COVID-SeroKlir Kantaro SARS-CoV-2 IgG Ab Kit (EUA)
COVID-SeroKlir Kantaro SARS-CoV-2 IgG Ab Kit (EUA) 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 - 125 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
The COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit is a two-step Enzyme-Linked Immunosorbent Assay (ELISA) intended for qualitative and semi-quantitative detection of human IgG antibodies to the SARS-CoV-2 virus in serum and Li-Heparin plasma. An initial qualitative ELISA step is performed against recombinant Receptor Binding Domain of SARS-CoV-2, followed, for positive specimens, by a confirmatory semi-quantitative ELISA step against full-length SARS-CoV-2 Spike protein. The Kantaro Biosciences Clinical Agreement Study has demonstrated a 99% specificity and 99% sensitivity in subjects 15 days post-symptom onset.
Performance Characteristics
| Analytical Measuring Range | 3.2 – 125 AU/mL |
|---|---|
| Linear Range | 1.89 - 125.7 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 | 99.15% in subjects 15 days post symptom onset |
| Negative Percent Agreement | 99.6% |
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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