TOTAL ANTIBODY TO INFLIXIMAB

Enzyme immunoassay for the semi-quantitative determination of total (free and drug-bound) antibodies to Infliximab (Remicade®, Remsima®) in serum and plasma.
Due to the specific assay design this test measures the antibodies against Infliximab even in a high excess of the drug (up to 20-fold). Results are expressed in tAU (total arbitrary units).
 
Required Volume (µL) 20
Incubation Time (min) 75
Sample Serum or Plasma
Plate Size 96 Tests
Results in Total Arbitrary Units (tAU/mL)
Cut-Off (tAU/mL) 10
Detection Limit (tAU/mL) 10
Shelf Life (years) 2
 
Intended Use: This kit has been developed for the detection of total level of anti-drug antibodies in research and diagnostic uses. It is suitable for Therapeutical Drug Monitoring (TDM) purposes.
 
Remicade® is a trademark of Janssen Biotech, Inc./Merck & Co.
Remsima® is a trademark of CellTrion Inc.

SPECIFICITY

88 different naive samples have been measured for estimating the cut-off value.

In order to avoid a sample from being reported as false positive the cut-off value was determined by 2 times of the mean of Negative Control. All 88 screened naive samples showed ODs (ranged from 0.053 to 0.105) lower than the 1,5 times of the mean OD of Negative Control.

PRECISION

Intra-assay CV: <10%.

Inter-assay CV: <10%

AUTOMATION

Experiments have shown that the ImmunoGuide Total Antibody to Infliximab ELISA is suitable also for using by an automated ELISA processor.
1. Malickova K, Duricova D, Bortlik M, Hind'os M, Machkova N, Hruba V, Lukas M, Zima T, Lukas M. Serum trough infliximab levels: A comparison of three different immunoassays for the monitoring of CT-P13 (infliximab) treatment in patients with inflammatory bowel disease. Biologicals.2015. pii: S1045-1056(15)00110-4. doi: 10.1016/j.biologicals.2015.09.005.

2. Minar P, Saeed SA, Afreen M, Kim MO, Denson LA. Practical Use of Infliximab Concentration Monitoring in Pediatric Crohn's Disease. J Pediatr Gastroenterol Nutr. 2015 Nov 5.doi: 10.1097/MPG.0000000000001029

3. Plasencia C, Jurado T, Villalba A, Peitedado D, Casla MT, Nuño L, Bonilla MG, Martínez-Feito A, Martín-Mola E, Pascual-Salcedo D, Balsa A. Effect of Infliximab Dose Increase in Rheumatoid Arthritis at Different Trough Concentrations: A Cohort Study in Clinical Practice Conditions. Front Med (Lausanne). 2015 Oct 8;2:71. doi: 10.3389/fmed.2015.00071.

4. Van Stappen T, Billiet T, Vande Casteele N, Compernolle G, Brouwers E, Vermeire S, Gils A. An Optimized Anti-infliximab Bridging Enzyme-linked Immunosorbent Assay for Harmonization of Anti-infliximab Antibody Titers in Patients with Inflammatory Bowel Diseases. Inflamm Bowel Dis. 2015;21(9):2172-7.

5. Hock BD, Stamp LK, Hayman MW, Keating PE, Helms ET, Barclay ML Development of an ELISA based competitive binding assay for the analysis of drug concentration and anti-drug antibody levels in patients receiving adalimumab or infliximab. Ther Drug Monit. 2015 Jul 24. [Epub ahead of print]

6. Ben-Horin S, Yavzori M, Benhar I, Fudim E, Picard O, Ungar B, Lee S, Kim S, Eliakim R, Chowers Y. Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima. Gut. 2015 Apr 20. pii: gutjnl-2015-309290. doi: 10.1136/gutjnl-2015-309290.

7. Ungar B, Anafy A, Yanai H, Ron Y, Yavzori M, Picard O, Fudim E, Loebstein R, Kopylov U, Chowers Y, Dotan I, Eliakim R, Ben-Horin S. Significance of low level infliximab in the absence of anti-infliximab antibodies. World J Gastroenterol. 2015;21(6):1907-14.9

8. Elberdín L, Outeda M, Salvador P, Paradela S, Fernández-Torres RM, Iglesias R, Fonseca E, Martín I. Infliximab drug and antibody levels in patients with dermatological conditions. Int J Clin Pharm. 2015;37(2):320-6.

9. Van Stappen T, Brouwers E, Tops S, Geukens N, Vermeire S, Declerck PJ, Gils A Generation of a Highly Specific Monoclonal Anti-Infliximab Antibody for Harmonization of TNF-Coated Infliximab Assays. Ther Drug Monit. 2015;37(4):479-85.

10. Hernández-Flórez D, Valor L, de la Torre I, Nieto JC, Martínez-Estupiñán L, González C, López-Longo FJ, Monteagudo I, Garrido J, Naredo E, Carreño L. Comparison of two ELISA versions for infliximab serum levels in patients diagnosed with ankylosing spondylitis. Rheumatol Int. 2015;35(6):1021-5.

11. Marinari B, Botti E, Bavetta M, Spallone G, Zangrilli A, Talamonti M, Richetta A, Chimenti S, Costanzo A. Detection of adalimumab and anti-adalimumab levels by ELISA: clinical considerations. Drug Dev Res. 2014;75 Suppl 1:S11-4.

12. Steenholdt C, Bendtzen K, Brynskov J, Thomsen OØ, Ainsworth MA Clinical implications of measuring drug and anti-drug antibodies by different assays when optimizing infliximab treatment failure in Crohn's disease: post hoc analysis of a randomized controlled trial. Am J Gastroenterol. 2014;109(7):1055-64.

13. Marits P, Landucci L, Sundin U, Davidsdottir L, Nilsson J, Befrits R, Wikström AC, Eberhardson M Trough s-infliximab and antibodies towards infliximab in a cohort of 79 IBD patients with maintenance infliximab treatment. J Crohns Colitis. 2014;8(8):881-9.

14. Ungar B, Chowers Y, Yavzori M, Picard O, Fudim E, Har-Noy O, Kopylov U, Eliakim R, Ben-Horin S; ABIRISK consortium. The temporal evolution of antidrug antibodies in patients with inflammatory bowel disease treated with infliximab. Gut. 2014;63(8):1258-64.

15. Corstjens PL, Fidder HH, Wiesmeijer KC, de Dood CJ, Rispens T, Wolbink GJ, Hommes DW, Tanke HJ A rapid assay for on-site monitoring of infliximab trough levels: a feasibility study. Anal Bioanal Chem. 2013;405(23):7367-75.

16. Steenholdt C, Ainsworth MA, Tovey M, Klausen TW, Thomsen OO, Brynskov J, Bendtzen K Comparison of techniques for monitoring infliximab and antibodies against infliximab in Crohn's disease. Ther Drug Monit. 2013;35(4):530-8.

17. Imaeda H, Takahashi K, Fujimoto T, Bamba S, Tsujikawa T, Sasaki M, Fujiyama Y, Andoh A Clinical utility of newly developed immunoassays for serum concentrations of adalimumab and anti-adalimumab antibodies in patients with Crohn's disease. J Gastroenterol. 2014;49(1):100-9.

18. Wang SL, Ohrmund L, Hauenstein S, Salbato J, Reddy R, Monk P, Lockton S, Ling N, Singh S Development and validation of a homogeneous mobility shift assay for the measurement of infliximab and antibodies-to-infliximab levels in patient serum. J Immunol Methods. 2012;382(1-2):177-88.

19. Kopylov U, Mazor Y, Yavzori M, Fudim E, Katz L, Coscas D, Picard O, Chowers Y, Eliakim R, Ben-Horin S . Clinical utility of antihuman lambda chain-based enzyme-linked immunosorbent assay (ELISA) versus double antigen ELISA for the detection of anti-infliximab antibodies. Inflamm Bowel Dis. 2012;18(9):1628-33.

20. Imaeda H, Andoh A, Fujiyama Y . Development of a new immunoassay for the accurate determination of anti-infliximab antibodies in inflammatory bowel disease. J Gastroenterol. 2012;47(2):136-43.

TOTAL ANTIBODY TO INFLIXIMAB

ESSAY CHARACTERISTICS

REFERENCES

INSTRUCTIONS FOR USE

SAFETY DATA SHEET

BATCH/LOT INFORMATION

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Required Volume (µL)	20
Incubation Time (min)	75
Sample	Serum or Plasma
Plate Size	96 Tests
Results in	Total Arbitrary Units (tAU/mL)
Cut-Off (tAU/mL)	10
Detection Limit (tAU/mL)	10
Shelf Life (years)	2