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Coronavirus COVID-19 (SARS-CoV-2) Antibody Test Kit

For Hospitals, Academic Research, and Clinical Laboratories

A laboratory is required to run the IONTOX Coronavirus COVID-19 (SARS-CoV-2) Antibody Test Kit
COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit

$550 per kit

Each kit tests up to 152 individuals

Volume Discounts Available

The IONTOX Coronavirus COVID-19 (SARS-CoV-2) Antibody Test Kit is an ELISA based kit that allows hospitals, academic institutions, and laboratories to screen for Coronavirus antibodies. The test kit was developed in collaboration with the Western Michigan University Homer Stryker M.D. School of Medicine to help protect health care workers during the Coronavirus outbreak.

Specifications

  • 99% Sensitivity and specificity

  • Gives information on COVID-19 Immunity

  • Analyzes short receptor binding domain (RBD) and the full-length Spike protein

  • Is relevant for long term reevaluation of exposed patients for more accurate epidemiological information

  • Can test up to 152 patients per kit

  • Requires a 20μl sample size

  • The kit is made in the United States

Coronavirus COVID-19 (SARS-CoV-2) Antibody Test Kit Overview

COVID-19 (SARS-CoV-2) Antibody Test Kit Background

In early 2020, Western Michigan University Homer Stryker M.D. School of Medicine contacted IONTOX, LLC to develop a sensitive and highly versatile SARS-CoV-2 antibody serological test. The result of this collaboration is an ELISA test that and allows clinical laboratories to screen for both the receptor binding domain (RBD) and the full spike protein. The test was developed using blood collected from pre-pandemic, COVID negative and those individuals who had COVID-19 and recovered. Samples from this latter group were collected 14 days after they tested negative for the virus (e.g. recovered). The company has completed a double blinded study and received a score of 99%. This means 99% sensitivity and specificity. The IONTOX test is specific for SARS-CoV-2. The test has outperformed both the Roche and Abbot tests and is considerably more informative. The test provides significant flexibility for test laboratories in that the ELISA plates have removable wells. The test also provides antibodies to IgG and IgM immunoglobulins. The test also enables testing laboratories and researchers to quantify SARS-CoV-2 antibody titer. This information is essential for understanding what stage of the disease the patient was in and for tracking population immunity (epidemiology). FDA approval is expected by July 2020.

Advantages of the IONTOX COVID-19 (SARS-CoV-2) 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. The kit includes secondary antibodies to IgG and IgM which means the end user can begin to understand early versus late exposure to COVID-19.

  • FDA Approval: Expected by July 2020

  • 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) Antibody Test Kit

  • 2 x 96 well test plates (one RBD and one Spike protein)

  • IgG antibodies (IgM antibodies optional)

  • 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

  • Timer

  • 96-well Polypropylene plates for dilutions

  • 15 and 50 mL sterile polypropylene conical tubes

  • Refrigerator

Overview of the IONTOX COVID-19 Coronavirus (SARS-CoV-2) Antibody ELISA Tests

Test Results and Clinical Significance
COVID-19 Coronavirus (SARS-CoV-2) Antibody ELISA Tests

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 ability to quantify IgG and IgM levels with SARS II Antibody allows the accumulation of important immunological data and immunity tracking in various populations.

Illustration Chart

Order Your Coronavirus COVID-19 (SARS-CoV-2) Antibody Test Kits

(For Hospitals, Academic Research and Clinical Laboratories)

COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit

The IONTOX Coronavirus COVID-19 (SARS-CoV-2) Antibody Test Kit is ELISA test kit that allows hospitals, academic institutions, and CLIA Certified Laboratories screen for Coronavirus antibodies. The test kit was developed in collaboration with the Western Michigan University Homer Stryker M.D. School of Medicine to help protect health care workers during Coronavirus outbreak.

Specifications

  • 99% Sensitivity and specificity

  • Gives information on COVID-19 Immunity

  • Analyzes short receptor binding domain (RBD) and the full-length Spike protein

  • Is relevant for long term reevaluation of exposed patients for more accurate epidemiological information

  • Can test up to 152 patients per kit

  • Requires a 20μl sample size

  • The kit is made in the United States

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.