COVID-19 (SARS-CoV-2) IgG Antibody Test Kit Background
Advantages of the IONTOX COVID-19 (SARS-CoV-2) IgG Antibody Test Kit
- Sensitivity and specificity: 100% STR based on a double blinded study. The IONTOX Coronavirus COVID-19 (SARS-CoV-2) Antibody Test Kit is highly specific for SARS-CoV-2 and was evaluated against pre-pandemic blood samples. The kit provides a confident and clear yes/no answer.
- Flexibility: The 96-well ELISA plates have removable rows allowing more flexibility for smaller laboratories.
- Higher Accuracy: The kit provides ELISAs for the short receptor binding domain the (RBD) and the full-length Spike protein. The ability to analyze both the RBD and the full-length Spike protein means higher accuracy.
- SARS Antibody Titer: The patient’s antibody titer can be quantified against a SARS-CoV-2 antibody standard curve. This means that important information on immunity versus antibody levels can be ascertained.
- Epidemiology: Relevant for long term reevaluation of exposed patients for more accurate epidemiological information.
- FDA Approval: Pending
- Cost: The end user gets much more than a yes/no answer and even with this added return the cost per test is $2.50 with order minimums.
What Comes In Each COVID-19 (SARS-CoV-2) IgG Antibody Test Kit
- 2 x 96 well test plates (one RBD and one Spike protein)
- Negative controls
- Positive controls
- Wash buffer
- Sample dilution buffer
- HRP conjugate 2o antibody
- HRP substrate solution
- Stop solution
- Instructions for use
What You Need In Your Facility
- 96-well plate reader for measuring absorbance (450-490 nm)
- Class II biological safety cabinet
- Automated 96 well microplate washer (optional)
- Multichannel pipettor(s) and pipette tips
- 96-well Polypropylene plates for dilutions
- 15 and 50 mL sterile polypropylene conical tubes
Overview of the IONTOX COVID-19 Coronavirus (SARS-CoV-2) IgG Antibody ELISA Tests
Test Results and Clinical Significance
Enzyme-Linked ImmunoSorbent Assays (ELISAs) are important because, unlike qualitative lateral flow devices (LFDs), ELISAs can be quantitative if compared to a standard curve. They also allow greater degrees of fine-tuning and specification.
ELISA tests are not read with the naked eye. They require a plate reader to analyze the amount of a specific color wavelength produced as a result of the amount of enzyme which is linked to the antibodies present.
This procedure was developed as a two-stage ELISA in which the first stage includes relatively high-throughput screening of samples in a single serum dilution against the RBD (which expresses well and therefore can be produced in greater quantities). This is followed by a second stage in which positive samples from the first stage are subjected to a confirmatory ELISA against the full-length spike protein (which is harder to express and is less available). For the second stage, a dilution curve is performed.
Samples that exceed a specified optical density cutoff value (cutoff: optical density = 0.15 to 0.2) are assigned as presumptive positives and will be tested in the confirmatory ELISA using full-length spike protein. The OD490 cutoff must be experimentally determined in each testing laboratory and depends on assay background and noise.
The IONTOX COVID-19 (SARS-CoV-2) IgG Antibody Test Kit Offers Added Value Compared To Other Marketed Options
Order Your Coronavirus COVID-19 (SARS-CoV-2) IgG Antibody Test Kits Today
(For Hospitals, Academic Research and Clinical Laboratories)
IONTOX, LLC is a contract research laboratory located in Kalamazoo, MI. Through, consulting, product development, and laboratory services the company serves a global client base in the healthcare and consumer products industries. In 2020, in collaboration with the Western Michigan University Homer Stryker MD School of Medicine, IONTOX launched the Coronavirus COVID-19 (SARS-CoV-2) Antibody Test Kit for to help protect public health during the COVID-19 outbreak. To read more about IONTOX click here.