ANTIBODY TO INFLIXIMAB ELISA

Enzyme immunoassay for the quantitative and qualitative determination of free antibodies to Infliximab (Remicade®, Remsima®) in serum and plasma.

The solid phase (MTP) is coated by the drug Infliximab. Due to the assay design this test measures the free antibodies which are not bound to Infliximab. Results could be expressed in both qualitative and quantitative manner (nanogram per mililiter-ng/mL).

Required Volume (µL)	50
Incubation Time (min)	135
Sample	Serum/Plasma
Plate Size	96 Tests
Results in	Qualitative & Quantitative (ng/mL)
Shelf Life (years)	2

Intended Use: This kit has been developed for the detection 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.

ANALYTICAL SENSITIVITY-THRESHOLD VALUE

The Detection Threshold for the assay is 0,5 ng/mL.

The assay sensitivity for undiluted clinical samples corresponds to 1 ng/mL

Because the serum or plasma samples are instructed to be diluted at two-fold (1:2) before starting the assay.

ASSAY RANGE

For anti-Infliximab antibodies in serum and plasma, the method has been demonstrated to be highly (>0.99 %) linear from 0 to 30 ng/mL.

ASSAY PRECISION

Mean

CV (%)

30 2,7

10 2,6

3 3,5

ASSAY RECOVERY

Recovery rate was found to be 85-115% using native serum and plasma samples spiked with exogenous Anti Drug Antibody (ADA) positive samples.

AUTOMATION

The ImmunoGuide ADA ELISA is suitable also for being used 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, et al. 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.

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.

ANTIBODY TO INFLIXIMAB ELISA

ESSAY CHARACTERISTICS

REFERENCES

INSTRUCTIONS FOR USE

SAFETY DATA SHEET

BATCH/LOT INFORMATION

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Mean	CV (%)
30	2,7
10	2,6
3	3,5