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Riv. Ital. Med. Labor. ; 1(16): 7-17, 20200301.
Article in Italian | ELSEVIER | ID: covidwho-659439


COVID-19 infection (SARS-CoV-2) is a viral disease first encountered in Wuhan, China, in December 2019, then rapidly spreading around the world. During this current public health emergency of international concern, screening and diagnosing patients quickly in order to aid containment is a priority. Most of our knowledge on diagnostics comes from previous studies on SARSCoV. Since SARS-CoV-2 belongs to the same large family of viruses as those that cause the MERS and SARS outbreak, we could assume that its antibody generation process should be similar. The high contagiousness and the characteristics of high lethality of the epidemic require efficient diagnostics, able to quickly identify the sources of the infection. The identification of patients with active SARS-CoV-2 infection is currently based on the amplification of a viral genome sequence using molecular biology techniques (real-time polymerase chain reaction), which can be subsequently confirmed by gene sequencing. However, the variability linked to the execution of the swab and the limitations of the test (complexity, biosecurity levels, costs and long response times) makes molecular diagnostics unsuitable for use in the field. Consequently, new tools such as serological tests capable of tracking the virus through each phase of the disease are in great demand. Serological antibody tests are already being developed and have already been introduced to the market. To date, however, there is no robust scientific evidence on the clinical-diagnostic reliability of these tests which therefore, at the moment, cannot replace the molecular test. The few studies in the literature are of limited thickness, sometimes discordant with each other and conducted on a small scale mainly on the Chinese population. In the absence of specific references, there is an open debate on the best use of these serological tests and on the ideal moment of their execution. In this review we describe the main characteristics of the SARS-CoV-2 virus, the diagnostic molecular strategies available today, and the first experimental data on the determination of antibodies directed towards SARS-CoV-2.

J Med Virol ; 92(9): 1671-1675, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-116658


A pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been spreading throughout the world. Though molecular diagnostic tests are the gold standard for COVID-19, serological testing is emerging as a potential surveillance tool, in addition to its complementary role in COVID-19 diagnostics. Indubitably quantitative serological testing provides greater advantages than qualitative tests but today there is still little known about serological diagnostics and what the most appropriate role quantitative tests might play. Sixty-one COVID-19 patients and 64 patients from a control group were tested by iFlash1800 CLIA analyzer for anti-SARS CoV-2 antibodies IgM and IgG. All COVID-19 patients were hospitalized in San Giovanni di Dio Hospital (Florence, Italy) and had a positive oro/nasopharyngeal swab reverse-transcription polymerase chain reaction result. The highest sensitivity with a very good specificity performance was reached at a cutoff value of 10.0 AU/mL for IgM and of 7.1 for IgG antibodies, hence near to the manufacturer's cutoff values of 10 AU/mL for both isotypes. The receiver operating characteristic curves showed area under the curve values of 0.918 and 0.980 for anti-SARS CoV-2 antibodies IgM and IgG, respectively. iFlash1800 CLIA analyzer has shown highly accurate results for the anti-SARS-CoV-2 antibodies profile and can be considered an excellent tool for COVID-19 diagnostics.

Antibodies, Viral/immunology , COVID-19/diagnosis , COVID-19/immunology , Immunoassay , Immunoglobulin G/immunology , Immunoglobulin M/immunology , Luminescent Measurements , SARS-CoV-2/immunology , Aged , Aged, 80 and over , Antibodies, Viral/blood , Automation, Laboratory , COVID-19/virology , Female , Humans , Immunoassay/methods , Immunoassay/standards , Immunoglobulin G/blood , Immunoglobulin M/blood , Luminescent Measurements/methods , Luminescent Measurements/standards , Male , Middle Aged , ROC Curve , Reproducibility of Results , Sensitivity and Specificity