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Editor-in-chief
Maria Stella Graziani

Deputy Director
Martina Zaninotto

Associate Editors
Ferruccio Ceriotti
Davide Giavarina
Bruna Lo Sasso
Giampaolo Merlini
Martina Montagnana
Andrea Mosca
Paola Pezzati
Rossella Tomaiuolo
Matteo Vidali

EIC Assistant
Francesco Busardò

International Advisory Board Khosrow Adeli Canada
Sergio Bernardini Italy
Marcello Ciaccio Italy
Eleftherios Diamandis Canada
Philippe Gillery France
Kjell Grankvist Sweden
Hans Jacobs The Netherlands
Eric Kilpatrick UK
Magdalena Krintus Poland
Giuseppe Lippi Italy
Mario Plebani Italy
Sverre Sandberg Norway
Ana-Maria Simundic Croatia
Tommaso Trenti Italy
Cas Weykamp The Netherlands
Maria Willrich USA
Paul Yip Canada


Publisher
Biomedia srl
Via L. Temolo 4, 20126 Milano

Responsible Editor
Giuseppe Agosta

Editorial Secretary
Chiara Riva
Biomedia srl
Via L. Temolo 4, 20126 Milano
Tel. 0245498282
email: biochimica.clinica@sibioc.it

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ISSN print: 0393 – 0564
ISSN digital: 0392- 7091



Articoli con TAG: SARS-CoV-2

SARS-CoV-2 e la nuova era dei vaccini - Parte I: Introduzione sulle tipologie dei vaccini e sui loro meccanismi di azione
SARS-CoV-2 and the new era of vaccines - Part I: Introduction to the available vaccine platforms and their mechanism of action
<p>The introduction of vaccination programs aiming at inducing an active immune response against pathogens dates back to the first experimental approaches at the end of the 18th century and, since then, has represented a turning point in public health measures to contrast infections. The scientific improvements of the last few years in the field of molecular biology, immunology and genetic engineering have allowed to design new vaccines able to solve, at least in part, the hurdles of conventional vaccine platforms. From the first vaccines based on the inoculation of the whole microorganism, the scientific research has gone in the direction of platforms able to carry only a few or even a single antigenic component of the pathogen, ranging from subunit vaccines to those based on mRNA or DNA. This achievement has made vaccines easier and quicker to develop and, above all, much safer, and it has involved scientific fields that extend far beyond the attempt to fight infectious diseases, such as cancer research. The purpose of this review is to present an overview of the currently available vaccine platforms, their mechanism of action, and the advantages and pitfalls behind each approach.</p>
Biochimica Clinica ; 17(1)
Rassegne - Reviews
 
SARS-CoV-2 e la nuova era dei vaccini – Parte II: I vaccini oggi in uso per contrastare la pandemia da COVID-19 e il ruolo del laboratorio nella campagna vaccinale
SARS-CoV-2 and the new era of vaccines – Part II Currently available vaccines to fight the COVID-19 pandemic and the laboratory role in the vaccination campaign
<p>The COVID-19 pandemic has prompted an unprecedented race to find the means to contrast the SARS-CoV-2 infection, resulting in a huge common effort to develop an efficacious vaccine as soon as possible and an exceptional acceleration of the review process to ensure its safety and efficacy. Many technological platforms are currently under investigation or have already been approved, including those based on the inactivated virus, mRNA- or DNA-based vaccines expressing viral antigens, recombinant SARS-CoV-2 proteins and vector-based vaccines exploiting chimeric adenoviruses. The emergence of new viral variants has represented ad additional challenge and has induced the entire scientific community to potentiate the monitoring process of the ongoing vaccination campaigns. In this scenario, laboratory medicine certainly plays a pivotal role not only in the diagnosis of the infection but also in monitoring the immune response to vaccines and in the detection and prevention of clinically significant adverse events, ultimately contributing to the determination of the biological and clinical efficacy of the available vaccines. This review offers an overview of the most recent and updated data on anti-SARS-CoV-2 vaccines and the technological principles behind them as well as on the resources that laboratory medicine can offer to support the vaccination campaigns. All these aspects represent a rapid step forward in the clinical field which transcends the COVID-19 outbreak and that will certainly pave the way for the future scientific research.</p>
Biochimica Clinica ; 17(1)
Rassegne - Reviews
 
Presentazione del Supplemento
Biochimica Clinica ; 44(4) 000-000
COVID-19 - COVID-19
 
Il valore della medicina di laboratorio nella pandemia da SARS-CoV-2
The value of laboratory medicine in SARS-CoV-2 outbreak
<p>Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) represents a challenge to all heathcare systems. It represents, however, a formidabile opportunity to highlight the value of laboratory medicine. Laboratory tests, in fact, play a key role in allowing the etiological diagnosis thanks to the reverse transcription-plymerase chain reaction (rRT-PCR) to detect the virus in nasopharingeal specimes as well as in other samples collected by using a flocked swab. The second essential contribution that laboratory tests are providing encompasses staging, prognostication and therapeutic monitoring of COVID-19. Finally, serological tests play a central role for surveillance purposes, for using plasma containing antibodies from recovered patients as experimental treatment and for better understanding the immune response to SARS-CoV-2 to eventually address vaccine developments.</p>
Biochimica Clinica ; 44(4) 001-002
COVID-19 - COVID-19
 
Guida sintetica alla diagnostica della malattia da coronavirus 2019 (COVID-19)
Concise guide to coronavirus disease 2019 (COVID-19) diagnostics
<p>Several months after its emergence, the coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is still prepotently disrupting health, societies and economies worldwide. The current approach for diagnosing SARS-CoV-2 remains based on identification of viral RNA by means of molecular biology techniques in upper or lower respiratory tracts specimens. Nevertheless, the development of immune response against the virus may also provide valuable diagnostic information. The paradigmatic kinetics of anti-SARS-CoV-2 antibodies in patients with COVID-19 would allow to conclude that serological testing shall not replace viral RNA detection in diagnosing acute SARS-CoV-2 infection, but may instead remain an essential tool for identifying patients who have been infected and have developed an immune response, as well as for monitoring the progress of herd immunity. For this purpose, the choice of the antigens used for constructing the immunoassays appears critical, as these shall use epitopes towards which neutralizing antibodies could be generated. Other important aspects in serological testing encompass the absence of cross-reactivity with other coronaviruses, the ability to distinguish the antibody class (i.e. IgG, IgA and/or IgM), quantitative assessment, wide range of linearity and low imprecision at diagnostic thresholds. A finalaspect, almost essential for both clinical and public health purposes, is the evidence of analytical and clinical validation before each method enters clinical practice.</p>
Biochimica Clinica ; 44(4) 003-004
COVID-19 - COVID-19
 
Mortalità da COVID-19: una epidemia senza denominatore. Ma conosciamo il numeratore?
COVID-19 death rate: an epidemic without a denominator. But what do we know about the numerator?
<p>Since many COVID-19 patients display few, if any, symptoms, assessing infection rate, hospitalization rate, and mortality rate is very challenging. Not only we do not know the denominator of these ratios, but in assessing the mortality rate, we also have problems to estimate the numerator. Between March and April 2020, Italy recorded 42633 excess deaths compared to the average of the five previous years. In the same period, 27 846 deaths were classified as due to COVID-19. Since the international definition of a COVID-19 case requires a microbiological confirmation of the presence of the virus, 34.7% of the excess deaths remain unexplained. Part of these may be COVID-19 deaths, left unconfirmed for the lack of a microbiological swab; but further deaths may be caused by delayed care of other diseases, due to the reluctance of many patients to visit the hospitals during the pandemic. The same apparent underestimation of COVID-19 deaths emerges for other European countries, with more evident differences in the United Kingdom and in the Netherlands. In other countries, the number of excess deaths is lower than the average of the previous years, probably due to a delay in recording deaths. In conclusion, we have uncertainty about the real number of victims of this pandemic; we will improve our knowledge when numbers will be no longer provisional, but there are areas where it is impossible to get the perfect assessment; however these figures are rather important to better face a possible further epidemic wave.</p>
Biochimica Clinica ; 44(4) 005-006
COVID-19 - Opinions
 
Iper-infiammazione e squilibrio del sistema renina-angiotensina-aldosterone in corso di COVID-19: una nuova ipotesi per il sospetto clinico di ipercoagulabilità e immuno-trombosi microvascolare
Hyperinflammation and derangement of renin-angiotensin-aldosterone system in COVID-19: A novel hypothesis for clinically suspected hypercoagulopathy and microvascular immunothrombosis.
<p>Early clinical evidence suggests that severe cases of coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), are frequently characterized by hyperinflammation, imbalance of renin-angiotensin-aldosterone system, and a particular form of vasculopathy, thrombotic microangiopathy, and intravascular coagulopathy. In this paper, we present an immunothrombosis model of COVID-19. We discuss the underlying pathogenesis and the interaction between multiple systems, resulting in propagation of immunothrombosis, which through investigation in the coming weeks, may lead to both an improved understanding of COVID-19 pathophysiology and identification of innovative and efficient therapeutic targets to&nbsp;reverse the otherwise unfavorable clinical outcome of many of these patients.</p>
Biochimica Clinica ; 44(4) 007-008
COVID-19 - COVID-19
 
Diagnosi del diabete gestazionale durante l’emergenza COVID-19: semplificazione del protocollo
Biochimica Clinica ; 44(4) 009-010
COVID-19 - COVID-19
 
Importanza dello screening per il deficit di G6PD durante l’emergenza COVID-19
Screening for G6PD deficit during COVID-19 emergency
<p>Hydroxychloroquine, a well known anti-malaria drug, is now widely used in the early treatment of patients infected with SARS-CoV-2. Since chloroquine and its derivatives may cause an acute hemolytic crisis in subjects with glucose 6-phoshpate dehydrogenase (G6PD) deficiency, with different penetrance in men and in women, we recommend that: a) before using these drugs, especially in elderly subjects, the G6PD catalytic activity should be quantitatively estimated; b) all the G6PD deficient subjects treated with chloroquine and its derivatives have to be characterized at molecular level, in order to identify G6PD deficient subjects in their families; c) to be on the safe side, the use of hydoxycholoroquine or chloroquine in carriers of severe G6PD deficiency, and infected by SARS-CoV-2, should be avoided; if treated, the patients should be alerted on the possible hemolytic risks, and care should be paid to the best laboratory indicators of such episodes (whole blood cell count, serum bilirubin, serum LDH, and hemoglobinuria).</p>
Biochimica Clinica ; 44(4) 011-012
COVID-19 - COVID-19
 
COVID-19 e coagulazione: un legame indissolubile
Biochimica Clinica ; 44(4) 013-014
COVID-19 - COVID-19
 
Alterazioni dei meccanismi dell’emostasi in corso di infezione da SARS-CoV-2 (COVID-19)
Alterations of hemostasis during SARS-CoV-2 infection (COVID-19)
<p>The corona virus infection (named COVID-19), first identified in December 2019 in Wuhan, China, has contributed to significant mortality in several countries with the number of infected cases increasing exponentially worldwide, in particular in Italy and in the USA. The majority of the most severely ill patients initially presents with single organ failure (i.e. severe respiratory syndrome), but some of them progress to more systemic disease and multiple organ failure (MOF). One of the most significant poor prognostic features in these patients is the development of coagulopathy, similarly to patients who develop sepsis from various infectious agents. Coagulopathy in patients with COVID-19 may be asymptomatic but, in some cases, the septic state may evolve into Sepsis-Induced Coagulopathy (SIC) and overt Disseminated Intravascular Coagulopathy (DIC). In patients with severe clinical manifestations, a cytokine storm occurs that contributes to triggering a greater imbalance of the hemostatic mechanisms by promoting the development of microthrombosis at the level of the pulmonary endothelium. The effectiveness of anticoagulant therapies, performed primarily with low-molecular weight heparin, is greater the earlier the diagnosis is made. This is possible through the adoption of diagnostic protocols that include laboratory tests and clinical scores. The laboratory tests suggested for this purpose by the available Guidelines are prothrombin time, platelet count, D-dimer and fibrinogen. D-dimer appears to be the parameter with the greatest prognostic significance since it also allows a stratification of the thrombotic risk.</p>
Biochimica Clinica ; 44(4) 015-016
COVID-19 - COVID-19
 
Il ruolo del laboratorio di coagulazione nel monitoraggio del trattamento eparinico dei pazienti con COVID-19
The role of laboratory monitoring in heparin treatment of COVID-19 patients
<p>Coronavirus disease 2019 (COVID-19) can be associated with serious clinical complications such as acute respiratory distress syndrome (ARDS), sepsis and multiple organ failure (MOF). A key event in the pathophysiology of ARDS is immunothrombosis, a process initiated by the innate immune system that provides a first line of defense for local control of infection. In its physiological form, immunothrombosis is intended to facilitate the recognition, containment and destruction of pathogens, thus protecting the integrity of the host without inducing significant collateral damage. The cytokine storm that occurs during COVID-19 induces often venous and arterial thrombotic events affecting different organs, not limited to the respiratory system. It is therefore necessary to introduce an anticoagulant treatment in patients with COVID-19 to prevent the onset and the extension of thrombotic events. The low molecular weight heparin (LMWH) is the first-choice drug recommended by the main international scientific societies; alternatively, unfractionated heparin (UFH) or fondaparinux can be used. The dosage of these drugs in patients with COVID-19 is still under discussion. The coagulation testing plays an important role in monitoring the efficacy and safety of UFH treatment; in the case of LMWHs, these usually do not require monitoring but, if alterations of renal function occur, it is important to perform the chromogenic determinations of the anti-Xa activity, paying a particular attention to the timing of sampling, the pre-analytical variables, calibration of the test and reference ranges.</p>
Biochimica Clinica ; 44(4) 017-018
COVID-19 - COVID-19
 
Al “cuore” del quadro clinico di COVID-19
To the “heart” of the clinical picture of COVID-19
<p>Several studies document cardiac involvement in COVID-19 patients, as evidenced by cardiac biomarkers elevation. Hospitalized patients with cardiac involvement have a poorer prognosis, in terms of need for intensive care unit, or mortality. This paper provides a review of the wealth of literature on heart involvement in COVID 19. The majority of the available papers reports data from the Chinese experience and it is not clear at the moment whether the observations are related to really different populations of patients. The mechanism of the cardiac injury is likely multifactorial. There could be direct myocardial damage by the virus, but the few heart histologic specimens available do not evidence the presence of virus RNA in myocytes. The infection in the lungs may produce a cytokine storm which in turn could damage myocytes. Coagulation system is also affected by COVID-19: D-dimer is increased, while platelets are reduced in most studies, and both parameters relate directly with the risk of death. These alterations are probably the cause of the many cases of pulmonary embolism, venous thromboembolisms, and arterial embolism reported. Hypertension and previous cardiovascular diseases are also likely involved in the severity of the observed cardiac injury. Although all these mechanisms may play a role in cardiac involvement, the severe lung infection alone could justify cardiac damage, due to the simultaneous reduced supply and increased demand of myocardial oxygen. We still know very little about this new viral disease, but as knowledge is accumulating, the medical community will pinpoint the mechanism of cardiac involvement and find the optimal strategy to prevent its severe consequences.</p>
Biochimica Clinica ; 44(4) 019-020
COVID-19 - COVID-19
 
Impatto dell’emergenza COVID-19 nei laboratori: esperienze e opinioni dei SIBioC Young Scientists
The impact of COVID-19 emergency in clinical laboratories: experiences and opinions of SIBioC Young Scientists
<p>The recent pandemic status declared worldwide for the spreading of the new coronavirus-SARS-CoV-2 has emphasized the key role of the Laboratory Medicine in the health care process. In this context, the clinical laboratories needed to rapidly reorganize the internal workflow to face the emergency and to continue ensuring rapid and accurate responses. This has been possible only thanks to the contribution of all the personal working in the laboratory, including administrative staff, nurses, technical staff, and clinical chemists. The competence and the commitment of the Young Scientists (YS), can be considered an essential contribution to the efficient and successful management of the pandemic in clinical laboratories.<br />This paper reports the experiences and the opinions of some of the members of the SIBioC YS Study Group, who have been involved in the clinical laboratory management of the COVID-19 pandemic. The paper is focused to present and discuss the use of the molecular and serological tests for the screening and diagnosis of COVID-19, the reorganization of laboratories, the development of panels of biochemical markers for organ damage and cardiovascular involvement diagnosis. Finally, issues are addressed regarding the importance of safety procedures for biohazard containment, and of future research and development perspectives, thanks to the availability of biological specimens from patients affected by COVID-19, safely and correctly stored in biobanks, together with the associated clinical data.</p>
Biochimica Clinica ; 44(4) 021-022
COVID-19 - COVID-19
 
SARS-CoV-2: nuove prospettive della diagnostica di laboratorio
SARS-CoV-2: new perspectives for the clinical laboratory diagnostics
<p>The new Coronavirus Disease 2019 (COVID-19), caused by the virus SARS-CoV-2, is characterized by a broad spectrum of clinical manifestations and different degrees of severity, ranging from asymptomatic/mild symptoms to Acute Respiratory Distress Syndrome (ARDS) and Multiple Organ Failure (MOF), potentially life-threatening. The clinical course of COVID-19 includes usually three stages. The first stage, defined as &ldquo;early infection&rdquo;, occurs at the time of virus infiltration in the lung parenchyma, via the interaction of SARS-CoV-2 with the angiotensin-converting enzyme 2 (ACE2) in ciliated bronchial epithelial cells. The second step, the &ldquo;pulmonary phase&rdquo;, is characterized by viral pneumonia with localized inflammation within the lung. The third stage, the &ldquo;hyperinflammation phase&rdquo;, is the most severe because of the development of a systemic inflammation and cytokine overproduction leading to ARDS and MOF.<br />In this complex contest, the laboratory can provide a strong support for the appropriate clinical management of COVID-19 for diagnosis, prognosis, and monitoring of the disease. Current research focuses on the potential role of immune and/or inflammatory biomarkers as useful tools in COVID-19 patients. In this narrative review, we will provide an overview about some of these biomarkers: procalcitonin, mid regional-pro adrenomedullin, presepsin, soluble fms-like tyrosine kinase 1/placental growth factor, ACE2, interleukin-6 and vitamin D.</p>
Biochimica Clinica ; 44(4) 023-024
COVID-19 - COVID-19
 
Valutazione di IgG e IgM anti-SARS-CoV-2 su Maglumi 800 (Snibe)
Evaluation of Anti-SARS-CoV-2 immunoglobulin G and M on Snibe Maglumi 800
<p>Introduction: the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a due to new beta-coronavirus causing the pandemic called Coronavirus disease 2019 (COVID-19). The evaluation of the presence of immunoglobulin G and M anti-SARS-CoV-2 (IgG and IgM) is important to understand the epidemiology of the disease and to confirm the presence of the disease when clinical signs are present, but RNA is not detected.<br />Methods: leftover serum samples from different types of patients were used: sera from biobank collected in 2018 as negative controls; patients recovering from the disease as positive controls; patients presenting at the Emergency Room with a positive rhino-pharyngeal swab; patients in Intensive Care Units. Anti-SARS-CoV-2 IgG and IgM were measured with MAGLUMI 2019-nCoV IgM/IgG Kits on Maglumi 800.<br />Results: one out of 61 expected negative resulted positive, and 2 were borderline for IgG (95% specificity, 95%CI 89.6-100), 1 positive for IgM (98.4% specificity, 95%CI 95.2-100); one out of 41 expected IgG positive resulted negative (97.6% sensitivity, 95%CI 92.8-100). All the 13 Intensive Care patients were positive for IgG, 11 for IgM. IgG were negative in 50.9% of the 55 swab positive from Emergency Room patients, while IgM were negative in 87.3%.<br />Discussion: sensitivity and specificity of the test appear good for IgG, some false positive is expected and low antibody titles in subjects with no disease story should be rechecked with an alternative method. IgM show a good specificity, but the unexpected low percentage of positivity in Emergency Room patients compared to IgG, pose some relevant doubts on the sensitivity of the test.</p>
Biochimica Clinica ; 44(4) 025-026
COVID-19 - COVID-19
 
Prevalenza di anticorpi anti-SARS-CoV-2 in una popolazione di operatori sanitari e amministrativi di un ospedale toscano
Serum prevalence of anti-SARS-CoV-2 antibody in a population of health care and administrative workers in a hospital in Tuscany (Italy).
<p>Introduction: the challenges due to COVID-19 pandemic forced scientific community to focus their efforts to improve diagnosis and management of patients. The recognized gold standard for the diagnosis is the reverse transcription polymerase chain reaction (RT-PCR) on orofaringeal and nasal swabs. Recently, the antibody detection surge to attention with the aim of estimating the epidemiological impact of the pandemic.<br />Methods: the Screen Test COVID-19 2019-nCov IgG/IgM (Screen Italia, Perugia, Italy) an immunochromatographic lateral flow test has been used to assess the immunological status of 356 asymptomatic healthcare and administrative workers of our hospital.<br />Results: only 26 (7.3%) of the screened subjects was positive for IgM and/or IgG anti SARS-CoV-2 virus although the beginning of the epidemic in Tuscany can be dated two months before. The RT-PCR performed on these samples revealed that only 5 (19%) of them were positive for viral RNA on orofaringeal swab.<br />Conclusions: antibody detection will be of great value in the near future to assess global pandemic impact on population and to drive health policy for the lock down release.</p>
Biochimica Clinica ; 44(4) 027-028
COVID-19 - COVID-19
 
The role of acute phase proteins for predicting SARS-CoV-2 positivity upon emergency department admission
<p>Background: due to the important abnormalities observed in the concentration of many inflammation/infection biomarkers in patients with coronavirus disease 2019 (COVID-19), this study was aimed to evaluate whether the assessment of C-Reactive Protein (CRP), interleukin 6 (IL-6) and procalcitonin (PCT) could help predicting SARS-CoV-2 positivity at emergency department (ED) presentation in patients with suspected infection.<br />Methods: the study population consisted of patients consecutively admitted to the ED of the University Hospital of Verona, with clinical suspicion of SARS-CoV-2 infection over a 2-week period. Blood samples as well as oropharyngeal and nasopharyngeal swabs were collected upon ED admission.<br />Results: the final study population consisted of 92 patients, 48 with negative and 44 with positive SARS-CoV-2 swabs. No significant differences were observed in concentrations of CRP, IL-6, or PCT between patients with or without acute SARS-CoV-2 infection. A significant correlation was found between CRP and IL-6 in both negative (r=0.77) and positive (r=0.74) SARS-CoV-2 cases, between CRP and PCT in SARS-CoV-2 negative (r=0.38) and positive (r=0.44) cases, and between IL-6 and PCT in SARS-CoV-2 negative (r=0.37) and positive (r=0.40) cases. The area under the curve (AUC) of none of the biomarkers could efficiently discriminate patients with negative or positive swabs (CRP: 0.52; IL-6: 0.51; PCT: 0.53).<br />Conclusions: routine measurement of CRP and IL-6, together with PCT, does not seem a useful pre-test strategy in ED patients with clinical suspicion of COVID-19.</p>
Biochimica Clinica ; 44(4) 031-032
COVID-19 - COVID-19
 
Kinetics of SARS-CoV-2 IgG response: a model from a case report
Biochimica Clinica ; 44(4) 033-034
COVID-19 - COVID-19
 
Sindrome simil-Kawasaki in una bambina positiva al SARS-CoV-2: l’approccio di laboratorio
Kawasaki–like disease in a positive SARS-CoV-2 child: a laboratory approach
<p>This case describes the clinical presentation of a Kawasaki-like syndrome, an inflammatory process that can affect all blood vessels of the body and may cause cardiac complications, such as coronary artery aneurysms. Patients are typically children, the majority of them are below 5-year-old, who initially present high fever and non-specific skin rash. The girl who came to our attention showed typical clinical symptoms and the diagnosis of Kawasaki disease was made based on the clinical evaluation, anamnesis and interpretation of laboratory results. This case came to our observation during the recent Coronavirus pandemic infection in Northeast of Italy, and can be classified as a Kawasaki-like syndrome. The laboratory data recorded at the time of diagnosis and during the follow-up are presented and discussed.</p>
Biochimica Clinica ; 44(4) 035-036
COVID-19 - COVID-19
 
Raccomandazioni ad interim di SIBioC per l’analisi sierologica dell’infezione da SARS-CoV-2
Ad interim SIBioC recommendations for serological assessment of SARS-CoV-2 infection
<p>The recent pandemic outbreak caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and associated with the pathology called COVID-19 (coronavirus disease 2019), has now become one of the most strenuous health care challenges since the emergence of the three pandemics caused by influenza viruses during the past century. Throughout the clinical decision-making of COVID-19, laboratory tests are essential for supporting the screening, diagnosis, prognostication and therapeutic monitoring of this severe infectious disease. Serological testing, that reflects the humoral immune response developing after interaction between the host and the virus (or its components), enables to garner a vast array of clinical information which can be especially used in seroprevalence or seroconversion studies. To this end, the Task Force on COVID-19 of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) has endorsed a series of technical, practical and clinical ad interim recommendations, aimed at facilitating and optimizing the introduction, clinical usage and governance of SARS-CoV-2 serological immunoassays in routine practice.</p>
Biochimica Clinica ; 45(1) 091-099
Documenti SIBioC - SIBioC Documents
 
Longitudinal monitoring of anti-SARS-CoV-2 RBD IgG antibodies after BNT162b2 vaccination in healthcare workers
Biochimica Clinica ; 17(1) 10.19186/B
Lettere all'Editore - Letters to the Editors
 
La Medicina di Laboratorio nella pandemia da SARS-CoV-2
Biochimica Clinica ; 44(2) 115
Editoriale - Editorial
 
Valutazione degli anticorpi anti SARS-COV-2 nell’ambito di un progetto di costituzione di una banca di plasma iperimmune
SARS-COV-2 antibodies in patients candidates as donors of immune plasma
<p>Background: in this study SARS-CoV-2 serology was investigated, using three different methods, in a cohort of convalescent patients from SARS-CoV-2 infection, recruited for the establishment of a hyperimmune plasma bank.<br />Methods: SARS-CoV-2 serology was investigated in 326 subjects using three commercial methods: MAGLUMI (MAG) 2019-nCoV IgM CLIA, MAGLUMI 2019-nCoV IgG CLIA and DiaSorin (SOR) LIAISON SARS-CoV-2 S1/S2 IgG. Moreover, 143 subjects were tested using a plaque reduction micro neutralization assay.<br />Results: MAG IgG test and SOR IgG test showed a good agreement (Cohen&#39;s K index = 0.65, CI 95% 0.55 &ndash; 0.78). Considering SOR IgG test versus micro neutralization test, the observed cut-off values were: 85 AU/mL for a neutralizing titer of 1/80; 108 AU/mL for 1/160 titer and 144 AU/mL for 1/320 titer. Considering MAG IgG test versus micro neutralization test, the observed cut-off values were: 4 AU/mL for a neutralizing titer of 1/80, 5 AU/mL for 1/160 titer and 7 AU/mL for 1/320 titer.<br />Conclusions: in our experience, the MAG and SOR tests showed good agreement in identifying subjects with IgG antibodies to SARS-CoV-2. Obtained results confirmed a good correlation between the antibody concentration detected by the SOR IgG and the neutralizing titer determined by the plaque reduction test.</p>
Biochimica Clinica ; 45(2) 146-152
Contributi Scientifici - Scientific Papers
 
Identificazione di positività al SARS-CoV-2 attraverso metodi di Machine Learning sui dati dell’esame emocromocitometrico: validazione esterna di modelli allo stato dell'arte
Identification of SARS-CoV-2 positivity using machine learning methods on blood count data: external validation of state-of-the-art models.
<p>Introduction: The aim of the paper is to present the results from the process of external validation of a number of machine learning (ML) models that had been previously developed to detect SARS-CoV-2 virus positivity on both symptomatic and asymptomatic patients on the basis of the complete blood count (CBC) test.<br />Methods: Briefly, models were trained using a dataset of 816 COVID-19 positive and 920 negative cases collected at the emergency departments of IRCCS Hospital San Raffaele and IRCCS Istituto Ortopedico Galeazzi. 21 parameters, including the results of the CBC analysis, age [60.9 (0.9) years], gender (57% males) and the presence of COVID-19 related symptoms were used. The validation regarded the evaluation of the error rate (through different metrics, including accuracy, sensitivity, specificity and the area under the curve (AUC)) of the models considered. This external validation was conducted on two well balanced datasets coming from two different hospitals in Northern Italy: Desio hospital and Bergamo Papa Giovanni XXIII hospital. 163 positive and 174 true negative patients from Desio, and 104 positive and 145 true negative from Bergamo were included in the validation.<br />Results: The performance of the predictive models is satisfactory as we can report an average AUC of 95% for both external datasets.<br />Conclusion: ML models have been applied to hematological parameters for a more rapid and cost-effective detection of the COVID-19 disease. We make the point that validated models may be useful in the management and early detection of potential COVID-19 patients.</p>
Biochimica Clinica ; 45(3) 281-289
Contributi Scientifici - Scientific Papers
 
Tecniche di apprendimento automatico basato sui risultati di esami di medicina di laboratorio nella diagnosi e prognosi per i pazienti COVID-19: una revisione sistematica
Machine Learning based on laboratory medicine test results in diagnosis and prognosis for COVID-19 patients: a systematic review
<p>The rapid detection of SARS-CoV-2 infections is essential for both diagnostic and prognostic reasons: however, the current gold standard for COVID-19 diagnosis, that is the rRT-PCR test, is affected by long turnaround time, potential shortage of reagents, high false-negative rates and high costs. Thus, Machine Learning (ML) based methods have recently attracted increasing interest, especially when applied to digital imaging (x-rays and CT scans).<br />In this article, we review the literature on ML-based diagnostic and prognostic methods grounding on hematochemical parameters. In doing so, we address the gap in the existing literature, which has so far neglected the application of ML to laboratory medicine. We surveyed 20 research articles, extracted from the Scopus and PubMed indexes. These studies were characterized by a large heterogeneity, in terms of considered laboratory and clinical parameters, sample size, reference population, employed ML methods and validation procedures. Most studies were found to be affected by reporting and replicability issues: among the surveyed studies, only three reported complete information regarding the analytic methods (units of measure, analyzing equipment), while nine studies reported no information at all. Furthermore, only six studies reported results on independent external validation. In light of these results, we discuss the importance of a tighter collaboration between data scientists and medicine laboratory professionals, so as to correctly characterize the relevant population, select the most appropriate statistical and analytical methods, ensure reproducibility, enable the correct interpretation of the results, and gain actual usefulness by applying ML methods in clinical practice.</p>
Biochimica Clinica ; 45(4) 348-364
Rassegne - Reviews
 
Clinical assessment of FREND COVID-19 Ag test in an unselected population referred for routine SARS-CoV-2 testing
<p>Background: this observational retrospective study was aimed at evaluating the clinical performance of the novel microfluidic fluorescence immunoassay FREND COVID-19 Ag test in a population of unselected individuals undergoing routine SARS-CoV-2 (severe acute respiratory coronavirus 2) testing.<br />Methods: the study population consisted of a series of outpatients referred to the Service of Laboratory Medicine of Pederzoli Hospital (Peschiera del Garda, Verona, Italy) between April 12 and 30, 2021, for SARS-CoV-2 testing for being either symptomatic or having had close contact with one or more COVID-19 cases. A routine nasopharyngeal sample was collected at hospital admission and analyzed with both molecular (Altona Diagnostics RealStar&reg; SARS-CoV-2 RT-PCR Kit) and antigen (FREND COVID-19 Ag) tests.<br />Results: the area under the curve (AUC) of FREND COVID-19 Ag in all nasopharyngeal samples compared to molecular testing was 0.69 (95%CI, 0.64-0.75). At the &ge;1.0 TCID50/mL manufacturer&rsquo;s cut-off, accuracy, sensitivity, specificity, negative (NPV) and positive (PPV) predictive values were 61.3%, 0.27, 1.00, 0.55 and 1.00, respectively. The AUC of FREND COVID-19 Ag in samples with cycle threshold (Ct) values of both SARS-CoV-2 S and E genes &lt;29.5 was 1.00. At &ge;1.0 TCID50/mL (median tissue culture infective dose per mL) manufacturer&rsquo;s cut-off, accuracy, sensitivity, specificity, NPV and PPV values were 99.2%, 1.00, 0.99, 1.00 and 0.95, respectively.<br />Conclusions: FREND COVID-19 Ag could not replace routine molecular testing for achieving a definitive diagnosis of SARS-CoV-2 infection, but can be used as a surrogate test for identifying patients with higher nasopharyngeal viral load and thus greater infectious potential.</p>
Biochimica Clinica ; 45(4) 395-399
Contributi Scientifici - Scientific Papers
 
Proteinuria nel COVID-19: l’importanza di un esame consolidato in una patologia complessa
Biochimica Clinica ; 45(3) s097-s099
Lettere all'editore - Letters to the editor