Infliximab-Remicade ELISA has been especially developed for the quantitative analysis of free infliximab in serum and plasma samples.
| Required Volume ( μl ) |
|
| Total Time (min) |
70 |
| Sample |
Serum, Plasma |
| Pack Size |
96 |
| Dedection Limit ( ng/mL) |
30 |
| Spike Recovery (%) |
97 |
| Shelf Life (year) |
1
|
Intended Use
Enzyme immunoassay for the quantitative determination of free infliximab
(Remicade®) in serum and plasma. Matriks Biotek Infliximab ELISA has been especially
developed for the quantitative analysis of free infliximab in serum and plasma samples
at high specificity.
Summary and Explanation
Infliximab (Remicade®) is a chimeric monoclonal antibody and used to treat autoimmune
disorders. Infliximab reduces the amount of active human tumour necrosis
factor alpha (hTNFα) in the body by binding to it and preventing it from signaling
the receptors for TNFα on the surface of various cell types. TNFα is one of the key
cytokines that triggers and sustains the inflammatory reactions. Infliximab is used for
the treatment of psoriasis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis,
rheumatoid arthritis, ulcerative colitis, and approved by FDA.
Single intravenous (IV) infusions of 3 mg/kg to 20 mg/kg showed a linear relationship
between the dose administered and the maximum serum concentration. The volume
of distribution at steady state was independent of dose and indicated that infliximab
was distributed primarily within the vascular compartment. Median pharmacokinetic
results for doses of 3 mg/kg to 10 mg/kg in rheumatoid arthritis and 5 mg/kg in Crohn’s
disease indicate that the terminal half-life of infliximab is 8.0 to 9.5 days.
In controlled trials, clinical response rates of 20-40% have been achieved with abovementioned
regimens in Crohn’s disease and rheumatoid arthritis. However, the
therapeutic benefits must be balanced against the risk of a variety of severe adverse
events (e.g. severe infectionsincluding tuberculosis, hepatotoxicity, infusion reactions,
serum sickness-like disease and lymphoma). The volume of distribution of infliximab
is low (3-6 L) and represents the intravascular space. Elimination of infliximab is most
probably accomplished through degradation by unspecific proteases. It seemed that
methotrexate delayed the decline in the serum concentrations of infliximab. When
relating serum concentrations to the clinical response in patients, it can be assumed
that through concentrations above 1mg/mL could be used as a kind of therapeutic
target. The rate of clinical remission was higher for patients with a detectable trough
serum infliximab compared with patients in whom serum infliximab was undetectable,
including those without antibodies. A detectable trough serum infliximab was
also associated with a lower C-reactive protein and a higher rate of endoscopic
improvement. For Crohn’s disease patients treated with scheduled maintenance
Specimen Collection and Storage
Serum, Plasma (EDTA, Heparin)
The usual precautions for venipuncture should be observed. It is important to
preserve the chemical integrity of a blood specimen from the moment it is collected
until it is assayed. Do not use grossly hemolytic, icteric or grossly lipemic specimens.
Samples appearing turbid should be centrifuged before testing to remove any
particulate material.
Storage: 2-8°C for two days, or -20°C for 6 months. Keep away from heat or direct sun light
Avoid repeated freeze-thaw cycles
