Abstract
On March 12, the World Health Organization declared a pandemic following the exponential increase of SARS-CoV-2 cases. The rapid spread of the virus is due to both its high infectivity and the free circulation of unrecognized infectious cases. Thus, diagnostic testing is a key element to prevent further dissemination of the virus. Urged by WHO's call, laboratories worldwide have been working on nucleic acid tests protocols and immunoassays that became available, albeit poorly validated, within a comparatively short time. Since then, external studies evaluating these diagnostic tests have been published. The present study is a review of the COVID-19 diagnostic approaches, discussing both direct and indirect microbiological diagnoses. A compendium of the literature on commercial assays kits available to date is provided together with the conclusions drawn as well as RT-PCR protocols published by the WHO. Briefly, diagnostic accuracy varies according to time elapsed since symptom onset and evolves together with understanding of the COVID-19 disease. Taking into account all these variables will allow determining the most adequate diagnostic test to use and how to optimize diagnostic testing for COVID-19.
Highlights
In December 2019, Chinese authorities reported an outbreak of cases of pneumonia of unknown etiology in Wuhan, China, of unknown cause
Based on the current evidence and what has been learned to date about the infectivity and physiopathology of the virus, as well as the kinetics profile of the specific antibodies to severe acute respiratory syndrome (SARS)-CoV-2, we provide suggestions on how to optimize diagnostic testing for COVID-19 and the usefulness of antibody detection
Since the beginning of the pandemic, 7 different in-house developed molecular assays protocols (RT-PCR) have been posted on the World Health Organization (WHO) website [25]. These protocols have been elaborated by different investigation centers: Hospital Charité (Berlin, Germany) [26, 27], Hong-Kong University-Faculty of Medicine (HKU Med) (Hong-Kong, China) [28], Center for Disease Control of China (China Centers for Disease Control and Prevention (CDC)) [29], Institut Pasteur (Paris, France) [30], Center for Disease Control of USA (US CDC) (Atlanta, USA) [31], National Institute of Infectious Diseases (Tokyo, Japan) [32], and the National Institute of Health (Bangkok, Thailand) to guide laboratories involved in testing SARS-CoV-2 worldwide [33]
Summary
In December 2019, Chinese authorities reported an outbreak of cases of pneumonia of unknown etiology in Wuhan, China, of unknown cause. Characterization of the disease in a cluster of reported cases of pneumonia was associated with the spread of a novel coronavirus named SARSCoV-2 [1]. The rapid increase of Coronavirus Disease 2019 (COVID-19) cases, already being reported outside the Asian continent and evidence of human-to-human transmission, led to the declaration of a pandemic by the World Health Organization (WHO) on March 12th, 2020 [2, 3]. A race to develop and distribute reliable diagnostic assays has been encouraged by World Health Organization [6]. Like SARS-CoV, the novel CoV belongs to the Betacoronavirus genus, subgenus Sarbecovirures [14]
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