How will the new Beckman Coulter test be used in the fight against COVID-19?

 

The purpose of the Access SARS-CoV-2 IgG assay is to determine if a patient was exposed to COVID-19 and has potentially developed an immune reaction to SARS-CoV-2.

The recommended method to diagnose a COVID-19 infection is a molecular diagnostic PCR test based on the detection of the virus RNA,

 Antibody assays play a critical role in:

1- Tracking the spread of the virus

2- Identifying individuals that have recovered from COVID-19 infection

3- Potentially identifying individuals no longer susceptible to the virus who can return to work

4- Identifying individuals who may donate a part of their blood called convalescent plasma, which may serve as a possible treatment for those seriously ill

5- Identifying those who require a vaccine once available.

 

 

 

 

There are a lot of rapid tests in the market right now. How are these tests different from the one Beckman Coulter is going to produce?

 

 

There are a lot of rapid tests in the market right now.

 

How are these tests different from the one Beckman Coulter is going to produce?

 

Diagnostic and serology tests are complementary as one is used in infectious patients—mostly those with symptoms (diagnostic)—and one is used to determine immune response (antibody, or serology).

The readily available serology tests are lateral flow assays. In general, lateral flow assays are qualitative, single-test assays. Our test will be a high-throughput immunoassay laboratory test that can be integrated in an automated workflow, regardless of the size of the laboratory.

 

 

 

How soon after contracting COVID-19 could this test be used to identify immunity in an asymptomatic person?

 

The Access SARS-CoV-2 IgG assay can be used 14–20 days after the infection.

However, the time it takes could vary from individual to individual, virus to virus, and assay to assay.

 

 

 

What is the potential clinical usage of a serology assay for SARS-CoV-2?

Serology tests like the Access SARS-CoV-2 IgG assay can detect if an individual has been exposed to the virus—even if they had no symptoms—and if the individual has potentially developed an immune response by creating antibodies to the virus.

 

How does the Beckman Coulter assay work?

The principle of the assay is to immobilize the virus antigens using magnetic particles to capture IgG antibodies in patient samples and reveal them using labeled anti-IgG antibodies.

 

Is the test qualitative or quantitative?

The Access SARS-CoV-2 IgG assay is designed as a qualitative immunoassay.

 

What type of samples can be used?

A serum or plasma specimen may be used.

 

 

 

With the Beckman Coulter Access SARS-CoV-2 IgG assay, is any additional maintenance on the instrument before or after running the assay required? Do I need to collect and batch samples?

No, the Access SARS-CoV-2 IgG assay is a random-access assay. No batching and no special maintenance is necessary.

 

What is the difference between a SARS-CoV-2 IgG assay developed with an antigen target of the nucleocapsid protein in comparison to an assay developed against the spike protein?

Beckman Coulter in an effort of providing direct detection of antigens developed specifically to SARS-CoV-2 chose as an antigen target the proteins of the receptor-binding domain (RBD) of the coronavirus spike protein S1.

In the study, “Detection of SARS-CoV-2-specific humoral and cellular immunity in COVID-19 convalescent individuals”1, researchers tested sera from COVID-19 patients who had recently become virus-free, and were discharged from the hospital. They detected SARS-CoV-2-specific humoral and cellular immune response – specifically they saw antibodies specific to the receptor-binding domain of the coronavirus spike protein (S-RBD) indicating a significant correlation between neutralizing antibody titers and anti-S-RBD IgG. Researchers observed no such correlation with anti-nucleocapsid protein IgG and concluded that, “Anti-S-RBD IgG might be useful in analyzing serum neutralization capabilities in COVID-19 patients.”²

Furthermore, researchers noted that S-RBD seemed to induce a greater immune cell response. This observation suggests that S-RBD may be a promising target for both serology tests and vaccines to SARS-CoV-2, which could help individuals build humoral immunity or cellular immunity to this disease.

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