SHIKARI® Q-REMS

Enzyme immunoassay for the quantitative determination of free Infliximab (Remsima®) in serum and plasma

Remsima®,the world first biosimilar mAb (approved in 2013 by EMA). The Agencys Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Remsima® has been shown to have a comparable quality, safety and efficacy profile to Remicade®. The Matriks Biotek Shikari® Infliximab-Remsima® ELISA has been especially developed for the quantitative analysis of free infliximab in serum and plasma samples.



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Required Volume (µl) 10
Total Time (min) 70
Sample Serum, plasma
Sample Number 96
Detection Limit (ng/mL) 100
Spike Recovery (%) Between 85-115
Shelf Life (year) 1

SHIKARI® S-AIR

Enzyme immunoassay for the quantitative determination of antibodies to infliximab Remsima® in serum and plasma.

Remsima®, the world first biosimilar mAb (approved in 2013 by EMA). The Agencys Committee for Medicinal Products for Human Use(CHMP) decided that, in accordance with EU requirements, Remsima® has been shown to have a comparable quality, safety and efficacy profile to Remicade. Infliximab (Remsima®) was associated to the development of anti- Infliximab antibodies, even some were reported to be neutralizing, in various percentages of patients during therapy with the drug Remsima®. This might lead to severe complications. The Matriks Biotek Shikari®Antibody to Infliximab®ELISA Kit can be efficiently used for monitoring anti- Infliximab antibodies during therapy and offers the clinician a tool for decision on possible preventive measures such as possible addition of immunosuppressive drug to reduce anti- Infliximab antibodies.




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Required Volume (µl) 20
Total Time (min) 140
Sample Serum, plasma
Sample Number 96
Detection Limit (ng/mL) 30
Spike Recovery (%) Between 85-115
Shelf Life (year) 1

Total Antibody to Infliximab-biosimilar CT-P13 (Remsima®,Inflektra®) ELISA

Enzyme immunoassay for the semi-quantitative determination (screening) of total antibodies to infliximab biosimilar (Remsima®) in serum and plasma

Remsima®, the world first biosimilar mAb (approved in 2013 by EMA). In this context, demonstration of anti-infliximab antibodies during treatment with infliximab (Remsima®) has a major concern and monitoring for the presence and/or quantitation of specific antibodies during clinical trials is an important issue for follow up of the treatment regimens. With the Matriks Biotek S-AIR-T ELISA Kit infiliximab-specific antibodies that are bound to infiliximab in serum and can not be detected by free antibody detection kits can be determined in patients receiving Remsima®.






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Required Volume (µl) 10
Total Time (min) 95
Sample Serum, plasma
Sample Number 96
Detection Limit (ng/mL) 156
Spike Recovery (%) -
Shelf Life (year) 1
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PEER REVIEWED JOURNAL ARTICLES:
#  M. Kolar et al., "Pregnancy outcomes in women with inflammatory bowel disease treated with biosimilar infliximab" Gastroent Hepatol (2018) 72(1): 20-26




MATRIKS BIOTECHNOLOGY CO., LTD

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(B Blok Zemin Kat BZ17),
06830,
Gölbaşı/ANKARA/TÜRKİYE

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