Aids in management of individuals treated with interferon beta.
Cell Culture/Chemiluminescent Immunoassay
Collect specimens before Interferon beta treatment, or more than 48 hours following the most recent dose. Patient should not be on steroid therapy in excess of 10 mg prednisolone (or equivalent) daily. High endogenous levels of Interferon beta, alpha, or gamma may interfere with this assay.
Serum separator tube.
Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.3 mL)
Contaminated, hemolyzed, icteric, or lipemic specimens.
After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)
|Interferon Beta Screen||Negative|
|Interferon Beta Titer||Less than 20: Negative
20 to 99: Moderate levels of neutralizing antibodies present
100 or greater: High levels of neutralizing antibodies present
A titer of 20 to 99 suggests moderate levels of neutralizing antibodies present. A titer of 100 or greater suggests high levels of neutralizing antibodies present. Either case warrants continued patient monitoring. The titer is reported as the reciprocal of the dilution of patient serum that reduces the interferon activity by 10 fold.
Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
If Interferon Beta Neutralizing Antibody screen result is positive, then Interferon Beta Neutralizing Antibody titer will be added.
This test is performed pursuant to an agreement with Biomonitor.
86352; if reflexed, add 86352
|Component Test Code*||Component Chart Name||LOINC|
|2003391||Interferon Beta Neutralizing Ab Screen||29647-5|
|2003392||Interferon Beta Neutralizing Ab Titer||35139-5|