Patient Testing: Patient samples were tested using the SARS-CoV-2 Spike Protein Serological IgG ELISA Kit #20154. Serum or plasma was obtained from donors who had been diagnosed with SARS-CoV-2 (confirmed positive n=17) or from uninfected donors collected prior to the SARS-CoV-2 outbreak (confirmed negative n= 62). Samples were heat-inactivated (56°C for 30 min) and diluted 1:800 prior to running the assay, as described in the attached protocol. Samples were considered positive, negative, or inconclusive based on the criteria described in the “Data Analysis” section of the attached protocol. Positive percent agreement (PPA) and negative percent agreement (NPA) were calculated from these data.
Intra-Assay Precision: Three different serum samples were each tested in 16 replicates using a single assay kit of SARS-CoV-2 Spike Protein Serological IgG ELISA #20154. Intra-assay CV (%) was calculated for each sample, and each replicate was correctly identified as being positive or negative when compared to the Negative Control using the cutoff criteria described in the attached protocol.
Inter-Assay Precision: Six different assay kits from one lot of material were tested using 3 different serum samples run in duplicate wells and Positive and Negative Controls run in 4 replicate wells. Inter-assay CV (%) was calculated for each sample, and each assay kit correctly identified the samples as being positive or negative when compared to the Negative Control using the cutoff criteria described in the attached protocol.
|Spike Protein Coated Microwells||96 次测试|
|Anti-Human IgG, HRP-linked Antibody (ELISA Formulated)||1 个||红色（冻干）|
|Sample Diluent A||25 ml|
|HRP Diluent||11 ml||红色|
|ELISA Wash Buffer (20X) 9801||25 ml|
|TMB Substrate 7004||11 ml|
|STOP Solution 7002||11 ml|
|Sealing Tape||2 ea|
|ELISA Kit #20154 Positive Control||1 个|
|ELISA Kit #20154 Negative Control||1 个|
The SARS-CoV-2 Spike Protein Serological IgG ELISA Kit is a solid phase ELISA that detects binding of human IgG to full-length SARS-CoV-2 spike protein (S-protein). Full-length spike protein has been coated onto microwells. After incubation with sample, human IgG specific for spike protein is captured on the plate. 然后洗涤微孔以除去未结合的物质。Anti-Human IgG, HRP-linked antibody is then used to recognize the bound IgG. 加入 HRP 底物 (TMB) 来显色。The magnitude of optical density for this developed color is proportional to the quantity of IgG specific for spike protein.
This ELISA Kit Is Intended For Research Use Only. Not For Use in Diagnostic or Clinical Procedures.
NOTE: Sample storage/handling, including heat-inactivation of samples, can potentially affect observed signals. Therefore, it is strongly recommended that in addition to the Positive and Negative Controls included with the kit, the user includes their own negative and positive patient samples as controls when running the assay in order to establish an appropriate cutoff value.
注意：阳性反应的初始颜色为蓝色，一旦添加 STOP 溶液，就变为黄色。
The SARS-CoV-2 Spike Protein Serological IgG ELISA Kit detects endogenous levels of human IgG directed to full-length SARS-CoV-2 spike protein (S-protein).
COVID-19 疫情的病因是一种新型的高致病性冠状病毒，称为 SARS-CoV-2（严重急性呼吸系统综合症冠状病毒 2）。SARS-CoV-2 是冠状病毒家族的成员（1）。SARS-CoV-2 的基因组与其他冠状病毒相似，并且由四个关键结构蛋白组成：S，刺突蛋白；E，包膜蛋白；M，膜蛋白；N，核衣壳蛋白（2）。冠状病毒刺突蛋白是 I 类融合蛋白，具有胞外域、跨膜域和胞内尾巴（3,4）。高度糖基化的胞外域从病毒包膜表面突出，并促进与宿主细胞质膜的附着和融合。胞外域可进一步细分为宿主受体结合域（RBD）（S1）和膜融合（S2）亚基，它们是由宿主蛋白酶在 S1/S2 和 S2' 位点进行蛋白水解产生的。S1 和 S2 亚基在切割后仍保持结合并组装成冠状三聚体（2,4）。在人类中，SARS-CoV 和 SARS-CoV-2 刺突蛋白均利用血管紧张素转化酶2（ACE2）蛋白作为进入细胞的受体（5-7）。刺突蛋白亚基代表冠状病毒毒粒的关键抗原特征，因此代表疫苗、新型治疗性抗体和小分子抑制剂（8,9）的重要靶标。
探索与本品相关的通路 + 蛋白。
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