Pooling strategy in the wake of the COVID-19 pandemic: A solution for mass population screening of SARS-CoV-2

A rapid, cheap and reliable pooling strategy for screening of SARS-CoV-2 for maximization of available RT-PCR testing kits and resources in the COVID-19 pandemic, reports The Journal of Molecular Diagnostics


Philadelphia, July 30, 2020

In a report in The Journal of Molecular Diagnostics, published by Elsevier, researchers at Augusta University and PerkinElmer Genomics describe a cheaper, rapid and accurate pooling strategy for the RT-PCR–based detection of SARS-CoV-2 in clinical samples. This assay has a significant impact on large-scale population screening in the wake of the current COVID-19 pandemic.

The COVID-19 pandemic has caused a massive strain on global healthcare systems, governance and economies. Testing for SARS-CoV-2 has lagged in many countries due to various bottlenecks including, but not limited to, the failure of the reagent supply chain, lack of adequate test kits and hindrances in the analytical and regulatory processes.

“We have proposed a mass population screening approach based on sample pooling strategy for rapid and wide-scale population screening that may be adopted by laboratories currently using RT-PCR–based methods to test for SARS-CoV-2,” explained Ravindra Kolhe, MD, PhD, Vice-Chair for Translational Research in the Department of Pathology, Medical College of Georgia, Augusta University, Augusta, GA, USA.

According to Dr. Kolhe, this strategy would lead to an approximately 5- to 10-fold reduction in the cost of testing of SARS-CoV-2. PerkinElmer’s FDA-EUA (Emergency Use Authorization) RT-PCR kit for SARS-CoV-2 detection (with a limit of detection of 5-20 copies/mL) has been implemented in the laboratory by Dr. Kolhe since March 2020.

Flowchart illustrating the cost-effective and rapid workflow of the pooling strategy for screening of SARS-CoV-2 in clinical samples for mass population screening.
The cost-effective and rapid workflow of the pooling strategy for screening of SARS-CoV-2 in clinical samples for mass population screening. Credit: The Journal of Molecular Diagnostics.

The investigators analyzed approximately 1,000 samples using this pooled sampling approach and achieved 91.6 percent PPA (positive percent agreement) and 100 percent NPA (negative percent agreement) compared to the routine screening approach. The study demonstrates the clinical utility and accuracy of sample pooling strategy and presents a carefully planned layout for mass population testing that can be executed by laboratories using RT-PCR–based methods for detecting SARS-CoV-2. The proposed methodology has the potential to allow institutions to ramp up their testing needs in a cost-efficient manner with minimal turnaround times. This testing allows for the timely isolation and treatment of COVID-19–positive patients, specifically in populations with a lower prevalence of the disease, for example, screening large numbers of students returning to college campuses.

“In terms of cost analysis, one million individuals can be tested for around US$9.1 million with the proposed mass population screening approach compared to approximately US$58 million with current routine diagnostic methods. These cost projections highlight significant savings of healthcare dollars that could be achieved in both high- and low/middle-income countries,” said Amyn Rojiani, MD, PhD, Chair of the Department of Pathology, Augusta University, Augusta, GA, USA. The global impact of these enormous savings has the potential to enhance laboratory operations throughout the pandemic and can be deployed to laboratories that are facing dire constraints in supplies.

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Notes for editors
The article is “Proposal of RT-PCR–Based Mass Population Screening for SARS-CoV-2 (COVID-19),” by Nikhil Shri Sahajpal, Ashis K. Mondal, Allan Njau, Sudha Ananth, Kimya Jones, Pankaj K. Ahluwalia, Meenakshi Ahluwalia, Yasmeen Jilani, Alka Chaubey, Madhuri Hegde, Vamsi Kota, Amyn Rojiani, and Ravindra Kolhe (https://doi.org/10.1016/j.jmoldx.2020.07.001). It will appear in The Journal of Molecular Diagnostics, volume 22, issue 10 (October 2020) published by Elsevier.

It is openly available at https://jmd.amjpathol.org/article/S1525-1578(20)30407-4/fulltext.

Full text of this study is also available to credentialed journalists upon request; contact Eileen Leahy at +1 732 238 3628 or jmdmedia@elsevier.com. Journalists wishing to interview the authors should contact Ravindra Kolhe at rkolhe@augusta.edu.

Elsevier’s Novel Coronavirus Information Center provides the latest early stage and peer-reviewed research on the novel coronavirus and COVID-19. All resources are free to access and include guidelines for clinicians and patients. The Information Center links to the Coronavirus Hub on ScienceDirect, with more than 37,000 articles relevant to coronavirus, SARS, and MERS freely available. The center also links to a Healthcare Hub with resources for clinicians treating COVID-19 patients. www.elsevier.com/connect/coronavirus-information-center

About The Journal of Molecular Diagnostics
The Journal of Molecular Diagnostics, the official publication of the Association for Molecular Pathology, co-owned by the American Society for Investigative Pathology, and published by Elsevier, seeks to publish high quality original papers on scientific advances in the translation and validation of molecular discoveries in medicine into the clinical diagnostic setting, and the description and application of technological advances in the field of molecular diagnostic medicine. The editors welcome review articles that contain: novel discoveries or clinicopathologic correlations, including studies in oncology, infectious diseases, inherited diseases, predisposition to disease, or the description of polymorphisms linked to disease states or normal variations; the application of diagnostic methodologies in clinical trials; or the development of new or improved molecular methods for diagnosis or monitoring of disease or disease predisposition. jmd.amjpathol.org

About Elsevier
Elsevier is a global information analytics business that helps scientists and clinicians to find new answers, reshape human knowledge, and tackle the most urgent human crises. For 140 years, we have partnered with the research world to curate and verify scientific knowledge. Today, we’re committed to bringing that rigor to a new generation of platforms. Elsevier provides digital solutions and tools in the areas of strategic research management, R&D performance, clinical decision support, and professional education; including ScienceDirect, Scopus, SciVal, ClinicalKey and Sherpath. Elsevier publishes over 2,500 digitized journals, including The Lancet and Cell, 39,000 e-book titles and many iconic reference works, including Gray's Anatomy. Elsevier is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers. www.elsevier.com

Media contacts
Eileen Leahy
Elsevier
+1 732 238 3628
jmdmedia@elsevier.com

Chhavi Chauhan, PhD, Director of Scientific Outreach
The Journal of Molecular Diagnostics
+1 240 283 9724
cchauhan@asip.org