
| Serum | Serum Separator Tube (SST) | Red Top Tube (RTT) | 2.0 mL | 2.0 mL | 0.5 mL |
Collection/Processing Instructions
Send ambient or cold pack. Do not freeze.
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
|
Serum |
Refrigerated | 14 days |
| Ambient | 14 days |
Rejection Criteria
Frozen specimens
Test Components
Serum risankizumab (RZB) concentration, Antibodies to Risankizumab (ATR) concentration
Test Information
This test was developed and its performance characteristics determined by Prometheus Laboratories, CAP-accredited (6805501) and CLIA-certified (05D0917432) as qualified to perform high complexity testing. It has not been cleared or approved by the US Food and Drug Administration
The Anser RZB test is a quantitative therapeutic drug monitoring (TDM) assay that allows healthcare providers to measure and monitor serum risankizumab (RZB) and antibodies-to-risankizumab (ATR) levels at any time during therapy.
Serum concentrations of RZB may vary among equally dosed patients which can ultimately affect patient outcomes. In adult Crohn's disease (CD) patients, an exposure-response relationship was observed for RZB with significantly higher mean serum RZB concentrations in cases of clinical and biochemical remission than in the absence of remission (p=0.001). ATR development can associate with lower RZB concentrations, reduced clinical response, hypersensitivity and infusion site reactions. Therefore, the quantitative measurement of RZB and ATR levels in serum provides valuable information to healthcare providers to better assess a patient's risk or reason for losing response to RZB and helps them decide an appropriate course of action.
Serum Risankizumab Lower Limit of Quantification: < 0.5 ug/mL
Antibodies to Risankizumab Lower Limit of Quantification: < 3.5 U/mL
Performing Laboratory Name
Prometheus Labs
Referral Laboratory Information
| Address | Telephone | Website Link | Marshfield Lab Account # |
|---|---|---|---|
| 9410 Carroll Park Drive San Diego, CA 92121 |
888-423-5227 | https://prometheuslabs.com/ | 1299 |
Performing Information
| Performing Location | Analytical Time |
|---|---|
| Prometheus | 3 days |
CPT Codes
| CPT | Modifier (if needed) |
Quantity | Description | Comments |
|---|---|---|---|---|
| 80299 |
|
1 | Serum risankizumab (RZB) concentration |
|
| 82542 |
|
1 | Antibodies to risankizumab (ATR) concentration |
Ordering Applications
| Ordering Application | Description |
|---|---|
| Cerner | Anser RZB, Prometheus (Risankizumab) (3140) |