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J Med Virol ; 93(4): 2160-2167, 2021 04.
Article in English | MEDLINE | ID: covidwho-866130


Plenty of serologic tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been developed so far, thus documenting the importance of evaluating the relevant features of the immune response to this viral agent. The performance of these assays is currently under investigation. Amongst them, LIAISON® SARS-CoV-2 S1/S2 IgG by DiaSorin and Elecsys Anti-SARS-CoV-2 cobas® by Roche are currently used by laboratory medicine hospital departments in Italy and many other countries. In the present study, we firstly compared two serologic tests on serum samples collected at two different time points from 46 laboratory-confirmed coronavirus disease-2019 (COVID-19) subjects. Secondly, 85 negative serum samples collected before the SARS-CoV-2 pandemic were analyzed. Thirdly, possible correlations between antibody levels and the resulting neutralizing activity against a clinical isolate of SARS-CoV-2 were evaluated. Results revealed that both tests are endowed with low sensitivity on the day of hospital admission, which increased to 97.8% and 100% for samples collected after 15 days for DiaSorin and Roche tests, respectively. The specificity evaluated for the two tests ranges from 96.5% to 100%, respectively. Importantly, a poor direct correlation between antibody titers and neutralizing activity levels was evidenced in the present study. These data further shed light on both potentials and possible limitations related to SARS-CoV-2 serology. In this context, great efforts are still necessary for investigating antibody kinetics to develop novel diagnostic algorithms. Moreover, further investigations on the role of neutralizing antibodies and their correlate of protection will be of paramount importance for the development of effective vaccines.

Antibodies, Viral/blood , COVID-19 Testing/methods , COVID-19/immunology , SARS-CoV-2/immunology , Serologic Tests/methods , Animals , Antibodies, Neutralizing , COVID-19/blood , COVID-19/epidemiology , COVID-19/virology , Chlorocebus aethiops , Humans , Immunoglobulin G/blood , Italy/epidemiology , Pandemics , Sensitivity and Specificity , Vero Cells
Acta Biomed ; 91(3): e2020003, 2020 09 07.
Article in English | MEDLINE | ID: covidwho-761227


BACKGROUND: The COVID-19 outbreak is now a pandemic disease reaching as much as 210 countries worldwide with more than 2.5 million infected people and nearly 200.000 deaths. Amplification of viral RNA by RT-PCR represents the gold standard for confirmation of infection, yet it showed false-negative rates as large as 15-20% which may jeopardize the effect of the restrictive measures taken by governments. We previously showed that several hematological parameters were significantly different between COVID-19 positive and negative patients. Among them aspartate aminotransferase and lactate dehydrogenase had predictive values as large as 90%. Thus a combination of RT-PCR and blood tests could reduce the false-negative rate of the genetic test. METHODS: We retrospectively analyzed 24 patients showing multiple and inconsistent RT-PCR, test during their first hospitalization period, and compared the genetic tests results with their AST and LDH levels. RESULTS: We showed that when considering the hematological parameters, the RT-PCR false-negative rates were reduced by almost 4-fold. CONCLUSIONS: The study represents a preliminary work aiming at the development of strategies that, by combining RT-PCR tests with routine blood tests, will lower or even abolish the rate of RT-PCR false-negative results and thus will identify, with high accuracy, patients infected by COVID-19.

Betacoronavirus/genetics , Coronavirus Infections/diagnosis , Pandemics , Pneumonia, Viral/diagnosis , RNA, Viral/analysis , Real-Time Polymerase Chain Reaction/methods , Adult , Aged , Aged, 80 and over , Aspartate Aminotransferases/blood , Biomarkers/blood , COVID-19 , Coronavirus Infections/blood , Coronavirus Infections/epidemiology , Diagnosis, Differential , False Negative Reactions , Female , Follow-Up Studies , Hematologic Tests/methods , Humans , Italy/epidemiology , L-Lactate Dehydrogenase/blood , Male , Middle Aged , Pneumonia, Viral/blood , Pneumonia, Viral/epidemiology , Reproducibility of Results , Retrospective Studies , SARS-CoV-2
Clin Chem Lab Med ; 58(7): 1095-1099, 2020 06 25.
Article in English | MEDLINE | ID: covidwho-72358


Objectives The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to date, the epidemic has gradually spread to 209 countries worldwide with more than 1.5 million infected people and 100,000 deaths. Amplification of viral RNA by rRT-PCR serves as the gold standard for confirmation of infection, yet it needs a long turnaround time (3-4 h to generate results) and shows false-negative rates as large as 15%-20%. In addition, the need of certified laboratories, expensive equipment and trained personnel led many countries to limit the rRT-PCR tests only to individuals with pronounced respiratory syndrome symptoms. Thus, there is a need for alternative, less expensive and more accessible tests. Methods We analyzed the plasma levels of white blood cells (WBCs), platelets, C-reactive protein (CRP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), γ-glutamyl transpeptidase (GGT), alkaline phosphatase and lactate dehydrogenase (LDH) of 207 patients who, after being admitted to the emergency room of the San Raffaele Hospital (Milan, Italy) with COVID-19 symptoms, were rRT-PCR tested. Of them, 105 tested positive, whereas 102 tested negative. Results Statistically significant differences were observed for WBC, CRP, AST, ALT and LDH. Empirical thresholds for AST and LDH allowed the identification of 70% of either COVID-19-positive or -negative patients on the basis of routine blood test results. Conclusions Combining appropriate cutoffs for certain hematological parameters could help in identifying false-positive/negative rRT-PCR tests. Blood test analysis might be used as an alternative to rRT-PCR for identifying COVID-19-positive patients in those countries which suffer from a large shortage of rRT-PCR reagents and/or specialized laboratory.

Biomarkers/blood , Coronavirus Infections/diagnosis , Hematologic Tests/methods , Pneumonia, Viral/diagnosis , Adult , Aged , Aged, 80 and over , Alanine Transaminase/analysis , Alanine Transaminase/blood , Alkaline Phosphatase/analysis , Alkaline Phosphatase/blood , Aspartate Aminotransferases/analysis , Aspartate Aminotransferases/blood , Betacoronavirus/pathogenicity , Blood Platelets , C-Reactive Protein/analysis , COVID-19 , Coronavirus Infections/blood , Female , Humans , Italy , L-Lactate Dehydrogenase/analysis , L-Lactate Dehydrogenase/blood , Laboratories , Leukocytes , Male , Middle Aged , Pandemics , Pneumonia, Viral/blood , RNA, Viral , Real-Time Polymerase Chain Reaction/methods , Retrospective Studies , SARS-CoV-2 , gamma-Glutamyltransferase/analysis , gamma-Glutamyltransferase/blood