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| Assay Type | Sandwich-ELISA |
| Analyte | IFN-γ |
| Format | 96T |
| Reactivity | Human |
| Sensitivity | <4.0 pg/mL |
| Standard Curve Range | 7.18 pg/mL-1000 pg/mL |
| Assay Time | 2 hr |
| Suitable Sample Type | For the quantitative determination of human IFN-γ in Plasma and Serum. |
| Sample volume | 50 μL |
| ID | Components | Size |
| CEA006-C01 | Pre-coated Anti-IFN-γ Antibody Microplate | 1 plate |
| CEA006-C02 | IFN-γ Calibrator | 15 μg×2 |
| CEA006-C03 | Biotin-Anti-IFN-γ Antibody Concentrated Solution | 100 μL |
| CEA006-C04 | Biotin Antibody Dilution Buffer | 8 mL |
| CEA006-C05 | IFN-γ Streptavidin-HRP Concentrated Solution | 0.5 mL |
| CEA006-C06 | Streptavidin-HRP Dilution Buffer | 15 mL |
| CEA006-C07 | 20× Washing Buffer | 50 mL |
| CEA006-C08 | Sample Dilution Buffer | 15 mL×2 |
| CEA006-C09 | Substrate Solution | 12 mL |
| CEA006-C10 | Stop Solution | 6 mL |
A comprehensive validation of the ELISA method was performed following the ICH M10 on bioanalytical method validation and the FDA’s bioanalytical method validation guidance for industry. This validation included assessments of linearity, accuracy, precision, dilution linearity, recovery, and the hook effect. For details information, please refer to the DS.
ClinMax™ ELISA Kits are manufactured in a GMP-certified facility and comply to the ISO 13485 standard, ensuring a high level of quality and reliability.
Results are obtained by Log-Log Linear regression equation are used to draw the standard curve and calculate the sample concentration. The verification results indicate that this kit can be used for the quantitative determination of natural and recombinant human IFN-γ concentrations.
It has been calibrated against a highly purified human IFN-γ and is evaluated with standard from NIBSC/WHO. Reference Reagent INTERFERON GAMMA (Human, rDNA derived) NIBSC code: 87/586.
It is for research use only.
The opened kit should be stored per components table. The shelf life is 30 days from the date of opening.
For each experiment, each ELISA plate needs to set the standard curve. The minimum detectable concentration of CEA-C006 is less than 4.0 pg/mL.
Ten replicates of each of five samples containing different IFN-γ concentrations were tested in one assay, Intra-Assay Precision CV<10%.
Five samples containing different concentrations of IFN-γ were tested in three independent assays, Inter-Assay Precision CV<15%.
Recombinant IFN-γ（8000，6000，4000pg/mL）was spiked into 5 human serum samples, and then analyzed. On average, 98.28% of IFN-γ was recovered from serum samples.
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