ANTIBODY TO TOCILIZUMAB ELISA

Name: ANTIBODY TO TOCILIZUMAB ELISA
Brand: Immunoguide
SKU: BB108

Certification

RuO - Research Use Only

Enzyme immunoassay for the quantitative and qualitative determination of free antibodies to Tocilizumab (Actemra®) in serum and plasma.

The solid phase (MTP) is coated by the drug Tocilizumab. Due to the assay design this test measures the free antibodies which are not bound to Tocilizumab. 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 or 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.

Actemra® is a trademark of Chugai Seiyaku Kabushiki Kaisha Corp.

ANALYTICAL SENSITIVITY-THRESHOLD VALUE

The Detection Threshold for the assay is 2 ng/mL.

The assay sensitivity for undiluted clinical samples corresponds to 4 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-Tocilizumab antibodies in serum and plasma, the method has been demonstrated to be highly (>0.99 %) linear from 0 to 100 ng/mL.

ASSAY PRECISION

Intra-assay CV:

Mean

CV (%)

100 <10

30 <10

10
<10

Inter-assay CV: <10%.

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.
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3. Besada E. Potential patient benefit of a subcutaneous formulation of tocilizumab for the treatment of rheumatoid arthritis: a critical review. Patient Prefer Adherence. 2014;8:1051-9.

4. Ohta S, Tsuru T, Terao K, Mogi S, Suzaki M, Shono E, Ishida Y, Tarumi E, Imai M. Mechanism-based approach using a biomarker response to evaluate tocilizumab subcutaneous injection in patients with rheumatoid arthritis with an inadequate response to synthetic DMARDs (MATSURI study). J Clin Pharmacol. 2014;54(1):109-19.

5. Lee SJ, Park W, Park SH, Shim SC, Baek HJ, Yoo DH, Kim HA, Lee SK, Leee YJ, Park YE, Cha HS, Park JK, Lee EY, Lee EB, Song YW. Low baseline interleukin-17A levels are associated with better treatment response at 12 weeks to tocilizumab therapy in rheumatoid arthritis patients. J Immunol Res. 2015;2015:487230. doi: 10.1155/2015/487230. Epub 2015 Apr 2

6. Ogata A, Tanimura K, Sugimoto T, Inoue H, Urata Y, Matsubara T, Kondo M, Ueki Y, Iwahashi M, Tohma S, Ohta S, Saeki Y, Tanaka T; Musashi Study Investigators. Phase III study of the efficacy and safety of subcutaneous versus intravenous tocilizumab monotherapy in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2014;66(3):344-54.

7. Mori S, Ueki Y. Primary lack of efficacy of infliximab therapy for rheumatoid arthritis: pharmacokinetic characterization and assessment of switching to tocilizumab. Mod Rheumatol. 2011;21(6):628-36.

8. Zhang X, Peck R. Clinical pharmacology of tocilizumab for the treatment of patients with rheumatoid arthritis. Expert Rev Clin Pharmacol. 2011 Sep;4(5):539-58. doi: 10.1586/ecp.11.33.

9. Burmester GR, Rigby WF, van Vollenhoven RF, Kay J, Rubbert-Roth A, Kelman A, Dimonaco S, Mitchell N. Tocilizumab in early progressive rheumatoid arthritis: FUNCTION, a randomised controlled trial. Ann Rheum Dis. 2015 Oct 28. pii: annrheumdis-2015-207628. doi: 10.1136/annrheumdis-2015-207628. [Epub ahead of print]

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ANTIBODY TO TOCILIZUMAB ELISA

ESSAY CHARACTERISTICS

REFERENCES

INSTRUCTIONS FOR USE

SAFETY DATA SHEET

BATCH/LOT INFORMATION

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Mean	CV (%)
100	<10
30	<10
10	<10