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TRASTUZUMAB ELISA

TRASTUZUMAB ELISA

Enzyme immunoassay for the quantitative determination of free Trastuzumab (Herceptin®, Herclon®) in serum and plasma.
The solid phase (MTP) is coated by the target molecule, in this case HER2/neu receptor.
 
Required Volume (µL)10
Incubation Time (min)110
SampleSerum or Plasma
Package Size96 Tests
Standard Range (ng/mL, 10x)0-2000
Detection Limit (ng/mL)5
Spike Recovery (%)>95
Shelf Life (years)2
 
 
Intended Use: This kit has been developed for the measurement of drug levels in research, diagnostic and biosimilar uses. It is suitable for Therapeutical Drug Monitoring (TDM) purposes.
 
Herceptin® and Herclon® are trademarks Genentech Inc

  • SPECIFICITY

    There is no cross reaction with any other proteins present in native human serum. A screening test was performed with 36 different native human sera. All produced OD450/620 nm values less than the mean OD of standard D (6 ng/mL). No cross reaction was observed with sera spiked with the other therapeutic antibodies including Infliximab, Adalimumab, Etanercept, Rituximab, Tocilizumab, and Bevacizumab at concentrations up to 200 µg/mL. All produced mean OD450/620 nm values ranged from 0.01 to 0. 04.

     

    SENSITIVITY

    The lowest detectable level that can be clearly distinguished from the zero standard is 5 ng/mL (zero standard +2SD read from the curve) under the above-described conditions. Analytical sensitivity is 5 ng/mL, and corresponding to the detection limit (limit of quantification) of 5 µg/mL for undiluted clinical samples because the serum or plasma samples are instructed to be diluted at 1:1000 before starting the assay.

     

    PRECISION

    Intra-assay CV: <10%.

    Inter-assay CV: <10%.

     

    RECOVERY

    Recovery rate was found to be >95% with native human serum and plasma samples when spiked with exogenous Trastuzumab.

     

    AUTOMATION

    The ImmunoGuide Trastuzumab ELISA is suitable also for being used by an automated ELISA processor.

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