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ANTIBODY TO NIVOLUMAB ELISA
Enzyme immunoassay for the quantitative and qualitative determination of free antibodies to Nivolumab (Opdivo®) in serum and plasma.
The solid phase (MTP) is coated by the drug Nivolumab. Due to the assay design this test measures the free antibodies which are not bound to Nivolumab. 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/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.
Opdivo® is a trademark of Bristol Myers Squibb Company.
ANALYTICAL SENSITIVITY-THRESHOLD VALUE
The Detection Threshold for the assay is 5 ng/mL.
The assay sensitivity for undiluted clinical samples corresponds to 10 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-Nivolumab antibodies in serum and plasma, the method has been demonstrated to be highly (>0.99 %) linear from 0 to 300 ng/mL.
ASSAY PRECISION
Intra-assay CV:
Mean
CV (%)
300 <10 100 <10 30 <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.