COVID-19 Antibody Platforms: Determining Global Health Impact Robert 1Donald
1 Shaarbay ,
Amanda
1 Aguiló-Cuadra ,
and Barbara Zucker School of Medicine at Hofstra/Northwell
and Dr. Frances Santiago
1 Schwarz
Background
Methods
Results, Conclusions
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) is a new strain of the Coronavirus Family that is responsible for the COVID-19 pandemic. Given the success of the use of convalescent plasma (CP) in the management of other illnesses caused by members of the Coronavirus family in the past, namely SARS and MERS, questions have surfaced if CP could be effective in treating patients suffering severe reactions. Analysis of the effectiveness in treating SARS and MERS have shown that high levels of neutralizing antibodies helped prevent entry into host cells and when given early, helped reduce severe symptoms. In the case of SARS-COV-2, antibodies towards the S protein, responsible for mediating viral entry, could offer some protection and prevent viral entry. Therefore, measuring these neutralizing antibodies within CP could be beneficial in helping to establish guidelines for the use of CP in the context of COVID-19. Several antibody test platforms have been used by Northwell Health System and hospitals in Puerto Rico for screening CP to be given to patients. Companies are required to provide information regarding the sensitivity and specificity of their various testing platforms, but in-house validation is recommended to verify these claims. Northwell has conducted thorough in-house validation testing to substantiate claims and decide which antibody platforms to use or retire. Due to differences in access to resources and infrastructure, some hospitals might not have the ability to conduct in-house validation like Northwell. This could lead to healthcare disparities related to the quality of convalescent plasma, from an inability to effectively measure neutralizing antibodies present.
Information regarding COVID-19 antibody platforms used in Northwell and several hospitals in Puerto Rico were obtained through contacts within the health systems. In addition, data regarding sensitivity and specificity of the respective antibody tests were obtained from brochures published by each company. Focus was given exclusively to tests detecting IgG antibodies or total antibody content.
We were informed that tests were retired by Northwell based on in-house validation data and we are awaiting access to this data for review and analysis. Therefore, conclusion is pending.
Hypothesis
1. Health systems with more resources may have a greater ability to conduct in-house validation, thus identifying platforms whose company claims are inaccurate. 2. Differences in tests used across health systems may lead to health disparities related to Convalescent Plasma screening.
100.00
Comparison of Sensitivity and Specificity between Serologic Platforms in Northwell Health
Future Direction
95.00 90.00 85.00 80.00
Euroimmun Ortho Vitros Ortho Vitros (IgG) (Total Ab) RETIRED S1 Protein Sensitivity
100.00
DiaSorin
Ansh Labs RETIRED
Total S N+S Protein Protein Specificity
Abbott
Roche Total
N Protein
Comparison of Sensitivity and Specificity between Serologic Platforms in Puerto Rico
Resources
95.00 90.00
Brochures for Euroimmun, Ortho-VITROS (IgG and Total Ab), DiaSorin, Ansh Labs, Abbott, Roche Total, Abbott-Alinity, Roche-Elecsys, Beckman-Coulter, and Siemens-ADVIA Centaur
Figure 7: Independent CRISPR knockout of CDK4 or CDK6 does not cause dropout in most breast cancer cell lines 85.00 studied.
80.00
Once we receive access to the in-house validation data, we will compare it to data received from the various brochures to determine if discrepancies exist that affected the quality of CP used.
Abbo-Alinity(IgG) Roche-Elecsys Beckman Ortho-VITROS Siemens-ADVIA (IgG) Coulter- Access (IgG) Centaur (IgG) (IgG) N Protein
S1 Protein Sensitivity Sensitivity
Total S Protein
Cascella M, Rajnik M, Cuomo A, et al. Features, Evaluation and Treatment Coronavirus (COVID-19) [Updated 2020 Jul 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK554776/ Hung, Ivan FN, Kelvin KW To, Cheuk-Kwong Lee, Kar-Lung Lee, Kenny Chan, Wing-Wah Yan, Raymond Liu, et al. “Convalescent Plasma Treatment Reduced Mortality in Patients With Severe Pandemic Influenza A (H1N1) 2009 Virus Infection.” Clinical Infectious Diseases 52, no. 4 (February 15, 2011): 447–56. https://doi.org/10.1093/cid/ciq106.