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Article ; Online: Implementation of the new EUR IVD regulation and relation with ISO15189 accreditation: Guidance is urgently required for haemostasis testing.

Testa, Sophie / Meijer, Piet / Lasne, Dominique / Mullier, François

International journal of laboratory hematology

2022 Volume 44 Suppl 1, Page(s) 71–78

Abstract: On May 26th 2017 the European Parliament and the Council of The European Union adopted the new regulation on in vitro diagnostic medical devices (IVDR)-Regulation EU 2017/746-planned to be applied from May 26th 2022 in substitution to the previous IVD ... ...

Abstract	On May 26th 2017 the European Parliament and the Council of The European Union adopted the new regulation on in vitro diagnostic medical devices (IVDR)-Regulation EU 2017/746-planned to be applied from May 26th 2022 in substitution to the previous IVD directives (IVDD 98/79 EC). After several health and legal causes due to medical device malfunctions, the European Union (EU) extensively reviewed the previous regulatory, which had remained unchanged since 1998. Aim of the work is to analyse the effects of the new IVDR on the field of haemostasis and thrombosis testing with particular attention to specific clinical conditions. Clinical laboratories will mainly deal with three different situations: (1) Diagnostic test performed with IVDR products used according with clinical indication certified by manufacturers. (2) Diagnostic test performed with certified IVDR products without clinical validation. (3) Diagnostic test performed with reagents classified as Research Use Only (RUO). At present, only few clinical laboratories through different European countries have been prepared to the new IVDR, while many laboratories are not yet aware about crucial aspects of the new process that deeply involves laboratory medicine. In conclusion, each laboratory should be aware of the IVDR certification of the reagents/instruments used in its laboratory. There are several urgent needs regarding IVDR certification: studies about the clinical performance of haemostasis tests, guidelines for LDTs (definition and documentation), internal and external quality controls for the tests recommended/suggested in the guidance/guidelines and finally implementation and/or update of clinical and laboratory guidelines.
MeSH term(s)	Accreditation ; European Union ; Hemostasis ; Humans ; Laboratories ; Reagent Kits, Diagnostic
Chemical Substances	Reagent Kits, Diagnostic
Language	English
Publishing date	2022-09-08
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2268590-X
ISSN	1751-553X ; 1751-5521 ; 0141-9854
ISSN (online)	1751-553X
ISSN	1751-5521 ; 0141-9854
DOI	10.1111/ijlh.13936
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Zs.A 1499: Show issues

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Article ; Online: Machine learning approach for prediction of outcomes in anticoagulated patients with atrial fibrillation.

Bernardini, Andrea / Bindini, Luca / Antonucci, Emilia / Berteotti, Martina / Giusti, Betti / Testa, Sophie / Palareti, Gualtiero / Poli, Daniela / Frasconi, Paolo / Marcucci, Rossella

International journal of cardiology

2024 , Page(s) 132088

Abstract: Background: The accuracy of available prediction tools for clinical outcomes in patients with atrial fibrillation (AF) remains modest. Machine Learning (ML) has been used to predict outcomes in the AF population, but not in a population entirely on ... ...

Abstract	Background: The accuracy of available prediction tools for clinical outcomes in patients with atrial fibrillation (AF) remains modest. Machine Learning (ML) has been used to predict outcomes in the AF population, but not in a population entirely on anticoagulant therapy. Methods and aims: Different supervised ML models were applied to predict all-cause death, cardiovascular (CV) death, major bleeding and stroke in anticoagulated patients with AF, processing data from the multicenter START-2 Register. Results: 11078 AF patients (male n = 6029, 54.3%) were enrolled with a median follow-up period of 1.5 years [IQR 1.0-2.6]. Patients on Vitamin K Antagonists (VKA) were 5135 (46.4%) and 5943 (53.6%) were on Direct Oral Anticoagulants (DOAC). Using Multi-Gate Mixture of Experts, a cross-validated AUC of 0.779 ± 0.016 and 0.745 ± 0.022 were obtained, respectively, for the prediction of all-cause death and CV-death in the overall population. The best ML model outperformed CHA Conclusions: In AF patients, ML models showed good discriminative ability to predict all-cause death, regardless of the type of anticoagulation strategy, and major bleeding on DOAC therapy, outperforming CHA
Language	English
Publishing date	2024-04-22
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	779519-1
ISSN	1874-1754 ; 0167-5273
ISSN (online)	1874-1754
ISSN	0167-5273
DOI	10.1016/j.ijcard.2024.132088
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Zs.A 1673: Show issues

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Article ; Online: COVID-19. Comparison of D-dimer levels measured with 3 commercial platforms.

Scalambrino, Erica / Clerici, Marigrazia / Scardo, Sara / Capecchi, Marco / Della Noce, Claudia / Testa, Sophie / Peyvandi, Flora / Tripodi, Armando

Research and practice in thrombosis and haemostasis

2023 Volume 7, Issue 8, Page(s) 102247

Language	English
Publishing date	2023-11-02
Publishing country	United States
Document type	Journal Article
ISSN	2475-0379
ISSN (online)	2475-0379
DOI	10.1016/j.rpth.2023.102247
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Article ; Online: The role of anticoagulation clinics needs to be reassessed to include follow up of patients on direct oral anticoagulants.

Tripodi, Armando / Chantarangkul, Veena / Poli, Daniela / Testa, Sophie / Bucciarelli, Paolo / Peyvandi, Flora

Thrombosis research

2023 Volume 225, Page(s) 11–15

Abstract: A survey was carried out to assess the state of organization of care (including clinical and laboratory) delivered to patients on vitamin K antagonists (VKA) or direct oral anticoagulants (DOAC) followed by clinics affiliated with the Italian Federation ... ...

Abstract	A survey was carried out to assess the state of organization of care (including clinical and laboratory) delivered to patients on vitamin K antagonists (VKA) or direct oral anticoagulants (DOAC) followed by clinics affiliated with the Italian Federation of Thrombosis Centers (FCSA), traditionally engaged to assist anticoagulated outpatients within the country. Participants were asked to answer questions concerning (i) proportion of patients on VKA-vs-DOAC and (ii) whether dedicated testing for DOAC is available. The proportion of patients on VKA-vs-DOAC was 60 % vs 40 %. This proportion is in sharp contrast with the real-life distribution where DOAC outweigh VKA prescriptions. Furthermore, the proportion of anticoagulation clinics that provide DOAC testing (even in special situations) is relatively small (i.e., 31 % of the respondents). Furthermore, 25 % of those that declared to follow DOAC patients do not provide any testing at all. The answers to the above questions cause concerns as (i) most patients on DOAC within the country are probably on self-management, or they are managed by general practitioners or specialists outside thrombosis centers. (ii) Most patients on DOAC have no access to testing even in special situations where it would be needed. We feel that there is a (false) perception that the care needed for DOAC treatment can be much less than that required for VKA, as DOAC require prescription and not regular follow-up. A call for action should be urgently made to reassess the role of anticoagulation clinics, which should pay the same attention to patients on DOAC as those on VKA.
MeSH term(s)	Humans ; Follow-Up Studies ; Anticoagulants/adverse effects ; Outpatients ; Fibrinolytic Agents/therapeutic use ; Administration, Oral ; Vitamin K
Chemical Substances	Anticoagulants ; Fibrinolytic Agents ; Vitamin K (12001-79-5)
Language	English
Publishing date	2023-02-02
Publishing country	United States
Document type	Journal Article
ZDB-ID	121852-9
ISSN	1879-2472 ; 0049-3848
ISSN (online)	1879-2472
ISSN	0049-3848
DOI	10.1016/j.thromres.2023.01.030
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Zs.A 863: Show issues

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Article ; Online: COVID-19 pandemic affects the ability of negative D-dimer to identify venous thromboembolism patients at low risk of recurrence: insights from the Apidulcis study.

Palareti, Gualtiero / Legnani, Cristina / Poli, Daniela / Ageno, Walter / Pengo, Vittorio / Testa, Sophie / Tosetto, Alberto / Prandoni, Paolo

Haematologica

2023 Volume 108, Issue 3, Page(s) 923–925

MeSH term(s)	Humans ; Venous Thromboembolism/diagnosis ; Venous Thromboembolism/epidemiology ; COVID-19 ; Pandemics ; Fibrin Fibrinogen Degradation Products ; Anticoagulants ; Risk Factors ; Recurrence
Chemical Substances	fibrin fragment D ; Fibrin Fibrinogen Degradation Products ; Anticoagulants
Language	English
Publishing date	2023-03-01
Publishing country	Italy
Document type	Letter
ZDB-ID	2333-4
ISSN	1592-8721 ; 0017-6567 ; 0390-6078
ISSN (online)	1592-8721
ISSN	0017-6567 ; 0390-6078
DOI	10.3324/haematol.2022.282130
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Article: Persistence Pays Off: Live Birth after Uterus Transplant, Overcoming Recurrent Pregnancy Loss with Cerclage Placement.

Johannesson, Liza / Anderson, Sophie / Putman, J Michael / Gunby, Robert T / Zhang, Lilly / Testa, Giuliano / Gregg, Anthony R

Journal of clinical medicine

2023 Volume 12, Issue 20

Abstract: Recipients of uterus transplantation have unique factors that may increase their risk of cervical insufficiency. This report describes a uterus transplant recipient with cervical insufficiency resulting in two second-trimester miscarriages. After ... ...

Abstract	Recipients of uterus transplantation have unique factors that may increase their risk of cervical insufficiency. This report describes a uterus transplant recipient with cervical insufficiency resulting in two second-trimester miscarriages. After McDonald cerclages (one that failed), she underwent an interval transabdominal cerclage and delivered a healthy term child in her third pregnancy. The longitudinal information of this case provides observations from which we can propose testable hypotheses that address venous outflow and inflammation. This case also suggests that there could be a role for prophylactic cerclage placement at the time of transplantation.
Language	English
Publishing date	2023-10-11
Publishing country	Switzerland
Document type	Case Reports
ZDB-ID	2662592-1
ISSN	2077-0383
ISSN	2077-0383
DOI	10.3390/jcm12206463
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Article ; Online: Practical Suggestions for an Optimal Management of Vitamin K Antagonists: Italian Federation of Centers for the Diagnosis of Thrombotic Disorders and the Surveillance of the Antithrombotic Therapies (FCSA) Position Paper.

Galliazzo, Silvia / Bucciarelli, Paolo / Barcellona, Doris / Ciampa, Antonio / Grandone, Elvira / Malcangi, Giuseppe / Rescigno, Giuseppe / Squizzato, Alessandro / Toschi, Vincenzo / Testa, Sophie / Poli, Daniela

Thrombosis and haemostasis

2024

Abstract: In the era of direct oral anticoagulants, vitamin K antagonists retain a clinically relevant role in thrombotic disorders. In Italy, approximately 20% of the patients on anticoagulant therapies receives a VKA, in most cases warfarin. The optimal ... ...

Abstract	In the era of direct oral anticoagulants, vitamin K antagonists retain a clinically relevant role in thrombotic disorders. In Italy, approximately 20% of the patients on anticoagulant therapies receives a VKA, in most cases warfarin. The optimal management of this drug is challenging and cannot disregard its intricate and unpredictable pharmacokinetic properties and patient's thrombotic and bleeding risk. Several clinical issues encountered during warfarin treatment are still unanswered and are tentatively addressed by physicians. In this regard, the Italian Federation of Centers for the diagnosis of thrombotic disorders and the Surveillance of the Antithrombotic therapies (FCSA) provides some experience-based good clinical practice's suggestions on the following topics: (1) how to start the anticoagulant treatment with warfarin and warfarin induction regimen; (2) how to manage a subtherapeutic INR value; (3) how to manage a supratherapeutic INR value in asymptomatic patients; and (4) how to manage the association of warfarin with interfering drugs.
Language	English
Publishing date	2024-04-16
Publishing country	Germany
Document type	Journal Article
ZDB-ID	518294-3
ISSN	2567-689X ; 0340-6245
ISSN (online)	2567-689X
ISSN	0340-6245
DOI	10.1055/s-0044-1782688
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Uh III Zs.192: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
Zs.MO 433: Show issues

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Article ; Online: Apixaban-induced fatal liver injury with a cholestatic pattern: A case report and brief review of the Literature.

Pasin, Federico / Esteban, Maria Del Pilar / Testa, Sophie

European journal of internal medicine

2019 Volume 70, Page(s) e17–e18

MeSH term(s)	Aged, 80 and over ; Atrial Fibrillation/drug therapy ; Chemical and Drug Induced Liver Injury/etiology ; Cholestasis ; Factor Xa Inhibitors/adverse effects ; Fatal Outcome ; Female ; Humans ; Pyrazoles/adverse effects ; Pyridones/adverse effects
Chemical Substances	Factor Xa Inhibitors ; Pyrazoles ; Pyridones ; apixaban (3Z9Y7UWC1J)
Language	English
Publishing date	2019-11-02
Publishing country	Netherlands
Document type	Case Reports ; Journal Article ; Review
ZDB-ID	1038679-8
ISSN	1879-0828 ; 0953-6205
ISSN (online)	1879-0828
ISSN	0953-6205
DOI	10.1016/j.ejim.2019.10.003
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Zs.A 2608: Show issues

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Article ; Online: The risk of hospitalisation from RSV is not increased by co-infection in children under 24-months-of-age.

Ferrari, Alessandra Chiara Francesca / Giani, Elisa / Scaramuzza, Andrea Enzo / Cutuli, Vera / Giambarda, Martina / Rota, Francesca / Verderio, Cecilia / Cimardi, Leonardo / Fumagalli, Gloria / Soliani, Martina / Drera, Bruno Angelo / Testa, Sophie / Cavalli, Claudio

European journal of pediatrics

2024 Volume 183, Issue 4, Page(s) 1943–1945

Abstract: The recent pandemic prompted renewed interest in paediatric respiratory infections, including whether co-infections - particularly with RSV - have an adverse prognostic impact. We evaluated the charts of all children presenting with respiratory symptoms ... ...

Abstract	The recent pandemic prompted renewed interest in paediatric respiratory infections, including whether co-infections - particularly with RSV - have an adverse prognostic impact. We evaluated the charts of all children presenting with respiratory symptoms to our unit between October 2022 and April 2023, each of whom was subjected to a multiplex PCR assay to detect eight viral targets and one bacterial target and examine the relationships between mono- and co-infections and hospitalization outcomes. We observed that younger age and RSV infection were both associated with the need for hospitalisation and the duration of hospitalisation after adjusting for confounders. Co-infection was, however, not associated with these outcomes. Conclusion: This real-world data add to a growing consensus that RSV increases the risk of hospitalisation, while other co-infections, except for co-infection with SARS-CoV-2, do not. Given the timeframe over which our study was conducted, only a few children had SARS-CoV-2 co-infection, so we could not confirm any significant effect from this interaction. What is Known: • RSV increases the risk of hospitalisation and the need tor ventilatory support, especially in very young children. What is New: • Younger age and RSV infection were both associated with the need for hospitalisation and the duration of hospitalisation after adjusting for confounders. • Co-infection was, however, not associated with these outcomes.
MeSH term(s)	Humans ; Child ; Infant ; Child, Preschool ; Respiratory Syncytial Virus Infections/complications ; Respiratory Syncytial Virus Infections/diagnosis ; Respiratory Syncytial Virus Infections/epidemiology ; Coinfection/epidemiology ; Risk Factors ; Hospitalization ; Respiratory Tract Infections/epidemiology ; Respiratory Tract Infections/complications
Language	English
Publishing date	2024-01-20
Publishing country	Germany
Document type	Journal Article
ZDB-ID	194196-3
ISSN	1432-1076 ; 0340-6199 ; 0943-9676
ISSN (online)	1432-1076
ISSN	0340-6199 ; 0943-9676
DOI	10.1007/s00431-024-05440-7
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Um IV Zs.75: Show issues

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Article ; Online: SARS-CoV-2 and gastrointestinal tract: The dark side of the pandemic.

Grassia, Roberto / Testa, Sophie / Pan, Angelo / Conti, Clara Benedetta

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver

2020 Volume 52, Issue 7, Page(s) 700–701

MeSH term(s)	Betacoronavirus ; COVID-19 ; Coronavirus Infections ; Gastrointestinal Tract ; Humans ; Pandemics ; Pneumonia, Viral ; Severe acute respiratory syndrome-related coronavirus ; SARS-CoV-2
Keywords	covid19
Language	English
Publishing date	2020-04-29
Publishing country	Netherlands
Document type	Letter ; Comment
ZDB-ID	1459373-7
ISSN	1878-3562 ; 1125-8055
ISSN (online)	1878-3562
ISSN	1125-8055
DOI	10.1016/j.dld.2020.04.028
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