Prometheus # 3150 Anser IFX

Test Code

3150

CPT Codes
84999 (x1)

Preferred Specimen

Serum, 2.0 mL

Transport Container

SST or Red Top Tube

Transport Temperature

Ambient or refrigerated

Specimen Stability

7 days Ambient & Refrigerated

Methodology
A quantitative monitoring assay of IFX and ATI levels.

FDA Status
This test was developed and its performance characteristics determined by Prometheus Laboratories Inc. It has not been cleared or approved by the U.S. Food and Drug Administration. Prometheus Laboratories Inc. is a CAP-accredited CLIA laboratory.

Report Available

3 business days from date of receipt

Reference Range

"Serum infliximab (IFX) concentration: <1.0 ug/mL
Antibody to infliximab (ATI) concentration: <3.1 U/mL"

Clinical Significance

"Serum concentrations of 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 antibodies to Infliximab (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 healthcare providers with valuable information to help them gain a better understanding of the factors that may be affecting a patient’s loss of response.
The PROMETHEUS Anser IFX test is a new generation and more sensitive quantitative infliximab monitoring assay that allows healthcare providers to measure and monitor serum IFX and ATI levels anytime during therapy. Incorporating drug monitoring may clarify what factors are contributing to a patient’s loss of response and help guide treatment decisions by providing information to help determine an appropriate course of action."

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.