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Successful implementation of SARS-CoV-2 testing in midst of pandemic with emphasis on all phases of testing
  1. Jeffrey Ming Petersen1,2,
  2. Sharvari Dalal1,2,
  3. Darshana Jhala1,2
  1. 1 Department of Pathology and Laboratory Medicine, Corporal Michael J Crescenz VA Medical Center, Philadelphia, Pennsylvania, USA
  2. 2 Department of Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
  1. Correspondence to Dr Darshana Jhala, Department of Pathology and Laboratory Medicine, Corporal Michael J Crescenz VA Medical Center, Philadelphia, PA 19104, USA; darshana.jhala{at}va.gov

https://doi.org/10.1136/jclinpath-2020-207175

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    Introduction

    From its humble beginnings as a zoonotic coronavirus infection originating in Wuhan, China, the SARS-CoV-2 virus has spread worldwide to become an international pandemic.1–3 The World Health Organization (WHO), given the highly contagious and potentially lethal nature of this widespread virus, has classified this pandemic as a global health emergency, with significant impact and infection within the USA.2

    The extraordinary circumstances of the highly contagious SARS-CoV-2 pandemic have led the Food and Drug Administration (FDA) to approve diagnostic assays for SARS-CoV-2 infection with emergency use authorisations (EUA).4 5 The use of EUA assays for a widespread pandemic in the absence of any non-EUA approved equivalent assays has led to an unprecedented situation for the clinical laboratory for which practical considerations of dealing with the aftermath have been described at a hospital in Singapore and in an abstract poster presentation of this manuscript’s data at the 2020 national meeting of the American Society for Clinical Pathology.5 6 However, a description of the practical considerations has not been similarly well described for the severely affected USA or even for that matter within its large and integrated Veterans Affairs Medical System Center (VAMC).

    Challenges

    Given the emergency requiring implementation of an in-house SARS-CoV-2 test to ensure adequate turnaround times (to allow clinical decisions to be influenced in a timely manner), several challenges arose. Initial challenges summarised in the valley of successful implementation (figure 1) included (1) selection of the testing platform(s), (2) ensuring that sufficient viral transport media (VTM) and reagent would be available for the selected testing platforms, (3) validating and composing standard operating procedures for assays despite the limited data presented by the EUA situation, (4) ensuring enough trained staff and (5) ensuring an appropriate environment with the appropriate biosafety level (BSL). As testing was being performed, additional …

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    Footnotes

    • Handling editor Tahir S Pillay.

    • Presented at Data from this manuscript presented as a virtual poster at the American Society for Clinical Pathology National Conference on 9 September 2020 to 12 September 2020 (see references 5 and 10).

    • Contributors All authors contributed to the manuscript.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.