Analytical Performance of COVID-19 Detection Methods (RT-PCR): Scientific and Societal Concerns
Roberto Verna,
Walter Alallon,
Masami Murakami,
Catherine P. M. Hayward,
Abdel Halim Harrath,
Saleh H. Alwasel,
Nairo M. Sumita,
Ozkan Alatas,
Valeria Fedeli,
Praveen Sharma,
Andrea Fuso,
Daniela Maria Capuano,
Maria Capalbo,
Antonio Angeloni,
Mariano Bizzarri
Affiliations
Roberto Verna
In Unam Sapientiam, 00185 Rome, Italy
Walter Alallon
Department of Clinical Laboratory, Hospital de Clínicas, Facultad de Medicina, Universidad de la República, Montevideo 11000, Uruguay
Masami Murakami
Department of Clinical Laboratory Medicine, Gunma University Graduate School of Medicine, 3-39-15 Showa-Machi, Maebashi 371-8511, Japan
Catherine P. M. Hayward
Health Science Center, Departments of Pathology and Molecular Medicine, and Medicine, Room 2N29A, McMaster University, 1200 Main Street West, Hamilton, ON L8N 3Z5, Canada
Abdel Halim Harrath
Department of Zoology, College of Science, King Saud University, Riyadh 11451, Saudi Arabia
Saleh H. Alwasel
Department of Zoology, College of Science, King Saud University, Riyadh 11451, Saudi Arabia
Nairo M. Sumita
Grupo Fleury, Central Laboratory Division, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo 05508, Brazil
Ozkan Alatas
Department of Medical Biochemistry, Eskisehir Osmangazi University Medical School, Eskisehir 33400, Turkey
Valeria Fedeli
Department of Experimental Medicine, Sapienza University, 00160 Rome, Italy
Praveen Sharma
Department of Biochemistry, All India Institute of Medical Sciences, Jodhpur 342005, India
Andrea Fuso
Department of Experimental Medicine, Sapienza University, 00160 Rome, Italy
Daniela Maria Capuano
WASPaLM, CT Corporation, P.O. Box 4349, Carol Stream, IL 60197-4349, USA
Maria Capalbo
Azienda Ospedaliera Ospedali Riuniti Marche Nord (DG), 61121 Pesaro, Italy
Antonio Angeloni
Department of Experimental Medicine, Sapienza University, 00160 Rome, Italy
Mariano Bizzarri
Department of Experimental Medicine, Sapienza University, 00160 Rome, Italy
Background. Health and social management of the SARS-CoV-2 epidemic, responsible for the COVID-19 disease, requires both screening tools and diagnostic procedures. Reliable screening tests aim at identifying (truely) infectious individuals that can spread the viral infection and therefore are essential for tracing and harnessing the epidemic diffusion. Instead, diagnostic tests should supplement clinical and radiological findings, thus helping in establishing the diagnosis. Several analytical assays, mostly using RT-PCR-based technologies, have become commercially available for healthcare workers and clinical laboratories. However, such tests showed some critical limitations, given that a relevant number of both false-positive and false-negative cases have been so far reported. Moreover, those analytical techniques demonstrated to be significantly influenced by pre-analytical biases, while the sensitivity showed a dramatic time dependency. Aim. Herein, we critically investigate limits and perspectives of currently available RT-PCR techniques, especially when referring to the required performances in providing reliable epidemiological and clinical information. Key Concepts. Current data cast doubt on the use of RT-PCR swabs as a screening procedure for tracing the evolution of the current SARS-COV-2 pandemic. Indeed, the huge number of both false-positive and false-negative results deprives the trustworthiness of decision making based on those data. Therefore, we should refine current available analytical tests to quickly identify individuals able to really transmit the virus, with the aim to control and prevent large outbreaks.
