膜杰作
Star Staining
产品描述（Product Details）
| 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 |
组分（Materials Provided）
| 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 |
背景（Background）
ClinMax™ ELISA Kit is convenient ready-to-use immunoassay Kit, specifically designed to quantitate human PCSK9 that is present in complex biological samples, such as human serum, plasma, and cell culture supernates.
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.
应用说明（Application）
The kit is developed for quantitative detection of human PCSK9 in serum, plasma and cell culture supernates.
It is for research use only.
存储（Storage）
Keep the unopened kit stored at 2-8 °C. Avoid using the kit beyond its expiration date. The opened kit should be stored per components table. The shelf life is 30 days from the date of opening.
原理（Assay Principles）
典型数据-Typical Data Please refer to DS document for the assay protocol.
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.
验证（Validation）
批内差异（Intra-Assay Statistics）
Ten replicates of each of 3 samples containing different PCSK9 concentrations were tested in one assay. Acceptable criteria: CV＜10%.
批间差异（Inter-Assay Statistics）
3 samples containing different concentrations of PCSK9 were tested in independent assays. Acceptable criteria: CV<15%.
回收率（Recovery）
Recombinant PCSK9 was spiked into 3 human serum samples, and then analyzed. The average recovery of PCSK9 for serum samples is 96.4%.
背景（Background）：PCSK9
Proprotein convertase subtilisin/kexin type 9, also know as PCSK9, is act via a non-proteolytic mechanism to enhance the degradation of the hepatic LDLR through a clathrin LDLRAP1/ARH-mediated pathway. May prevent the recycling of LDLR from endosomes to the cell surface or direct it to lysosomes for degradation. Can induce ubiquitination of LDLR leading to its subsequent degradation.
