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| Assay Type | Sandwich-ELISA |
| Analyte | PCSK9 |
| Format | 96T |
| Reactivity | Human |
| Sensitivity | 0.45 ng/ml |
| Standard Curve Range | 0.625 ng/mL-20 ng/mL |
| Assay Time | 2.75 hr |
| Suitable Sample Type | For the quantitative determination of human PCSK9 in Cell Culture Supernatants, Plasma, Serum. |
| Sample volume | 50 uL |
| ID | Components | Size |
| CEA202-C01 | Pre-coated Anti-PCSK9 Antibody Microplate | 1 plate |
| CEA202-C02 | Human PCSK9 Standard | 20 μg×2 |
| CEA202-C03 | Biotin-Anti-PCSK9 Antibody Con. Solution | 100 μL |
| CEA202-C04 | Biotin-Antibody Dilution Buffer | 8 mL |
| CEA202-C05 | Streptavidin-HRP Con. Solution | 500 μL |
| CEA202-C06 | Streptavidin-HRP Dilution Buffer | 15 mL |
| CEA202-C07 | 20× Washing Buffer | 50 mL |
| CEA202-C08 | Sample Dilution Buffer | 15 mL×2 |
| CEA202-C09 | Substrate Solution | 12 mL |
| CEA202-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-like facility and comply to the ISO 13485 standard, ensuring a high level of quality and reliability.
The kit is developed for quantitative detection of human PCSK9 in serum, plasma and cell culture supernates.
It is for research use only.
For each experiment, a standard curve needs to be set for each microplate, and the specific OD value may vary depending on different laboratories, testers, or equipment. The following example data is for reference only. The sample concentration was calculated based on the results of the standard curve. The minimum detectable concentration of PCSK9 is less than 0.45 ng/mL.
Ten replicates of each of 3 samples containing different PCSK9 concentrations were tested in one assay. Acceptable criteria: CV＜10%.
3 samples containing different concentrations of PCSK9 were tested in independent assays. Acceptable criteria: CV<15%.
Recombinant PCSK9 was spiked into 3 human serum samples, and then analyzed. The average recovery of PCSK9 for serum samples is 96.4%.
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