Pembrolizumab ELISA Kit

Sample

Serum and Plasma

Detection Method

classic bridging ELISA

Intended Use

The Pembrolizumab ELISA kit is a validated tool for whole Pembrolizumab and its biosimilar quantification in biological matrices for drug research and development. The kit can be also used for the detection of single chain variable fragment (scFv) of Pembrolizumab.

Contents of Kit

1. Capture Plate: 1 plate
2. Standard Stock: 1 vial (50 μL)
3. Sample Dilution Buffer: 1 bottle (60 mL)
4. Biotin Anti-Pembrolizumab Antibody: 1 bottle (12 mL)
5. Streptavidin-HRP: 1 bottle (12 mL)
6. TMB Solution: 1 bottle (12 mL)
7. 20× Wash Solution: 1 bottle (60 mL)
8. Stop Solution: 1 bottle (6 mL)
9. Plate Sealer: 2 pieces
Note: l Capture Plate: 96 well microplates (8 wells x 12 strips); 12 strips are configured in plate; plate is sealed in a foil pouch with a desiccant.
l Standard Stock contains 100 μg/mL of Pembrolizumab.

Storage

The unopened kit is stable for at least 12 months from the date of manufacture at 2°C to 8°C, and the opened kit is stable for up to 1 month from the date of opening at 2°C to 8°C.

Performance Characteristics

LLOQ 5 ng/mL
ULOQ 160 ng/mL
Intra-assay CV ≤10%
Inter-assay CV ≤15%
Minimum required dilution (MRD) 1:100 selected by cynomolgus monkey plasma
Specificity No cross-reactivity at 1600 ng/mL of Human IgG4
Hook effect Not observed at 15000 ng/mL of Pembrolizumab

Precision

Pembrolizumab Quality Controls at five concentrations (ULOQ of 160 ng/mL, HQC of 120 ng/mL, MQC of 30 ng/mL, LQC of 15 ng/mL and LLOQ of 5 ng/mL) were measured for intra-and inter-assay accuracy.

Detection Range

5 ng/mL-160 ng/mL