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1.
Biochimica Clinica ; 44(SUPPL 2):S14, 2020.
Article | WHO COVID | ID: covidwho-984806

ABSTRACT

Introduction: D-Dimer assessment represents a cornerstone in the diagnostic approach of several thrombotic disorders Recent literature has highlighted the role of D-Dimer also in the diagnostic pathway of COVID-19 and the importance of a harmonized reporting [D-dimer unit (DDU) or fibrinogen equivalent unit (FEU);unit of measure;cut-off] in order to guarantee the correct interpretation of the results1 Purpose and Methods: Evaluation of D-Dimer data from 100 EQA participants and the inter-laboratory variability (CV%) of the last 7 years for the most used analytical systems: HemosIL HS, IL-HS (n=37}4), HemosIL HS-500, IL-HS500 (n=8}1), Sclavo Auto, SCLA (n=12}5), Siemens Innovance, INN (n=14}3), bioMerieux VIDAS, VID (n=10}3), Stago STA Liatest, STA (n=10}3) Results: Concerning the results expression in DDU or FEU, there is a prevalence of FEU (55 1%) over DDU (44 9%), value confirmed in the last 7 years (average FEU = 55 6%), differently from data obtained in the survey conducted in 2014 at national level2 The units used are: Ng/mL (67 7%), μg/L (29 0%) and mg/L (3 2%) for D-Dimer DDU;ng/mL (57 9%), μg/mL (21 1%), μg/L (15 8%) and mg/L (5 3%) for D-Dimer FEU Inter-laboratory variability (mean CV%}SD) calculated on a total of 68 control samples (range, μg/L):-D-Dimer, DDU = SCLA: 8 8}3 3 (82-170);5 4}2 7% (402-1482);IL-HS: 12 8}6 1 (122-166);6 4}2 7% (480-1705) -D-Dimer, FEU = IL-HS: 13 9}2 0 (192-340);5 2}2 3 (1016-3158);IL-HS500: 5 1}2 6 (1430-3442);INN: 11 3}5 6 (191-330);6 3}2 3% (1439-4521);VID: 6 9}3 5 (158-378);5 4}2 3 (673-2018);STA: 7 1}6 6% (220-385);5 1}2 0% (860-2600) Discussion: This study demonstrates that the reporting of D-Dimer results does not comply with the 2014 SIBioC consensus document which recommended the use of μg/L FEU3, and highlights 8 different types of information The CV% is lower for all diagnostic systems at pathological levels than the ones at concentrations near to the cut-off Conclusion: Data reported in this study call for the harmonization of D-Dimer reporting in order to guarantee the correct interpretation of information, both of COVID-19 and all diseases already

2.
Biochimica Clinica ; 44(SUPPL 2):S12-S13, 2020.
Article | WHO COVID | ID: covidwho-984715

ABSTRACT

Clinical laboratories are at a cross-roads The focus on automation, distorted economics which subordinated medical objectives to economic ones turning the laboratory into a mega-factory, has resulted in the devaluation of laboratory medicine which is considered a support service rather than a true clinical department However, in addition to a series of papers and visionary opinions, the SARS-CoV-2 pandemia has highlighted the central role of clinical laboratories as a vital part of the continuum of patient care and disease prevention In fact, in the case of COVID-19, as in many other diseases and medical conditions, the diagnosis is performed by a laboratory test (rRT-PCR), many biomarkers and "conventional" laboratory tests play a relevant role in disease monitoring and prognostication, and serological assays are used for epidemiological surveillance Clinicians, patients, citizens and politicians have finally realized the importance of laboratory medicine and the need for implementing a more value-based patient centric model for delivering laboratory services, Moving from the traditional to a value-based model of organizing medical laboratory practices requires a) a patient centric view;b) integration with other clinical services e g imaging);c) optimized test request and utilization;d) focus on all phases of testing cycle, not only on the intra-analytical;e) aggregation of "big data";f) use of artificial intelligence to improve the value of laboratory information;and g) the promotion of precision and personalized medicine To improve outcomes for populations and individual patients requires laboratory professionals to increase their scope of practices influence outside the traditional laboratory model to diagnostic management throughout clinical care pathways, interdisciplinary collaborations to break down traditional practice silos, and outcomes research Diagnostic stewardship, teleconsultations, integration in diagnostic management teams, efforts in improving patient safety using appropriate quality indicators are valuable tools in order to create value and improve the visibility of laboratory professionals

3.
Biochimica Clinica ; 44(SUPPL 2):S11-S12, 2020.
Article | WHO COVID | ID: covidwho-984714

ABSTRACT

The natural history of serological assays for SARS-CoV2 antibodies is comparable to that of other biomarkers: After an initial and excessive emphasis on the diagnostic role of serological assays, a series of papers raised serious concerns on their clinical usefulness, finally leading to a more rational and evidence-based identification of the main areas of clinical use, linked to a better methodological validation The multifaced rationale for serological testing in COVID-19 management should be summarized as follows: A) to improve knowledge on immunoresponse to SARS-CoV-2;b) to define and monitor the extent of virus spread;c) to screen particular populations and sub-populations at higher risk (e g healthcare workers) and define disease prevalence;d) to characterize efficacy of containment measures at local and global level;e) to screen convalescent sera for both therapeutic and prophylactic use;f) to combine the results of molecular tests (rRT-PCR) for a more accurate diagnosis (in "difficult patients") ;g) to allow the diagnosis for later stages of infection (when the virus has been eliminated);and finally h) to identify individuals who have been infected but suffered only minor suymptoms (or asymptomatics) and did not seek medical attention From a methodological view point, the main issues are represented by the type of test (laboratory-based, pointof-care and/or neutralizing activity);the target (spike protein and/or S1/S2 subunits, nucleocapside, receptor binding protein, native antigen etc), and the immunoglobulin class or classes (IgA, IgG, IgM) recognized by the assay Testing strategies aim to maximize specificity and thus positive predictive value (PPV), particularly as the overall prevalence is likely low;they should be summarized as: 1) Choosing a test with a very high specificity (95% or greater);2) Focus testing with a high pre-test probability (e g history of COVID-19 illness) and 3) Employ an orthogonal testing algorithm (positive persons tested with a second test) The standardization/harmonization initiatives to improve the clinical comparability of results obtained by different assays are currently based on the optimization of the diagnostic thresholds (cut-offs), and the definition of the predictive positive and negative values (PPV/NPV) in relation to a different disease prevalence In fact, epidemiological surveys have highlighted significant variations in seroprevalence ranging from 2-3% to 40-50% in different regional or national areas The knowledge of antibody kinetics represents an essential issue to define the right timing for identifying the immune response and to better understand the duration of protection This, in turn, plays a relevant role in evaluating the answer to therapies and vaccines, even if current research on the immunoresponse due to B and T lymphocytes may provide useful information for better understanding the host response to the "misterious" SARS-CoV-2 virus

4.
Biochimica Clinica ; 44(SUPPL 2):S67, 2020.
Article | WHO COVID | ID: covidwho-983996

ABSTRACT

Introduction Saliva has been proposed as a valid alternative to naso-pharyngeal swabs for detecting viral SARS-CoV-2 RNA sequences In addition salivary glands have been described as a potential SARSCoV-2 virus reservoir, thus supporting the search for antibodies in saliva Furthermore, the non-invasive nature of saliva collection is conducive to self-collection, patients' compliance for repeated testing, and reduction of risk to operators, thus making saliva an eligible matrix in the SARS-CoV-2 diagnostic process Aim The aim of this study was to verify whether standardized and safe saliva collection is suitable for SARS-CoV-2 molecular detection and IgA class antibody measurement Methods A total of 49 COVID-19 patients hospitalized at the University-Hospital of Padova (Italy) and 326 subjects who underwent screening underwent naso-pharyngeal (NP) swab and saliva collection using Salivette® Repeat blood collections were performed to evaluate hematological and coagulation parameters, biochemical markers of inflammation, and renal, liver, heart and pancreatic involvement in hospitalized patients In all patients and subjects, saliva SARS-CoV-2 (gene E) rRT-PCR was undertaken in parallel with NP swabs Salivary IgA and serum IgA, IgG, IgM were measured on samples from hospitalized patients Results NP swabs were SARSCoV-2 positive in 9/49 patients The comparison with saliva testing was possible for 43/49 patients, 7 of whom shared positivity, and 35 negativity while in one, the saliva result, not NP-swab, was positive Positive molecular testing results were significantly associated with disease duration (p=0 0049) All the 326 screened subjects were SARS-CoV-2 negative on both NP and saliva swabs Among the 27 saliva samples tested for IgA, 18 were IgA positive Salivary IgA positivity was significantly associated with pneumonia (p=0 002) and CRP values (p=0 0183), not with other clinical and molecular data, or with immunoglubulins in serum Conclusions The results reported in the present study demonstrate that a standardized and safe saliva collection method can be adopted to detect SARS-CoV-2 infection in alternative to NP-swabs Preliminary data on salivary IgA also support the use of saliva in local adaptive immunity patient monitoring

5.
J Clin Microbiol ; 2020.
Article | WHO COVID | ID: covidwho-939843

ABSTRACT

This study assessed the diagnostic performance of the new COVID-19 SEROSpeed IgM/IgG Rapid Test (BioSpeedia, spin-off of the Pasteur Institute of Paris) for the detection of antibodies against SARS-CoV-2 in comparison to other commercial antibody assays through a large cross-European study The clinical specificity was assessed on 215 pre-pandemic sera (including some from patients with viral infections or autoimmune disorders) The clinical sensitivity was evaluated on 710 sera from 564 patients whose SARS-CoV-2 infection was confirmed by qRT-PCR and whose antibody response was compared to that measured by five other commercial tests The kinetics of the antibody response were also analyzed in seven symptomatic patients The specificity of the test (BioS) on pre-pandemic specimens was 98 1% (95% CI: 96 2-99 4) When tested on the 710 pandemic specimens, BioS showed an overall clinical sensitivity of 86 0% (95% CI: 0 83-0 89), with good concordance with the Euroimmun assay (overall concordance of 0 91;Cohen's kappa coefficient of 0 62) Due in part to simultaneous detection of IgM and IgG for both S1 and N proteins, BioS exhibited the highest positive percent agreement ≥11 days post symptom onset (PSO) In conclusion, the BioS IgM/IgG rapid test was highly specific and demonstrated higher positive percent agreement compared to all the ELISA/CLIA commercial tests considered in this study Moreover, by detecting the presence of antibodies prior to 11 days PSO in 78 2% of the patients, the BioS test increased the efficiency of the diagnosis of SARS-CoV-2 infection in the early stages of the disease

6.
Clinical Chemistry and Laboratory Medicine ; 58(7):1081-1088, 2020.
Article | WHO COVID | ID: covidwho-937249

ABSTRACT

Background: Coronavirus disease 2019, abbreviated to COVID-19, represents an emerging health threat worldwide as, after initial reports in China, it has continued to spread rapidly The clinical spectrum of the disease varies from mild to severe acute respiratory distress syndrome (ARDS) Moreover, many patients can be asymptomatic, thus increasing the uncertainty of the diagnostic work-up Laboratory tests play a pivotal role in the diagnosis and management of COVID-19, the current gold standard being real-time reverse transcription polymerase chain reaction (rRT-PCR) on respiratory tract specimens However, the diagnostic accuracy of rRT-PCR depends on many pre-analytical and analytical variables The measurement of specific COVID-19 antibodies (both IgG and IgM) should serve as an additional, non-invasive tool for disease detection and management

7.
ERJ Open Research ; 6(4):1-9, 2020.
Article | WHO COVID | ID: covidwho-917913

ABSTRACT

Objectives: The aim of this study was to validate a composed coronavirus disease 2019 (COVID-19) chest radiography score (CARE) based on the extension of ground-glass opacity (GG) and consolidations (Co), separately assessed, and to investigate its prognostic performance Methods: COVID-19-positive patients referring to our tertiary centre during the first month of the outbreak in our area and with a known outcome were retrospectively evaluated Each lung was subdivided into three areas and a three-grade score assessing the extension of GG and Co was used The CARE was derived from the sum of the subscores A mixed-model ANOVA with post hoc Bonferroni correction was used to evaluate whether differences related to the referring unit (emergency room, COVID-19 wards and intensive care unit (ICU)) occurred Logistic regression analyses were used to investigate the impact of CARE, patients’ age and sex on the outcome To evaluate the prognostic performance of CARE, receiver operating characteristic curves were computed for the entire stay and at admission only Results: A total of 1203 chest radiographs of 175 patients (120 males;mean age 67 81±15 5 years old) were examined On average, each patient underwent 6 8±10 3 radiographs Patients in ICU as well as deceased patients showed higher CARE scores (p<0 05, each) Age, Co and CARE significantly influenced the outcome (p<0 05 each) The CARE demonstrated good accuracy (area under the curve (AUC)=0 736) using longitudinal data as well as at admission only (AUC=0 740) A CARE score of 17 5 during hospitalisation showed 75% sensitivity and 69 9% specificity Conclusions: The CARE was demonstrated to be a reliable tool to assess the severity of pulmonary involvement at chest radiography with a good prognostic performance

8.
EBioMedicine ; 61:103087, 2020.
Article | WHO COVID | ID: covidwho-912157
9.
Clin Chem Lab Med ; 2020.
Article | WHO COVID | ID: covidwho-792091
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