Beckman_Leader_Board
Sridhar Natarajan
Managing Director
Beckman Coulter Diagnostics (South West Asia)

Access SARS-CoV-2 IgG antibody assay

As the COVID-19 pandemic continues to evolve, on a positive note, the recovery rate in India is steeply rising and the mortality rate is sharply declining. This is testimony to the effective and prompt clinical management of COVID-19 cases in India.

As we enter Unlock 3.0 and eventually move to a lesser restricted lifestyle, the efforts are on in a calibrated manner to revive and reverse the U shaped economy inflicted due to the pandemic. With more sectors opening, the biggest challenge for policy makers is to balance the ongoing quest of economic recovery and the rise of new infections as a result of increased activities & relaxations.

One of the imperatives which goes a long way in averting a second wave of new infections, is ensuring safe workplace environments. Adoption of Sero Surveillance as recommended by ICMR using the SARS-CoV-2 IgG test will help employers to identify and segregate the percentage of employees who have been exposed to the COVID-19 virus and are now immunized from the ones who have not been exposed enabling employees to take decisions related to task allocation as an example in a Hospital, doctors and paramedical staff who have developed the IgG Antibodies can be posted in the COVID ward and the ones who are not exposed to the virus yet can be posted in the Non COVID ward .

Beckman Coulter R&D team worked meticulously to develop a highly sensitive and specific assay. With 100 percent positive percent agreement and 99.6 percent negative percent agreement, our test significantly reduces the risk for false positives, delivering the results that healthcare providers and their patients can trust.

A lot had been written about accuracy issues with the initially launched antibody tests, but a test at this level offers positive predictive values greater than 90 percent even in very low prevalence communities. And, in areas hardest hit by the virus, the positive predictive values of our assay are greater than 98 percent1,2.

Beckman Coulter’s Access SARS-CoV-2 IgG assay targets antibodies that recognize the receptor binding domain (RBD) of the spike protein which SARS-CoV-2 uses to bind to a human cell receptor. This is significant as antibodies which target the RBD have the potential to be neutralizing and thus prevent future infection by blocking the virus from entering the cell. It is for this reason many vaccine developers are also targeting the RBD of the spike protein in their vaccine development3.

We anticipate that understanding the immune status of communities and convalescent plasma donation will play important roles in the fight against COVID-19 before a vaccine is widely available. While there is more to learn regarding how long an individual’s immune response to the SARS-CoV-2 virus lasts, this test may be crucial to determining the portion of the population that may already be immune.

Our assay can be utilized in a variety of healthcare settings, including central laboratories, as well as smaller clinics and hospitals in underserved communities with a range of Beckman Coulter immunoassay analyzers. This accessibility is vital to ensuring all communities, including rural and urban have access to this testing and answers they can trust.

References:

At 3.5 percent prevalence rate, PPV is 90.1 percent; at 16 percent prevalence rate PPV is 97.9 percent. When equivocal results are excluded, a 2 percent prevalence rate yields a 91.1 percent PPV and a 16 percent prevalence rate yields 99 percent PPV.

Koenig, D. Evidence Mounts for Greater COVID Prevalence, WebMD, https://www.webmd.com/lung/news/20200424/more-data-bolsters-higher-covid-prevalence

Grifoni, A., et al., Targets of T cell responses to SARS-CoV-2 coronavirus in humans with COVID-19 disease and unexposed individuals, Cell (2020), prepublication, doi: https://doi.org/10.1016/j.cell.2020.05.015 

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