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Test Code PIFXSO Anser IFX, Prometheus (Infliximab/Remicade) (3150)

Important Note

For internal ordering only. Not available to outreach clients. Test is available to MMC-Dickinson.

Additional Codes

Prometheus Test Code: 3150

Useful For

To measure and monitor serum infliximab (IFX) and antibodies-to-infliximab (ATI) levels at any time during therapy.

Synonyms/Keywords

Test is NOT available for Outreach clients (but is available to MMC-Dickinson).

Specimen Requirements

Fasting Required 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    

Collection/Processing Instructions

Send ambient or cold pack. Do not freeze.

Specimen Stability Information

Specimen Type Temperature Time
Serum Ambient 14 days
Refrigerated 14 days

Rejection Criteria

Frozen specimens, Whole blood

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 IFX test is a quantitative therapeutic drug monitoring (TDM) assay that allows healthcare providers to measure and monitor serum infliximab (IFX) and antibodies-to-infliximab (ATI) levels at any time during therapy.

 

Serum concentrations of infliximab (IFX) may vary among equally dosed patients which can ultimately affect patient outcomes. Suboptimal levels of IFX have been linked to lower response rates in IBD patients. Furthermore, some patients may develop immunogenicity to IFX by producing ATI. The presence of ATI has also been associated with increased rates of infusion reactions and drug clearance leading to lower response rates. Therefore, the quantitative measurement of IFX and ATI levels in serum provides valuable information to healthcare providers to better assess a patient's risk or reason for losing response to IFX and helps them decide an appropriate course of action.

 

Serum infliximab (IFX) Lower Limit of Quantification: < 1.0 ug/mL

Antibody to infliximab (ATI) Lower Limit of Quantification: < 3.1 U/mL

Performing Laboratory Name

Prometheus Labs

Referral Laboratory Information

Address Telephone Website Link Marshfield Lab Account #
9410 Carroll Park Dr.
San Diego, CA 92121
888-423-5227 https://prometheuslabs.com/ 1299

Performing Information

Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
Prometheus Laboratories
 
3 days  

CPT Codes

CPT Modifier
(if needed)
Quantity Description Comments
80230   1 Serum infliximab (IFX) concentration  
82542   1 Antibody to infliximab (ATI) concentration  

Ordering Applications

Ordering Application Description
Cerner Anser IFX, Prometheus (Infliximab/Remicade) (3150)