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SHIKARI® T-CAP Nab Assay™-Nivolumab ELISA Kit

Target Capture Neutralizing Antibodies Immunoassay-Nivolumab

Enzyme immunoassay to detect neutralizing antibodies to nivolumab in serum and plasma samples

This kit has been developed for detecting ‘Free’ neutralizing antibodies to nivolumab. The kit is composed of 4 different controls,

  • Positive control: It contains netralizing antibody
  • Negative control
  • Cut-Off control: Contains certain amounted neutralizing antibody. Corresponse to lower limit of detection (LLOD)
  • Non-Neutralizing Antibody Negative Control: Contains non-neutralizing antibodies binding to the drug

With these controls, the kit provides reliable results.

The Cut Off serum contains the LLOD amount and provides accurate true positive or negative results. 

A non-neutralising antibody that binds to the drug without affecting the test results can be considered as a negative control. 

The kit was also checked with various negative serum samples, including RF(+), CRP(+), ANA(+) sera. All these negative sera did not interfere with the test system. Please refer to the validation report.

We strictly recommend taking sample just before the next dose administration from the patient.

All SHIKARI® ELISA kits are produced under ISO 13485 quality system and have CE IVD mark.

For technical inquiry, please contact techsupport@matriksbiotek.com

Required Volume (µl) 10
Total Time (min) 140
Sample Serum, plasma
Sample Number 96
Detection Limit (ng/mL) 50
Spike Recovery (%) -
Shelf Life (month) 6
Assay type Qualitative
Species Reactivity Human
Storage conditions Store at +4°C. Please refer to protocols.
Shipping conditions At room temperature
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Publications with this drug

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Sureda, Manuel, et al. "Therapeutic drug monitoring of nivolumab in routine clinical practice. A pilot study." Farmacia Hospitalaria 44.3 (2020): 81-86. Visit Link
Nieto, Juan C., et al. "Posttransplant cyclophosphamide after allogeneic hematopoietic cell transplantation mitigates the immune activation induced by previous nivolumab therapy." Leukemia 34.12 (2020): 3420-3425. Visit Link
Abe, Kazuki, et al. "Quantitative LC-MS/MS method for nivolumab in human serum using IgG purification and immobilized tryptic digestion." Analytical Methods 12.1 (2020): 54-62. Visit Link
Sureda, Manuel, et al. "Therapeutic drug monitoring of nivolumab in clinical practice: Preliminary experience." (2019): e14089-e14089. Visit Link
García Gil S, Ramos Díaz R., ANÁLISIS DE LA CONCENTRACIONES PLASMÁTICAS DE NIVOLUMAB EN EL TRATAMIENTO DEL CPNM Visit Link