TNFα Therapeutic Drug Monitoring

Therapeutic-Drug-Monitoring

The BÜHLMANN Quantum Blue® Infliximab and Adalimumab assays are the first rapid tests to measure trough level in patient’s serum allowing timely decision making for dose adjustments before the next dose.

  • Quantitative range:
    – Infliximab: 0.4 – 20µg/ml – Linear up to 180µg/ml
    – Adalimumab: 1.3 – 35µg/ml
  • Single use assay:
    – No need to batch samples
    – Individually packaged test
  • Available in two pack sizes
  • Assay time of 15 minutes
  • Correlation with ELISA method
  • Control included on each cassette
  • Read using a simple bench top reader (about the size of a desk top telephone)

The BÜHLMANN Quantum Blue® Infliximab assay is an immunoassay for the quantitative determination of infliximab trough levels in human serum which can be used to support therapy monitoring. Generally, trough levels in serum that reach a value of 3µg/ml and above correlate well with remission, endoscopic healing of the gut mucosa and low CRP values as well as prediction of sustained response to infliximab therapy.

The test is designed for the selective measurement of infliximab by a sandwich immunoassay.

Recombinant tumour necrosis factor alpha (TNFα) is conjugated to gold colloids. On the test cassette the conjugate is released from the pad onto the reaction system as the sample is applied. Infliximab present in the sample will bind to the conjugate. A highly specific monoclonal antibody is immobilised on the test membrane and will capture the conjugate/analyte complex, resulting in a colouring of the test line. The remaining free TNFα/gold conjugate will bind to the control line. The signal intensities of the test line and the control line are measured quantitatively by the BÜHLMANN Quantum Blue® reader.

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Quantum Blue anti-TNFα Drug Monitoring
Product Code Description Pack Size
LF-TLIF25 Quantum Blue® Infliximab 25 Tests
LF-TLIF10 Quantum Blue® Infliximab 10 Tests
Alfonso et al ECCO

The new biosimilar of infliximab SB2 can be quantified by IFX-optimized therapeutic drug monitoring assays

Alfonso et al. ECCO 2018

The new infliximab point-of-care quantitative test can equally be used for therapeutic drug monitoring of biosimilars of infliximab

Alfonso et al. Poster at ECCO 2018

ECCO-P767

Quantum Blue® Infliximab POC User Performance Evaluation

Fellay et al. ECCO 2018 Poster No. 767

Alfonso_TDM_CT-P13

Therapeutic drug monitoring of CT-P13: a comparison of four different immunoassays

Alfonso et al. Aug 17

Magro-et-al

Clinical performance of an infliximab rapid quantification assay

Magro et al. Aug 17

QB-infliximab-poster

Patient-near Infliximab trough-level testing by a novel quantitative rapid test: The Quantum Blue Infliximab test

Lindsjø et al. Poster – UEG Week October 2016

QB-infliximab-paper

Proactive therapeutic drug monitoring of infliximab: a comparative study of a new point-of-care quantitative test with two established ELISA assays

Afonso J et al. Aliment Pharmacol Ther. 2016 Oct;44(7):684-92

Infliximab_QB_Poster

Performance of the BÜHLMANN Quantum Blue® Infliximab point-of-care assay dedicated for therapeutic drug monitoring of serum infliximab trough levels

ECCO, March 16-19, 2016, Poster No. 242

TDM-References

Therapeutic Drug Monitoring

References Summary

BÜHLMANN Quantum Blue® Adalimumab is an in vitro diagnostic lateral flow immunoassay for the quantitative determination of trough levels of adalimumab in serum samples.

The assay serves as an aid to therapeutic drug monitoring in patients with inflammatory bowel disease (IBD) under adalimumab therapy, in conjunction with other clinical and laboratory findings. Quantum Blue Adalimumab is combined with the Quantum Blue Reader. The test is designed for the selective measurement of adalimumab by a sandwich immunoassay.

Recombinant tumor necrosis factor alpha (TNFα) is conjugated to gold colloids. On the test cassette the gold conjugate is released from a pad into the reaction system as the sample is applied. Adalimumab present in the sample will bind to the gold conjugate. A monoclonal antibody, highly specific for adalimumab, is immobilised on the analytical membrane and will capture the complex of gold conjugate and the adalimumab analyte, resulting in a colouring of the Test Line (T). The remaining free TNFα-gold conjugate will bind to the Control Line (C). The signal intensities of the Test Line (T) and the Control Line (C) are measured quantitatively by the Quantum Blue Reader.

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Quantum Blue anti-TNFα Drug Monitoring
Product Code Description Pack Size
LF-TLAD25 Quantum Blue® Adalimumab 25 Tests
LF-TLAD10 Quantum Blue® Adalimumab 10 Tests
ECCO-P283

Quantum Blue® Adalimumab: Development of the first point of care rapid test for therapeutic drug monitoring of serum adalimumab levels

Bantleon et al. ECCO P283

UEGW-P1014

Performance of QB Adalimumab Rapid Test for TDM of Serum Adalim Trough Levels

Wieser et al. UEGW P1014

TDM-References

Therapeutic Drug Monitoring

References Summary

Infliximab Assay Videos

Joana Afonso from the University of Porto presents data that confirms the validated use of the Quantum Blue® Infliximab assay to quantify the new infliximab biosimilar SB2.

Dr. Afif from McGill presents a pilot study for the Quantum Blue® Infliximab rapid test application in loss of response patients.

Dr. Rentsch from the Alfred Health Melbourne shows very promising data on infliximab management supported by the Quantum Blue® Infliximab rapid test and implications for therapy cost reduction.

Dr. Maria Pia Santos from the Beatriz Angelo Hospital presents data on an easy integration of the Quantum Blue® TDM rapid test in clinical routine.