COVID-SeroIndex, Kantaro SARS-COV-2 IgG Antibody IVD Kit
COVID-SeroIndex (100% seroprevelance)
COVID-SeroIndex, Kantaro SARS-COV-2 IgG Antibody IVD Kit Summary
| Sample Type & Volume Required Per Well | Serum (10 uL), EDTA Plasma (10 uL), Heparin Plasma (10 uL) |
|---|---|
| Sensitivity | 3.2 AU/mL |
| Assay Range | 3.2 - 160 AU/mL (Serum, EDTA Plasma, Heparin Plasma) |
| Specificity | Natural and recombinant human anti-SARS-CoV-2 IgG |
| Cross-reactivity | < 0.5% cross-reactivity observed with available related molecules.< 50% cross-species reactivity observed with species tested. |
| Interference | No significant interference observed with available related molecules. |
Product Summary
COVID-SeroIndex is a 2-phase ELISA optimized for accurate detection of SARS-CoV-2 IgG antibodies, present in human plasma or serum samples. Validation studies have demonstrated a specificity a PPA of 97.8% and an NPA of 99.6%. Sufficient reagents are provided to test 360 samples per kit.
Phase 1 is a qualitative ELISA in which negative samples are eliminated from further analysis. Phase 2 is a quantitative ELISA confirming positive samples and providing an antibody titer for SARS-CoV-2 IgG antibodies present in the sample.
Performance Characteristics:
| Analytical Measuring Range | 3.2 – 160 AU/mL |
|---|---|
| Linear Range | 3.1 – 160 AU/mL |
| Within-Site Imprecision | See product datasheet for details. |
| Lot-to-Lot Imprecision | See product datasheet for details. |
| Site-to-Site Reproducibility | See product datasheet for details. |
| Analytical Sensitivity | 3.20 AU/mL (see product datasheet for additional information) |
| Positive Percent Agreement | 97.8% |
| Negative Percent Agreement | 99.6% |
| Antibody Class Specificity | See product datasheet for details. |
Background: SARS-CoV-2
Specifications
Product Datasheets
Background: Spike RBD
The coronavirus Spike protein receptor binding domain (RBD) resides within the S1 subunit and is responsible for binding to host cell receptors and initiating viral infection. Past coronaviruses SARS and MERS along with the global pandemic caused by SARS-CoV-2 have sparked great interest and scientific discovery leading to new vaccines and drug development. At the heart of coronavirus biology lies the Spike protein and its receptor binding domain. The Spike RBD is a 26 kDa domain consisting of a twisted five-stranded antiparallel beta sheet and sits at the apex of each Spike protein monomer. The Spike RBD is flexible thanks to a hinge region that allows for conformational changes that expose (up or open conformation) or hide (down or closed conformation) its receptor contacts. For SARS-CoV-2, the Spike RBD recognizes and tightly binds to the human receptor ACE-2. In the closely related MERS coronavirus, human DPPIV/CD26 acts as the receptor.
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