RiskImmune®
Use
RiskImmune® is designed to help identify patients with inflammatory bowel disease (IBD) who are at greater risk of forming anti-TNF antibodies (ADAb). This information is critical for clinicians to optimize treatment choices and monitor therapeutic drugs in IBD patients. The test detects a genetic variant (HLADQA1*05, rs2097432) associated with an increased risk of developing antibodies to infliximab or adalimumab, which can result in loss of response to therapy and more frequent discontinuation of treatment.
Special Instructions
RiskImmune® is a laboratory-developed test performed at Prometheus Laboratories under CLIA guidelines. Informed consent for genetic testing is required and the test results must be interpreted considering individual patient conditions and history.
Limitations
RiskImmune® is not FDA cleared or approved and is performed exclusively as a laboratory-developed test. It does not detect all variants within the HLADQA1*05 gene or variants in other genes. Clinical decisions should not be based solely on this test; a comprehensive clinical evaluation is essential.
Methodology
PCR-based (qPCR)
Biomarkers
Result Turnaround Time
4 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
2.0 mL
Minimum Volume
Not provided
Container
EDTA/Lavender-Top Tube
Storage Instructions
Ambient or cold pack. Do not freeze.
Causes for Rejection
Unlabeled specimens will not be accepted.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 10 days |
| Refrigerated | 30 days |