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

Target Capture Neutralizing Antibodies Immunoassay-Trastuzumab

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

This kit has been developed for detecting ‘Free’ neutralizing antibodies to trastuzumab. 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) 20
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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Instructions for Use Download
SDS Download

Publications with this drug

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Mocenigo, Marco, et al. "Rapid, cost-effective peptide/nucleic acid-based platform for therapeutic antibody monitoring in clinical samples." ACS sensors 5.10 (2020): 3109-3115. Visit Link
Padrón, Ivette Mourani, et al. "Anti-drug antibodies anti-trastuzumab in the treatment of breast cancer." Journal of Oncology Pharmacy Practice 27.6 (2021): 1354-1356. Visit Link
González García, Jonathan, et al. "Pharmacokinetics of trastuzumab after subcutaneous and intravenous administration in obese patients." Annals of Pharmacotherapy 54.8 (2020): 775-779. Visit Link
Puente‐Massaguer, Eduard, et al. "A statistical approach to improve compound screening in cell culture media." Engineering in life sciences 19.4 (2019): 315-327. Visit Link
González-García, Jonathan, et al. "Long-term stability of trastuzumab in plasma and whole blood samples stored under different conditions." Farmacia Hospitalaria 43.2 (2019): 50-52. Visit Link
González García, Jonathan, et al. "Influence of anthropometric characteristics in patients with Her2-positive breast cancer on initial plasma concentrations of trastuzumab." Annals of Pharmacotherapy 51.11 (2017): 976-980. Visit Link
Iwamoto, Noriko, Akinobu Hamada, and Takashi Shimada. "Antibody drug quantitation in coexistence with anti-drug antibodies on nSMOL bioanalysis." Analytical biochemistry 540 (2018): 30-37. Visit Link
Chen, Jing, et al. "Tailor-making fluorescent hyaluronic acid microgels via combining microfluidics and photoclick chemistry for sustained and localized delivery of herceptin in tumors." ACS applied materials & interfaces 10.4 (2018): 3929-3937. Visit Link
Hollevoet, Kevin, et al. "Prolonged in vivo expression and anti-tumor response of DNA-based anti-HER2 antibodies." Oncotarget 9.17 (2018): 13623. Visit Link
González-García, J., et al. "Plasma levels of trastuzumab in gastric cancer: Case report." Journal of Oncology Pharmacy Practice 23.8 (2017): 635-637. Visit Link
Genetically modified micro-organ secreting antibody and methods of use Reem MiariNir ShapirInbal ZAFIR-LAVIE Visit Link
Hollevoet, Kevin, et al. "Bridging the clinical gap for DNA-based antibody therapy through translational studies in sheep." Human Gene Therapy 30.11 (2019): 1431-1443. Visit Link
Nanoparticle and Macromolecular Transfer across the Human Placental Barrier Download
Iwamoto, Noriko, and Takashi Shimada. "Method for quantifying monoclonal antibody having antigen or anti-antibody bonded thereto." U.S. Patent No. 11,619,616. 4 Apr. 2023. Visit Link